Archive for March, 2015

(ISR) Gynecologic Cancers Successfully Treated Using IsoRay’s Cesium-131

Peer Reviewed Paper Now Supports the Use of Cesium-131 for Primary as Well as Recurrent Gynecologic Cancers

RICHLAND, WA–(Mar 24, 2015) – IsoRay Inc. (NYSE MKT: ISR) (www.isoray.com), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced it will host a dinner presentation on March 28 by Dr. Jonathan Feddock describing the use, procedure and outstanding results in treating gynecologic cancers utilizing Cesium-131. IsoRay will have booth #516 at the 2015 Annual Meeting of the Society of Gynecologic Oncology (SGO). The annual meeting will take place March 28-31, 2015 at the Chicago Hilton in Chicago, Illinois.

According to IsoRay CEO Dwight Babcock, “With the recently published and peer-reviewed results for gynecologic cancer, we are seeing a growing level of interest by gynecologic oncologists due to the significant results being achieved using Cesium-131. Cesium-131’s reported success in treating primary as well as recurrent gynecologic cancers that have not responded to other treatments continues to get the attention of physicians who need new treatment options.”

IsoRay is very pleased to have Dr. Feddock, an industry leader who practices at University of Kentucky HealthCare, discuss the success, methods and new approaches being implemented in brachytherapy.

Mr. Babcock added, “The medical community is continually being shown the unique ability of IsoRay’ s Cesium-131 (Cs-131) seeds, seed sutured, seeded mesh and GliaSite® system for the treatment of a wide array of cancers throughout the body. Medical thought leaders recognize the need for a new powerful weapon in the battle against cancer and we believe Cesium-131 is that solution. Our products offer an important advance over previous brain, head and neck, lung, prostate, abdominal wall and gynecological cancer treatments. We are extremely excited that published studies, posters and abstracts continue to be released showing positive results realized in treating metastasized brain cancers, gynecological cancers, lung cancer and prostate cancer using Cs-131 or GliaSite®.”

IsoRay’s Cesium-131 sutured seeds, stranded mesh and the GliaSite® radiation therapy system each give physicians the ability to directly place a specified dosage of radiation in areas where cancer is most likely to remain after tumor removal. The ability to precisely place a specified dose of radiation means there is less likelihood for damage to occur to healthy tissue as well as critical structures compared to other alternative treatments. IsoRay’s cancer fighting products reduce the ability of the tumor to recur, which means important benefits for patients in longevity as well as quality of life.

IsoRay is the exclusive manufacturer of Cesium-131. Cesium-131 is the first new isotope to be available in seed form for brachytherapy in approximately 20 years. Cesium-131 allows for the precise treatment of many different cancers because of its unrivaled blend of high energy and its 9.7 day half-life (its unequaled speed in giving off therapeutic radiation).

In addition to its CMS codes, Cesium-131 is FDA-cleared and holds a CE mark for international sales in seed form for the treatment of brain cancer, prostate cancer, lung cancer, ocular melanoma cancer, colorectal cancer, gynecologic cancer, head and neck cancer and other cancers throughout the body. The treatment can be deployed using several delivery methods including single seed applicators, implantable strands and seed sutured mesh, and several new implantable devices. IsoRay also distributes the GliaSite® radiation therapy system, used to treat brain cancers.

About IsoRay
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of GliaSite® and Cesium-131 by visiting www.isoray.com. Join us on Facebook/Isoray. Follow us on Twitter @Isoray.

Safe Harbor Statement
Statements in this news release about IsoRay’s future expectations, including: the advantages of our products and their delivery systems, future demand for IsoRay’s existing and planned products, whether IsoRay will be able to continue to expand its base beyond prostate cancer, whether the use of our products will increase or continue, whether additional studies will be published or presented with favorable outcomes from treatment with our products, whether we will continue to receive support from industry leaders, whether awareness of our products in the medical community will continue or increase, whether future studies of treatment of various cancers using our products will have favorable results, whether awareness and adoption of our products by gynecologic oncologists will continue or grow, and all other statements in this release, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of IsoRay’s products, changing levels of demand for IsoRay’s current and proposed future products, IsoRay’s ability to reduce or maintain expenses while increasing sales, patient results achieved using our products in both the short and long term, success of future research and development activities, patient results achieved when Cesium-131 is used for the treatment of cancers and malignant diseases beyond prostate cancer, IsoRay’s ability to successfully manufacture, market and sell its products, IsoRay’s ability to manufacture its products in sufficient quantities to meet demand within required delivery time periods while meeting its quality control standards, the success of our sales and marketing efforts, IsoRay’s ability to enforce its intellectual property rights, changes in reimbursement rates, changes in laws and regulations applicable to our products, whether additional studies and protocols are released and support the conclusions of past studies and protocols, whether ongoing patient results with our products are favorable and in line with the conclusions of clinical studies and initial patient results, whether we, our distributors and our customers will successfully obtain and maintain all required regulatory approvals and licenses to market, sell and use our products in their various forms, continued compliance with ISO standards as audited by BSI, and other risks detailed from time to time in IsoRay’s reports filed with the SEC.

Contact:
IsoRay Medical
(509) 375-1202
Info@Isoray.com

Or

Worldwide Financial
Info@wwfinancial.com
(954) 360-9998

Tuesday, March 24th, 2015 Uncategorized Comments Off on (ISR) Gynecologic Cancers Successfully Treated Using IsoRay’s Cesium-131

(MARK) roomlia® Partners With SiteMinder to Seamlessly Expand Hotel Inventory Reach

LAS VEGAS, March 24, 2015  — roomlia®, a mobile booking app that offers two-way connections for instant hotel bookings up to seven days in advance, has announced a partnership with SiteMinder, the hotel industry’s leading provider of online distribution and direct booking technology. The mobile travel agent is the latest 2-way addition to SiteMinder’s distribution platform.

David Chestler, SiteMinder’s EVP of Global Enterprise Sales & Business Development believes that the technology is necessary in today’s mobile market. “The connection with roomlia® is exceptionally exciting for our hotel clients in the US, as they have the ability to easily reach travelers booking via mobile devices. With mobile set to account for a fifth of all online travel bookings in 20151, it’s critical hoteliers not only reach their guests on the go, but that they provide a user-friendly booking experience.”

The partnership at the outset will offer hotels based in the United States with a two-way connection via SiteMinder to roomlia® by providing inventory and rates on the OTA.  roomlia® plans to set their footprint in all major United States markets. As they continue to expand to these new markets, increasingly more hotels will benefit from this connection and leverage the growth of the mobile booking space.

“As a leader in online distribution and direct booking technology, SiteMinder is an ideal partner to expand our reach and enable hotels to easily and cost effectively connect to roomlia®,” said Michael Reichartz, Co-Founder at roomlia®. “With the addition of SiteMinder’s technology we will continue to expand our markets and grow our partnerships with hotels throughout the US.”

About roomlia®

roomlia® is the next generation hotel booking app designed for savvy, contemporary travelers founded in 2014 by Michael Reichartz and Jim Ferguson, formerly of Expedia (EXPE). Both Reichartz and Ferguson drove the growth of Expedia’s merchant hotel business from the beginning stages to the multi-billion dollar business it remains today. They also co-developed the Market Management concept, which has been globally adopted by all Online Travel Agencies (OTA’s). roomlia® was founded in order to be both user friendly as well as beneficial and convenient to its hotel affiliates. roomlia® is the first app of its kind to launch with connectivity, ensuring a seamless experience for both travelers and hospitality partners. roomlia® is currently available in leading U.S. destinations including New York, Los Angeles, Las Vegas, Miami and Orlando, with new hotels and cities added daily. roomlia® was acquired by Remark Media in May 2014; Remark Media is listed on The NASDAQ Capital Market under the ticker (Nasdaq-CM: MARK). To partner with roomlia®, contact us at addyourhotel@roomlia.com.

About Remark Media

Remark Media, Inc. (Nasdaq-CM: MARK), is a global media company that owns and operates a portfolio of assets focused on the 18-to-34-year-old (otherwise known as “The Millennials” or “Gen Y”) demographic across a variety of lifestyle verticals. These include fashion, sports, travel, entertainment, health and wellness, personal finance, and informational know-how.

Remark Media’s assets presently include: Bikini.com, an aspirational lifestyle and ecommerce destination for the beach globetrotter; roomlia®, a mobile hotel booking app that provides a superior user travel experience while balancing the needs of hotel owners; HowStuffWorks China and Brazil, locally known as BoWenWang and Comotudofunciona, respectively; PPTV Boxing, the first ever digital boxing channel in China launched in partnership with PPTV, China’s largest leading online TV service; and Banks.com, US Tax Center at www.irs.com, FileLater.com, and TaxExtension.com, a suite of digital sites focused on personal finance.  Additionally, Remark Media is a founding partner and equity owner of Sharecare, Inc. Created by Jeff Arnold, founder of WebMD, and Dr. Mehmet Oz, in partnership with Harpo Productions, Sony Pictures Television, and Discovery Communications, Sharecare is a highly searchable social healthcare platform organizing and answering the questions of health.

The Company is headquartered in Las Vegas with operations in Beijing and Sao Paulo. Remark Media is listed on The NASDAQ Capital Market under the ticker MARK.

About SiteMinder

SiteMinder is the global hotel industry’s leading provider of online distribution and direct booking technology. Founded in 2006, SiteMinder offers award-winning, cloud-based products – including the world’s largest channel manager, a customizable booking engine, deep PMS/CRS integration and GDS connection tools – to help hotels increase online revenue, streamline business processes and lower operational costs.

Driven by a no-contract, commission-free business model, SiteMinder’s robust product suite and exceptional customer support has made the business one of the most recognizable in the industry. In addition to its global head office in Sydney, SiteMinder has operations in Bangkok, Cape Town, Dallas and London, and more than 16,000 customers in over 160 countries. For more information about SiteMinder and its market-leading products, visit www.siteminder.com

roomlia® contact
Michael Reichartz
+01 701 702 9530 Ext 5002
media@roomlia.com

SiteMinder contact
Maria Franco
+61 410 233 735
media@siteminder.com

Tuesday, March 24th, 2015 Uncategorized Comments Off on (MARK) roomlia® Partners With SiteMinder to Seamlessly Expand Hotel Inventory Reach

(LXK) to Acquire (KFX)

Kofax Limited:

  • Lexmark International, Inc. (NYSE: LXK) and Kofax Limited (NASDAQ and LSE: KFX) today announced that the two companies have entered into a merger agreement in which Lexmark will acquire Kofax. Under the terms of the merger agreement, Lexmark will acquire all of the outstanding shares of Kofax for $11.00 per share in cash for a total enterprise value of approximately $1 billion, net of cash acquired.
  • Lexmark will fund the acquisition with its non-U.S. cash on hand and its existing credit facility programs.
  • Kofax’s Board of Directors has unanimously recommended in favor of the merger agreement. Kofax shareholders, holding approximately 25 percent of the outstanding shares of Kofax, have signed a voting agreement committing to support the merger.
  • Upon successful completion of the acquisition, Lexmark will nearly double the size of its enterprise software business to an approximately $700 million business competing in the expanding $10 billion content and process management software market. This market is expected to have a compounded annual growth rate of approximately 10 percent. In addition to the significant increase in scale, Kofax will help accelerate the growth and significantly increase the operating margins of Lexmark’s software business.
  • The addition of Kofax immediately enhances Lexmark’s industry-leading enterprise content management and business process management offerings. In the capture technology field, the combination of Kofax’s smart process applications with Perceptive Intelligent Capture will create the broadest and deepest portfolio of capture solutions in the market, ranging from Web portals and mobile devices to smart MFPs.
  • The acquisition will result in an enhanced, more efficient balance sheet benefiting from the deployment of available overseas cash and existing balance sheet capacity.
  • Founded in 1985 and headquartered in Irvine, California, Kofax reported 2014 revenue of $297 million. Kofax has over 20,000 customers worldwide, including 80 on the Fortune Global 100 list. The company operates in all regions of the world and has more than 850 channel partners globally.
  • The acquisition of Kofax demonstrates the continued execution of Lexmark’s capital allocation framework, which is to pursue acquisitions that strengthen and support the growth of Lexmark’s solutions capabilities, while returning capital to shareholders. Since the first quarter of 2011, Lexmark has returned 78 percent of its free cash flow to shareholders in the form of dividends and share repurchases. The transaction will not impact Lexmark’s quarterly dividend.
  • The acquisition is expected to close in the second quarter of 2015 and is contingent on Kofax shareholder approval, applicable regulatory clearances and other customary closing conditions.
  • Goldman, Sachs and Co. is serving as exclusive financial advisor to Lexmark. Lazard is serving as exclusive financial advisor to Kofax on this transaction.

Supporting Quotes

“The acquisition of Kofax enhances our best-in-class offerings so our customers can capture, manage, access, and act upon their information more efficiently, and extends Lexmark into the high-growth smart process applications market,” said Paul Rooke, Lexmark chairman and chief executive officer. “Our customers will have a breadth of hardware and software solutions that connect their information silos and automate their business processes – enabling them to access the most relevant information at the moment they need it to drive business forward.

“Kofax accelerates Lexmark’s development of industry-specific solutions while also immediately expanding our reach into the midmarket, where there is increasing demand for technology to better manage the growing amount of unstructured information and improve customer engagement,” added Rooke.

“The combination of Perceptive Software and Kofax solutions strengthens the breadth and depth of our offering, giving us an unmatched ability to help customers of all sizes, in all industries and across the globe to connect unstructured information to their systems of record,” said Scott Coons, Perceptive Software president and chief executive officer and Lexmark vice president.

“We believe joining forces with Lexmark benefits our customers, partners, employees and shareholders and the merger will build on Kofax’s rich history of continuous innovation,” said Reynolds C. Bish, chief executive officer, Kofax. “Our market-leading ability to simplify and transform the First Mile™ of customer engagement is a strong complement to Perceptive Software’s strength in managing information across silos. As a result, we’re excited about the future and working together to realize the full potential of this opportunity to the benefit of all stakeholders.”

Conference Call Today

The company will host a conference call with securities analysts today at 5:00 p.m. (EDT). A live broadcast and a complete replay of this call can be accessed from Lexmark’s investor relations website at http://investor.Lexmark.com. If you are unable to connect to the Internet, you can access the call via telephone at 888-693-3477 (outside the U.S. by calling 973-582-2710) using access code 12656168. Lexmark’s Kofax presentation slides will be available on Lexmark’s investor relations website prior to the live broadcast.

About Lexmark

Lexmark is uniquely focused on connecting unstructured printed and digital information across enterprises with the processes, applications and people that need it most. For more information, please visit www.Lexmark.com.

About Kofax

Kofax is a leading provider of smart process applications to simplify and transform the First Mile™ of customer engagement. Success in the First Mile can dramatically improve the customer experience, greatly reduce operating costs and increase competitiveness, growth and profitability. Kofax software and solutions provide a rapid return on investment to more than 20,000 customers in financial services, insurance, government, healthcare, supply chain, business process outsourcing and other markets. Kofax delivers these through its direct sales and service organization, and a global network of more than 800 authorized partners in more than 75 countries throughout the Americas, EMEA and Asia Pacific. For more information, visit Kofax.com.

Lexmark and Lexmark with diamond design are trademarks of Lexmark International, Inc., registered in the U.S. and/or other countries. All other trademarks are the property of their respective owners.

© 2015 Kofax Limited. Kofax and Kofax TotalAgility are registered trademarks and First Mile is a trademark of Kofax Limited.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Statements in this release which are not historical facts are forward-looking and involve risks and uncertainties which may cause the company’s actual results or performance to be materially different from the results or performance expressed or implied by the forward-looking statements. Factors that may impact such forward-looking statements include, but are not limited to, fluctuations in foreign currency exchange rates; failure to successfully integrate newly acquired businesses; continued economic uncertainty related to volatility of the global economy; inability to execute the company’s strategy to become an end-to-end solutions provider; decreased supplies consumption; possible changes in the size of expected restructuring costs, charges, and savings; market acceptance of new products; aggressive pricing from competitors and resellers; changes in the company’s tax provisions or tax liabilities; excessive inventory for the company’s reseller channel; failure to manage inventory levels or production capacity; periodic variations affecting revenue and profitability; inability to realize all of the anticipated benefits of the company’s acquisitions; the failure of information technology systems, including data breaches or cyber attacks; the inability to develop new products and enhance existing products to meet customer needs on a cost competitive basis; reliance on international production facilities, manufacturing partners and certain key suppliers; business disruptions; increased competition in the aftermarket supplies business; inability to obtain and protect the company’s intellectual property rights and defend against claims of infringement and/or anticompetitive conduct; ineffective internal controls; customer demands and new regulations related to conflict-free minerals; fees on the company’s products or litigation costs required to protect the company’s rights; inability to perform under managed print services contracts; the inability to attract, retain and motivate key employees; terrorist acts; acts of war or other political conflicts; increased investment to support product development and marketing; the financial failure or loss of business with a key customer or reseller; credit risk associated with the company’s customers, channel partners, and investment portfolio; the outcome of litigation or regulatory proceedings to which the company may be a party; unforeseen cost impacts as a result of new legislation; changes in a country’s political or economic conditions; disruptions at important points of exit and entry and distribution centers; and other risks described in the company’s Securities and Exchange Commission filings. The company undertakes no obligation to update any forward-looking statement.

Lexmark Investor Contact:
John Morgan
859-232-5568
jmorgan@Lexmark.com
or
Lexmark Media Contact:
Jerry Grasso
859-232-3546
ggrasso@Lexmark.com
or
Perceptive Software Media Contact:
Sherlyn Manson
913-227-6076
sherlyn.manson@perceptivesoftware.com
or
Kofax Media Contact:
Laura Brandlin
949-783-1545
Laura.brandlin@kofax.com
or
Kofax Investor Contact:
Todd Kehrli
323-468-2300
kfx@mkr-group.com

Tuesday, March 24th, 2015 Uncategorized Comments Off on (LXK) to Acquire (KFX)

(OCLR) to Demo Industry’s First SFP Transceiver Transmitting 28Gbps over 10km Single Mode Fiber

– Doubles the Transmission Rate for Gen 6 Fibre Channel (32GFC) Applications Compared to Previous 16GFC Solutions – Ideal for Potential Future Applications such as 25G Ethernet and New Storage Networking Technology for Hyper-Scale SSD Storage Systems and Data Centers.

SAN JOSE, Calif., March 23, 2015  — Oclaro, Inc. (NASDAQ: OCLR), a leading provider and innovator of optical communications solutions, today announced it will be demonstrating the industry’s first SFP28-LR transceiver capable of transmitting 28Gbps data rates over 10km with approximately 1 Watt of power consumption. Timed with the market availability of Gen 6 Fibre Channel (32GFC, 28.05Gbps) applications, the Oclaro SFP28 transceivers double the transmission rate of previous Fibre Channel solutions (16GFC, 14.025Gbps) and enable the high throughput, energy efficiency and enhanced security required by new hyper-scale SSD storage systems and data centers. Oclaro will be demonstrating prototypes of the new SFP28-LR transceiver at this week’s OFC show in Los Angeles, CA in the Oclaro booth #2011.

Hyper-scale SSD storage systems and data centers are a vital part of the core infrastructure used in cloud computing, where rapid and reliable storing, accessing, and processing of Big Data represent major technical challenges. Serial transmission rates of around 25Gbps may also be required in a variety of emerging applications, such 25G Ethernet, which is currently being standardized by the IEEE. In these next generation network architectures, SFP28 transceivers provide a cost-effective migration path from existing 10G SFP+ designs by offering a 2.5X increase in capacity. SFP28 modules are also lower in cost, smaller in size, and consume less power than other available options to upgrade the bandwidth, such as 40G QSFP+ transceivers, which are based on four 10G lanes that are multiplexed in wavelength for applications requiring a reach of 10km.

“With the SFP28-LR transceiver, Oclaro customers will be ready to meet the needs of Gen 6 Fibre Channel applications,” said Yves LeMaitre, President of Optical Connectivity Business at Oclaro. “In addition, enterprise and data center hardware customers will be able to leverage this innovative new product, which represents Oclaro’s first contribution to the fast expanding 25G Ethernet eco-system.”

“We see initial demand for 32G Fibre Channel materializing in early 2016, and a large portion of the revenue will be in the single mode segment,” said Vladimir Kozlov, Founder and CEO of LightCounting Market Research. “In addition, we are expecting demand for data rates above 10Gbps in next generation applications such as wireless or 25G Ethernet, once these become standardized.”

About the SFP28-LR Transceiver

The Oclaro SFP28-LR transceiver is SFF-8432 compliant and delivers data rates of 25.78125Gbps (25GE) / 28.05Gbps (32GFC) with a reach of up to 10km. Additional features include a BER of less than 10-6, C-Temp, and a power consumption of approximately 1W. Target applications for SFP transceivers operating in the range of 24-28Gbps include Ethernet (25GE) and fiber channel (32GFC).

Oclaro is expected to start sampling the SFP28-LR transceivers in the second half of 2015 with a production release scheduled for early 2016.

About Oclaro
Oclaro, Inc. (Nasdaq: OCLR), is a leader in optical components, modules and subsystems for the core optical, enterprise and data center markets. Leveraging more than three decades of laser technology innovation, photonics integration, and subsystem design, Oclaro’s solutions are at the heart of the fast optical networks and high-speed interconnects driving the next wave of streaming video, cloud computing, voice over IP and other bandwidth-intensive and high-speed applications. For more information, visit www.oclaro.com or follow on Twitter at @OclaroInc.

Copyright 2015. All rights reserved. Oclaro, the Oclaro logo, and certain other Oclaro trademarks and logos are trademarks and/or registered trademarks of Oclaro, Inc. or its subsidiaries in the US and other countries. All other trademarks are the property of their respective owners. Information in this release is subject to change without notice.

PR Contact Info:
Kelly Karr
Tanis Communications, Inc.
+1 (408) 718-9350
kelly.karr@taniscomm.com

Monday, March 23rd, 2015 Uncategorized Comments Off on (OCLR) to Demo Industry’s First SFP Transceiver Transmitting 28Gbps over 10km Single Mode Fiber

(KMDA) Awarded European Orphan Drug Designation for Its Alpha-1 Antitrypsin

Kamada Ltd. (Nasdaq:KMDA) (TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications, announces that the European Commission, acting on the recommendation from the Committee for Orphan Medicinal Products of the European Medicines Agency (EMA), has designated the Company’s proprietary human intrevenous (IV) Alpha-1 Antitrypsin (AAT) as an orphan medicinal product to treat Graft-versus-host disease (GvHD). In October 2014 Kamada received Orphan Drug designation from the U.S. Food and Drug Administration (FDA) for its AAT by IV to treat GvHD.

Orphan designation is a status assigned by regulatory authorities, and in this case, the EMA to a medicine intended to treat a rare condition (prevalence of not more than 5 in 10,000 people in the European Union). The orphan designation allows the awarded pharmaceutical company to benefit from incentives offered by the EU to develop the designated medicine for the rare indication. In addition to a 10-year period of market exclusivity after product approval, Orphan Drug designation provides incentives for companies seeking protocol assistance from the EMA during the product-development phase, reduced regulatory fees, direct access to centralized marketing authorization, European Commission grant programs and more.

“Receipt of European Orphan Drug designation for our AAT to treat GvHD is a key milestone that supports our global regulatory and development strategy,” stated David Tsur, co-Founder and Chief Executive Officer of Kamada. “GvHD is a disease of significant unmet medical need, and both the disease and current therapy options carry considerable, debilitating side effects.”

Preliminary human and animal studies indicate that AAT may be able to treat and reduce the severity of GvHD, which is one of the key, life-threatening complications of allogeneic stem cell transplantation. GvHD is an immunologically-based disease that may result in significant damage to multiple organs and tissues such as the liver, gastrointestinal tract, skin and mucosal membranes. Tissue destruction also leads to increased inflammatory signals, perpetuating and augmenting the disease process by contributing to the cytokine storm that fuels GvHD even further and, thereby, the damage continues and its intensity is increased.

In recent years, AAT has been investigated extensively and found to have anti-inflammatory, tissue-protective, immune-modulatory and anti-apoptotic properties in direct or indirect consequence of its underlying anti-protease capabilities. These properties may attenuate inflammation by lowering levels of pro-inflammatory mediators such as cytokines, chemokines and proteases that are associated with this severe disease.

Kamada’s AAT therapy is being investigated in a clinical U.S. Phase 1/2 study that is evaluating 24 GvHD patients with inadequate response to steroid treatment following allogeneic bone-marrow stem cell transplant. The patients are enrolled into 4 dose cohorts, in which they receive up to 8 doses of Kamada’s AAT. The study is being conducted by the Fred Hutchinson Cancer Research Center in Seattle in cooperation with Baxter International.

Interim results from this study were presented in a poster at the American Society of Hematology Annual Meeting in December 2014. Preliminary results indicated that continuous administration of AAT as therapy for steroid-resistant gut GvHD is feasible in the subject population. Indication of healing of the bowel mucosa was seen in a decrease in diarrhea, in a decrease in intestinal AAT loss, and improvement in endoscopic evaluation. Additionally, in the preliminary results AAT administration suppressed serum levels of pro-inflammatory cytokines and interfered with GvHD biomarkers.

Separately, investigators at the Fred Hutchinson Cancer Research Center published additional non-clinical and clinical observational data in the September edition of Blood, in an article entitled “α-1-antitrypsin (AAT)-modified donor cells suppress GvHD but enhance the GVL effect – a role for mitochondrial bioenergetics.”

“The positive interim results from ongoing studies are very encouraging and support continuation of our global clinical development plans for AAT in treating and preventing GvHD. Importantly, the preclinical data support the positive interim results from the Phase 1/2 clinical study of AAT, which is aimed at treating the gut involvement in steroid-resistant GvHD. Given the favorable safety profile of AAT, there is a strong rationale to support the development of this new indication and an increased likelihood of our AAT becoming an effective therapy for this potentially life-threatening disease. With these encouraging results, we intend to commence a Phase 3 trial in 2016, in order to bring this life saving treatment to the market not before 2019,” concluded Mr. Tsur.

About Graph-versus-Host Disease

Graft-versus-host disease is a common complication following an allogeneic tissue transplant. It is typically associated with stem cell transplant, but the term also applies to other forms of tissue graft. In GvHD, immune cells (white blood cells) in the tissue (the graft) recognize the recipient (the host) as “foreign,” and then attack the host’s body cells.

GvHD occurs in 30-70% of patients who undergo a medical procedure of allogeneic hematopoietic stem cell transplantation (HSCT), usually as a treatment to leukemia or other blood cancers or blood conditions. HSCT is a stem cell transplantation that is usually derived from an external (allogeneic) bone marrow donor. One of the most common and dangerous complications of HSCT is GvHD. GvHD is expressed in damage to the recipients’ tissues including damage to the liver, gastrointestinal system, skin and mucosal tissues, and is a major cause of morbidity and mortality in these patients.

Intravenous glucocorticoids such as prednisone are the standard of care in acute GvHD1 and chronic GvHD.2 The use of these glucocorticoids is designed to suppress the T cell-mediated immune onslaught on the host tissues; however, in high doses this immune suppression raises the risk of infections and cancer relapse. In addition, more than 50% of patients do not respond well to steroids, and consequently have very low survival rates.

About Glassia and AAT

Glassia is the first available ready-to-infuse liquid alpha1-proteinase inhibitor (Alpha1-PI) and is indicated as a chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe congenital AAT deficiency. Glassia is administered intravenously once a week to augment the levels of AAT in the blood. AAT is a protein derived from human plasma with known and newly discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties. Glassia is approved by the U.S. Food and Drug Administration and is marketed through a strategic partnership with Baxter International in the U.S. Please see the full prescribing information for Glassia at: http://www.baxter.com/downloads/healthcare_professionals/products/Glassia_PI.pdf

About Kamada

Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan indications, and has a commercial product portfolio and a robust late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived proteins. AAT is a protein derived from human plasma with known and newly-discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties. The Company’s flagship product is Glassia®, the first and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration. Kamada markets Glassia in the U.S. through a strategic partnership with Baxter International. In addition to Glassia, Kamada has a product line of nine other pharmaceutical products that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America, Eastern Europe and Asia. Kamada has five late-stage plasma-derived protein products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency that completed a pivotal Phase 2/3 clinical trials in Europe and has initiated Phase 2 clinical trials in the U.S. Kamada also leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing about 10 complementary products in Israel that are manufactured by third parties.

Cautionary Note Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to financial results forecast, commercial results, clinical trials, Intellectual Property, the EMA and U.S. FDA filings and authorizations and timing of clinical trials. Forward-looking statements are based on Kamada’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, unexpected results of clinical trials, delays or denial in the U.S. FDA or the EMA approval process, additional competition in the AATD market or further regulatory delays. The forward-looking statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

1 Goker, H; Haznedaroglu, IC; Chao, NJ (2001). “Acute graft-vs-host disease Pathobiology and management”. Experimental Hematology 29 (3): 259–77. doi:10.1016/S0301-472X(00)00677-9. PMID

2 Menillo, S A; Goldberg, S L; McKiernan, P; Pecora, A L (2001). “Intraoral psoralen ultraviolet a irradiation (PUVA) treatment of refractory oral chronic graft-versus-host disease following allogeneic stem cell transplantation”. Bone Marrow Transplantation 28 (8): 807–8. doi:10.1038/sj.bmt.1703231. PMID 11781637.

Kamada Ltd.
Gil Efron
CFO
ir@kamada.com
or
Anne Marie Fields
LHA
212-838-3777
afields@lhai.com

Monday, March 23rd, 2015 Uncategorized Comments Off on (KMDA) Awarded European Orphan Drug Designation for Its Alpha-1 Antitrypsin

(SIXD) Acquires Leading Analytics, SEO & Digital Advertising Firm SwellPath

NEW YORK, March 23, 2015  — 6D Global Technologies, Inc. (Nasdaq:SIXD), a premier digital business solutions company has acquired SwellPath, a professional services firm that delivers digital analytics, search engine optimization (SEO), paid media, and digital advertising services to medium and large scale enterprises across North America.

SwellPath is expected to be immediately accretive to 6D Global’s revenue and earnings in 2015 and beyond. SwellPath enables clients to align and maximize their digital marketing initiatives by tracking both online and offline marketing campaigns and performing more effective targeting to enhance return on investment. SwellPath complements 6D Global’s overall strategy to provide full-service digital marketing solutions to its clients, while leveraging Google Analytics Premium and 6D Global’s existing offering of Adobe Analytics.

SwellPath’s customers are Nike, Intel, UC Berkeley, Yakima, Activision, Good Data, WebMD, Hanna Anderson, and many more.

Similar to 6D Global’s most recent acquisition of Storycode, a leading web, creative, and mobile application development firm, SwellPath is headquartered in Portland, Oregon. SwellPath has an additional office in Minneapolis, Minnesota.

“The acquisition of SwellPath represents our strong commitment to providing digital solutions to our clients that enable predictive and qualitative results, and higher ROI,” said Matthew Sullivan, Executive Vice President of 6D Global Technologies, Inc. “We are very excited to offer SwellPath’s unmatched innovation and depth of expertise in digital analytics, search optimization, and pay-per click media to our clients. This digital offering provides a new growth platform for 6D Global.”

“Joining 6D gives SwellPath global scale and a more powerful face to the market which we can leverage to constantly expand our offering and give our clients the solutions they won’t get anywhere else,” said Adam Ware, Founder and CEO of SwellPath. “We were impressed with how 6D’s vision aligned with our own, and the role they saw digital analytics and paid media playing in their growth. We knew it was an opportunity we had to take advantage of.”

About 6D Global Technologies, Inc.

6D Global Technologies, Inc. (Nasdaq:SIXD) is a premier digital business solutions company serving the digital marketing and technology needs of enterprise-class organizations worldwide. 6D Global Technologies offers a full suite of services and solutions to help large organizations optimize digital business channels and create better experiences for their customers, resulting in increased revenue growth and market share. 6D Global Technologies’ services include web content management, web analytics, marketing automation, mobile applications, business intelligence, marketing cloud, and IT infrastructure staffing solutions. For more information, visit www.6DGlobal.com.

CONTACT: Media Contact:
         Hilary Smith, Director of Marketing
         info@6DGlobal.com  |  303-513-1776
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(CRNT) Tier 1 African Operator Expands its Ceragon-based Backbone

Unprecedented operational efficiency achieved by utilizing Ceragon’s unique multicore and high power radio technologies

PARAMUS, New Jersey, March 23, 2015  —

Ceragon Networks Ltd. (NASDAQ: CRNT), the #1 wireless backhaul specialist, today announced that a Tier 1 mobile operator in Africa is investing approximately $4 million to expand its large scale Ceragon-based backbone network, deploying the IP-20 Platform Long Haul solution. The solution will provide hybrid 3G connectivity, and in the future full packet-based 4G connectivity, to remote locations, bridging the digital divide between rural and urban regions.

Challenged with the need to quickly and efficiently provision telecommunication services, the operator searched for a solution capable of providing wireless links at long distances with the smallest possible footprint to lower tower leasing costs, minimal use of frequencies and equipment, as well as a simple modernization path to a full packet-based backbone. To maximize service availably and customer experience, the operator also searched for a solution capable of providing high capacity and low latency, as well as meeting its current 3G and future 4G needs.

The operator chose to deploy the Ceragon IP-20LH solution for its exceptional high transmit power capabilities, offering longer reach across wide sections of the country and the benefit of using smaller antennas for improved total cost of ownership (TCO). With its unique multicore technology, available only by Ceragon, the IP-20LH allows for the unprecedented distribution of SDH traffic, combined with Ethernet traffic, on all radio channels. This unique technology reduces the number of frequency channels needed for the backbone, as well as enables the deployment of fewer wireless backbone transmission units thereby greatly increasing available network capacity and lowering latency – providing a remarkable TCO advantage.

“We are pleased to continue this important relationship and gratified that this operator has chosen to deploy our IP-20 platform,” said Ira Palti, Ceragon’s president and CEO. “This demonstrates the exceptional benefits our solution offers for backbone infrastructures by enabling the operator to improve service availability while maintaining a close watch on network total cost of ownership. Our unique field-proven multicore technology has once again proven to be a key factor operators consider as they plan their network for the years to come.”

About Ceragon Networks Ltd.

Ceragon Networks Ltd. (NASDAQ: CRNT) is the #1 wireless backhaul specialist. We provide innovative, flexible and cost-effective wireless backhaul and fronthaul solutions that enable mobile operators and other wired/wireless service providers to deliver 2G/3G, 4G/LTE and other broadband services to their subscribers. Ceragon’s high-capacity, solutions use microwave technology to transfer voice and data traffic while maximizing bandwidth efficiency, to deliver more capacity over longer distances under any deployment scenario. Based on our extensive global experience, Ceragon delivers turnkey solutions that support service provider profitability at every stage of the network lifecycle enabling faster time to revenue, cost-effective operation and simple migration to all-IP networks. As the demand for data pushes the need for ever-increasing capacity, Ceragon is committed to serve the market with unmatched technology and innovation, ensuring effective solutions for the evolving needs of the marketplace. Our solutions are deployed by more than 430 service providers in over 130 countries.

Ceragon Networks® and FibeAir® are registered trademarks of Ceragon Networks Ltd. in the United States and other countries. CERAGON ® is a trademark of Ceragon Networks Ltd., registered in various countries. Other names mentioned are owned by their respective holders.

Safe Harbor

This press release contains statements concerning Ceragon’s future prospects that are “forward-looking statements” under the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements include: projections of capital expenditures and liquidity, competitive pressures, revenues, growth prospects, product development, financial resources, restructuring costs, cost savings and other financial matters. You can identify these and other forward-looking statements by the use of words such as “may,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “expects,” “intends,” “potential” or the negative of such terms, or other comparable terminology. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including risks associated with increased working capital needs; risks associated with the ability of Ceragon to meet its liquidity needs; the risk that Ceragon will not achieve the benefits it expects from its expense reduction and profit enhancement programs; the risk that Ceragon will not comply with the financial or other covenants in its agreements with its lenders; the risk that sales of Ceragon’s new IP-20 products will not meet expectations; risks associated with doing business in Latin America, including currency export controls and recent economic concerns; risks relating to the concentration of our business in the Asia Pacific region and in developing nations; the risk of significant expenses in connection with potential contingent tax liability associated with Nera’s prior operations or facilities; and other risks and uncertainties detailed from time to time in Ceragon’s Annual Report on Form 20-F and Ceragon’s other filings with the Securities and Exchange Commission, and represent our views only as of the date they are made and should not be relied upon as representing our views as of any subsequent date. We do not assume any obligation to update any forward-looking statements.

Media Contact:
Justine Schneider
Calysto Communications
Tel: +1-(404)-266-2060 x507
jschneider@calysto.com

Company Contact:
Tanya Solomon
Ceragon Networks
Tel: +972-3-543-1163
tanyas@ceragon.com

Investor Contact:
Claudia Gatlin
Tel. +1-(212)-830-9080
claudiag@ceragon.com

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(IMGN) Takeda Licenses Novel Antibody-Drug Conjugate Tech Rights

Takeda Pharmaceutical Company Limited (TSE:4502) and ImmunoGen, Inc. (Nasdaq: IMGN), a biotechnology company that develops targeted anticancer therapeutics using its state-of-the-art antibody-drug conjugate (ADC) technology, today announced that Takeda has licensed exclusive rights to use ImmunoGen’s ADC technology including ImmunoGen’s new DNA-acting IGN payload agents to develop and commercialize targeted anticancer therapeutics to up to two undisclosed targets. The agreement also provides Takeda with the option to take a license for a third target for an additional upfront fee.

ImmunoGen will receive $20 million upfront and for each target is eligible to receive milestone payments potentially totaling up to $210 million plus royalties on the commercial net sales of any resulting ADC products. Takeda is responsible for the development, manufacturing and marketing of any ADC products resulting from this agreement.

“Takeda shares our commitment to developing novel anticancer therapies that meaningfully improve the lives of patients, and we look forward to collaborating with them to create important new ADC product candidates,” commented Daniel Junius, ImmunoGen President and CEO.

“ADC technology is a critically important tool in addressing unmet needs in oncology,” said Christopher Claiborne, Ph.D., Head of the Oncology Drug Discovery Unit at Takeda. “By partnering with ImmunoGen, we are able to leverage this important technology in Takeda’s R&D program and bring novel agents through the clinic.”

Takeda signed an agreement with ImmunoGen through its wholly owned subsidiary, Millennium Pharmaceuticals, Inc.

ImmunoGen is not updating its guidance for its 2015 fiscal year at this time.

About ImmunoGen’s ADC Technology Portfolio

ImmunoGen created and continues to expand its proprietary portfolio of ADC technology to enable the creation of new treatments for people with cancer.

An ADC consists of a monoclonal antibody that binds to a target found on cancer cells with a cancer-cell killing agent, or “payload,” attached. The antibody serves to target the payload specifically to the cancer cells and the payload serves to kill these cells. In some cases, the antibody also has meaningful anticancer activity.

ImmunoGen has established a deep portfolio of ADC technology to enable the development of an optimal ADC design for each cancer target, including a selection of potent payload agents and engineered linkers.

ImmunoGen’s cell-killing payload agents have been developed specifically for delivery to cancer cells using a targeting vehicle: they are more potent than traditional chemotherapy agents and can be attached to the targeting vehicle via ImmunoGen’s engineered linkers. The Company’s portfolio of proprietary payload agents includes its tubulin-acting maytansinoids, which are used in over ten ADCs in the clinic today including the marketed product, Kadcyla®. ImmunoGen created its DNA-acting IGN family of payload agents to further expand the types of cancers potentially addressable with effective ADC therapies, such as cancers insensitive to tubulin-acting agents or with less-robust target expression.

ImmunoGen’s engineered linkers are designed to be stable while the ADC is traveling through the blood stream to the cancer cells and then optimize payload release and antitumor activity. The Company has established a rich portfolio of intracellularly cleavable and non-cleavable linkers. To facilitate assessment of alternative linker/payload pairings in optimizing ADC design, ImmunoGen’s linkers are compatible with both its maytansinoid and IGN platforms.

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

About ImmunoGen, Inc.

ImmunoGen, Inc. develops targeted anticancer therapeutics. The Company’s ADC technology uses tumor-targeting antibodies to deliver an ImmunoGen cell-killing agent specifically to cancer cells; the Company has also developed antibodies with anticancer activity of their own. The first product with ImmunoGen’s ADC technology is Roche’s Kadcyla. ImmunoGen has three wholly owned product candidates in clinical testing with additional compounds in clinical testing through the Company’s partnerships with Amgen, Bayer HealthCare, Biotest, Novartis and Sanofi. More information about ImmunoGen can be found at www.immunogen.com.

Kadcyla® is a registered trademark of Genentech, a member of the Roche Group.

For Takeda:

This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda’s plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as “may,” “believe,” “will,” “expect,” “project,” “estimate,” “should,” “anticipate,” “plan,” “assume,” “continue,” “seek,” “pro forma,” “potential,” “target,” “forecast,” “guidance,” “outlook” or “intend” or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda’s business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.

The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.

For ImmunoGen:

This press release includes forward-looking statements related to ImmunoGen’s collaboration with Takeda. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. Various factors could cause ImmunoGen’s actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to the timing and outcome of ImmunoGen’s and the Company’s collaboration partners’ research and clinical development processes; the difficulties inherent in the development of novel therapeutics, including uncertainties as to the timing, expense and results of preclinical studies, clinical trials and regulatory processes; industry merger and acquisition activity; and other factors more fully described in ImmunoGen’s Annual Report on Form 10-K for the fiscal year ended June 30, 2014 and other reports filed with the Securities and Exchange Commission.

 

For Investors:
ImmunoGen, Inc.
Carol Hausner, 781-895-0600
info@immunogen.com
or
For Media:
Pure Communications, Inc.
Dan Budwick, 973-271-6085
or
Takeda Pharmaceutical Company Limited
Elizabeth Pingpank, 617-444-1495
Elizabeth.pingpank@takeda.com
or
Corporate Communications Department
+81-3-3278-2037

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(RADA) Selected by Lockheed Martin (LMT) for Laser Weapon Research Projects

RADA’s Tactical Multi-Mission Hemispheric Radar Provides Volume Surveillance and Detection of Multiple Threat Types, Including UAVs, Mortars, and Rockets

NETANYA, Israel, March 23, 2015  — RADA Electronic Industries Ltd. announces the selection by Lockheed Martin Space Systems Company of its Multi-Mission Hemispheric Radar (MHR) to support internally funded high energy laser weapon system prototype testing. The radar will be used by Lockheed Martin in combination with other sensors.

The MHR — an S-Band, Software-Defined, Pulse-Doppler, Active Electronically Scanned Array radar — has sophisticated beam forming capabilities and advanced signal processing, provides multiple missions on each radar platform, and offers unprecedented performance-to-price ratio. It is compact and mobile, delivering ideal organic, tactical surveillance solutions for force and border protection applications such as counter rockets and mortars, counter unmanned aerial systems, ground moving target indicator, air surveillance, and more.

According to Zvi Alon, RADA’s CEO, “We are very happy with Lockheed Martin’s selection of our unique MHR, which is particularly suited for use with systems that counter rockets and mortars.”

About RADA

RADA Electronic Industries Ltd. is an Israel-based defense electronics contractor. The Company specializes in the development, production, and sale of Tactical Land Radars for Force and Border Protection, Inertial Navigation Systems for air and land applications, and Avionics Systems and Upgrades.

CONTACT: RADA
         Dubi Sella (CBDO)
         Tel: +972-9-892-1111
         mrkt@rada.com
         www.rada.com

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(BLBD) 92 Propane Buses Used in Student Transportation, Inc. New Contract

92 Blue Bird (Nasdaq: BLBD) propane-fueled school buses will now power the youngest and largest ‘green fleet’ of school vehicles in Colorado. Student Transportation of America, Inc. (STA), has been awarded a new $6 million annual contract with Mesa County Valley School District 51 in Grand Junction, Colorado to provide school transportation services.

The five year contract starts in July, and provides for customer paid fuel. The school district was able to qualify for additional incentives, such as the “Innovative Motor Vehicle and Alternative Fuel Vehicle Credit”, as identified by STA’s Innovation Team. This allowed STA to lower the total cost of the proposal to the school district, since the buses are a qualifying motor vehicle.

“Blue Bird’s proven propane solution will save the district thousands of dollars per year, per bus,” said Trey Jenkins, Vice President of Alternative Fuels for Blue Bird Corporation. “In addition, we are delighted that this district was able to benefit from one of the many incentives that state and local authorities offer to alternative fuel vehicle solutions. We are excited to have Mesa County experience the industry’s best, and most cost-effective, alternative fuel system.”

While this is the first operation in Colorado for STA, they are experienced with other large propane autogas fleets. In 2013, over 400 Blue Bird propane buses were delivered to STA’s operation in Omaha, NE. STA also operates other large fleets in Los Angeles, Milwaukee, and Meridian, Idaho.

“This is a great bid win for us and we are excited about expanding our operations in Colorado. We will be looking to show other school districts in the state how our public-private partnership can not only upgrade their fleet and improve service, but lower their cost of operation,” stated Don Kissell, Senior Vice President at STA. “Our talented team in operations is looking forward to getting started and forging a strong local relationship while drawing upon our years of experience and demonstrating our outstanding culture of compassion, caring and customer service.”

About Blue Bird:

Blue Bird offers a complete line of Type A, C and D school buses in a variety of options and configurations. For more than 85 years, Blue Bird Corporation has continued to set industry standards with its innovative design and manufacturing capabilities. Additionally, Blue Bird provides comprehensive financial solutions through Blue Bird Capital Services. Today, Blue Bird has more than 1,700 employees, Georgia-based manufacturing facilities and an extensive network of Dealers and service-parts facilities throughout North America. Its global presence can be seen in more than 60 countries through sales into Africa, Asia, the Caribbean, Latin America, Europe and the Middle East. For more information, visit the Blue Bird Corporation web site at www.blue-bird.com.

About Student Transportation Inc.

Founded in 1997, STI is North America’s third-largest and most progressive provider of school bus transportation services, operating more than 12,000 vehicles. STI’s family of local companies delivers safe, reliable and cost-effective transportation solutions to school districts throughout the U.S. and Canada. Services are delivered by drivers, dispatchers, maintenance technicians, terminal managers and others who are caring members of their local communities. For more information, please visit www.RideSTBus.com.

Blue Bird Corporation
David Bercik, 478-822-2528
Director of Product Development
David.Bercik@blue-bird.com

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(BIIB) Positive Results, Phase 1B Study of Alzheimer’s Disease Treatment Aducanumab

Today Biogen Idec (NASDAQ:BIIB) announced data from a pre-specified interim analysis of PRIME, the Phase 1b study of aducanumab (BIIB037), in which aducanumab demonstrated an acceptable safety profile and positive results on radiologic and clinical measurements in patients with prodromal or mild Alzheimer’s disease (AD). These data are being presented today at the 12th International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders in Nice, France.

Treatment with aducanumab produced a dose- and time-dependent reduction of amyloid plaque in the brain. Amyloid plaque is believed to play a key role in the development of the symptoms of AD. In exploratory analyses, a dose-dependent, statistically significant effect of slowing clinical decline was observed on the Mini Mental State Examination (MMSE) and Clinical Dementia Rating (CDR) scales.

“This is the first time an investigational drug for Alzheimer’s disease has demonstrated a statistically significant reduction on amyloid plaque as well as a statistically significant slowing of clinical impairment in patients with prodromal or mild disease,” said Alfred Sandrock, M.D., Ph.D., group senior vice president and chief medical officer at Biogen Idec. “Based on these results, we are advancing the aducanumab clinical program to Phase 3 with plans to initiate enrollment later this year.”

PRIME Study

PRIME is an ongoing Phase 1b randomized, double-blind, placebo-controlled, multiple-dose study evaluating the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of aducanumab in patients with prodromal or mild AD.

This interim analysis of PRIME reflects data for 166 patients, up to week 54 in the placebo (n=40), 1 mg/kg (n=31), 3 mg/kg (n=33) and 10 mg/kg (n=32) dose arms, and up to week 30 data for the 6 mg/kg (n=30) dose arm.

Radiologic Results for Amyloid Plaque

In patients receiving aducanumab, a dose- and time-dependent reduction of amyloid plaque was observed over 54 weeks of treatment.

PET imaging using the radiotracer florbetapir1, which binds to amyloid plaque, was used to measure plaque levels in the brain. A composite standardized uptake value ratio (SUVR) of six regions of the brain –frontal, parietal, lateral temporal, sensorimotor, anterior and posterior cingulate – was calculated at baseline, at 26 weeks and at 54 weeks using whole cerebellum as a reference.

In the placebo arm, the SUVR was virtually unchanged at 26 and 54 weeks. Aducanumab treatment resulted in a statistically significant reduction of amyloid plaque in the 3 mg/kg [average change of -0.087, p<0.01)], 6 mg/kg [-0.143 (p<0.001)] and 10 mg/kg [-0.205 (p<0.001)] dose arms compared to placebo at 26 weeks. Amyloid plaque levels were reduced by -0.030 in the 1 mg/kg arm, which was not significant.

At week 54, a statistically significant reduction of amyloid plaque was observed in the 3 mg/kg [-0.139 (p<0.001)] and 10 mg/kg [-0.266 (p<0.001)] dose arms. The reduction of amyloid plaque in the 1 mg/kg (-0.056) arm was not significant. The 6 mg/kg arm is ongoing and the week 54 data will become available at a later date.

Clinical Results

The effect of aducanumab on AD-related impairment was measured using the MMSE and Clinical Dementia Rating sum of boxes (CDR-SB). The MMSE is used to assess a patient’s cognitive status and the CDR-SB characterizes a patient’s cognitive and functional performance.

On the MMSE, patients in the placebo group worsened by an average of 3.14 at one year, whereas the decline was 2.21 in the 1 mg/kg arm, 0.75 in the 3 mg/kg arm and 0.58 in the 10 mg/kg arm. Relative to placebo, the 3 mg/kg and 10 mg/kg doses demonstrated a statistically significant slowing of cognitive decline on the MMSE, both with p-values <0.05.

On the CDR-SB, patients in the placebo group worsened by an average of 2.04 at one year. In comparison, the worsening was 1.70 in the 1 mg/kg arm, 1.33 in the 3 mg/kg arm and 0.59 in the 10 mg/kg arm. Relative to placebo, the 10 mg/kg showed a statistically significant slowing of clinical decline on the CDR-SB with p-value <0.05.

Pharmacokinetic activity and exposure were linear with dose. Treatment-emergent immunogenicity, which occurred in approximately 3 percent of patients, was transient and without apparent effect on aducanumab PK.

Safety Results

Aducanumab demonstrated an acceptable safety and tolerability profile in this analysis. The most frequently reported treatment-related serious adverse event (SAE) and adverse event (AE) was ARIA (amyloid-related imaging abnormalities).

Based on MRI scans, the incidence of ARIA-E (edema) was dose- and apolipoprotein E4-(ApoE4) status-dependent. In general, the onset of ARIA-E was observed early in the course of treatment and was asymptomatic or with mild, transient symptoms. The majority of patients with ARIA-E continued treatment and did so at a lower dose.

In ApoE4 carriers, the incidence of ARIA-E was 5 percent in the 1 mg/kg and 3 mg/kg arms, 43 percent in the 6 mg/kg arm and 55 percent in the 10 mg/kg arm. In ApoE4 non-carriers, the incidence of ARIA-E was 9 percent, 11 percent and 17 percent in the 3 mg/kg, 6 mg/kg and 10 mg/kg aducanumab arms, respectively; no cases were reported in the 1 mg/kg arm.

In ApoE4 carriers, the incidence of patients who developed ARIA-E and discontinued treatment was 5 percent in the 1 mg/kg arm, 10 percent in the 6 mg/kg arm, and 35 percent in the 10 mg/kg arm. There were no discontinuations in the 3 mg/kg arm. In ApoE4 non-carriers, the incidence of patients who developed ARIA-E and discontinued treatment was 11 percent in the 6 mg/kg arm and 8 percent in the 10 mg/kg arm. There were no discontinuations in the 1 mg/kg and 3 mg/kg arms.

Headache occurred in 22 percent of patients receiving aducanumab compared to 5 percent in the placebo groups and appeared to be dose-dependent. Three deaths were reported in the time period of this analysis, two in the placebo group and one in the 10 mg/kg study arm; none were considered to be treatment related. Other AEs and SAEs were consistent with what is typically observed in the study population.

About Aducanumab (BIIB037)

Aducanumab (BIIB037) is an investigational compound being developed for the treatment of Alzheimer’s disease (AD). Aducanumab is a human recombinant monoclonal antibody (mAb) selected from a population of elderly, healthy donors and cognitively stable patients using Neurimmune’s technology platform called Reverse Translational Medicine (RTM). Biogen Idec licensed aducanumab from Neurimmune under a collaborative development and license agreement.

Aducanumab targets aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of AD patients. Based on pre-clinical and interim Phase 1b data, treatment with aducanumab has been shown to reduce amyloid plaque levels.

About Alzheimer’s Disease

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder characterized by cognitive decline and behavioral disturbances that eventually result in a person’s inability to perform daily activities. In 2010, it was estimated that 25 million individuals were living with AD worldwide2. Evidence suggests that pathophysiological changes typically begin years prior to the symptoms that lead to a clinical diagnosis. As the disease progresses, cognitive impairments, behavioral changes and functional disability commonly associated with AD begin to manifest.

About Biogen Idec

Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hematologic conditions and autoimmune disorders. Founded in 1978, Biogen Idec is the world’s oldest independent biotechnology company and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For product labeling, press releases and additional information about the Company, please visit http://www.biogenidec.com.

Biogen Idec Safe Harbor

This press release contains forward-looking statements, including statements about the clinical potential of aducanumab and the advancement of this program to Phase 3 and timing thereof. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Interim results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials. Factors which could cause actual results to differ materially from our current expectations include the risk that unexpected concerns may arise from additional data or analysis of the full results or results obtained during our clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates, or we may encounter other unexpected hurdles. For more detailed information on the risks and uncertainties associated with our drug development and commercialization activities, please review the Risk Factors section of our most recent annual or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statements.

1 Amyvid™ (florbetapir) is a trademark of Eli Lilly and Company.

2 World Health Organization Dementia a Public Health Priority. http://www.who.int/mental_health/publications/dementia_report_2012/en/. Accessed 10 Dec 2014.

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(QUNR) CEO CC Zhuang Named Young Global Leader by World Economic Forum

BEIJING, March 20, 2015  — Qunar today announced that the company’s CEO, Chenchao (CC) Zhuang, has been named among the World Economic Forum’s Young Global Leaders (YGLs) for 2015. Mr. Zhuang was one of 187 business leaders, chosen from a global pool of 2000 entrepreneurs under the age of 40, recognized by the WEF for their outstanding professional accomplishments and tangible contributions to their countries and industries.

The World Economic Forum lists 11 heads of state and government, 10 heads of Fortune 500 companies, 15 UN Goodwill Ambassadors, six Guinness World Record holders, four Oscar winners, three Olympic gold medalists, two Nobel Prize winners and an astronaut among its current and former YGLs.

“The YGLs include the world’s most pioneering, next-generation leaders who have developed in their journey to produce positive, tangible impacts in their countries, industries and societies,” said John Dutton, Director and Head of the Young Global Leaders Community at the World Economic Forum. “The class of 2015, together with the community over the past 10 years, shows how the future of business and public leadership is becoming more gender-equal, more geographically diverse, more varied in its expertise and is challenging established ways to get things done.”

About Qunar

Qunar Cayman Islands Limited is the leading online and mobile travel platform for the travel industry in China. Qunar’s goal is to empower Chinese travelers to define their travel experience. Founded in May 2005 and headquartered in Beijing, Qunar is committed to providing travelers with a one-stop travel information source on both PC and mobile devices. The Company enables travelers to find the best-value deals by aggregating and processing highly fragmented travel product information from tens of thousands of travel service providers into an organized and user-friendly display through its proprietary technology. According to research firm iResearch, Qunar has ranked No. 1 among all non-state-owned online travel companies in China in terms of monthly unique visitors since November 2010. Qunar’s mobile application “Qunar Travel” was ranked the most frequently used mobile travel application in China by China Internet Network Information Center in September 2012.

Leveraging its large user base and advanced technologies, the Company provides an attractive value proposition to its customers, which include travel service providers and display advertisers.

Qunar means “where to go” in Mandarin Chinese.

About the Forum of Young Global Leaders

Established by Professor Klaus Schwab, Founder and Executive Chairman of the World Economic Forum, in 2004, the Forum of Young Global Leaders is a unique, multistakeholder community of more than 900 exceptional young leaders. Bold, brave, action-oriented and entrepreneurial, these individuals commit both their time and talent to make the world a better place. Every year, the Forum honours about 200 outstanding young leaders from around the world for their professional accomplishments, commitment to society and potential to contribute to shaping the future of the world.

CONTACT: For more information regarding Qunar, please contact:

         China
         Jenna Qian
         Qunar
         Tel: +86-10-5760-3609
         press@qunar.com

         Nick Beswick
         Brunswick Group
         Tel: +86-10-5960-8600
         Email: qunar@brunswickgroup.com

         U.S.
         Rachel Hunter
         Brunswick Group
         Tel: +1-212-333-3810
         Email: qunar@brunswickgroup.com
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(VGGL) Founder, CEO Proposes 25% Acquisition of Company’s Wetpaint Business

Robert F.X. Sillerman, the founder, executive chairman and chief executive officer of Viggle Inc. (NASDAQ:VGGL), has proposed to acquire, either individually or through his affiliates, 25 percent of the company’s Wetpaint business for $10 million in cash.

In addition, as part of his proposal, he would receive an option to acquire the remaining 75 percent of Wetpaint within 24 months for $40 million. The latter amount would be payable by a minimum of $20 million in cash, and the balance by the issuance of a five-year note bearing interest at 6 percent per annum

Viggle Inc. is a mobile and web-based entertainment marketing platform for media companies, brands, and consumers. Wetpaint, a property of Viggle, is an entertainment web destination that targets the 18-34 female demographic.

In a March 19, 2015 message to Viggle’s board of directors, the Wetpaint business is defined as everything related to conducting the business of Wetpaint as it currently operates.

“This proposal should be attractive to the Viggle board of directors and its shareholders,” said Mr. Sillerman. “I have asked Viggle’s board to consider this a serious offer that, although subject to certain customary conditions, is in every party’s best interest.”

The offer would be subject to the receipt of all necessary approvals by the Viggle board of directors and any special committee formed for the purpose of evaluating the proposal, and the execution of a mutually agreeable stock purchase agreement.

Mr. Sillerman has retained the law firm Fried, Frank, Harris, Shriver & Jacobson LLP as counsel in connection with the proposal. Mr. Sillerman also said that he intended to file an amendment to his Schedule 13D disclosing this proposal.

Cautionary statement

Statements in this document represent the intentions, plans, expectations and beliefs of Mr. Sillerman and involve risks and uncertainties that could cause actual events to differ materially from the events described in this release, including risks or uncertainties related to whether the proposed transaction will be completed, as well as changes in general economic conditions, stock market trading conditions, government regulation, and changes in the business or prospects of the Company. These factors, as well as factors described in Mr. Sillerman’s and the Viggle’s SEC filings are among the factors that could cause actual events or results to differ materially from Mr. Sillerman’s current expectations described in this release.

This document does not constitute an offer to sell or the solicitation of an offer to buy any securities. Any offering of securities will be made only by means of a prospectus meeting the requirements of Section 10 of the U.S. Securities Act of 1933, as amended.

Media:
The Marino Organization
Steve Vitoff, 212-889-0808
steve@themarino.org

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(NXTD) Wocket Biometric Smart Wallet to Air on “I Want That” International CES Special

OXFORD, Conn., March 20, 2015  — NXT-ID, Inc. (NASDAQ:NXTD) (“NXT-ID” or the “Company”), a biometric authentication company focused on the growing mobile commerce market, announces its biometric payment technology, the Wocket® smart wallet is one of the products featured in 2015 “I Want That” International CES Special, airing today, March 20th at 11:00 PM EST on the DIY Network.

DIY’s “I Want That” travels to Las Vegas, site of the 2015 International CES for a firsthand look at the emerging innovations, connectivity and cross-industry collaborations. It’s where everyone who cares about the future of technology comes to see what’s new … and this year, “I Want That” is in the middle of it all! In this special hour of “I Want That”, find out what’s the best and the most buzz worthy in ground breaking technology. The special features the wildest and smartest gadgets, state of the art appliances for the home, and the high tech toys everyone is talking about.

To catch the segment, tune into the DIY Network this Friday at 11pm EST. Please check your local listings for the channel number. http://www.diynetwork.com/diy/programdaily/0,,DIY_33156_EST,00.html

Some of the accolades for the Wocket™ smart wallet at CES 2015 in Las Vegas include Wocket being named one of the “11 Hot Products at CES” in a review published in Wired.com, one of the “5 Best Products Launched At CES So Far” by Newseveryday.com and “The top 10 gadgets from CES 2015” by Danny Jacobs at the Daily Record.

Wocket is a smart wallet designed to protect your identity and replace all the cards in your wallet, with no smart phone or cloud required. Wocket works anywhere credit cards are accepted and only works with your biometric stamp of approval.

All your credit, debit, loyalty, gift, ID, membership, insurance, tickets, medical information, passwords, and virtually any other card can be protected on Wocket.

Watch the Wocket video as seen on CNBC: https://www.youtube.com/watch?v=qRxloq-n8Ks

Order your Wocket by invitation at www.wocketwallet.com

About NXT- ID Inc. – Mobile Security for a Mobile World: (NXTD) (NXTDW):

NXT-ID, Inc.’s innovative MobileBio® solution mitigates consumer risks associated with mobile computing, m-commerce and smart OS-enabled devices. The company is focused on the growing m-commerce market, launching its innovative MobileBio® suite of biometric solutions that secure consumers’ mobile platforms led by Wocket®; a next generation smart wallet designed to replace all the cards in your wallet, no smart phone required. Wocket was recognized as one of the top technology products at CES 2015 by multiple media outlets including Wired.com. The Wocket works anywhere credit cards are accepted and only works with your biometric stamp of approval. http://www.wocketwallet.com/

NXT-ID’ wholly owned subsidiary, 3D-ID LLC, is engaged in biometric identification and has 22 licensed patents in the field of 3D facial recognition http://www.nxt-id.com/, http://3d-id.net/

Forward-Looking Statements for NXT-ID: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company’s business strategy. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Such risks and uncertainties include, among other things, our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the availability of financing; the Company’s ability to implement its long range business plan for various applications of its technology; the Company’s ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company’s technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission.

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(IDI) Announces Completion of One-for-Five Reverse Stock Split

Tiger Media, Inc. (“Tiger Media” or the “Company”) (NYSE MKT: IDI), a Shanghai-based multi-platform media company, announced today that the previously approved reverse stock split of the Company’s ordinary shares, par value $0.0001 per share, at a ratio of one-for-five (the “Stock Split”), became effective after the close of business on March 19, 2015. The Company’s common stock will begin trading on a split-adjusted basis at the open of business on the morning of March 20, 2015. The Company’s common stock will continue to trade on the NYSE MKT under the symbol IDI with a new CUSIP of 88674Y 105. The ability to trade in the Company’s common stock should be unaffected by the Stock Split. Also, the Company announced the completion of its domestication as a Delaware corporation (the “Domestication”), effective before the open of business on March 20, 2015. The Company expects to complete the previously announced acquisition of The Best One, Inc. after the close of business on Friday.

About Tiger Media, Inc.

Tiger Media is a leading Shanghai-based multi-platform media company in China which provides advertising services in the out-of-home advertising industry, including iScreen Outdoor LCD screens, billboards and street furniture. Tiger Media’s network of street level LCD screen displays, which captivate eye-level awareness, is complemented by outdoor billboards which are mostly built on rooftops with good visibility from far distances. Tiger Media’s network attracts advertising clients from a wide range of industries including telecommunications, insurance and banking, automobile, electronics and fast moving consumer goods. Learn more at www.tigermedia.com.

FORWARD LOOKING STATEMENTS

This press release contains “forward-looking statements,” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipate,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning. Such forward looking statements include statements about the expected completion of the Merger. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: the ability of each of Tiger Media and TBO to satisfy the closing conditions and consummate the transaction, and the other risks set forth in Tiger Media’s Annual Report on Form 20-F, filed with the SEC on March 31, 2014, and Tiger Media’s proxy statement for the Special Meeting of Ordinary Shareholders held on March 17, 2015, filed with the SEC on February 13, 2015, as well as the other factors described in the filings that Tiger Media makes with the SEC from time to time.

The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements, except as required under applicable law. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

 

Tiger Media, Inc.
Investor Relations:
Joshua Weingard, 305-575-4602
ir@tigermedia.com

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(CANF) Completes Commercial Biomarker Test to Predict Patient Response

Patented blood test to be used in clinical trials and as a companion diagnostic for Can-Fite’s Drugs

PETACH TIKVA, Israel, March 18, 2015  — Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that are being developed to treat inflammatory diseases, cancer and sexual dysfunction, announced today it has completed the development of a commercial predictive biomarker blood test kit for the A3 adenosine receptor (A3AR). The biomarker test can be used at any molecular biology lab, where a small blood sample from a prospective patient would be tested and within just a few hours, results indicate if the patient would benefit from treatment with Can-Fite’s drugs, which are currently in clinical trials for rheumatoid arthritis, psoriasis, and liver cancer.

A3AR is present in high concentrations in inflammatory cells and cancer cells. Can-Fite’s proprietary drugs target and bind to A3AR, causing cancer and inflammatory cell apoptosis (programmed cell death). This creates a targeted anti-cancer and anti-inflammatory effect, while leaving normal cells unharmed. Identifying patients with elevated A3AR levels would indicate which patients would benefit most from Can-Fite’s drugs, thereby offering personalized medicine.

“The completion of the development of our commercial A3AR biomarker test kit comes at a very important time since we plan to use the test kit in our upcoming advanced clinical studies. We believe the test kit will create efficiencies in our trials in patient enrollment and monitoring. As we progress into late-stage clinical trials for CF101 in auto-immune diseases, our A3AR biomarker test kit is ready for wide-scale use to help doctors and their patients identify who will be most responsive to Can-Fite’s drugs. We believe these patients can significantly benefit from personalized medicine due to the high degree of clinical heterogeneity,” stated Can-Fite CEO Dr. Pnina Fishman.

The U.S. Patent and Trademark Office issued Can-Fite a patent for the utilization of A3AR as a biomarker to predict patient response to its drug CF101 in autoimmune inflammatory indications. In December 2013, Can Fite reported favorable results from its Phase IIb rheumatoid arthritis clinical trial for CF101, an A3AR agonist. Only patients with elevated baseline expression levels of the biomarker A3AR were enrolled in the study. CF101 met all primary efficacy endpoints, showing statistically significant superiority over placebo in reducing signs and symptoms of rheumatoid arthritis.

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, inflammatory disease and sexual dysfunction. The Company’s CF101 is in Phase II/III trials for the treatment of psoriasis and the Company is preparing for a Phase III CF101 trial for rheumatoid arthritis. Can-Fite’s liver cancer drug CF102 is in Phase II trials and has been granted Orphan Drug Designation by the U.S. Food and Drug Administration. CF102 has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. The Company’s CF602 has shown efficacy in the treatment of erectile dysfunction. Can-Fite has initiated a full pre-clinical program for CF602 in preparation for filing an IND with the U.S. FDA in this indication.  These drugs have an excellent safety profile with experience in over 1,200 patients in clinical studies to date. For more information please visit: www.can-fite.com

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements, including, but not limited to, the factors summarized in Can-Fite’s filings with the SEC and in its periodic filings with the TASE.  In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control.  Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or otherwise.

Contact

Can-Fite BioPharma

Motti Farbstein

info@canfite.com

+972-3-9241114

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Biometric Company (NXTD) Ships Wocket Smart Wallets to Early Access Pre-Order Customers

OXFORD, CT–(Mar 17, 2015) – NXT-ID, Inc. (NASDAQ: NXTD) (NASDAQ: NXTDW) (“NXT-ID” or the “Company”), a biometric authentication company focused on the growing mobile commerce market, announces it has shipped the first Wocket® smart wallets.

“We will be shipping a limited number of Wockets to early access pre-order customers over the next few weeks in preparation of fulfilling all pre-orders,” said Gino Pereira, Chief Executive Officer of NXT-ID. “We will incorporate early access customer feedback from these shipments into Wockets we will ship to all pre-paid customers this spring to ensure a positive experience for all of our early adopters.”

He went on to say, “We are extremely excited to see the Wocket evolving into the revolutionary payment and smart wallet technology we envisioned at inception. This shipment marks the introduction of a new era in smart, privacy-centric products, and represents a major milestone in establishing Wocket as the smart wallet of the future.”

Wocket is a smart wallet designed to protect your identity and replace all the cards in your wallet, with no smart phone or cloud required. Wocket works anywhere credit cards are accepted and only works with your biometric stamp of approval.

All your credit, debit, loyalty, gift, ID, membership, insurance, tickets, medical information, passwords, and virtually any other card can be protected on Wocket.

Watch the Wocket video as seen on CNBC: https://www.youtube.com/watch?v=qRxloq-n8Ks

Order your Wocket by invitation at www.wocketwallet.com

About NXT-ID Inc. – Mobile Security for a Mobile World: (NXTD) (NXTDW):
NXT-ID, Inc.’s innovative MobileBio® solution mitigates consumer risks associated with mobile computing, m-commerce and smart OS-enabled devices. The company is focused on the growing m-commerce market, launching its innovative MobileBio® suite of biometric solutions that secure consumers’ mobile platforms led by Wocket®; a next generation smart wallet designed to replace all the cards in your wallet, no smart phone required. Wocket was recognized as one of the top technology products at CES 2015 by multiple media outlets including Wired.com. The Wocket works anywhere credit cards are accepted and only works with your biometric stamp of approval. http://www.wocketwallet.com/

NXT-ID’s wholly owned subsidiary, 3D-ID LLC, is engaged in biometric identification and has 22 licensed patents in the field of 3D facial recognition http://www.nxt-id.com/, http://3d-id.net/

Forward-Looking Statements for NXT-ID: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company’s business strategy. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Such risks and uncertainties include, among other things, our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the availability of financing; the Company’s ability to implement its long range business plan for various applications of its technology; the Company’s ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company’s technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission.

NXT-ID Inc. Contact:
Corporate info:
Email Contact

Investors:
Email Contact

Media:
D. Van Zant
800 665-0411
Email Contact

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FDA Approves (RTRX) Cholbam for the Treatment of Rare Bile Acid Synthesis Disorders

Retrophin, Inc. (NASDAQ:RTRX) announced today that the U.S. Food and Drug Administration (FDA) has approved Cholbam (cholic acid) capsules, the first FDA approved treatment for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).

As a result of the approval, Retrophin will exercise its right to purchase from Asklepion Pharmaceuticals, LLC all worldwide rights, titles, and ownership of Cholbam and related assets. Under the terms of the agreement announced on January 12, 2015, Retrophin will pay Asklepion a one-time cash payment of $27 million, in addition to approximately 661,278 shares of Retrophin common stock (initially valued at $9 million at the time of the agreement), which assumes Cholbam received an approval for a CTX indication. Asklepion will also be eligible to receive up to $37 million in cumulative sales milestones, as well as tiered royalties based on future net sales of Cholbam.

The FDA also granted Asklepion a Rare Pediatric Disease Priority Review Voucher (“Pediatric PRV”), a provision that encourages development of new drugs and biologics for the prevention and treatment of rare pediatric diseases. This voucher is designed to be transferable or sold and provides the bearer with an expedited FDA review for any new drug application. The Pediatric PRV will be transferred to Retrophin under the original terms of the agreement with Asklepion.

“With FDA approval, Cholbam will be available to patients suffering from several life-threatening diseases that until now, had no approved treatment. Cholbam complements Retrophin’s existing bile acid therapy, Chenodal (chenodeoxycholic acid), and will position us as the leading provider of treatments for patients with these bile acid synthesis and peroxisomal disorders,” said Stephen Aselage, Chief Executive Officer of Retrophin.

The effectiveness of Cholbam has been demonstrated in clinical trials for bile acid synthesis disorders and the adjunctive treatment of peroxisomal disorders. There are approximately 30 patients currently receiving Cholbam through an open label extension of these trials. The estimated incidence of bile acid synthesis disorders due to single enzyme defects is 1 to 9 per million live births. Peroxisomal disorders are believed to affect approximately 1 in 50,000 live births.

Cholbam will have seven years market exclusivity in the United States conferred by its designation as an orphan drug. Retrophin expects to close the acquisition and be able to begin distributing therapy in as few as two to four weeks, subject to the satisfaction of customary closing conditions.

About Retrophin

Retrophin is a pharmaceutical company focused on the development, acquisition and commercialization of drugs for the treatment of serious, catastrophic or rare diseases for which there are currently no viable options for patients. The Company’s approved products include Chenodal® and Thiola®, and its pipeline includes compounds for several catastrophic diseases, including focal segmental glomerulosclerosis (FSGS), pantothenate kinase-associated neurodegeneration (PKAN), infantile spasms, nephrotic syndrome and others. For additional information, please visit www.retrophin.com.

Forward-Looking Statements

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Without limiting the foregoing, these statements are often identified by the words “may”, “might”, “believes”, “thinks”, “anticipates”, “plans”, “expects”, “intends” or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with the Company’s ability to consummate the acquisition of Cholbam or the Pediatric PRV, the effectiveness of Cholbam in treating bile acid synthesis disorders or peroxisomal disorders, the Company’s ability to leverage Cholbam as a complement to the Company’s existing bile acid therapy, the Company’s ability to position itself as the leading provider of treatments for patients with bile acid synthesis and peroxisomal disorders, the incidence rate of bile acid synthesis disorders and peroxisomal disorders, Cholbam receiving an approval for a CTX indication, the Company’s business and finances in general, as well as risks and uncertainties associated with the Company’s sales and marketing strategies. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties as included in the Company’s filings with the Securities and Exchange Commission.

Retrophin, Inc.
Chris Cline, CFA, 646-564-3680
Manager, Investor Relations
IR@retrophin.com

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(MSCC) to Acquire (VTSS)

— Expands differentiated technology offering for strategic communication infrastructure applications and customers — Increases traction in carrier, enterprise and industrial-IoT markets enabling broader solution sale — Delivers immediate EPS accretion and synergies

ALISO VIEJO, Calif. and CAMARILLO, Calif., March 18, 2015  — Microsemi Corporation (Nasdaq: MSCC), a leading provider of semiconductor solutions differentiated by power, security, reliability and performance, and Vitesse Semiconductor Corporation (Nasdaq: VTSS), jointly announced today that Microsemi has entered into a definitive agreement to acquire Vitesse for $5.28 per share through a cash tender offer, representing a premium of 32 percent based on the average closing price of Vitesse’s shares of common stock during the 30 trading days ended March 17, 2015. The board of directors of Vitesse unanimously recommends that Vitesse’s stockholders tender their shares in the tender offer. The total transaction value is approximately $389 million.

Headquartered in Camarillo, California, Vitesse designs a diverse portfolio of high-performance semiconductors, application software, and integrated turnkey systems solutions for carrier, enterprise and Internet of Things (IoT) networks worldwide. Vitesse’s products enable the fastest-growing network infrastructure markets including mobile access/IP edge, enterprise cloud access, and industrial-IoT networking.

“This acquisition is further evidence of Microsemi’s continuing commitment to grow as a communications semiconductor company,” stated James J. Peterson, Microsemi chairman and CEO. “Vitesse’s highly complementary technology suite will expand our product offering and accelerate growth with differentiated technology in emerging markets, while benefitting from the increased scale, consolidated infrastructure and cost savings of the combined entity.”

“The proposed acquisition of Vitesse by Microsemi will create a powerful combination,” said Chris Gardner, Vitesse’s chief executive officer. “I believe Microsemi will be able to leverage Vitesse’s Ethernet technology and capabilities further into the communications market and has the scale to implement the adoption of our industrial IoT strategy.”

Microsemi expects significant synergies from this transaction and expects to see immediate accretion in the first full quarter of completion. Based on current assumptions, Microsemi expects the acquisition to be $0.16 to $0.20 per share accretive in its first full fiscal year ending September 30, 2016.

As of this date, Microsemi remains comfortable with its Jan. 22, 2015 non-GAAP guidance for its second fiscal quarter of 2015, ending March 29, 2015. Microsemi currently intends to announce its second fiscal quarter results on April 23, 2015. Further details will be forthcoming.

Tender Offer and Closing

Under the terms of the definitive acquisition agreement, Microsemi will commence a cash tender offer to acquire Vitesse’s outstanding shares of common stock at $5.28 per share, net to each holder in cash. Upon satisfaction of the conditions to the tender offer and after such time as all shares tendered in the tender offer are accepted for payment, the agreement provides for the parties to effect, as promptly as practicable, a merger which would result in all shares not tendered in the tender offer being converted into the right to receive $5.28 per share in cash. The tender offer is subject to customary conditions, including the tender of at least a majority of the outstanding shares of Vitesse’s common stock on a modified fully diluted basis and certain regulatory approvals, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, and is expected to close in Microsemi’s fiscal third quarter, ending June 28, 2015. No approval of the stockholders of Microsemi is required in connection with the proposed transaction. Terms of the agreement were unanimously approved by the boards of directors of both Microsemi and Vitesse. Microsemi has received support agreements from Vitesse stockholders holding approximately 22 percent of Vitesse’s outstanding common shares. Under the terms of the support agreements, these stockholders have agreed to tender their shares in the tender offer.

Under the terms of the merger agreement, Vitesse may solicit superior proposals from third parties for a “go shop” period of 21 calendar days continuing through April 7, 2015. It is not anticipated that any developments will be disclosed with regard to this process unless and until Vitesse’s board of directors makes a decision to pursue a potential superior proposal. Deutsche Bank will assist Vitesse with its go shop process. There are no guarantees that this process will result in a superior proposal. The merger agreement provides Microsemi with a customary right to match a superior proposal. The agreement also provides for certain break-up fees payable to Microsemi in connection with the termination of the agreement in certain circumstances.

BofA Merrill Lynch is providing customary committed debt financing for the acquisition.  BofA Merrill Lynch and RBC Capital Markets acted as financial advisors, and O’Melveny & Myers LLP is acting as legal adviser to Microsemi. Deutsche Bank and Needham & Company are acting as financial advisors and Stubbs Alderton & Markiles, LLP is acting as legal advisor to Vitesse.

Webcast

Microsemi is hosting an analyst day today in New York, and will briefly address details of the transaction at that event. A live webcast and the accompanying presentation relating to the transaction will be available in the “Investors” section of Microsemi’s website at www.microsemi.com.

Webcast date: March 18, 2015
Time: 9-11:30 a.m. EDT
Webcast link: http://investor.microsemi.com/Microsemi-s-Analyst-Day-2015

A replay of the company’s analyst day webcast will also be available in the “Investors” section of Microsemi’s website.

About Microsemi

Microsemi Corporation (Nasdaq: MSCC) offers a comprehensive portfolio of semiconductor and system solutions for communications, defense & security, aerospace and industrial markets. Products include high-performance and radiation-hardened analog mixed-signal integrated circuits, FPGAs, SoCs and ASICs; power management products; timing and synchronization devices and precise time solutions, setting the world’s standard for time; voice processing devices; RF solutions; discrete components; security technologies and scalable anti-tamper products; Power-over-Ethernet ICs and midspans; as well as custom design capabilities and services. Microsemi is headquartered in Aliso Viejo, Calif., and has approximately 3,400 employees globally. Learn more at www.microsemi.com.

Microsemi and the Microsemi logo are registered trademarks or service marks of Microsemi Corporation and/or its affiliates. Third-party trademarks and service marks mentioned herein are the property of their respective owners.

About Vitesse

Vitesse (Nasdaq: VTSS) designs a diverse portfolio of high-performance semiconductors, application software, and integrated turnkey systems solutions for Carrier, Enterprise and Internet of Things (IoT) networks worldwide. Vitesse products enable the fastest-growing network infrastructure markets including Mobile Access/IP Edge, Cloud Access and Industrial-IoT Networking. Visit www.vitesse.com or follow us on Twitter @VitesseSemi.

Vitesse is a registered trademark of Vitesse Semiconductor Corporation in the United States and other jurisdictions. All other trademarks or registered trademarks mentioned herein are the property of their respective holders.

Microsemi Safe Harbor Statement

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements based on current expectations or beliefs, as well as a number of assumptions about future events, and these statements are subject to factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The reader is cautioned not to put undue reliance on these forward-looking statements, which are not a guarantee of future performance and are subject to a number of uncertainties and other factors, many of which are outside the control of Microsemi and Vitesse. The forward-looking statements in this release address a variety of subjects including, for example, the expected date of closing of the acquisition, the potential benefits of the merger, including the potentially accretive and synergistic benefits, Microsemi’s revenue and earnings guidance, and any other statements of belief or about the Microsemi’s plans, beliefs or expectations. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the risk that Vitesse’s business will not be successfully integrated with Microsemi’s business or complement its products, including product mix and acceptance, gross margins and operational and other cost synergies; costs associated with the merger, tender offer and financing; the unsuccessful completion of the tender offer; matters arising in connection with the parties’ efforts to comply with and satisfy applicable regulatory approvals and closing conditions relating to the transaction; increased competition and technological changes in the industries in which Microsemi and Vitesse compete; Microsemi’s reliance on government contracts for a portion of its sales, including impacts of any federal government shutdown; Microsemi’s failure to continue to move up the value chain in its customer offerings; negative or worsening worldwide economic conditions or market instability; downturns in the highly cyclical semiconductor industry; intense competition in the semiconductor industry and resultant downward price pressure; inability to develop new technologies and products to satisfy changes in customer demand or the development by the company’s competitors of products that decrease the demand for Microsemi’s products; unfavorable or declining conditions in end markets; inability of Microsemi’s compound semiconductor products to compete successfully with silicon-based products; production delays related to new compound semiconductors; variability of the company’s manufacturing yields; the concentration of the factories that service the semiconductor industry; delays in beginning production, implementing production techniques, resolving problems associated with technical equipment malfunctions, or issues related to government or customer qualification of facilities; potential effects of system outages; the effect of events such as natural disasters and related disruptions on our operations; inability by Microsemi to fulfill customer demand and resulting loss of customers; variations in customer order preferences; difficulties foreseeing future demand; rises in inventory levels and inventory obsolescence; potential non-realization of expected orders or non-realization of backlog; failure to make sales indicated by the company’s book-to-bill ratio; risks related to the company’s international operations and sales, including availability of transportation services, political instability and currency fluctuations; increases in the costs of credit and the availability of credit or additional capital only under more restrictive conditions or not at all; unanticipated changes in Microsemi’s tax provisions, results of tax examinations or exposure to additional income tax liabilities; changes in generally accepted accounting principles; principal, liquidity and counterparty risks related to Microsemi’s holdings in securities; environmental or other regulatory matters or litigation, or any matters involving contingent liabilities or other claims; the uncertainty of litigation, the costs and expenses of litigation, the potential material adverse effect litigation could have on Microsemi’s business and results of operations if an adverse determination in litigation is made, and the time and attention required of management to attend to litigation; uncertainty as to the future profitability of acquired businesses, and delays in the realization of, or the failure to realize, any accretion from acquisition transactions; any circumstances that adversely impact the end markets of acquired businesses; and difficulties in closing or disposing of operations or assets or transferring work, assets or inventory from one plant to another. In addition to these factors and any other factors mentioned elsewhere in this news release, the reader should refer as well to the factors, uncertainties or risks identified in the company’s most recent Form 10-K and all subsequent Form 10-Q reports filed by Microsemi with the SEC. Additional risk factors may be identified from time to time in Microsemi’s future filings. The forward-looking statements included in this release speak only as of the date hereof, and Microsemi does not undertake any obligation to update these forward-looking statements to reflect subsequent events or circumstances. Guidance is provided only on a non-GAAP basis due to the inherent difficulty of forecasting the timing or amount of certain items that have been excluded from the forward-looking non-GAAP measures, and a reconciliation to the comparable GAAP guidance has not been provided because certain factors that are materially significant to Microsemi’s ability to estimate the excluded items are not accessible or estimable on a forward-looking basis.

Vitesse Safe Harbor Statement

Certain statements either contained in or incorporated by reference into this press release, other than purely historical information, including estimates, projections and statements relating to Vitesse’s business plans and objectives, and the assumptions upon which those statements are based, are “forward-looking statements.” These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Such forward-looking statements include the ability of Vitesse and Microsemi to complete the transactions contemplated by the merger agreement, including the parties’ ability to satisfy the conditions to the consummation of the tender offer and the other conditions set forth in the merger agreement and the possibility of any termination of the merger agreement. The forward-looking statements contained in this release are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Actual results may differ materially from current expectations because of risks associated with uncertainties as to the timing of the tender offer and the subsequent merger; uncertainties as to how many of Vitesse’s stockholders will tender their shares in the tender offer; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the tender offer or the merger may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the tender offer or the merger; the effects of disruption from the transactions contemplated by the merger agreement on Vitesse’s business and the fact that the announcement and pendency of the transactions may make it more difficult to establish or maintain relationships with employees, suppliers and other business partners; the risk that stockholder litigation in connection with the tender offer or the merger may result in significant costs of defense, indemnification and liability; other uncertainties pertaining to the business of Vitesse, including those set forth in Vitesse’s filings with the SEC, especially in “Item 1A. Risk Factors” of Vitesse’s Annual Report on Form 10-K for the year ended September 30, 2014 filed with the SEC on December 4, 2014 and in other periodic reports and filings with the SEC from time to time, including Vitesse’s Quarterly Reports on Form 10-Q. The reader is cautioned not to unduly rely on these forward-looking statements. Vitesse expressly disclaims any intent or obligation to update or revise publicly these forward-looking statements except as required by law.

Notice to Investors

The tender offer for the outstanding shares of common stock of Vitesse has not yet commenced. This press release is for informational purposes only and no statement in this press release is an offer to purchase or a solicitation of an offer to sell securities. At the time the tender offer is commenced, Microsemi Corporation and a wholly-owned subsidiary of Microsemi Corporation will file a tender offer statement on Schedule TO with the Securities and Exchange Commission, and Vitesse will file a solicitation/recommendation statement on Schedule 14D-9 with respect to the tender offer. The tender offer statement (including an offer to purchase, a related letter of transmittal and other offer documents) and the solicitation/recommendation statement will contain important information that should be read carefully before any decision is made with respect to the tender offer. Such materials will be made available to Vitesse’s stockholders at no expense to them. In addition, such materials (and all other offer documents filed with the SEC) will be available at no charge on the SEC’s Web site: www.sec.gov.

Wednesday, March 18th, 2015 Uncategorized Comments Off on (MSCC) to Acquire (VTSS)

(GLMD) to Present at the Metabolic Leaders’ Forum 2015

TEL AVIV, Israel, March 17, 2015  — Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) (“Galmed”), a clinical-stage biopharmaceutical company focused on the development and commercialization of a once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones, announced today that Dr. Maya Halpern, Galmed’s Chief Medical Officer, will present at the Metabolic Leaders’ Forum 2015, which will be held in Boston beginning on Tuesday, March 24, 2015.  Dr. Halpern’s presentation will be given on Wednesday, March 25, 2015, at 3:05pm Eastern Time/12:05pm Pacific Time, on the topic of “Treatment of Non-Alcoholic Fatty Liver Diseases:  How early is early?”

“I am excited to present our pioneering strategy of developing aramchol to treat Non-Alcoholic Steato-Hepatitis, or NASH, patients not only as a liver-related disorder, but also as a significant factor in the worsening of metabolic syndrome,” commented Dr. Halpern.  “We also believe our compelling safety data to date differentiates aramchol as a possible chronic treatment for NASH patients with a high risk of cardiovascular disease.”

Dr. Halpern concluded, “The Metabolic Leaders’ Forum is a great opportunity for Galmed to gain greater exposure to, and interaction with the pharmaceutical industry’s relevant stakeholders.”

Galmed’s ARREST study is a multi-center, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb clinical trial of aramchol.  The study’s primary end-point is a statistically significant reduction of liver fat content measured by MRS, and the study’s secondary end-points are the complete resolution of NASH, as measured by two biopsies at the beginning and end of the study, and improvement of the Non-Alcoholic Fatty Liver Diseases activity score, as well as an improvement in the markers of liver inflammation and various metabolic biomarkers.

About Galmed Pharmaceuticals Ltd.
Galmed is a clinical-stage biopharmaceutical company focused on the development and commercialization of a novel, once-daily, oral therapy for the treatment of liver diseases and cholesterol gallstones utilizing its proprietary first-in-class family of synthetic fatty-acid/bile-acid conjugates, or FABACs. Galmed believes that its product candidate, aramchol, has the potential to be a disease modifying treatment for fatty liver disorders, including NASH, which is a chronic disease that Galmed believes constitutes a large unmet medical need.

Forward-Looking Statements
This press release includes forward-looking statements. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Applicable risks and uncertainties include those identified under the heading “Risk Factors” included in the registration statement on Form F-1 (File No. 333 -193792), initially filed with the Securities and Exchange Commission, or the SEC, on February 6, 2014 and declared effective by the SEC on March 12, 2014, and in other filings that Galmed has made and may make with the SEC in the future. The forward-looking statements contained in this press release reflect Galmed’s current views with respect to future events, and Galmed does not undertake and specifically disclaims any obligation to update any forward-looking statements.

Tuesday, March 17th, 2015 Uncategorized Comments Off on (GLMD) to Present at the Metabolic Leaders’ Forum 2015

(PCYO) Announces $53 Million Sale of Agricultural Holdings

DENVER, CO–(Mar 17, 2015) –  Pure Cycle Corporation (NASDAQ: PCYO) announces today that it has entered into a Purchase and Sale Agreement with Arkansas River Farms LLC, an affiliate of C&A Companies and Resource Land Holdings LLC, to sell its approximate 14,600 acres of Farm land.

Farm Sale

Pure Cycle has entered into an agreement with Arkansas River Farms, LLC, to sell its approximate 14,600 acres of farm holdings and water interests in the Fort Lyon Canal Company for approximately $53 million. “We have very much enjoyed our experience with our operations in the region, working with our tenant farmers, the Fort Lyon Canal Company, other ditch systems and interests in the valley and believe Arkansas River Farms will continue this effort with their focus on improving and expanding these agricultural operations in the Fort Lyon system and Arkansas Valley,” commented Mr. Mark Harding President and CEO. “We were impressed with C&A’s history and stewardship in the Arkansas Valley, coupled with Resource Land Holdings’ track record of investing in agriculture,” continued Mr. Harding.

“This sale will expand our opportunities to develop water and infrastructure from our Denver portfolio assets including our Sky Ranch property, which we continue to work to identify a development partner with expertise in developing projects of this size to bring this project to market. Additionally, we are excited with the recent completion of the WISE Project, which interconnects water systems among 13 Denver area water providers to pursue regional water supply projects,” added Harding.

Pursuant to our agreement, Arkansas River Farms will have a 60-day due diligence period, subject to one 30-day extension, with a closing expected mid-June 2015. The Company looks forward to assisting with the transition of this farm portfolio and look forward to expanding our opportunities in the Denver water service market.

Company Information

Pure Cycle owns water assets in the Denver, Colorado metropolitan area. Pure Cycle provides water and wastewater services to customers located in the Denver metropolitan area including the design, construction, operation and maintenance of water and wastewater systems.

Additional information including our recent press releases and Annual Reports are available at www.purecyclewater.com, or you may contact our President, Mark W. Harding, at 303-292-3456 or at info@purecyclewater.com.

C & A Companies is a Colorado based real estate investment and operations company with interests ranging from residential to multifamily and commercial real estate investments. The firm has invested in agricultural projects in the Arkansas River Valley for 15 years and most recently completed a forage assemblage of over 10,000 irrigated acres in a joint venture with Syracuse Dairy.

Resource Land Holdings, LLC is a real estate private equity firm based in Denver, Colorado with a focus on natural resource real estate including agricultural, timber and mining properties throughout the US and Canada. Resource Land Holdings has organized private equity funds with in excess of $550 million of committed equity and purchased assets across twenty five US states and Canada.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements are all statements, other than statements of historical facts, included in this press release that address activities, events or developments that we expect or anticipate will or may occur in the future, such as statements about the expansion of opportunities in the Denver water service market, including opportunities to develop water and infrastructure from the Company’s Denver assets, plans to develop the Sky Ranch property, and the anticipated timing of the closing of the proposed transaction. The words “anticipate,” “likely,” “may,” “should,” “could,” “will,” “believe,” “estimate,” “expect,” “plan,” “intend” and similar expressions are intended to identify forward-looking statements. Investors are cautioned that forward-looking statements are inherently uncertain and involve risks and uncertainties that could cause actual results to differ materially. Factors that could cause actual results to differ from projected results include, without limitation: the possibility that we may be unable to obtain shareholder approval or the parties to the Purchase and Sale Agreement may be unable to satisfy the other conditions to closing the proposed transaction; the proposed transaction may involve unexpected costs; the risk factors discussed in Part I, Item 1A of our most recent Annual Report on Form 10-K; and those factors discussed from time to time in our press releases, public statement and documents filed or furnished with the U.S. Securities and Exchange Commission. Except as required by law, we disclaim any obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Mark W. Harding
President
303-292-3456
Email Contact

Tuesday, March 17th, 2015 Uncategorized Comments Off on (PCYO) Announces $53 Million Sale of Agricultural Holdings

(ESPR) Announces Positive Top-Line Phase 2b Results for ETC-1002

ETC-1002-009 Study Meets Primary Endpoint LDL-Cholesterol Lowering Significantly Greater Than Placebo ETC-1002 Observed to Be Safe and Well-Tolerate Conference Call and Webcast on Tuesday, March 17, 2015 at 8:00 a.m. Eastern Time

ANN ARBOR, MI–(March 17, 2015) – Esperion Therapeutics, Inc. (NASDAQ: ESPR), an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral low-density lipoprotein cholesterol (LDL-cholesterol) lowering therapies for the treatment of hypercholesterolemia and other cardiometabolic risk markers, today announced positive top-line results from ETC-1002-009, a Phase 2b study evaluating the efficacy and safety of ETC-1002 (bempedoic acid) compared with placebo in patients with hypercholesterolemia on stable statin therapy.

Top-line results showed the 12-week study met its primary endpoint of greater LDL-cholesterol lowering from baseline with ETC-1002 compared with placebo. ETC-1002-treated patients achieved 17 and 24 percent incremental reductions in LDL-cholesterol at doses of 120 mg and 180 mg, respectively, compared with patients on stable statin therapy alone. These reductions were significantly different from placebo (p=.0055 and p<.0001, respectively), occurred within the first two weeks of initiating therapy, and continued throughout the treatment period.

Consistent with prior studies, ETC-1002 demonstrated reductions of up to 30 percent in high-sensitivity C-reactive protein (hsCRP), an important marker of inflammation in coronary disease.

“Many patients with hypercholesterolemia still have elevated LDL-cholesterol levels despite being on statin therapy, and are often unable to tolerate the statin doses necessary to achieve optimal LDL-cholesterol lowering,” said Tim M. Mayleben, president and chief executive officer of Esperion. “ETC-1002 has once again demonstrated impressive incremental LDL-cholesterol lowering. Importantly, ETC-1002 was observed to be safe and well-tolerated when added to stable statin therapy, and may be an appropriate addition to existing therapy in these patients.”

ETC-1002 produced no increases in muscle-related adverse events (AEs). There was one reported serious adverse event (SAE) in the ETC-1002 treatment arms, which was not drug-related. Discontinuation rates were low overall and lower in ETC-1002-treated patients than those seen in placebo, and were not muscle-related.

“We are encouraged by these results, not only because ETC-1002 demonstrated clinically meaningful reductions in LDL-cholesterol in this population, but because they are consistent with our previous studies,” said Mayleben. “With the continued attractive safety and tolerability profile, this Phase 3-enabling study reinforces the potential for ETC-1002 to provide a once-daily, oral treatment option for a broad range of patients with hypercholesterolemia, including those with uncontrolled LDL-cholesterol levels despite stable statin therapy.”

ETC-1002-009 Design

The 12-week, multicenter, randomized, double-blind, placebo-controlled, parallel group Phase 2b study evaluated the efficacy and safety of ETC-1002 versus placebo when added to stable statin therapy in patients with hypercholesterolemia. Secondary objectives were to characterize the dose response; assess the effect of ETC-1002 on additional lipid and cardiometabolic risk markers, including hsCRP; characterize the safety and tolerability of ETC-1002; and qualitatively assess pharmacokinetic plasma trough concentrations. A total of 134 patients with hypercholesterolemia were washed out of any lipid-regulating therapies, except atorvastatin, simvastatin, rosuvastatin, or pravastatin. Forty-three* patients received ETC-1002 120 mg; 45 patients received ETC-1002 180 mg; 45 patients received placebo.

*One patient was randomized but did not receive study drug.

ETC-1002-009 Results

ETC-1002-treated patients achieved LDL-cholesterol lowering of up to an additional twenty-four (24) percent at 12 weeks compared with four (4) percent in the placebo group. Levels of hsCRP were reduced by up to thirty (30) percent with ETC-1002. ETC-1002 was safe and well tolerated, with no muscle-related AEs or ETC-1002-related SAEs.

Conference Call and Webcast Details

The Esperion management team will host a conference call and webcast today at 8:00 a.m. Eastern Time (ET) to discuss these results. The live event will be accessible on the investor relations section of the Esperion website at www.esperion.com, or by calling (877) 831-3840 (domestic) or (253) 237-1184 (international). The access code is 4415939. A replay of the event will be available approximately one hour after completion and will be archived on the Company’s website for approximately 90 days following the event.

Esperion’s Commitment to Cardiometabolic Disease

Esperion is committed to improving the lives of patients with cardiometabolic diseases. The Esperion team leverages its understanding of, and experience with, key biological pathways to discover and develop innovative therapies for the treatment of patients with hypercholesterolemia who have uncontrolled cholesterol levels despite the use of currently available therapies. Esperion has assembled a portfolio of programs including one product candidate in late-stage clinical evaluation (ETC-1002) and two preclinical product candidates.

About Esperion Therapeutics

Esperion Therapeutics, Inc. is an emerging pharmaceutical company focused on developing and commercializing first-in-class, oral, LDL-cholesterol lowering therapies for the treatment of patients with hypercholesterolemia and other cardiometabolic risk markers. ETC-1002, Esperion’s lead product candidate, is a first-in-class, orally available, once-daily small molecule designed to lower LDL-cholesterol levels and avoid the side effects associated with therapies currently available for lowering LDL-cholesterol. ETC-1002 is being developed primarily for patients with hypercholesterolemia and a history of statin intolerance. For more information, please visit www.esperion.com and follow us on Twitter at https://twitter.com/EsperionInc.

Forward-Looking Statements

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding the therapeutic potential of, and clinical development plan for, ETC-1002. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion’s actual results to differ significantly from those projected, including, without limitation, the risk that positive results from a clinical study of ETC-1002 may not necessarily be predictive of the results of future clinical studies, particularly in different or larger patient populations, or the risk that other unanticipated developments could interfere with the development (and commercialization) of ETC-1002, as well as other risks detailed in Esperion’s filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this release. Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

Media Contact:
Elliot Fox
W2O Group
212.257.6724
efox@w2ogroup.com

Investor Contact:
Mindy Lowe
Esperion Therapeutics, Inc.
734.887.3903
mlowe@esperion.com

Tuesday, March 17th, 2015 Uncategorized Comments Off on (ESPR) Announces Positive Top-Line Phase 2b Results for ETC-1002

(RXDX) Acquisition of Four Oncology R&D Assets From (TEVA)

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (“Teva”), a world leading global pharmaceutical company, and Ignyta, Inc. (Nasdaq: RXDX) (“Ignyta”), a precision oncology biotechnology company, today announced the acquisition by Ignyta of the worldwide rights and assets relating to four targeted oncology development programs in exchange for 1.5 million shares (6%) of Ignyta’s common stock.

Concurrently, Ignyta has entered into stock purchase agreements with Teva, and selected additional healthcare investors, whereby Teva will purchase a further 1.5 million shares of common Ignyta stock at a price of $10 per share in a registered direct offering. The other investors will purchase an additional 2.7 million shares at $10 per share, valuing the total offering at approximately $41.6 million.

“Teva has committed to finding novel ways for the ongoing development of early clinical stage and pre-clinical oncology R&D programs, which hold significant promise for cancer patients,” said Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer. “Ignyta’s capabilities and focus in oncology will give these assets the best chance of realizing their potential for patients, and of maximizing their value for Teva.”

“Acquiring these four development stage programs from Teva is truly transformational for Ignyta and well aligned with our strategic focus on developing first-in-class and best-in-class precision medicines to help cancer patients with unmet needs,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “These oncology programs add critical mass to our pipeline and further enable us to leverage our precision oncology platform, including our proprietary multiplex diagnostic assays and our CLIA certified, QSR compliant diagnostic laboratory. Furthermore, these new assets complement our entrectinib development program and extend our ability to target the majority of known oncogenic drivers across multiple solid tumor indications. For example, in non-small cell lung cancer alone, we believe that our product candidates have potential activity against many of the most frequent oncogenic drivers in this disease, and we plan to explore these opportunities through innovative clinical trial designs such as master protocols.”

“We are also grateful to Teva and the financial investors who share Ignyta’s precision oncology vision and invested in this latest financing,” continued Dr. Lim. “We intend to use the funds to further advance our precision oncology vision by developing targeted therapies that provide meaningful benefit to specific populations of cancer patients.”

Overview of Asset Acquisition Transaction

Under the terms of the asset purchase agreement with Teva, Ignyta is acquiring all of Teva’s assets and worldwide rights relating to four oncology development programs in exchange for 1.5 million shares of Ignyta’s common stock. Teva has agreed not to sell or otherwise transfer any of these shares until March 17, 2016, and Ignyta is required to register the resale of these shares with the Securities and Exchange Commission (SEC) prior to such date.

The development programs Ignyta purchased from Teva include:

  • CEP-32496, which Ignyta has renamed RXDX-105, a potent small molecule inhibitor of BRAF, EGFR and RET that is currently in a Phase I/II dose escalation clinical trial;
  • CEP-40783, which Ignyta has renamed RXDX-106, a potent, highly selective, pseudo-irreversible inhibitor of AXL and cMET that is in late preclinical development;
  • CEP-40125, which Ignyta has renamed RXDX-107, a nanoformulation of a modified bendamustine with potential activity in solid tumors that is in late preclinical development; and
  • TEV-44229, which Ignyta has renamed RXDX-108, a potent, selective inhibitor of the atypical kinase PKCiota that is in preclinical studies. Ignyta has also acquired next generation PKCiota inhibitors in addition to the lead compound.

Ignyta also assumed all of Teva’s ongoing obligations under certain contracts relating to the purchased programs, including the agreements under which Teva in-licensed rights to the assets.

Concurrent Equity Financing

Teva has agreed to purchase 1.5 million shares of Ignyta common stock for a purchase price of $10 per share, resulting in gross proceeds to Ignyta of $15 million. Ignyta has also entered into stock purchase agreements with several additional investors that will purchase an aggregate of 2.7 million additional shares of Ignyta common stock. The offering is expected to result in aggregate gross proceeds to Ignyta of approximately $41.6 million. The offering closed concurrently with the asset purchase. Ignyta did not use a placement agent in connection with this transaction.

A shelf registration statement relating to the shares of common stock issued in the offering was filed with, and declared effective by, the SEC. A prospectus supplement relating to the offering will be filed with the SEC. This press release shall not constitute an offer to sell or a solicitation of an offer to buy any shares of common stock. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.

Ignyta Slide Deck and Conference Call

Ignyta has posted a slide presentation relating to the Teva transaction, its new development programs and the concurrent equity financing on the Investors page of the company’s website at http://investor.ignyta.com. On Tuesday, March 17, 2015, Ignyta will host a conference call with interested parties beginning at 5:00 p.m. ET (2:00 p.m. PT) to discuss the transactions and related matters. A live webcast of the conference call will be available online on the Investors page of the company’s website at http://investor.ignyta.com. The call will also be archived and accessible at that site for one year. Alternatively, callers may participate in the conference call by dialing (888) 734-0328 (domestic) or (678) 894-3054 (international), and entering passcode 5138138.

Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, Ignyta’s development plans for its new product candidates, its other product candidates and discovery programs, the company’s financial status, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions to millions of patients every day. Headquartered in Israel, Teva is the world’s largest generic medicines producer, leveraging its portfolio of more than 1,000 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva’s net revenues in 2014 amounted to $20.3 billion. For more information, visit www.tevapharm.com.

About Ignyta, Inc.

Ignyta, Inc., located in San Diego, California, is a precision oncology biotechnology company pursuing an integrated therapeutic (Rx) and companion diagnostic (Dx) strategy for treating cancer patients. The company’s goal with this Rx/Dx approach is to discover, develop and commercialize new drugs that target activated cancer genes and pathways for the customized treatment of cancer. It aims to achieve this goal by pairing each of its product candidates with biomarker-based companion diagnostics that are designed to identify, at the molecular level, the patients who are most likely to benefit from the precisely targeted drugs the company develops. For more information, please visit: www.ignyta.com.

Teva’s Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements, which are based on management’s current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products; competition for our innovative products, especially Copaxone® (including competition from orally-administered alternatives, as well as from potential purported generic equivalents) and our ability to migrate users to our 40 mg/mL version; the possibility of material fines, penalties and other sanctions and other adverse consequences arising out of our ongoing FCPA investigations and related matters; our ability to achieve expected results from the research and development efforts invested in our pipeline of specialty and other products; our ability to reduce operating expenses to the extent and during the timeframe intended by our cost reduction program; our ability to identify and successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; the extent to which any manufacturing or quality control problems damage our reputation for quality production and require costly remediation; increased government scrutiny in both the U.S. and Europe of our patent settlement agreements; our exposure to currency fluctuations and restrictions as well as credit risks; the effectiveness of our patents, confidentiality agreements and other measures to protect the intellectual property rights of our specialty medicines; the effects of reforms in healthcare regulation and pharmaceutical pricing, reimbursement and coverage; governmental investigations into sales and marketing practices, particularly for our specialty pharmaceutical products; adverse effects of political or economic instability, major hostilities or acts of terrorism on our significant worldwide operations; interruptions in our supply chain or problems with internal or third-party information technology systems that adversely affect our complex manufacturing processes; significant disruptions of our information technology systems or breaches of our data security; competition for our generic products, both from other pharmaceutical companies and as a result of increased governmental pricing pressures; competition for our specialty pharmaceutical businesses from companies with greater resources and capabilities; the impact of continuing consolidation of our distributors and customers; decreased opportunities to obtain U.S. market exclusivity for significant new generic products; potential liability in the U.S., Europe and other markets for sales of generic products prior to a final resolution of outstanding patent litigation; our potential exposure to product liability claims that are not covered by insurance; any failure to recruit or retain key personnel, or to attract additional executive and managerial talent; any failures to comply with complex Medicare and Medicaid reporting and payment obligations; significant impairment charges relating to intangible assets, goodwill and property, plant and equipment; the effects of increased leverage and our resulting reliance on access to the capital markets; potentially significant increases in tax liabilities; the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; variations in patent laws that may adversely affect our ability to manufacture our products in the most efficient manner; environmental risks; and other factors that are discussed in our Annual Report on Form 20-F for the year ended December 31, 2014 and in our other filings with the U.S. Securities and Exchange Commission. Forward-looking statements speak only as of the date on which they are made and we assume no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Ignyta Forward-Looking Statements

This press release contains forward-looking statements about Ignyta as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to the development of Ignyta’s new or other product candidates, the potential advantages and first-in-class or best-in-class nature of these drug programs and the potential for Ignyta to establish a leadership position in oncology personalized medicine and provide benefit to cancer patients. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; regulatory developments in the United States and foreign countries; Ignyta’s ability to develop, complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in Ignyta’s plans to develop and commercialize its product candidates; the potential for final results of the ongoing Phase I/II clinical trials of entrectinib, or any future clinical trials of entrectinib or other product candidates, to differ from preliminary or expected results; Ignyta’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; Ignyta’s ability to obtain and maintain intellectual property protection for its product candidates; the potential for the company to fail to maintain the CLIA registration of its diagnostic laboratory or to fail to achieve full CLIA accreditation of such laboratory; the loss of key scientific or management personnel; competition in the industry in which Ignyta operates; and market conditions. These forward-looking statements are made as of the date of this press release, and Ignyta assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the company files with the SEC available at www.sec.gov, including without limitation Ignyta’s Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent Quarterly Reports on Form 10-Q.

Teva IR Contacts:
Kevin C. Mannix
United States
(215) 591-8912
or
Ran Meir
United States
(215) 591-3033
or
Tomer Amitai
Israel
972 (3) 926-7656
or
Teva PR Contacts:
Iris Beck Codner
Israel
972 (3) 926-7687
or
Denise Bradley
United States
(215) 591-8974
or
Ignyta
Jacob Chacko
United States
(858) 255-5959
jc@ignyta.com

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(INVT) Announces Operational Restructuring of Its Product Businesses

Product Subsidiary Anticipated to Be Profitable and Cash Positive in Q2 2015

CAMPBELL, CA–(Mar 17, 2015) – Inventergy Global, Inc. (NASDAQ: INVT) (“Inventergy”), today announced operational restructuring and process improvements for the product-based businesses of its wholly-owned subsidiary, eOn Communications Systems, Inc. (“ECS”), to strategically position the company to increase earnings, reduce costs, improve cash flow and build shareholder value. ECS is managed by its President Stephen Swartz.

The ECS business has three product/service lines:

a) A royalty bearing agreement with a third party for use of a private branch exchange (PBX) business which they had purchased from Inventergy’s predecessor eOn Communications Corporation (“ECC”);
b) A valued-added reseller business of biometric security and access control products; and
c) A new business that provides outsourced sales, marketing and technical support services to business partners in the security products and services industry.

Additionally, as part of the reorganization, ECS announced it has terminated a legacy business that provided distribution services of facility security and access control products. Inventergy inherited this business as part of its June 6, 2014 reverse merger with ECC. In 2014, this legacy business had net operating losses of approximately $35,000 per month. Terminating this legacy business and selling off the remaining inventory and accounts receivables also netted approximately $200,000 in cash for Inventergy. The resources from this legacy business have been redeployed to ECS’s biometric security and access control product line. This business has recently completed its value-add product improvements and these products are now ready for shipment. As a result of all of these changes, Inventergy expects the ECS subsidiary to be profitable and cash positive in Q2 2015.

Joe Beyers, Chairman and CEO of Inventergy, said, “We believe the restructuring of ECS supports our corporate growth strategy and enhances Inventergy’s business by adding additional revenue streams to our core licensing programs. Stephen Swartz has been instrumental in turning ECS into a business with increased operational profit potential. With Stephen at the helm of ECS, it allows the Inventergy management team to focus our energies on driving our core patent licensing, monetization and patent asset acquisition initiatives.”

About Inventergy Global, Inc.
Inventergy Global, Inc. is Silicon Valley-based intellectual property company dedicated to identifying, acquiring and licensing the patented technologies of market-significant technology leaders. Led by IP industry pioneer and veteran Joe Beyers, the Company leverages decades of corporate experience, market and technology expertise, and industry connections to assist Fortune 500 companies in leveraging the value of their innovations to achieve greater returns. For more information about Inventergy Global, visit www.inventergy.com.

About eOn Communications Systems, Inc.
eOn Communications Systems, Inc. is a wholly owned subsidiary of Inventergy Global, Inc. It has a branch office located in Corinth, Mississippi and is headed by Stephen Swartz, the former Principal Executive Officer of eOn Communications Corporation and is engaged in the sale and support of security related products and services.

Cautionary Statement Regarding Forward-Looking Statements
This press release includes “forward-looking statements” intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These statements include statements about our plans, strategies, financial performance, prospects or future events and involve known and unknown risks that are difficult to predict. As a result, our actual results, performance or achievements may differ materially from those expressed or implied by these forward-looking statements. These statements may be identified by the use of words like “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “will”, “should”, “seek” and similar expressions and include any projections or estimates set forth herein. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Inventergy and our management team, are inherently uncertain. A more complete description of these risks and uncertainties can be found in our filings with the U.S. Securities and Exchange Commission. We caution you not to place undue reliance on any forward-looking statements, which are made as of the date of this press release. We undertake no obligation to update publicly any of these forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable laws. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements.

For further investor and media information, contact:
Robert Haag
Managing Partner
IRTH Communications
invt@irthcommunications.com
1-866-976-4784

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(NETE) to Acquire Leading Payment Innovator PayOnline

Proprietary integrated platform strengthens Net Element’s global service offering

MIAMI, March 17, 2015  — Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a global technology leader in mobile payments and value-added transactional services today announced the entry into a binding term sheet by its wholly owned subsidiary TOT Group Europe, Ltd. to acquire and operate PayOnline, a regional industry leader in online transaction processing services and payment-enabling technology.

PayOnline enables online payment for more than 10 million active consumers and thousands of merchants in Commonwealth of Independent States (“CIS”), Europe and Asia.

PayOnline’s proprietary integrated platform of payment solutions provides innovations such as card2card transfer and payment split that will be incorporated into the Company’s global service offering to enhance competitiveness and capture market share in the U.S. and internationally.

PayOnline’s status as a Validated Level 1 PCI Data Security Service Provider means that customers using PayOnline’s platform have access to a flexible payment-as-a-service platform that has been independently verified to conform to the highest PCI standards.

PayOnline is an online payment industry leader in Russia where according to McKinsey & Company; ecommerce is growing at an annual rate of greater than 22%. PayOnline also serves the broader CIS, Europe and Asia markets.

Extrapolating from a market size assessment based on the 2014 McKinsey Global Payments Map, we believe PayOnline accounts for 30% of the online payments segment and 5% of the overall payments market. In addition, according to The Paypers “2014 Cross Border e-Commerce Country Report”, Payonline ranks as a top payment service provider in Russia. Payonline is certified and accredited by Visa and MasterCard, and is a MasterPass (MasterCard’s e-wallet) partner in Russia.

According to McKinsey & Company, Russia is the 6th largest payments market globally, accounting for $50 billion in payments with a growing online population.  McKinsey also noted that card issuance is growing at 30% per year and 43% of the Russian population use the Internet.

Net Element’s business is expected to benefit from PayOnline direct agreements with seven acquiring banks in Europe and five banks in CIS that allow electronic transactions on behalf of foreign merchants.

The acquisition will allow the Company to cross-sell and monetize PayOnline’s merchant and reseller relationships, deploy technologies and services in selected emerging markets, and integrate PayOnline’s proprietary technologies into Unified Payments offering in the United States.

“Our market position and user base allows Net Element to accelerate growth in the region and gives our payment innovations greater global reach,” commented Marat Abasaliev, PayOnline chief executive officer. “We expect to contribute greatly to the success of Net Elements business plan.”

“Our vision in CIS is to become a leader in transactional services, which includes all technological aspects of the payments ecosystem including all value-added offerings,” states Konstantin Zaripov, General Director of Emerging Markets for Net Element “TOT Money is already recognized as a leader in mobile payments and commerce. By acquiring PayOnline we are creating synergy between PayOnline, TOT Money and Unified Payments businesses to create a customer solution that covers all methods of online and mobile payments in Russia. Moving forward we plan to build on this synergy and pursue other additions to complete the ecosystem.”

“PayOnline’s market-leading services, partnerships and technologies are an ideal fit for Net Element’s expansion initiatives and to its existing portfolio of subsidiaries,” added Oleg Firer, Chief Executive Officer of Net Element. “With this acquisition, we expect to grow business faster by catering to a broader range of users in the United States, Russia and other markets.”

Post acquisition, Social Discovery Ventures (“SD Ventures”), whose holdings include Shocase, Shazam and Anastasia Date, will become a Net Element shareholder and the companies intend to pursue further strategic collaboration.

Terms of the proposed acquisition are disclosed in Net Element’s Form 8-K filed with the SEC today.

Closing of the acquisition is subject to Net Element’s satisfactory completion of due diligence, definitive documentation and other customary closing conditions.

About Net Element  

Net Element (NASDAQ: NETE) is a global payments-as-a-service, technology leader with an integrated mobile and transactional services platform serving millions of emerging market clients. Wholly owned subsidiary, TOT Group operates Unified Payments and Aptito, a next generation, cloud-based point of sale payments platform and TOT Money, a leading mobile payments service provider, which captures a growing share of the mobile payments market in Russia and ranked as a Top 3 mobile payments provider for two consecutive years, by Beeline, Russia’s second largest telecommunications operator.  Further information is available at www.netelement.com.

About PayOnline

PayOnline provides flexible high-tech payment solutions to companies doing business on the Internet. They  have wide experience in integration and customization of payment solutions for websites and mobile apps. They are able to arrange payments on the website of any commercial organization that increases convenience with highest possible level of successful transactions. Thousands of companies in CIS, Europe and Asia use PayOnline to accept payments online.PayOnline offices are located in Russia and in the Republic of Cyprus. For more information, please visit: www.payonline.ru/en.

About SD Ventures (Social Discovery Ventures)

Social Discovery Ventures is the international umbrella brand for group of technology and software engineering companies, which provide platforms for social discovery, personal development, and online entertainment. SDV invests into, develops and supports a range of B2C Internet projects and brands under the framework of social discovery. For more information, please visit: www.sdventures.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, whether Net Element or its business continues to grow, whether the proposed acquisition of PayOnline will materialize, and if so, whether the acquisition will have any positive financial impact on the Company’s business, whether the Payonline acquisition will provide any synergies with the products and services currently offered by the Company or whether post acquisition the Company will be able to cross- sell any of the PayOnline offerings, whether the Company will derive growth, competitive advantage  or other benefit from the acquisition, whether the company will pursue further strategic collaboration with SD Ventures, whether Net Element can secure any additional financing and if such additional financing will be adequate to meet the Company’s objectives.  All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: (i) Net Element’s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element’s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element’s ability to successfully expand in existing markets and enter new markets; (iv) Net Element’s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element’s business; (viii) changes in government licensing and regulation that may adversely affect Net Element’s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element’s business; (x) Net Element’s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of further U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K and the subsequently filed quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.

Tuesday, March 17th, 2015 Uncategorized Comments Off on (NETE) to Acquire Leading Payment Innovator PayOnline

(FLKS) Thomas Wessel, M.D., Ph.D., Appointed Chief Medical Officer

Flex Pharma, Inc. (NASDAQ: FLKS), a biotechnology company that is developing innovative and proprietary treatments for exercise-associated muscle cramps, nocturnal leg cramps, and spasms associated with severe neuromuscular conditions, announced the appointment of Thomas Wessel, M.D., Ph.D., as its Chief Medical Officer, reporting to Christoph Westphal M.D., Ph.D., Flex Pharma’s President, CEO and Chair. Flex Pharma also announced that Elizabeth Woo, M.B.A., has been promoted to Senior Vice President, Investor Relations and Corporate Communications.

“Dr. Wessel is an accomplished, board-certified neurologist with extensive industry experience, who successfully led the clinical efforts for three approved neurology drugs,” stated Dr. Westphal. “With his track record in neurology, Tom is a tremendous asset as we advance our development efforts.”

Dr. Wessel is a board-certified neurologist with extensive drug development experience, including serving as the medical lead for three products approved in United States: Razadyne®, Lunesta® and Ampyra®. Previously, Dr. Wessel has been the Chief Medical Officer of Acorda Therapeutics and Senior Vice President of Clinical Research at Sepracor. Before joining Sepracor, Dr. Wessel worked on several CNS projects at Janssen Pharmaceuticals in Europe and the U.S. Before working in the pharmaceutical industry, Dr. Wessel held several academic and research positions. Dr. Wessel received his M.D. from the University of Munich School of Medicine and completed his Ph.D. in experimental neurobiology at the Max-Planck-Institute for Psychiatry in Martinsried, Germany. He completed his residency in neurology at New York Hospital and Memorial Sloan-Kettering Cancer Center (Cornell University Medical Center).

Flex Pharma also announced today the promotion of Elizabeth Woo to Senior Vice President, Investor Relations and Corporate Communications. Ms. Woo brings over 20 years of experience in investor relations, biotechnology and pharmaceuticals, previously serving as Vice President of Investor Relations for Biogen Idec. Ms. Woo earned an M.B.A. from The Kellogg Graduate School of Management, and graduated summa cum laude and Phi Beta Kappa with bachelor degrees in biochemistry and history from the University of California, Berkeley.

About Flex Pharma

Flex Pharma, Inc. is a biotechnology company that is developing innovative and proprietary treatments for exercise-associated muscle cramps, nocturnal leg cramps, and spasms associated with severe neuromuscular conditions. In three randomized, blinded, placebo-controlled, cross-over studies, Flex Pharma’s proprietary treatment has shown a statistically significant reduction in the intensity of muscle cramps in healthy normal volunteers.

Flex Pharma was founded by National Academy of Science members Rod MacKinnon, M.D. (2003 Nobel Laureate), and Bruce Bean, Ph.D., recognized leaders in the fields of ion channels and neurobiology, along with Chairman and Chief Executive Officer Christoph Westphal, M.D., Ph.D.

Flex Pharma, Inc.
Elizabeth Woo, 617-874-1829
SVP, Investor Relations & Corporate Communications
irdept@flex-pharma.com

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(MVIS) Receives $14.5 Million in Component Orders

MicroVision, Inc. (NASDAQ: MVIS), a leader in innovative ultra-miniature projection display technology, today announced it has received orders totaling $14.5 million for components for its Fortune Global 100 customer.

MicroVision plans to begin shipment of components for these orders in the second half of 2015 and expects fulfillment to continue into 2016. MicroVision and its Fortune Global 100 customer recently entered into a licensing agreement whereby MicroVision granted a non-exclusive license to its patented PicoP® display technology to the Fortune Global 100 company. The components MicroVision is selling to its customer are expected to be incorporated into display modules the Fortune Global 100 has developed. MicroVision will also be entitled to royalty payments upon any sales by its customer of the display modules. MicroVision is currently fulfilling component orders received in the second half of 2014 for this same customer.

About MicroVision

MicroVision is the creator of PicoP® display technology, an ultra-miniature laser projection solution for mobile consumer electronics, automotive head-up displays and other applications. MicroVision’s patented display technology helps OEMs break down display boundaries and offer enhanced visibility to mobile experiences. Nearly two decades of research has led MicroVision to become an independently recognized leader in the development of intellectual property. MicroVision’s IP portfolio has been recognized by the Patent Board as a top 50 IP portfolio among global industrial companies and is also included in the Ocean Tomo 300 Patent Index. The company is based in Redmond, Wash.

For more information, visit the company’s website at www.microvision.com, on Facebook at www.facebook.com/MicroVisionInc or follow MicroVision on Twitter at @MicroVision.

MicroVision and PicoP are trademarks of MicroVision, Inc. in the United States and other countries. All other trademarks are the properties of their respective owners.

Forward-Looking Statements

Certain statements contained in this release, including those relating to timing of shipments, future and future product royalty payments, sales and technology applications, and those containing words such as “scheduled,” “expects,” “plans,” and “will” are forward-looking statements that involve a number of risks and uncertainties. Factors that could cause actual results to differ materially from those projected in the company’s forward-looking statements include the following: our ability to raise additional capital when needed; products incorporating our PicoP display engine may not achieve market acceptance, commercial partners may not perform under agreements as anticipated, we may be unsuccessful in identifying parties interested in paying any amounts or amounts we deem desirable for the purchase or license of IP assets, our or our customers failure to perform under open purchase orders; our financial and technical resources relative to those of our competitors; our ability to keep up with rapid technological change; government regulation of our technologies; our ability to enforce our intellectual property rights and protect our proprietary technologies; the ability to obtain additional contract awards; the timing of commercial product launches and delays in product development; the ability to achieve key technical milestones in key products; dependence on third parties to develop, manufacture, sell and market our products; potential product liability claims; and other risk factors identified from time to time in the company’s SEC reports, including the company’s Annual Report on Form 10-K filed with the SEC. Except as expressly required by federal securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, changes in circumstances or any other reason.

MicroVision, Inc.
Investors:
Dawn Goetter, 425-882-6629
ir@microvision.com
or
Media:
Nicole Cobuzio, 732-212-0823 ext. 102
nicolec@lotus823.com

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(INO) & Academic Collaborators Receive $16 Million HIV Grant

PLYMOUTH MEETING, Pa., March 16, 2015  — Inovio Pharmaceuticals, Inc. (Nasdaq:INO) announced today that the company and its academic collaborators, including the University of Pennsylvania (UPenn), were awarded a new five-year $16 million Integrated Preclinical/Clinical AIDS Vaccine Development Program grant from the National Institute of Allergy and Infectious Diseases (NIAID).

This five-year program grant was awarded based on the clinical successes of Inovio’s PENNVAX® HIV vaccine program. The grant will fund research to expand PENNVAX coverage of HIV strains as well as to further enhance antibody responses generated by the vaccine.

New PENNVAX envelope constructs will be designed and tested with Inovio’s DNA-based immune activator encoding novel cytokine genes and will be studied in a prime-boost strategy with recombinant HIV envelope proteins. The collaborators will assess different combinations in preclinical models with the goal of generating high levels of neutralizing antibodies mirroring the robust CD8+ T cell responses generated by Inovio’s PENNVAX-B DNA vaccine in previously published clinical studies. The overall goal of this project is to further build upon this important HIV vaccine approach as well to gain fundamental insight into new technologies to improve vaccination outcomes.

As part of this grant consortium, Inovio will couple its expertise in constructing, developing and manufacturing HIV vaccines with researchers from four world-leading academic institutions (University of Pennsylvania, Emory University, Duke University and the University of Massachusetts) along with VGXi, a contract DNA plasmid manufacturer, and Waisman Biomanufacturing, a contract protein manufacturer.

Dr. J. Joseph Kim, President and CEO, said, “On behalf of our team of preeminent academic collaborators, we are honored to receive this significant new grant from the NIAID. Having completed the development of PENNVAX-GP under a prior $25 million NIAID grant, we are on track to separately initiate a phase I study of this HIV vaccine. This additional NIAID funding allows us to immediately continue and expand the development of PENNVAX vaccines. We have one of the most dynamic HIV programs in the world and we look forward to pursuing any and all scientific exploration to achieve an answer to this challenging disease using our novel DNA immunotherapy approach.”

The NIAID previously awarded Inovio a $25 million grant to develop PENNVAX-GP. UPenn was a collaborating partner on that award as well for the pre-clinical development activities. A phase I study of PENNVAX-GP is expected to start in the first half of 2015.

About PENNVAX® HIV Vaccines and Immunotherapies

Human immunodeficiency virus (HIV) is a retrovirus that causes acquired immunodeficiency syndrome (AIDS), a condition in which progressive failure of the immune system allows life-threatening opportunistic infections and cancers to thrive. HIV is classified into clades, sub-types within which the virus has genetic similarities. The most prevalent clades are B (found mainly in North America and Europe), A and D (found mainly in Africa), and C (found mainly in Africa and Asia).

Inovio completed initial clinical studies of its HIV immunotherapy PENNVAX-B, targeting clade B viruses, to achieve proof of principle in generating potent immune responses using its SynCon® vaccine technology. In two published phase I studies, PENNVAX-B immunization has been shown to generate high levels of activated, antigen-specific CD8+ killer T cells with proper functional characteristics. This ability uniquely positions PENNVAX as an important product candidate for both preventing and treating HIV infections.

Using a $25 million grant from the NIH, Inovio designed its multi-clade, multi-antigen PENNVAX-GP immunotherapy targeting viruses from clades A, B, C and D. PENNVAX-GP is Inovio’s lead preventive and therapeutic immunotherapy for HIV.

About Inovio Pharmaceuticals, Inc.

Inovio is revolutionizing the fight against cancer and infectious diseases. Our immunotherapies uniquely activate best-in-class immune responses to prevent and treat disease, and have shown clinically significant efficacy with a favorable safety profile. With an expanding portfolio of immune therapies, the company is advancing a growing preclinical and clinical stage product pipeline. Partners and collaborators include Roche, MedImmune, University of Pennsylvania, DARPA, Drexel University, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, and University of Manitoba. For more information, visit www.inovio.com.

This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines, our expectations regarding our research and development programs and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, including safety and efficacy for VGX-3100, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, our ability to support our broad pipeline of SynCon® active immune therapy and vaccine products, our ability to advance our portfolio of immune-oncology products independently, including INO-5150, and to commence a phase I clinical trial for INO-5150 in the first half of 2015, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, our ability to enter into partnerships in conjunction with our research and development programs, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company’s technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2014, and other regulatory filings from time to time. There can be no assurance that any product in Inovio’s pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proven accurate.

CONTACT: Investors:
         Bernie Hertel, Inovio Pharmaceuticals,
         858-410-3101, bhertel@inovio.com

         Media:
         Jeff Richardson, Inovio Pharmaceuticals,
         267-440-4211, jrichardson@inovio.com
Monday, March 16th, 2015 Uncategorized Comments Off on (INO) & Academic Collaborators Receive $16 Million HIV Grant

(STRL) Announces Credit Facility Amendment

Sterling Construction Company, Inc. (NasdaqGS:STRL) (“Sterling” or “the Company”) today announced that it has entered into an amended credit agreement with its primary lender, Comerica Bank and is actively considering several debt financing proposals to replace the credit facility. The amended agreement waives the breach of the tangible net worth covenant which occurred in the fourth quarter of 2014. The amendment reduces the total capacity of the revolving line of credit from $40 million to $35 million. The first covenant test subsequent to the amendment will be in May based on Sterling’s results for April 2015. This amendment allows the Company to complete the filing of its full year 2014 results with the agreement in place and provides it with adequate liquidity to fund its ongoing operations.

Additional conditions of the amendment include:

  • A reduction in the total capacity of the line of credit to $25 million on June 1, 2015 and a reduction to $15 million on September 1, 2015;
  • An increase in cost from Prime + 150 basis points to Prime + 350 basis points;
  • An amendment fee of $400,000 spread over four equal payments due at closing, June 30th, September 30th, and December 30, 2015;
  • Remaining unpaid fees are waived if at any point during the year the Company liquidates and terminates the line of credit a month before a payment becomes due; and,
  • The Tangible Net Worth covenant will be reset to $75 million and the Debt and Asset Coverage covenants remain the same.

The Company has been evaluating several debt financing proposals with new lenders and expects to replace the current revolving credit line with a new credit facility by the end of April. Thomas Wright, Sterling’s Executive Vice President and Chief Financial Officer, stated, “Sterling has a large asset base comprised of a sizeable fleet of modern construction equipment. As a result, a number of lenders have expressed an interest in potentially replacing our existing line of credit. We are currently in the process of evaluating several debt financing proposals, any of which will fully replace our previous facility of $40 million. This should provide us with adequate liquidity to fund our ongoing operations and support our growth for the foreseeable future.”

Sterling is a leading heavy civil construction company that specializes in the building and reconstruction of transportation and water infrastructure projects in Texas, Utah, Nevada, Arizona, California, Hawaii, and other states where there are construction opportunities. Its transportation infrastructure projects include highways, roads, bridges and light rail and its water infrastructure projects include water, wastewater and storm drainage systems.

This press release includes certain statements that fall within the definition of “forward-looking statements” under the Private Securities Litigation Reform Act of 1995. Any such statements are subject to risks and uncertainties, including overall economic and market conditions, federal, state and local government funding, competitors’ and customers’ actions, and weather conditions, which could cause actual results to differ materially from those anticipated, including those risks identified in the Company’s filings with the Securities and Exchange Commission. Accordingly, such statements should be considered in light of these risks. Any prediction by the Company is only a statement of management’s belief at the time the prediction is made. There can be no assurance that any prediction once made will continue thereafter to reflect management’s belief, and the Company does not undertake to update publicly its predictions or to make voluntary additional disclosures of nonpublic information, whether as a result of new information, future events or otherwise.

Sterling Construction Company, Inc.
Thomas R. Wright, 281-214-0800
EVP & Chief Financial Officer
or
Investor Relations Counsel:
The Equity Group Inc.
Fred Buonocore, 212-836-9607
Linda Latman, 212-836-9609

Monday, March 16th, 2015 Uncategorized Comments Off on (STRL) Announces Credit Facility Amendment

(NERV) Announces $31 Million Financing

WALTHAM, Mass., March 13, 2015  — Minerva Neurosciences, Inc. (Nasdaq:NERV) today announced that it will raise approximately $31 million of gross proceeds in a private placement offering to several institutional investors, including 6,281,661 shares of common stock and warrants to purchase up to 6,281,661 shares. The purchase price for the common stock will be $4.81 per share. The purchase price for the warrants will be $0.125 per share of common stock subject to such warrants. The warrants will have an exercise price of $5.772 per share. The private placement is expected to close on or about March 18, 2015 and is subject to the satisfaction of customary closing conditions.

The proceeds of the financing will be used to fund the clinical development of Minerva’s Central Nervous System (CNS) portfolio, including: MIN-101 for the treatment of schizophrenia; MIN-202 for the treatment of insomnia being developed under a collaboration with Janssen Research & Development, LLC; MIN-117 for the treatment of major depressive disorder (MDD); and MIN-301 for the treatment of Parkinson’s disease.

The securities being sold in the private placement have not been registered under the Securities Act of 1933, as amended, or state securities laws and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements.  Minerva has agreed to file a registration statement with the SEC covering the resale of the shares of common stock and the shares of common stock underlying the warrants issued in the private placement.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

About Minerva Neurosciences

Minerva Neurosciences, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of a portfolio of product candidates to treat CNS diseases. Minerva is developing first-in-class proprietary compounds, including its lead program MIN-101 in development for the treatment of schizophrenia, MIN-202 in development for primary and comorbid insomnia, MIN-117 in development for the treatment of major depressive disorder and MIN-301 in development for the treatment of Parkinson’s disease. Minerva’s common stock is listed on the NASDAQ Global Market where it trades under the symbol “NERV”.

Forward-Looking Safe-Harbor Statement:

This press release contains forward-looking statements which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, reflect management’s expectations as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the benefits of and our ability to leverage the proceeds of the private placement and management’s ability to successfully achieve its goals. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors including, without limitation, whether any of our other therapeutic products will advance further in the clinical trials process and whether and when, if at all, they will receive final approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies and for which indications; whether any of our therapeutic products will be successfully marketed if approved; whether any of our therapeutic product discovery and development efforts will be successful; our ability to achieve the results contemplated by our co-development agreements; management’s ability to successfully achieve its goals; our ability to raise additional capital to fund our operations on terms acceptable to us; and general economic conditions. These and other potential risks and uncertainties that could cause actual results to differ from the results predicted are more fully detailed under the caption “Risk Factors” in our filings with the Securities and Exchange Commission, including our Quarterly Report on Form 10-Q for the quarter ended September 30, 2014, filed with the Securities and Exchange Commission on November 6, 2014. Copies of reports filed with the SEC are posted on our website at www.minervaneurosciences.com. The forward-looking statements in this press release are based on information available to us as of the date hereof, and we disclaim any obligation to update any forward-looking statements, except as required by law.

CONTACT: Media contact:
         Bill Berry
         Berry & Company Public Relations
         212-253-8881
         bberry@berrypr.com

         Investor contact:
         Renee Leck
         Stern Investor Relations
         212-362-1200
         renee@sternir.com
Friday, March 13th, 2015 Uncategorized Comments Off on (NERV) Announces $31 Million Financing