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(ROVI) Names James E. Meyer Chairman of the Board

Rovi Corporation (NASDAQ:ROVI) a leading provider of advanced entertainment discovery, data analytics, and monetization solutions, today announced that James E. Meyer has been unanimously elected as independent Chairman of the Rovi Board of Directors effective July 7, 2015.

“Rovi has made great strides over the past several years in evolving its strategy and developing cloud-based solutions and other next-generation products to drive and complement its growing IP licensing business,” said James. E. Meyer. “Rovi’s products continue to gain momentum and traction in the market, and we are working on several very significant IP license renewals. I am honored to take on the role of Chairman during this exciting time at the Company, and believe Rovi is well positioned to capture the substantial opportunities ahead in the dynamic market in which we operate. I look forward to working alongside the other members of Rovi’s Board, as well as the management team, to build value for all of the Company’s stakeholders.”

Tom Carson, CEO of Rovi, said “Jim is a demonstrated leader with critical industry, technology and operational insights, as well as years of experience both on Boards and as the CEO of a public company. Jim knows Rovi and the industry we operate in very well, and is the right person to lead Rovi’s Board during our next stage of growth.”

Mr. Meyer has served as Chief Executive Officer of SiriusXM since December 2012. Prior to that role, Mr. Meyer served as President of Operations and Sales of SiriusXM and its predecessors from April 2004 to December 2012. From 1997 to 2002, Mr. Meyer served in various executive capacities at Thomson Multimedia Corporation. Mr. Meyer holds a B.S. in Economics and an MBA from St. Bonaventure University.

Additionally, the Audit and Compensation Committees were brought back into compliance with the Nasdaq Stock Market listing rules, as the Board of Directors unanimously constituted the membership of its committees as follows:

Audit Committee: Alan Earhart (Chair), Steve Lucas and Ruthann Quindlen
Compensation Committee: Glenn Welling (Chair), Steve Lucas and Jim Meyer
Corporate Governance & Nominating Committee: Jim Meyer (Chair), Alan Earhart and Raghu Rau

The Company intends to promptly notify the Nasdaq Stock Market of the above appointments.

About Rovi

Rovi is leading the way to a more personalized entertainment experience. The company’s pioneering guides, data, and recommendations continue to drive program search and navigation on millions of devices on a global basis. With a new generation of cloud-based discovery capabilities and emerging solutions for interactive advertising and audience analytics, Rovi is enabling premier brands worldwide to increase their reach, drive consumer satisfaction and create a better entertainment experience across multiple screens. The company holds over 5,000 issued or pending patents worldwide and is headquartered in Santa Clara, California. Discover more about Rovi at rovicorp.com.

Investors
Rovi Corporation
Peter Ausnit, 818-565-5200
or
Media
Sard Verbinnen & Co.
John Christiansen/Megan Bouchier, 415-618-8750

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(OCLS) Receives New U.S. Patent for Microcyn(R) Atopic Dermatitis Technology

PETALUMA, Calif., July 8, 2015  — Oculus Innovative Sciences, Inc. (Nasdaq:OCLS), a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care, today announced the receipt of a new U.S. patent for the use of the Microcyn® Technology hypochlorous acid in the treatment and mitigation of atopic dermatitis.

Dr. Bob Northey, Oculus senior vice president for research and development said: “Our intellectual property portfolio is perfectly synced with our new focus on the dermatology market with our direct sales force. The empirical evidence demonstrating Microcyn’s efficacy in the treatment of atopic dermatitis is highly compelling. This new patent provides Oculus market exclusivity for the use of hypochlorous acid with broad ranges of activity in the treatment of atopic dermatitis until the year 2027 when the patent expires.”

The latest-issued patent joins an intellectual property estate (either owned or licensed to Oculus) that now includes 44 issued and allowed patents (nine in the United States and 35 foreign patents) as well 82 pending applications (both U.S. and foreign) directed to chemical compositions, apparatuses, methods of manufacturing and therapeutic uses.

About Atopic Dermatitis

In a 2009 GlobalData study, it was estimated the global atopic dermatitis therapeutics market delivered revenues of $643 million in 2009. It is expected to grow to $810 million at a Compound Annual Growth Rate (CAGR) of 3.4% by 2016. Globally, the United States remains the largest market for atopic dermatitis therapeutics, and generated revenue of $402 million in 2009. It is forecast to grow at a CAGR of 3.8% over the next seven years to reach $582 million by 2016.

Physicians often define atopic dermatitis or eczema, as a long-lasting, or chronic, skin condition that causes intense itching and then a red, raised rash.  The current standard of care to mitigate the symptoms of atopic dermatitis are topical steroids.  In the United States, data from Wolters Kluwers suggests that physicians write prescriptions for topical steroids for atopic dermatitis approximately 12,500,000 times, each year.

Symptoms of atopic dermatitis are characterized by itchy skin, which can lead to rash, redness, swelling, crusting and scaling. The disease affects up to 20 percent of infants and young children, who continue to have symptoms as adults with significant impact on their quality of life. The exact cause is unknown, but genetics are considered a key factor.

Topical corticosteroids (such as hydrocortisone, betamethasone, and fluticasone) are the most common treatment for atopic dermatitis. As eczema tends to be persistent, most people will have to use topical steroids on and off for many years. If used continuously topical steroids may lose their effectiveness after a few weeks. This is known as tachyphylaxis.

About Oculus Innovative Sciences, Inc.

Oculus Innovative Sciences is a specialty pharmaceutical company that develops and markets solutions for the treatment of dermatological conditions and advanced tissue care. The company’s products, which are sold throughout the United States and internationally, have improved outcomes for more than five million patients globally by reducing infections, itch, pain, scarring and harmful inflammatory responses. The company’s headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at www.oculusis.com.

Forward-Looking Statements

Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of Oculus Innovative Sciences, Inc. and its subsidiaries (the “Company”). These forward-looking statements are identified by the use of words such as “provides” and “joins,” among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s common stock and warrants may be delisted from NASDAQ, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital needs, the Company may not be able to obtain additional funding, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its annual report on Form 10-K for the year ended March 31, 2015. The Company disclaims any obligation to update these forward-looking statements, except as required by law.

Oculus® and Microcyn® Technology are trademarks or registered trademarks of Oculus Innovative Sciences, Inc. All other trademarks and service marks are the property of their respective owners.

CONTACT: Media and Investor Contact:
         Oculus Innovative Sciences, Inc.
         Dan McFadden
         VP of Public and Investor Relations
         (425) 753-2105
         dmcfadden@oculusis.com
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(GBSN) Announces Commercial Launch of Group B Strep Molecular Test

Company Secures More than 40 Evaluations since Launch

Great Basin Scientific, Inc. (NASDAQ: GBSN, GBSNU), a molecular diagnostics company, announced today its Group B Streptococcus (GBS) test—which received U.S. Food and Drug Administration (FDA) clearance in April—is now available to hospitals and laboratories in the U.S. Two laboratories have already converted their Group B Strep testing to Great Basin’s molecular test, and as of July 7, more than 40 sites are in active evaluation or scheduled to evaluate the sample-to-result test for GBS. Further, the Company announced its customers evaluating the test are forecasting usage of the GBS test at volumes 50 percent greater than their usage of the Company’s C. diff test.

Vista Labs, a stand-alone reference lab and long-time customer of Great Basin, chose to adopt the GBS test shortly after evaluation: “The ease of use with no prep steps to run this assay—compared to our prior non-molecular method—provided a huge incentive for us to adopt this test. Our previous Lim broth culture method for GBS was time consuming and had low-sensitivity. Above all, patient care is a priority for our lab. Getting a definitive diagnostic result our clients can trust, plus hands-on time savings for our employees, combined with the cost savings inherent in their business model makes Great Basin the right choice for our needs,” said Vista Labs Molecular Supervisor Robin Johnson.

“Initial response to our GBS test has exceeded our expectations,” said Great Basin co-founder and Chief Executive Officer, Ryan Ashton. “We believe this speaks to an unmet need in the market that Great Basin addresses by delivering simplified workflow, at appropriate cost, and the sensitivity, specificity and speed of molecular testing that our lab customers demand. Our unique business model, we believe, enables us to launch products efficiently, and we will continue to work diligently to deliver against our product roadmap of tests that assist clinicians in better diagnosing and managing their patients’ infectious disease early and effectively.”

The Centers for Disease Control (CDC) continues to report that a high proportion of early onset GBS disease cases are occurring among infants born to women with negative prenatal GBS culture screens. Great Basin brings innovative technology to molecular diagnostic testing with the relative sensitivity of its assay over traditional culture method being 97.9 percent versus 42.3 percent. Additionally, the Company’s GBS assay has a simple workflow that saves critical time for lab clinicians and Great Basin’s no-cost instrumentation and low per-test costs streamlines entry into molecular testing.

The Company also announced today the GBS test has been released as a CE-IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices, making the test commercially available to more than 32 countries in Europe through the Company’s European distributor network. This is the second CE marked molecular diagnostic assay designation for Great Basin following its test for C. diff.

About Great Basin Scientific

Great Basin Scientific is a molecular diagnostics company that commercializes breakthrough chip-based technologies. The Company is dedicated to the development of simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases. The Company’s vision is to make molecular diagnostic testing so simple and cost-effective that every patient will be tested for every serious infection, reducing misdiagnoses and significantly limiting the spread of infectious disease. More information can be found on the company’s website at www.gbscience.com.

Forward-Looking Statements

This press release includes forward-looking statement regarding events, trends and business prospects, which may affect our future operating results and financial position. Forward-looking statements involve risk and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risk and uncertainties include, but are not limited to: (i) our limited operating history and history of losses; (ii) our ability to develop and commercialize new products and the timing of commercialization, including the GBS test mentioned herein; (iii) our ability to obtain capital when needed; and (iv) other risks set forth in the Company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Annual Report on Form 10-K for the year ended December 31, 2014. These forward-looking statements speak only as of the date hereof and Great Basin Scientific specifically disclaims any obligation to update these forward-looking statements, except as required by law.

 

ICR
Media Contact:
Kate Ottavio Kent, 203-682-8276
Kate.Ottavio-Kent@icrinc.com
or
Investor Relations Contact:
Bob Yedid, 646-277-1250
bob.yedid@icrinc.com

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(NTIP) Court Rules in Favor of Network-1 Subsidiary in Mirror Worlds Patent Litigation

Denies Motions to Dismiss by Apple and Microsoft

NEW YORK, July 8, 2015 — Network-1 Technologies, Inc. (NYSE: NTIP) today announced that the United States District Judge Robert Schroeder III of the Eastern District of Texas issued an order denying motions to dismiss the patent infringement suits filed by Mirror Worlds Technologies, Inc., a wholly owned subsidiary of Network-1, against Apple, Inc. and Microsoft, Inc.  The cases against Apple and Microsoft were stayed pending Judge Schroeder’s opinion.

In December 2014, Apple brought a motion for summary judgment based on the Kessler Doctrine arguing that Mirror Worlds was precluded from initiating patent litigation against Apple because of an earlier case brought by the previous owner of the Mirror Worlds patent portfolio against Apple.   Judge Schroeder denied the motion and granted Mirror Worlds’ motion that there was no preclusion based on the MW1 case holding that the Kessler Doctrine did not apply to the facts of the present Mirror Worlds case.

In early 2015, Apple and Microsoft each brought motions for a judgment on the pleadings that U.S. Patent No. 6,006,227, owned by Mirror Worlds, is invalid for covering subject matter not patentable under Section 101 of the U.S. Patent Act.  This argument was based on a recent decision by the United States Supreme Court in Alice vs. CLS Bank, which has led to the invalidation of numerous U.S. patents in the months since the decision. In applying the reasoning of Alice decision, Judge Schroeder found that although the ‘227 Patent is directed to an abstract idea, the abstract idea “is necessarily directed to improving computer technology” and that “the Defendants have not provided any evidence that claimed computer functions (using persistent mainstreams and substreams) were well-understood, routine, conventional activities previously known to the industry at the time of filing” as would be required to be invalid under Alice.

Based on the Court’s Order, the stay of cases against Apple and Microsoft has been lifted and the case against Microsoft and Apple will now proceed toward trial.

“We are obviously very pleased with today’s Order,” commented Corey M. Horowitz, Chairman and CEO of Network-1. “We feel strongly about the merits of our case, and our position on these motions in particular, and are gratified that the Court issued such a well-reasoned opinion.”

ABOUT NETWORK-1 TECHNOLOGIES, INC.

Network-1 Technologies, Inc. is engaged in the development, licensing and protection of its intellectual property and proprietary technologies.  Network-1 works with inventors and patent owners to assist in the development and monetization of their patented technologies. Network-1 currently owns twenty-four (24) patents covering various telecommunications and data networking technologies as well as technologies relating to document stream operating systems and the identification of media content. Network-1’s current strategy includes continuing to pursue licensing opportunities for its Remote Power Patent and its efforts to monetize two patent portfolios (the Cox and Mirror Worlds patent portfolios) acquired by Network-1 in 2013.  Network-1’s acquisition strategy is to focus on acquiring high quality patents which management believes have the potential to generate significant licensing opportunities as Network-1 has achieved with respect to its Remote Power Patent.

This release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements address future events and conditions concerning Network-1’s business plans. Such statements are subject to a number of risk factors and uncertainties as disclosed in the Network-1’s Annual Report on Form 10-K for the year ended December 31, 2014 and its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2015 filed with the Securities and Exchange Commission, including, among others, the continued validity of Network-1’s Remote Power Patent, the ability of Network-1 to successfully execute its strategy to acquire high quality patents with significant licensing opportunities, Network-1’s ability to achieve revenue and profits from the Mirror Worlds Patent Portfolio and the Cox Patent Portfolio as well as intellectual property it may acquire in the future, the ability of Network-1 to enter into additional license agreements, the ability of Network-1 to continue to receive material royalties from its existing license agreements for its Remote Power Patent, the uncertainty of patent litigation and proceedings at the United States Patent and Trademark Office, the difficulty in Network-1 verifying royalty amounts owed to it by its licensees, Network-1’s ability to enter into strategic relationships with third parties to license or otherwise monetize their intellectual property, the continued viability of the PoE market, future economic conditions and technology changes and legislative, regulatory and competitive developments. Except as otherwise required to be disclosed in periodic reports, Network-1 expressly disclaims any future obligation or undertaking to update or revise any forward-looking statement contained herein.

Corey M. Horowitz, Chairman and CEO
Network-1 Technologies, Inc.
(212) 829-5770
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(MATR) Announces Strong Bookings, Increased Revenue Guidance, Key Hires

CHICAGO, IL–(Jul 7, 2015) –  Mattersight Corporation (NASDAQ: MATR), the pioneer in personality-based software applications, today provided an update on its second quarter business activity.

“We are pleased with our continued progress and increasing business momentum,” says Kelly Conway, Mattersight President and CEO. “We had a strong bookings quarter fueled by new logo growth and pilot conversions, and are encouraged with what we see in the second half of the year. Our momentum is helping us attract great new customers and excellent new talent.”

Second Quarter 2015 Financial Highlights

  • Bookings: Annual Contract Value (ACV) bookings for the second quarter were $5.8 million, the second-highest bookings quarter in the company’s history. This brings ACV bookings over the last four quarters to a record $19.0 million, a 46% year-over-year increase. The strong bookings were driven by adding several important new logo customers, and by increasing sales momentum from Mattersight’s Predictive Behavioral Routing product.
  • Guidance: Based on its current outlook, Mattersight is raising its 2015 guidance as follows:
    • Total revenue growth guidance is increased to 33% to 38%, up from 30% to 35%
    • Total subscription growth guidance is increased to 38% to 43%, up from 35% to 40%

Key New Hires

  • New Chief Financial Officer
    Mattersight announces the appointment of Sheau-ming Ross as Vice President and Chief Financial Officer, effective July 6, 2015. Ms. Ross, who brings more than 17 years of finance, operations, corporate development, strategy, venture investing and investment banking experience to her new role, will be responsible for Mattersight’s finance and accounting functions.Before joining Mattersight, Ms. Ross was Chief Financial Officer of EPAY Systems, a high growth SaaS provider in the workforce management space. Prior to EPAY Systems, she served as Chief Financial Officer for Silver Chalice, a next-generation digital sports media company. Previously, Ms. Ross worked for twelve years in various financial leadership positions for the Tribune Company, including Chief Financial Officer for Chicago’s WGN-TV, CLTV, and WGN Radio as well as WGN America, a nationally distributed basic cable and satellite television channel. Ms. Ross also previously worked in the strategy, corporate development and corporate venture capital groups at Tribune Company. Ms. Ross started her career in investment banking Credit Suisse Group; and she holds a Bachelor’s degree in Economics from the University of Chicago and an MBA from Northwestern University’s Kellogg School of Management.
  • New Senior Vice President of Sales
    Mattersight also announces the hiring of Frank Suljic as Senior Vice President of Strategic Sales. Mr. Suljic returns to Mattersight after a previous tenure with the company, during which time he served as Vice President of Sales. Reporting to Executive Vice President of Sales Richard Dresden, in his new role Mr. Suljic will lead the team responsible for accelerating Mattersight’s penetration of the growing total addressable market within subscription clients.Mr. Suljic has 25 years of experience in the Fortune 500 enterprise technology market. His unique blend of business acumen and engineering expertise distinguish him as a trusted business advisor for clients. Mr. Suljic has held senior sales and leadership positions at companies including IBM, Oracle, Siebel Systems, SeeSaw Networks and Visual IQ. Notably, Mr. Suljic served as Co-Founder and EVP Practice Development for Inforte Corporation, where he led sales from inception through $1B IPO. Most recently, he was Vice President of Sales at AudienceScience. Mr. Suljic earned an engineering degree from the University of Wisconsin and an MBA from the University of Chicago’s Booth School of Business.

Mattersight will hold its second quarter earnings call on August 5th, after the close of the market. Further information regarding the conference call will be provided at a later date.

About Mattersight

Mattersight’s mission is to help brands have more effective and effortless conversations with their customers. Using a suite of innovative personality-based software applications, Mattersight can analyze and predict customer behavior based on the language exchanged during service and sales interactions. This insight can then facilitate real-time connections between customers and the agents best capable of handling their needs. Mattersight’s patented stack of SaaS applications has influenced hundreds of millions of shorter, more satisfying customer interactions. Organizations across the Financial Services, Healthcare, and Telco industries rely on Mattersight to drive customer retention, employee engagement, and operating efficiency. An independent research study documents the average return on investment for these organizations is 344%. To learn more about how Mattersight can help your company, please visit www.mattersight.com.

Contact is:
Jason Wesbecher
Chief Marketing Officer
Jason.Wesbecher@Mattersight.com

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(MZOR) Reports it Received Purchase Orders for Seven Renaissance Systems In Q2

Mazor Robotics Ltd. (TASE:MZOR; NASDAQGM:MZOR), a developer of innovative guidance systems and complementary products, announced today that it received purchase orders for and delivered seven Renaissance systems and one system upgrade in the second quarter ended June 30, 2015. Six of the systems were delivered to U.S. hospitals and one was delivered to Spain. The Company ended the quarter with 93 Renaissance systems installed globally, with 53 in the U.S., the Company’s primary growth market, compared with 72 and 39 systems for the second ended June 30, 2014, respectively.

“Our results in the second quarter demonstrate solid execution by our global sales and marketing team,” said Ori Hadomi, Chief Executive Officer. “The quarter reflects the successful implementation of several key initiatives, such as engaging with the hospital c-suite earlier in the sales cycle to have a better understanding of their process and level of commitment as well as expanding into new metropolitan markets. These continuing efforts together with the market’s increasing awareness and interest in Renaissance give us momentum as we enter the second half of 2015.”

The Company currently intends to report its complete financial results for the second quarter ended June 30, 2015 on July 28, 2015.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary robotic-based technology and products aimed at redefining the gold standard of quality care. Mazor Robotics Renaissance® Guidance System enables surgeons to conduct spine and brain procedures in a more accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the Company’s momentum as we enter the second half of 2015, or regarding the intended release date of the financial results for the quarter ended June 30, 2015, e, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on April 29, 2015 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

 

U.S.:
EVC Group
Investors
Michael Polyviou/Doug Sherk
212-850-6020; 415-652-9100
mpolyviou@evcgroup.com; dsherk@evcgroup.com
or
Media
David Schemelia, 646-201-5431
dave@evcgroup.com

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(ESPR) Announces Removal of 240 mg Partial Clinical Hold for ETC-1002

ANN ARBOR, MI–(July 07, 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 the U.S. Food and Drug Administration (FDA) has removed the 240 mg partial clinical hold on ETC-1002 (bempedoic acid). This action by FDA will now allow ETC-1002 to be used at doses above 240 mg in clinical studies. Esperion plans to initiate the Phase 3 clinical program for ETC-1002 in the fourth quarter of this year using the already optimized 180 mg dose.

“We are pleased to receive a positive and rapid response from the FDA following our submission in early June of a complete response to the 240 mg partial clinical hold,” said Tim M. Mayleben, president and chief executive officer of Esperion. “We look forward to continuing our discussions with the FDA at next month’s End-of-Phase 2 meeting as we advance ETC-1002 through the final phase of development.”

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 elevated LDL-cholesterol levels and avoid the side effects associated with currently available LDL-cholesterol lowering therapies. ETC-1002 is being developed for patients with primary hyperlipidemia and mixed dyslipidemia. 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. These statements are based on management’s current expectations and accordingly are subject to uncertainty and changes in circumstances. 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 and Quarterly Reports on From 10-Q. 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

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(IPDN) Exceeds 500,000 New Users Per Month

CHICAGO, July 7, 2015  — Professional Diversity Network, Inc. (“PDN”) (NASDAQ:IPDN), a developer and operator of online networks and technologies that provide access to employment opportunities for diverse professionals in the United States, announced today that it has sustained the rapid registered user growth it previously reported and surpassed 530,000 new registered users per month during June.

HIGHLIGHTS:

  • 1,535,226 new registered users in the past 6 months
  • 530,251 new registered users in June 2015 alone
  • Nearly 2,000% new registered user growth on a month over month basis in June 2015 (over 530K) versus October 2014 (26.5K), last full month before Noble Voice acquisition
  • Q2 bookings of $10.3 million, up nearly 800% compared to second quarter 2014

“In June we added over half a million new users, all of whom are job seekers who help us achieve our mission of matching diverse workers with the employers who need them,” said Jim Kirsch, CEO. Kirsch continued, “With the rollout of HireAdvantEDGE, our latest product, which helps employers improve candidate quality while reducing time to hire, it is critical to continue to bring new users into our system and feed our employer partners’ demand. The graph below proves the maxim that a picture is worth a thousand (or in this case over half a million) words, and tells us that we are succeeding.”

Sergio Zlobin, VP of Technology, added, “For a technology company to achieve success it must grow its user base in an efficient and sustainable way. At PDN our users are job seekers, and we have created a formula that allows us to add new users, at a declining marginal cost per user, while we are seeing similar growth in our employer partners. This means that we are growing supply (job seekers) while growing demand (employers), and matching the two in a manner we believe we can sustain and continue to grow. While our growth is always subject to market conditions and the like, we are absolutely prepared from a structural and technology perspective, and I am very confident that we can continue to refine and improve not only our formula for attracting new users but our technology for delivering them to employers.”

“It strikes me that when 2015 began we had enrolled just over 3 million users over the entire 12 year lifetime of our company,” said Mr. Kirsch. He continued, “So far in 2015 we have already registered over 1.5 million new users, with the rate growing every month. There is a very strong and fundamental relationship between registered users and our future potential. In recruitment, our greatest asset is the human capital inventory we can access and the efficiency in which we connect our diverse users and employers. That is why we are thrilled about the 497 employers utilizing our network to place our new registered users in careers across the nation. Our entire executive team believes that our prospects have never been better, and with $10.3 million in new bookings for the second quarter, the numbers we are reporting today back that up.”

About Professional Diversity Network, Inc.

Professional Diversity Network, Inc. (PDN) is an Internet software and services company that develops and operates online professional networking communities dedicated to serving diverse professionals in the United States and employers seeking to hire diverse talent. Our subsidiary, National Association of Professional Women (NAPW), is one of the largest, most recognized networking organizations of professional women in the country, spanning more than 200 industries and professions. Through an online platform and our relationship recruitment affinity groups, we provide our employer clients a means to identify and acquire diverse talent and assist them with their efforts to comply with the Equal Employment Opportunity Office of Federal Contract Compliance Program. Our mission is to utilize the collective strength of our affiliate companies, members, partners and unique proprietary platform to be the standard in business diversity recruiting, networking and professional development for women, minorities, veterans, LGBT and disabled persons globally.

Forward-Looking Statements

This press release contains certain forward-looking statements regarding the future based on our current expectations, forecasts, beliefs, intentions, strategies and assumptions. Forward-looking statements can be identified by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” and “would” or similar words. Forward-looking statements involve risks and uncertainties and our actual results may differ materially from those stated or implied in such forward-looking statements. Factors that could contribute to such differences include, but are not limited to: failure to realize synergies and other financial benefits from mergers and acquisitions within expected time frames, including increases in expected costs or difficulties related to integration of merger and acquisition partners; inability to identify and successfully negotiate and complete additional combinations with potential merger or acquisition partners or to successfully integrate such businesses, including our ability to realize the benefits and cost savings from, and limit any unexpected liabilities acquired as a result of, any such business combinations; our limited operating history in a new and unproven market; increasing competition in the market for online professional networks; our ability to comply with increasing governmental regulation and other legal obligations related to privacy; our ability to adapt to changing technologies and social trends and preferences; our ability to attract and retain a sales and marketing team, management and other key personnel and the ability of that team to execute on the Company’s business strategies and plans; our ability to obtain and maintain intellectual property protection for our intellectual property; any future litigation regarding our business, including intellectual property claims; and the risk factors disclosed in our Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2015 and any subsequent filings made by us with the SEC. Forward-looking statements in this release are based on information available to us as of the date hereof and we assume no obligation to update the information included in this press release, whether as a result of new information, future events or otherwise. The Form 10-K filed with the SEC on March 31, 2015, together with this press release are available on our website, www.prodivnet.com.

CONTACT: RedChip Companies, Inc.
         Jon Cunningham
         (800-733-2447), ext. 107
         jon@redchip.com
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(PBMD) Receives Positive Scientific Advice From EMA on Lead Product IMP321

The EMA Has Now Confirmed in Writing Its Endorsement of the Development Program of IMP321 in Metastatic Breast Cancer

SYDNEY, AUSTRALIA–(Jul 7, 2015) – Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) (“Prima” or the “Company”), a leading immuno-oncology company, is pleased to announce that it has received positive Scientific Advice from the European Medicines Agency (“EMA” or the “Agency”) on the development path for its lead product, IMP321 in metastatic breast cancer.

The EMA, located in London, is the agency responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. After dialogue between Prima and the EMA, the Agency has now confirmed in writing its endorsement of the development program of IMP321 in metastatic breast cancer.

Encouragingly, the planned Phase IIb study, to be called AIPAC (Active Immunotherapy PAClitaxel) is considered well designed by the Agency. AIPAC is now expected to initiate in Europe during the 4th quarter of 2015. While the EMA never endorses any statement on the likelihood of future regulatory decisions, the Agency’s communication has suggested that the achievement of certain clinical endpoints may lead to Marketing Authorization in the EU based on this one pivotal study.

After a smaller safety run-in phase that will extend into 2016 and will yield valuable safety, pharmacokinetic and pharmacodynamic data, AIPAC will proceed to recruit around 200 patients with HER-2 negative metastatic breast cancer, randomising them 1:1 to either standard-of-care paclitaxel plus placebo or paclitaxel plus IMP321.The trial will have Progression-Free Survival as its Primary Endpoint, with response rates according to the RECIST criteria and Overall Survival among the secondary endpoints. The study has been powered to show a four-month PFS advantage for the treatment group1. Allowing time for patient recruitment and follow-up, AIPAC’s expected duration is around three years.

Prima’s Chief Scientific and Medical Officer, Professor Frédéric Triebel, stated, “The EMA’s Scientific Advice represents a significant step forward in terms of IMP321 clinical development in Europe. We now have the opportunity to introduce active immunotherapy to metastatic breast cancer patients, a promising novel strategy that we believe has the potential to fulfil an unmet medical need,” Dr. Triebel added, “We wish to thank the EMA’s Scientific Advice Working Party for their input and guidance.”

About Scientific Advice

Scientific Advice is a procedure offered by the EMA to pharmaceutical industry participants for clarification of questions arising during development of medicinal products. Scientific Advice is prospective in nature and it focuses on development strategies rather than pre-evaluation of data to support a Marketing Authorisation Application (MAA). Scientific Advice is legally non-binding and is based on the current scientific knowledge which may be subject to future changes. Nevertheless, the advice provided is taken into consideration during MAA and any deviations from the advice given need to be well justified.

About AIPAC (Active Immunotherapy PAClitaxel)

AIPAC is the acronym for Prima’s planned multicenter, Phase IIb, randomized, double blinded, placebo-controlled clinical trial in HER-2 negative metastatic breast cancer patients receiving IMP321 or placebo as adjunctive to the standard-of-care chemotherapy drug paclitaxel. In a Phase IIa trial, IMP321 was able to increase the response rate (as per the RECIST criteria) at six months in these patients from the 25% expected of paclitaxel2 to 50% for IMP321 plus paclitaxel3. The primary purpose of the AIPAC trial is to determine the clinical benefit of IMP321 in terms of Progression-Free Survival in this patient population (power 80%). Details of the AIPC study will be posted on www.clinicaltrials.gov in due course.

About IMP321 and cancer immunotherapy

IMP321 is a cancer immunotherapy agent currently in mid-stage clinical development with Prima BioMed, where it is the company’s lead compound. Immunotherapy is a process whereby a disease such as cancer is treated either by activating or suppressing components of the immune system to generate a response. LAG-3, or Lymphocyte Activation Gene 3, is able to stimulate and in other cases inhibit an immune response, through involvement in a number of immune pathways. IMP321 is a soluble LAG-3Ig fusion protein which works by binding to MHC class II molecules on APCs such as dendritic cells to activate them. The APCs are important for showing cancer antigens to T cells and activating them to destroy cancer cells. IMP321 is a first-in-class APC activator.

About Prima BioMed

Prima BioMed is a globally active biotechnology company that is striving to become a leader in the development of immunotherapeutic products for the treatment of cancer. Prima BioMed is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximise value to shareholders.

Prima’s original product, called CVac, is an ex vivo dendritic cell priming therapy that in May 2015 yielded favourable Phase II data in second remission ovarian cancer patients. Prima is currently seeking partners for further development of this therapy. Prima’s current lead product is IMP321, based on the LAG-3 immune control mechanism which plays a vital role in the regulation of the T cell immune response. IMP321, which is soluble LAG-3, is a T cell immunostimulatory factor for cancer chemoimmunotherapy which has completed early Phase II trials. A number of additional LAG-3 products including antibodies for immune response modulation in autoimmunity and cancer are being developed by large pharmaceutical partners.

Prima BioMed is listed on the Australian Stock Exchange, on the NASDAQ in the US. For further information please visit www.primabiomed.com.au.

For further information please contact:

1 In HER2-negative metastatic breast cancer PFS can be as low as 6 months – see Miller et. al., N Engl J Med. 2007 Dec 27; 357(26):2666-76.

2 See Gray et. al., J Clin Oncol. 2009 Oct 20; 27(30): 4966-4972.

3 See Brignone et.al., J Transl Med. 2010 Jul 23;8:71.

Prima BioMed Ltd:
Stuart Roberts
Global Head of Investor Relations
+61 (0) 447 247 909
stuart.roberts@primabiomed.com.au

Australia Investor/Media:
Mr Matthew Gregorowski
Citadel-MAGNUS
+61 (0) 422 534 755
mgregorowski@citadelmagnus.com

Europe Investor/Media:
Mr. Axel Muhlhaus
edicto GmbH
+49 (0) 69 905505-52
amuehlhaus@edicto.de

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(DEPO) Confirms Receipt of Unsolicited Proposal from Horizon Pharma

Board Previously Reviewed and Rejected Identical Highly Conditional, Unsolicited Proposal

NEWARK, Calif., July 7, 2015  — Depomed, Inc. (NASDAQ: DEPO) (“Depomed” or the “Company”) today confirmed that it has received an unsolicited, highly conditional, non-binding proposal from Horizon Pharma plc (NASDAQ: HZNP) (“Horizon”) to acquire all of the outstanding shares of Depomed in an all-stock transaction valued at $29.25 per share (the “Proposal”).

Depomed noted that Horizon’s Proposal is identical in all material respects to the Horizon proposal received by Depomed on May 27, 2015 and reiterated on June 12, 2015 (the “Prior Proposal”).  The Depomed Board, after careful consideration and in consultation with its financial and legal advisors, unanimously determined that it was not in the best interests of Depomed or its shareholders to pursue the Prior Proposal. The Board is confident that continuing to execute on its strategic plan is the best path forward for the Company and its shareholders at this time.

In making its determination with respect to the Prior Proposal, the Depomed Board considered a number of factors, including:

  • The Prior Proposal does not reflect the inherent value of Depomed in light of the Company’s standalone prospects:
    • Depomed is in a period of significant growth given the highly successful execution of its acquisition and commercialization strategy which has delivered tremendous value to its shareholders, with Depomed’s stock price recently reaching an all-time high of $28.16 on April 27, 2015. The Prior Proposal suggests an acquisition premium of only approximately 3.9% over such price.
    • Depomed is expected to benefit from the NUCYNTA® franchise, which significantly increases the Company’s product revenue, cash flow, EBITDA and adjusted earnings per share in 2015 and beyond. This, together with Depomed’s other significant growth opportunities that extend well into the next decade, makes the timing of the Proposal opportunistic as a combination would transfer the future value of Depomed to Horizon at a price the Company believes does not represent the true value of its assets, business and prospects.
    • Depomed’s financial and share price performance over the last three years speaks to the soundness of the Company’s strategy and its ability to create value for all Depomed stakeholders. In 2012, Depomed had product sales of approximately $27.5 million. In 2014, Depomed’s product sales were $114.2 million and guidance for 2015 anticipates total product sales of $310-$335 million – and this includes only three quarters of NUCYNTA sales. At the midpoint of Depomed’s 2015 estimate, the Company’s revenues will have grown at a compound annual growth rate of 127%. Depomed’s share price has increased approximately 330% over the same time period, as of the date of Depomed’s response to Horizon on June 25, 2015.
  • The Prior Proposal further suggests that Depomed shareholders would own only approximately 27% of the combined company.  However, Depomed’s preliminary analysis shows that the Company’s contribution across various metrics such as revenue, EBITDA and unlevered free cash flow would be much greater.

The Depomed Board unanimously believes that the interests of Depomed shareholders would be best served by benefiting from 100% of the upside inherent in Depomed.

The following is the text of the letter that was sent on June 25, 2015, to Horizon’s Chairman, President and Chief Executive Officer, Timothy Walbert with respect to the Prior Proposal:

Dear Tim:

The Board of Directors (“Board“) of Depomed, Inc. (“Depomed” or the “Company“) received your letters dated May 27, 2015 and June 12, 2015 communicating an unsolicited proposal that Horizon Pharma plc (“Horizon“) acquire all of the outstanding shares of Depomed in an all-stock transaction (the “Proposal“).

The Board carefully reviewed the Proposal with the assistance of its financial advisors, Morgan Stanley & Co. LLC and Leerink Partners LLC, and its legal counsel, Baker Botts L.L.P. After deliberate and thorough consideration, it is the unanimous view of the Board that Horizon’s unsolicited proposal does not reflect the inherent value of Depomed in light of the Company’s standalone prospects, including the realization of the expected benefits from our transformational acquisition of the NUCYNTA franchise, and is not in the best interests of the Company and its shareholders.

Depomed’s Ongoing Transformation

Over the last four years, Depomed has transformed into a leading specialty pharmaceutical company focused on pain and neurology.  Unlike many of our peers in the industry, Depomed has built a portfolio of differentiated products with substantial, organic growth opportunities and lengthy patent exclusivity.  Depomed has demonstrated commercial success, significantly growing prescription demand for our products.  Further, Depomed has had unparalleled success in defending and enforcing its intellectual property rights, and in securing market exclusivity for its products that extend well into the next decade.

Since 2012, Depomed has acquired and re-launched Zipsor® (diclofenac potassium), indicated for mild to moderate pain, Lazanda® (fentanyl nasal spray CII), a nasally delivered formulation of fentanyl for the treatment of breakthrough cancer pain, and CAMBIA® (diclofenac potassium for oral solution), the only single agent in its therapeutic class approved in the U.S. for the treatment of acute migraine attacks in adults.

Building on this success, Depomed in April 2015 acquired the U.S. rights to the NUCYNTA® franchise – a transformational transaction for the Company.  The NUCYNTA franchise includes NUCYNTA ER (tapentadol) extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), severe enough to require daily, around-the-clock, long-term opioid treatment, NUCYNTA (tapentadol), an immediate release version of tapentadol, for management of moderate to severe acute pain in adults, and NUCYNTA (tapentadol) oral solution, an approved oral form of tapentadol that has not been commercialized.

Depomed re-launched NUCYNTA ER and NUCYNTA last week with an expanded, highly experienced pharmaceutical sales force and a focused marketing message that highlights the unique, differentiated aspects of the product. The NUCYNTA franchise is a flagship product for Depomed in the multi-billion dollar pain market. The Board is highly confident in the Company’s ability to deliver shareholder value by successfully executing its strategy for the NUCYNTA franchise and its other differentiated products.

Depomed’s financial and share price performance over the last three years speaks to the soundness of our strategy and our ability to create value for all Depomed stakeholders.  In 2012, Depomed had product sales of approximately $27.5 million.  In 2014, Depomed’s product sales were $114.2 million and guidance for 2015 is for total product sales between $310-$335 million, and this includes only three quarters of NUCYNTA sales. At the midpoint of our 2015 estimate, our product sales will have grown at a compound annual growth rate of 127%.  Depomed’s share price has increased approximately 330% over the same time period.

In summary, Depomed’s successful execution of its business plan has created a high-growth, pain-focused therapeutics company that is expected to become one of the top-five largest companies in the U.S. pain market based on revenues.  Given our broad pain product portfolio, including the recent NUCYNTA acquisition, we are poised for long-term, sustainable growth and will continue to deliver significant value to our shareholders.

Horizon’s Opportunistic Proposal Undervalues Depomed, and is Not in the Best Interest of Depomed Shareholders

Depomed’s transformation has delivered tremendous value to its shareholders, with Depomed’s stock price recently reaching an all-time high of $28.16 on April 27, 2015.  The Board notes that the Proposal suggests an acquisition premium of approximately 3.9% over such price.  Together with Depomed’s significant growth opportunities that extend well into the next decade, our Board believes the indicated value of the Proposal of $29.25 substantially undervalues Depomed and its business.

As outlined above, Depomed is expected to benefit from the NUCYNTA franchise, which significantly increases the Company’s product revenue, cash flow, EBITDA and adjusted earnings per share in 2015 and beyond.  The timing of the Proposal is opportunistic as the combination would transfer the future value of Depomed to Horizon at a price we believe does not represent the true value of our assets, business and prospects.

The Proposal further suggests that Depomed shareholders would own only 27% of the combined company.  However, Depomed’s preliminary analysis shows that our contribution across various metrics such as revenue, EBITDA and unlevered free cash flow would be much greater.  In addition, the organic growth rate for Depomed’s current product portfolio appears to far exceed that of Horizon’s current product portfolio in 2016 and beyond.

Conclusion

For the reasons stated above, the Board unanimously rejects the Proposal.  Given the highly successful execution of Depomed’s acquisition and commercialization strategy over the past several years, the Company is in a period of significant growth, and is well-positioned for future success.  Depomed has a highly experienced management team, talented and dedicated employees, a differentiated portfolio of products, a strong intellectual property position and lengthy market exclusivities for all of its products.  The Board strongly believes that an independent Depomed will create significant and sustainable, long-term value for its shareholders through the focused execution of our business plan and strategic vision.

Morgan Stanley & Co. LLC and Leerink Partners LLC are serving as financial advisors to Depomed and Baker Botts LLP is serving as legal counsel.

About Depomed

Depomed is a specialty pharmaceutical company that commercializes products for pain and neurology related disorders. Our NUCYNTA® franchise includes NUCYNTA® ER (tapentadol) extended release tablets indicated for the management of pain, including neuropathic pain associated with diabetic peripheral neuropathy (DPN), severe enough to require daily, around-the-clock, long-term opioid treatment, and NUCYNTA® (tapentadol), an immediate release version of tapentadol, for management of moderate to severe acute pain in adults.  Gralise® (gabapentin) is a once-daily treatment approved for the management of postherpetic neuralgia. CAMBIA® (diclofenac potassium for oral solution) is a non-steroidal anti-inflammatory drug indicated for acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Zipsor® (diclofenac potassium) Liquid Filled Capsules is a non-steroidal anti-inflammatory drug indicated for relief of mild to moderate acute pain in adults.  Lazanda® (fentanyl) Nasal Spray is an intranasal fentanyl drug used to manage breakthrough pain in adults (18 years of age or older) who are already routinely taking other opioid pain medicines around-the-clock for cancer pain. Gralise, Nucynta ER and various partner product candidates are formulated with Depomed’s proven, proprietary Acuform® drug delivery technology.   Additional information about Depomed may be found at www.depomed.com.

Forward-Looking Statements

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995.  The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to, those related to Depomed’s prospects as a standalone business, Depomed’s business strategy, expectations regarding Depomed’s future financial results, and other risks detailed in the company’s Securities and Exchange Commission filings, including the company’s Annual Report on Form 10-K for the year ended December 31, 2014 and its most recent Quarterly Report on Form 10-Q.  The inclusion of forward-looking statements should not be regarded as a representation that any of the company’s plans or objectives will be achieved.  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  The company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

Investor Contact:

August J. Moretti
Depomed, Inc.
510-744-8000
amoretti@depomed.com

Media Contact:

Joele Frank, Wilkinson Brimmer Katcher
Eric Brielmann
415-869-3950

Andy Brimmer and Averell Withers
212-355-4449

Tuesday, July 7th, 2015 Uncategorized Comments Off on (DEPO) Confirms Receipt of Unsolicited Proposal from Horizon Pharma

(NVIV) Significant Improvement In Neuro-Spinal Scaffold Implant Patients

– Third Patient Improves from Complete to Incomplete Spinal Cord Injury –

InVivo Therapeutics Holdings Corp. (NVIV) today announced a one-month post-implant update for the third study patient and a six-month post-implant update for the second study patient in the company’s ongoing pilot trial of its investigational Neuro-Spinal Scaffold in patients with complete acute spinal cord injury.

In the time between implantation and the one-month post-injury assessment of the third study patient, the patient improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury. The patient has regained sacral sensation with improved bladder function. Historically, fewer than 4% of patients with a high thoracic neurologic level of injury convert from AIS A to AIS B in the first month after injury. There were no reported serious adverse events associated with the Neuro-Spinal Scaffold.

The second patient demonstrated marked improvement in sensory function with partial sensation present five dermatome levels lower on the right side compared to the three-month assessment. This translates to regaining partial sensation from the lower ribs to the hip on the right. The patient continues to make meaningful progress in activities of daily living.

The Neuro-Spinal Scaffold was implanted in both patients by Dr. Dom Coric of Carolina Neurosurgery and Spine Associates, Chief of Neurosurgery at the Carolinas Medical Center (CMC) in Charlotte, NC. The study is being led at CMC by Dr. Coric and Dr. William Bockenek, Chief Medical Officer of Carolinas Rehabilitation and Chairman of the Department of Physical Medicine and Rehabilitation at CMC.

Dr. Coric said, “I am very encouraged with the third patient’s neurologic recovery following successful implantation of the investigational Neuro-Spinal Scaffold.” Dr. Bockenek further stated, “It is exciting and promising when a patient who is classified as a complete spinal cord injury becomes classified as incomplete. This is a relatively unusual occurrence and gives much more potential for further recovery.”

Mark Perrin, InVivo’s CEO, said, “We are excited about the neurologic progress that each of our three study patients has made to date. It is particularly noteworthy that two of the patients improved rapidly within the first month post-injury from a complete to incomplete spinal cord injury. Patient number one improved from AIS A to AIS C in one month which occurs in fewer than 5% of AIS A patients with T10-T12 injury, and patient number three exhibited improvement AIS A to AIS B which historically is observed in fewer than 4% of patients with a T4 injury. To date, the Neuro-Spinal Scaffold has been successfully implanted in three consecutive patients with no serious adverse events associated with either the scaffold or the surgical procedure. We look forward to continuing to follow these patients and expect to complete enrollment of the remaining two patients in our pilot trial within the coming months.”

About the Neuro-Spinal Scaffold

Following an acute spinal cord injury, the biodegradable Neuro-Spinal Scaffold is surgically implanted at the epicenter of the wound and is designed to act as a physical substrate for nerve sprouting. Appositional healing to spare spinal cord tissue, decreased post-traumatic cyst formation, and decreased spinal cord tissue pressure have been demonstrated in preclinical models of spinal cord contusion injury. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and is currently being studied in an Investigational Device Exemption (IDE) pilot study for the treatment of patients with complete (AIS A) traumatic acute spinal cord injury.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding continued enrollment in our pilot trial and the expected benefits, efficacy and future clinical outcomes of the company’s Neuro-Spinal Scaffold. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to obtain FDA approval to modify its pilot trial protocol or to conduct a future study; the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Annual Report on Form 10-K for the year ended December 31, 2014, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

InVivo Therapeutics Holdings Corp.
Investor Relations
Brian Luque, 617-863-5535
bluque@invivotherapeutics.com

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(CATB) Receives FDA Fast Track Designation for CAT-1004 in Muscular Dystrophy

Catabasis Pharmaceuticals, Inc. (NASDAQ: CATB), a clinical-stage drug development company built on a pathway pharmacology technology platform, today announced that CAT-1004 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of Duchenne muscular dystrophy (DMD). CAT-1004 is designed to inhibit activated NF-kB, which has the potential to reduce muscle inflammation and degeneration, and promote muscle regeneration for patients with DMD regardless of the underlying mutation. DMD is a rare disease that involves progressive muscle degeneration that eventually leads to death and for which there are no approved therapies in the United States.

“Fast Track designation for CAT-1004 highlights its potential to treat a serious, life threatening disease with few treatment options for these young patients,” said Jill C. Milne, Ph.D., co-founder and chief executive officer of Catabasis. “By targeting activated NF-kB in pre-clinical studies, CAT-1004 has demonstrated disease-modifying potential for this devastating condition.”

The FDA Fast Track process is designed to expedite the development and review of drugs to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. Companies that receive Fast Track designation are allowed to submit New Drug Applications (NDA) on a rolling basis, expediting the FDA review process, and benefiting from more frequent communication with the FDA to discuss all aspects of clinical development. In addition, drugs that receive Fast Track designation are eligible for accelerated approval and priority review if certain criteria are met.

About CAT-1004

CAT-1004 is an oral small molecule that inhibits activated NF-kB, a protein that coordinates cellular response to muscular damage, stress and inflammation and plays an important role in muscle health. In skeletal muscle, activated NF-kB drives muscle degeneration and suppresses muscle regeneration. In animal models of DMD, CAT-1004 inhibited activated NF-kB, reduced muscle inflammation and degeneration and increased muscle regeneration. In Phase 1 clinical trials, CAT-1004 inhibited activated NF-kB and was well-tolerated with no observed safety concerns. The FDA has previously granted CAT-1004 orphan drug designation for the treatment of DMD.

About Catabasis

Catabasis Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics using its proprietary Safely Metabolized And Rationally Targeted, or SMART, linker technology platform. The Company’s SMART linker technology platform is based on the concept of treating diseases by simultaneously modulating multiple targets in one or more related disease pathways. The Company engineers bi-functional product candidates that are conjugates of two molecules, or bioactives, each with known pharmacological activity, joined by one of its proprietary SMART linkers. The SMART linker conjugates are designed for enhanced efficacy and improved safety and tolerability. The Company’s focus is on treatments for rare diseases. The Company is also developing other product candidates for the treatment of serious lipid disorders. For more information on the Company’s technology and pipeline of drug candidates, please visit www.catabasis.com.

Catabasis Pharmaceuticals, Inc.
Andrea Matthews, 617-349-1971
amatthews@catabasis.com

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(RADA) Radar Selected by a Leading European Defense Contractor

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

NETANYA, Israel, July 6, 2015  — RADA Electronic Industries of Netanya, Israel (NASDAQ:RADA) announces the purchase by a leading European defense contractor of a Multi-Mission Hemispheric Radar (MHR). This contractor is the second major European defense contractor that purchased RADA’s MHR. The radar, which will be embedded in a test system by the contractor, will be delivered before the end of 2015.

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, and air surveillance. Zvi Alon, RADA’s CEO, remarked, “We are very happy with the selection of our MHR by another major defense contractor in Europe. It is an additional vote of confidence by a world-leading defense contractor for the unique capabilities that the MHR has to offer in this field. We are confident that the radars ordered during the last few weeks indicate the broad industry recognition of their advantages.”

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
         Dov Sella (CBDO)
         Tel: +972-9-892-1111
         mrkt@rada.com
         www.rada.com
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(PDII) Aetna Publishes Favorable Coverage Policy for ThyGenX™ Thyroid Mutation Panel

PARSIPPANY, N.J., July 6, 2015  — PDI, Inc. (NASDAQ: PDII) subsidiary Interpace Diagnostics announced today that effective June 2015, ThyGenX™,i the company’s genetic mutation panel, has been approved by Aetna for assessing fine needle aspiration (FNA) samples from indeterminate thyroid nodules. Aetna’s coverage decision now means that ThyGenX is considered medically necessary.  Aetna covers 46 million lives and its positive coverage decision brings the total number of lives covered for ThyGenX to more than 100 million.

Approximately 15-30% of the 525,000 thyroid FNA’s performed on an annual basis are indeterminate based on standard cytological evaluation, and thus are candidates for ThyGenX.  ThyGenX has been validated in a prospective, clinical study involving over 600 patients and has a specificity rate of 89%.ii

Guidelines from the National Comprehensive Cancer Network (NCCN) indicate that molecular diagnostic approaches may be useful in the evaluation of thyroid FNA samples that are indeterminate to assist in patient management, including identifying patients who are appropriate candidates for surgery and those for whom surveillance is appropriate.

According to Nancy Lurker, PDI’s CEO, “Aetna’s decision results in the first major commercial coverage for ThyGenX and it continues to affirm the value that ThyGenX offers to patients with indeterminate cytology for thyroid FNAs.  We are pleased that Aetna’s members now have access to ThyGenX, a test already validated through peer-reviewed publications and that can help reduce unnecessary thyroid surgeries.”

About PDI, Inc.

PDI is a leading healthcare commercialization company providing go-to-market strategy and execution to established and emerging pharmaceutical, biotechnology, diagnostics and healthcare companies in the United States through its Commercial Services business, and developing and commercializing molecular diagnostic tests through its Interpace Diagnostics business. PDI’s Commercial Services is focused on providing outsourced pharmaceutical, biotechnology, medical device and diagnostic sales teams to its corporate customers. PDI’s Interpace Diagnostics is focused on developing and commercializing molecular diagnostic tests, leveraging the latest technology and personalized medicine for better patient diagnosis and management. For more information about us, please visit www.pdi-inc.com.

About ThyGenX™

Interpace Diagnostics’ ThyGenX™ Thyroid Oncogene Panel molecular diagnostic test is used to improve surgical decision-making for patients with thyroid nodules when standard cytopathology does not provide a clear diagnosis of thyroid cancer. ThyGenX assists physicians in distinguishing between benign and malignant indeterminate thyroid nodules by utilizing state-of-the-art next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid malignancies. The ThyGenX panel design is based on the miRInform® test, whose high predictive value has been validated in a recent prospective clinical study involving over 600 patients. Interpace Diagnostics acquired the miRInform test from Asuragen in 2014, and has now enhanced it by upgrading to a NGS platform which provides greater genomic insights and increased panel content.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to our future financial and operating performance. PDI has attempted to identify forward looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.  These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond PDI’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause PDI’s actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, the market’s acceptance of our molecular diagnostic tests; projections of future revenues, growth, gross profit and anticipated internal rate of return on investments; the loss, early termination or significant reduction of any of our existing service contracts; the failure to meet performance goals in PDI’s incentive-based arrangements with customers; the inability to secure additional business; or our inability to develop more predictable, higher margin business through sales of our molecular diagnostic tests, in-licensing or other means. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in PDI’s periodic filings with the Securities and Exchange Commission (SEC), including without limitation, the Annual Report on Form 10-K filed with the SEC on March 5, 2015 and in PDI’s Form 10-Q filed with the SEC on May 12, 2015. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, PDI undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

Corporate Media:
Corinne de Palma
CD Public Relations
(212) 399-0887
Corinne@CDPublicrelations.net

Trade Media:
Caren Begun
Green Room Communications
(856) 424-2023
caren@greenroompr.com

Investor Relations:
Chris Dailey/Michael Polyviou
EVC Group, Inc.
(646) 445-4800
cdailey@evcgroup.com

 

i  ThyGenX is adapted and rebranded from Asuragen’s miRInform®

ii   Labourier, Emmanuel et al. The Journal of Clinical Endocrinology & Metabolism (2015): jc-2015.http://press.endocrine.org/doi/abs/10.1210/jc.2015-1158. Accessed July 1, 2015.

Monday, July 6th, 2015 Uncategorized Comments Off on (PDII) Aetna Publishes Favorable Coverage Policy for ThyGenX™ Thyroid Mutation Panel

(VSAR) Removal of FDA Partial Clinical Hold, Continuation of VRS-317 Clinical Trial

MENLO PARK, Calif., July 6, 2015  — Versartis, Inc. (NASDAQ:VSAR), an endocrine-focused biopharmaceutical company that is developing VRS-317, a novel, long-acting form of recombinant human growth hormone (rhGH) for growth hormone deficiency (GHD), today announced that the US Food and Drug Administration (FDA) has removed the partial clinical hold on the Company’s Investigational New Drug Application for VRS-317. With this action, the Company will proceed with the Phase 3 registration trial, VELOCITY, of VRS-317 in children with GHD.

Jay Shepard, Chief Executive Officer, said, “Our team has continued to work diligently with the FDA and we are excited to be moving forward with the Phase 3 clinical trial of VRS-317 in pediatric GHD patients. There is a significant need for these patients to have treatment options that are less burdensome than the daily injections that are the current standard of care. We continue to expect VRS-317 to be the first and longest-acting rhGH product candidate in development to reach the market and, with the removal of the partial clinical hold, we remain on track to achieve this goal.”

The Company reaffirmed its previously stated anticipated milestones for the VELOCITY Phase 3 clinical trial, including interim 6-month mean height velocity data by the end of 2016 and top line data on the 12-month mean height velocity primary endpoint by mid-2017, enabling a potential Biologics License Application submission, followed by a potential FDA approval by late-2018.

About the VELOCITY Trial

The Versartis Long-Acting Growth Hormone in Children compared To Daily rhGH (VELOCITY) Trial is a randomized, open-label, Phase 3 registration trial being conducted in the United States, Western Europe and Canada. This study is expected to enroll up to 136 naïve to treatment, pre-pubertal children with GHD and will include a 3:1 randomization of 3.5 mg/kg VRS-317 twice-monthly to daily rhGH at the highest approved dose on the labels of Genotropin® and Norditropin® 34 µg/kg/day. The primary endpoint is non-inferiority between the two treatment groups for 12-month mean height velocity. After completing the Phase 3 trial, all patients will be offered the opportunity to continue treatment with VRS-317 in the ongoing pediatric Extension Study. Additional information on the VELOCITY trial can be found at www.velocitytrial.com.

About Versartis, Inc.

Versartis, Inc. is an endocrine-focused biopharmaceutical company initially developing VRS-317, a novel, long-acting form of recombinant human growth hormone for the treatment of growth hormone deficiency (GHD). VRS-317 is intended to reduce the burden of daily injection therapy by requiring significantly fewer injections, potentially improving compliance and, therefore, treatment outcomes. The Company completed the Phase 2a stage of a Phase 1b/2a trial evaluating weekly, twice-monthly and monthly dosing regimens of VRS-317 in children with GHD in June 2014 and initiated a global Phase 3 registration trial, VELOCITY, in GHD children in January 2015. In addition, the Company initiated a Phase 2/3 trial in Japan for children with GHD in April 2015. Additional information on the VELOCITY trial can be found at www.velocitytrial.com. Further information on Versartis can be found at www.versartis.com.

Cautionary Note on Forward-Looking-Statements

This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding our intentions or current expectations concerning, among other things, plans and timing of our clinical trials and the potential for eventual regulatory approval of VRS-317. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our success being heavily dependent on VRS-317; VRS-317 being a new chemical entity; the risk that VRS-317 may not have favorable results in clinical trials or receive regulatory approval; potential delays in our clinical trials due to regulatory requirements or difficulty identifying qualified investigators or enrolling patients; the risk that VRS-317 may cause serious side effects or have properties that delay or prevent regulatory approval or limit its commercial potential; the risk that we may encounter difficulties in manufacturing VRS-317; if VRS-317 is approved, risks associated with its market acceptance, including pricing and reimbursement; potential difficulties enforcing our intellectual property rights; our reliance on our license of intellectual property from Amunix Operating, Inc. and our need for additional funds to support our operations. We discuss many of these risks in greater detail under the heading “Risk Factors” contained in our Annual Report on Form 10-K for the year ended December 31, 2014 and in our Quarterly Report on Form 10-Q for the three months ended March 31, 2015, which are on file with the Securities and Exchange Commission (SEC). Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

CONTACT: Corporate & Investors:
         Joshua Brumm
         Chief Financial Officer
         (650) 963-8582
         IR@versartis.com

         Investors:
         Nick Laudico
         The Ruth Group
         (646) 536-7030
         nlaudico@theruthgroup.com

         Media:
         Debra Bannister
         Corporate Communications
         (530) 676-7373
         media@versartis.com
Monday, July 6th, 2015 Uncategorized Comments Off on (VSAR) Removal of FDA Partial Clinical Hold, Continuation of VRS-317 Clinical Trial

(NETE) S&P Capital IQ Initiates Coverage in S&P Capital IQ Factual Stock Reports

NEW YORK, July 6, 2015  — S&P Capital IQ (MHFI) announced today that it has commenced Factual Stock Report coverage on Net Element Inc.

Net Element, Inc. (NETE) is a global technology-driven company specializing in mobile payments and value-added transactional services. It provides services in emerging countries, including the Russian Federation and the Commonwealth of Independent States, as well as the United States.

The company owns and operates a global mobile payments and transactional processing provider, TOT Group, Inc. TOT Group companies include Unified Payments, Aptito, a next generation cloud-based point-of-sale (POS) payments platform, and TOT Money, a provider of SMS messaging and mobile billing solutions.

TOT Group offers end-to-end payment solutions to enable commerce around the world with a focus on emerging markets. TOT Payments, which markets its services in the United States under the brand Unified Payments, is the company’s transactional processing group for small and medium-sized businesses, providing technology and services that businesses require to accept cashless transactions. TOT Payments processes cashless transactions for card-present (or “swipe”) or card-not-present transactions, including POS, mobile POS (mPOS), EMV, near field communication, Apple Pay, Internet businesses, service-oriented businesses and mail order/telephone order merchants. TOT Payments also processes other cashless transactions including checks and direct debits. TOT Payments services include merchant performance analytics and merchant back office reporting. TOT Payments services are distributed in most part through independent sales groups, value-added resellers, system integrators and affinity partners.

Aptito, an all-in-one digital solution for the food and beverage industry, helps restauranteurs to interact with customers and remotely manage operations. The cloud-based Software-as-a-Service (SaaS) restaurant management solution provides integrated functionality to drive consumer engagement via Apple iPad-based POS, kiosk and all other cloud-connected devices. Aptito’s Restaurant mPOS solution provides restaurants with tools designed to increase sales, productivity and customer loyalty. Aptito’s suite of integrated tools enables inventory management, complete payroll, staff scheduling, patron reservations and digital menus.

TOT Money, the company’s proprietary mobile payments and commerce platform, provides carrier-integrated mobile payments solutions, mobile campaign management and distribution. The TOT Money mobile platform provides carrier billing checkout and offers various mobile payment solutions for web services and mobile applications. Net Element provides mobile payment solutions to help digital merchants, such as social networks, games, online magazines and digital media, monetize their mobile clients and the subscription base.

Net Element believes that it provides users with a simple, secure and fast way to pay for purchases via mobile without a credit card or a bank account. Its mobile campaign tools allow for the delivery of scalable mobile campaigns on behalf of content partners. TOT Money’s relationships and integration with mobile operators gives Net Element substantial geographic coverage and the ability to offer its clients In-App payments, wireless access protocol (WAP) click, premium short message services (P-SMS), online and carrier billing.

The company enables mobile payment processing services for more than 390 million mobile users in Russia through strategic direct agreements and integrations with leading mobile operators such as Mobile TeleSystem, MegaFon and VimpelCom, Ltd. In January 2015, Net Element reached a company milestone by exceeding 1 million recurring mobile payment subscribers. As of December 31, 2014, Net Element’s mobile payments subscriber base consisted of 941,668 recurring mobile payments subscribers.

On May 27, 2015, Net Element announced the execution of definitive documentation to acquire PayOnline, an online payments company, for up to $8.4 million in total consideration. PayOnline processes online payments for over 10 million active consumers and thousands of merchants in the Russian Federation, Europe and Asia.

On June 4, 2015, Net Element launched its online payments processing business in Kazakhstan by securing a contract with Kassir.com, the country’s largest online events ticketing website and second largest online merchant serving the Kazakhstan market.

In June 2015, NETE announced it has secured a contract in Kazakhstan, with the country’s largest bank.

S&P Capital IQ’s Factual Stock Report coverage on Net Element Inc. will also be accessible on an ongoing basis to the investment community by scores of buy-side institutions and sell-side firms that utilize S&P Capital IQ research and information platforms daily. Millions of self-directed investors also have access to the report via their e-brokerage accounts. Please visit http://www.netelement.com/ for additional information.

About S&P Capital IQ’s Factual Stock Reports

Currently profiling approximately 400 issuers, S&P Capital IQ (MHFI) Factual Stock Reports increase market awareness of issuers in the investment community with insightful commentary, key statistics, and relevant corporate information.  The Reports provide factual research coverage about company fundamentals and business prospects, thereby enabling information on the covered companies to reach a wide spectrum of Buy and Sell-side investors. Updated weekly with the latest pricing, trading volume, and other data, the Reports also capture recent company developments, a financial review, key operating information, industry and peer comparisons, Street Consensus, performance charts, business summary, fundamental data, and timely news stories. Coverage of these reports is underwritten by the issuer, therefore S&P Capital IQ does not offer investment opinions concerning the advisability of investing in these stocks.

S&P Capital IQ Factual Stock Reports are produced separately from any other analytic activity of S&P Capital IQ or related organizations.  S&P Capital IQ does not trade on its own account.

About S&P Capital IQ

S&P Capital IQ, a part of McGraw Hill Financial (NYSE:MHFI), is a leading provider of multi-asset class and real time data, research and analytics to institutional investors, investment and commercial banks, investment advisors and wealth managers, corporations and universities around the world. S&P Capital IQ provides a broad suite of capabilities designed to help track performance, generate alpha, and identify new trading and investment ideas, and perform risk analysis and mitigation strategies. Through leading desktop solutions such as the S&P Capital IQ, Global Credit Portal and MarketScope Advisor desktops; enterprise solutions such as S&P Capital IQ Valuations; and research offerings, including Leveraged Commentary & Data, Global Markets Intelligence, and company and funds research, S&P Capital IQ sharpens financial intelligence into the wisdom today’s investors need.  For more information, visit www.spcapitaliq.com.

In the United States, research reports are prepared by Standard & Poor’s Investment Advisory Services LLC, a part of S&P Capital IQ and a registered investment adviser with the U.S. Securities and Exchange Commission. S&P Capital IQ provides a broad suite of capabilities designed to help track performance, generate alpha, and identify new trading and investment ideas, and perform risk analysis and mitigation strategies.

Monday, July 6th, 2015 Uncategorized Comments Off on (NETE) S&P Capital IQ Initiates Coverage in S&P Capital IQ Factual Stock Reports

(NVEE) Acquires Infrastructure Engineering Firm the RBA Group, Inc.

HOLLYWOOD, FL–(Jul 2, 2015) – NV5 Holdings, Inc. (the “Company” or “NV5”) (NASDAQ: NVEE), a provider of professional and technical engineering and consulting solutions, announced today that it has acquired the RBA Group, Inc., an infrastructure engineering firm focused on the provision of transportation engineering, planning, and construction inspection, environmental engineering, civil engineering, surveying, and architecture services to public and private clients throughout the East Coast. RBA has a very large presence in New York City and is headquartered in Parsippany, NJ, with other offices in Melville, LI, Trenton, NJ, Norwalk, CT, Philadelphia, PA and Silver Spring, MD. The Company has approximately 250 full-time employees and annualized revenues of $40 million.

The acquisition will be immediately accretive to NV5’s earnings and was primarily a cash transaction.

“RBA is our largest acquisition since 2010. With the acquisition of RBA we are significantly expanding the reach of our infrastructure vertical to capture key clients and markets in the Northeast,” said Dickerson Wright, PE, Chairman and CEO of NV5. “This is especially critical to our efforts to increase operating margins and profitability through cross-selling and synergies among our five service lines. While RBA has been a very successful and respected standalone business for more than 40 years, I am confident that the highly experienced infrastructure engineers at RBA will benefit greatly from the ability to collaborate with the construction quality assurance, program management, and environmental services groups that we have built up throughout the East Coast in the last year, and vice versa,” he added.

“The RBA team is extremely excited about joining the NV5 organization and looks forward to the opportunity to participate in projects geographically where NV5 already exists, and with the support of other areas of expertise existing in NV5, the team expects to provide additional services to our large existing client base,” said Neil Bernstein, PE, President and CEO of RBA.

About The RBA Group
The RBA Group has been providing professional engineering services to a diverse client base throughout the East Coast since 1968. RBA’s client base includes the New York City Department of Transportation, the New York City Department of Design and Construction, the New York Department of Transportation, the New Jersey Department of Transportation, the New Jersey Turnpike Authority, the U.S. Navy, and many other local, state, and federal agencies. The Company’s portfolio of services includes highway design, structural engineering, traffic engineering and transportation planning, construction management, environmental engineering, cultural resource management, site engineering, and surveying. RBA’s commitment to quality services and products and maintenance of a strict quality assurance program drives the Group’s central goal of project completion according to client satisfaction. For more detailed information on The RBA Group’s clients, projects and capabilities, please visit www.rbagroup.com.

About NV5
NV5 Holdings, Inc. (NASDAQ: NVEE) is a provider of professional and technical engineering and consulting solutions to public and private sector clients in the infrastructure, energy, construction, real estate and environmental markets. NV5 primarily focuses on five business verticals: construction quality assurance, infrastructure, engineering and support services, energy, program management, and environmental solutions. The Company operates 35 offices in Arizona, California, Colorado, Florida, Massachusetts, New Jersey, New Mexico, Ohio, Pennsylvania, Utah, Washington and Wyoming and is headquartered in Hollywood, Florida. For additional information, please visit the Company’s website at www.NV5.com. Also visit the Company on Twitter, LinkedIn, Facebook, and Vimeo.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements that the acquisition will be immediately accretive to NV5’s earnings. The Company cautions that these statements are qualified by important factors that could cause actual results to differ materially from those reflected by the forward-looking statements contained in this press release. Such factors include: (a) changes in demand from the local and state government and private clients that we serve; (b) general economic conditions, nationally and globally, and their effect on the market for our services; (c) competitive pressures and trends in our industry and our ability to successfully compete with our competitors; (d) changes in laws, regulations, or policies; and (e) the “Risk Factors” set forth in the Company’s most recent SEC filings. All forward-looking statements are based on information available to the Company on the date hereof, and the Company assumes no obligation to update such statements, except as required by law.

Contact
NV5 Holdings, Inc.
Lauren Wright, Ph.D.
Director of Investor Relations
Tel: +1-408-392-7233
Email: ir@nv5.com

Thursday, July 2nd, 2015 Uncategorized Comments Off on (NVEE) Acquires Infrastructure Engineering Firm the RBA Group, Inc.

(NAVB) Clinical Data Demonstrating KS Lesion Localization For Manocept™

– Reinforces Therapeutic Potential of Targeting Activated Macrophages via the CD206 Receptor-

– Data also suggest a new origin of KS as a macrophage fusion tumor –

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) and its subsidiary, Macrophage Therapeutics, Inc., today announced that imaging results from the Manocept™ clinical trial in Kaposi’s Sarcoma (KS) and other preclinical studies were presented at the 18th International Workshop on Kaposi’s Sarcoma Herpesvirus (KSHV) and Related Agents in Hollywood, Florida. The clinical imaging study, using Tc 99m tilmanocept, a Manocept platform product, in both HIV+ and HIV- patients suggests that KS tumor lesions, both cutaneous and suspected extra-cutaneous sites, can be easily visualized and mapped, demonstrating that this technique may potentially provide a means for routine patient assessment. The results also show that use of Manocept represents a potential therapeutic pathway for targeting tumor associated macrophages (TAMs). Manocept agents are designed to target CD206, which is highly expressed on TAMs and the KS tumor itself. As a potential therapeutic, Manocept could be used as a precision vehicle to deliver payloads to tumor sites throughout the body.

“These pre-clinical and clinical studies support using Kaposi’s sarcoma as a model tumor system for evaluating therapeutic approaches for the Manocept platform in other forms of solid tumors,” commented Michael Tomblyn, M.D., Navidea’s Chief Medical Officer. “They provide evidence that Manocept agents can target CD206 and are internalized into tumor associated macrophages and tumor cells. This along with clinical observations that demonstrate tilmanocept can be used to image KS tumors both externally and internally indicates excellent potential for immunotherapeutic utility.”

“Using a targeted imaging agent like tilmanocept in this group of HHV8+patients represents an elegant approach to potentially detect internal KS lesions that would previously be difficult or impossible to non-invasively locate,” commented Toby Maurer, M.D., FAAD, Professor of Dermatology at the University of California, San Francisco (UCSF), and Chief of Dermatology at San Francisco General Hospital and Trauma Center, who co-led the clinical study at UCSF with Michael S. McGrath, M.D., PhD. “Further, the specificity and the ability to quantify tumor burden could enable regular patient evaluations and monitoring of therapeutic effectiveness addressing important unmet patient needs.”

Five Human Herpes Virus8 positive (HHV8+) patients (4 HIV+, 1HIV-) were enrolled in the NAV03-12 study. Patients received a single subcutaneous injection of Technetium Tc 99m tilmanocept in the region of a cutaneous KS lesion and imaging was performed at 1, 4 and 24-hours post-injection to visualize localization of tilmanocept. Results represented by whole body Single-Photon Emission Computed Tomography (SPECT/CT) imaging scans from study patients were presented. Collectively, the scans show localization of tilmanocept and detected multiple cutaneous lesions in the extremities, face and genitalia, as well as extra-cutaneous localization found in the nasopharynx, lymph nodes and brain. Results also indicate that KS lesions are anatomically linked in chains by and within the lymph ducts. The study concludes that both HIV+ and HIV- patients have pan-tumor expression of CD206, strongly suggests tilmanocept crosses the blood brain barrier and that a Manocept-drug conjugate may have the potential as a therapeutic with high target effect and low off-target concerns.

The data from these studies also suggest a novel theory on the genesis of KS in which KS arises from an HHV8 infected macrophage type cell and its interaction with the lymphatic system. This interaction provides the means for access of the KS through CD206 receptor for diagnosis, evaluation, and potential therapy using the Manocept platform.

Navidea and Macrophage Therapeutics plan a webcast to provide investors with a complete look at the data being presented at the International Workshop on Kaposi’s Sarcoma Herpesvirus (KSHV) and Related Agents conference on July 7, 2015 at 1:00 pm EDT. Webcast details will be available on the Navidea website.

About the Manocept™ CD206-targeting platform

The Manocept™ platform is predicated on the ability to specifically target the CD206 mannose receptor expressed on macrophages. Macrophages play important roles in many disease states and are an emerging target in many disorders. This flexible and versatile platform acts as an engine for purpose-built molecules that may enhance diagnostic accuracy, clinical decision-making, targeted treatments and ultimately patient care. As a diagnostic tool, the Manocept technology has the potential to utilize a breadth of imaging modalities, including SPECT, PET, intra-operative and/or optical-fluorescence detection. By adding a therapeutic agent on the Manocept molecular backbone, there is the potential to develop novel, targeted immunotherapies specifically designed to selectively deliver an agent that can kill or alter disease-associated macrophages. Navidea’s FDA-approved precision diagnostic imaging agent, Lymphoseek® (technetium 99m tilmanocept) injection, is representative of the platform’s ability to successfully exploit this mechanism and offer the potential for development of new CD206-targeted diagnostic agents and therapeutics.

About Kaposi’s Sarcoma

Kaposi sarcoma (KS) is a cancer that develops from the cells that line lymph nodes or blood vessels. It usually appears as tumors on the skin or on mucosal surfaces such as inside the mouth, but tumors can also develop in other parts of the body, such as in the lymph nodes (bean-sized collections of immune cells throughout the body), the lungs, or digestive tract. The abnormal cells of KS form purple, red, or brown blotches or tumors on the skin. These affected areas are called lesions. The skin lesions of KS most often appear on the extremities, trunk and face. AIDS-related KS is the most common type of KS in the United States which develops in people who are infected with HIV, the virus that causes AIDS. KS can also develop in people whose immune systems have been suppressed after an organ transplant and is called transplant-related KS.1

About Lymphoseek®

Lymphoseek® (technetium Tc 99m tilmanocept) injection is the first and only FDA-approved receptor-targeted lymphatic mapping agent. It is a novel, receptor-targeted, small-molecule radiopharmaceutical used in the evaluation of lymphatic basins that may have cancer involvement in patients. Lymphoseek is designed for the precise identification of lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek is approved by the U.S. Food and Drug Administration (FDA) for use in solid tumor cancers where lymphatic mapping is a component of surgical management and for guiding sentinel lymph node biopsy in patients with clinically node negative breast cancer, melanoma or squamous cell carcinoma of the oral cavity. Lymphoseek has also received European approval in imaging and intraoperative detection of sentinel lymph nodes in patients with melanoma, breast cancer or localized squamous cell carcinoma of the oral cavity.

Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. Overall in the U.S., solid tumor cancers may represent up to 1.2 million cases per year. The sentinel node label in the U.S. and Europe may address approximately 235,000 new cases of breast cancer, 76,000 new cases of melanoma and 45,000 new cases of head and neck/oral cancer in the U.S., and approximately 367,000 new cases of breast cancer, 83,000 new cases of melanoma and 55,000 new cases of head and neck/oral cancer diagnosed in Europe annually.

Lymphoseek Indication and Important Safety Information

Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:

  • Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
  • Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.

Important Safety Information

In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).

Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.

Any radiation-emitting product may increase the risk for cancer. Adhere to dose recommendations and ensure safe handling to minimize the risk for excessive radiation exposure to patients or health care workers.

In clinical trials, no patients experienced serious adverse reactions and the most common adverse reactions were injection site irritation and/or pain (<1%).

FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
WWW.LYMPHOSEEK.COM

About Navidea

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision diagnostics, therapeutics and radiopharmaceutical agents. Navidea is developing multiple precision-targeted products and platforms including Manocept™ and NAV4694 to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making, targeted treatment and, ultimately, patient care. Lymphoseek® (technetium Tc 99m tilmanocept) injection, Navidea’s first commercial product from the Manocept platform, was approved by the FDA in March 2013 and in Europe in November 2014. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel radiopharmaceutical agents and therapeutics, and advancing the Company’s pipeline through global partnering and commercialization efforts. For more information, please visit www.navidea.com.

About Macrophage Therapeutics

Macrophage Therapeutics, a newly created subsidiary of Navidea Biopharmaceuticals, Inc. (NAVB), is developing therapeutics using the patented Manocept immunotherapy platform licensed from Navidea to target over-active macrophages implicated in cancer, cardiovascular, central nervous system, autoimmune, antiviral, and skin diseases. Manocept specifically targets CD206, or the mannose receptor prevalent on over-active macrophages. The technology enables highly specific targeted delivery of active (either existing or yet to be developed) agents that can modulate the activity of over-active macrophages that have been implicated in many diseases. Targeted delivery should significantly enhance a given compound’s efficacy and safety.

The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements within the meaning of the Act. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.

1 American Cancer Society web accessed 22May2015. http://www.cancer.org/cancer/kaposisarcoma/detailedguide/kaposi-sarcoma-what-is-kaposi-sarcoma

 

Navidea Biopharmaceuticals
Investors
Tom Baker, 617-532-0624
tbaker@navidea.com
or
Media
Sharon Correia, 978-655-2686
Associate Director, Corporate Communications

Thursday, July 2nd, 2015 Uncategorized Comments Off on (NAVB) Clinical Data Demonstrating KS Lesion Localization For Manocept™

(VRTX) FDA Approves Cystic Fibrosis Drug ORKAMBI™

-Approximately 8,500 people in the U.S. are ages 12 and older and have two copies of the F508del mutation, the most common genetic form of the disease-

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) approved ORKAMBI™ (lumacaftor/ivacaftor), the first medicine to treat the underlying cause of cystic fibrosis (CF) in people ages 12 and older with two copies of the F508del mutation. It is only indicated for these patients, who can be identified with a genetic test.

Cystic fibrosis is a rare, life-threatening genetic disease. People with two copies of the F508del mutation represent the largest group of people with CF. Of the 30,000 people in the United States with CF, approximately 8,500 ages 12 and older have two copies of the F508del mutation. ORKAMBI will be available for shipment to specialty pharmacies in the United States within days.

“Today is a remarkable day for science, medicine and the CF community,” said Jeffrey Leiden, M.D., Ph.D., Vertex’s Chairman, President and Chief Executive Officer. “More than 15 years ago, our scientists set out to discover and develop medicines to treat the underlying cause of cystic fibrosis. Today, the approval of ORKAMBI represents a fundamental change in the treatment of the most common form of CF, marking significant progress for us and for the entire CF community. While we celebrate this important step forward, we also recognize that two out of three patients in the U.S. still do not have a medicine to treat the underlying cause of their disease. We share their urgency and are committed to continuing our significant investment in research and development to discover new medicines for them and to improve upon what we offer patients today.”

Vertex will host an investor conference call on Thursday, July 2, at 2:15 p.m. ET. to provide more information on the approval of ORKAMBI.

The approval of ORKAMBI was based on data from two Phase 3 studies (TRAFFIC and TRANSPORT) that enrolled more than 1,100 people with CF ages 12 and older with two copies of the F508del mutation. Patients treated with ORKAMBI experienced statistically significant improvements in lung function. Patients also experienced reductions in pulmonary exacerbations and improvements in body mass index (BMI). The most common adverse events included shortness of breath and/or chest tightness, upper respiratory tract infection (common cold) and gastrointestinal symptoms (including nausea, diarrhea, or gas).

Vertex continues to invest in CF research and development with the goal of treating the vast majority of people with the disease and enhancing the benefit for those we treat. Multiple Phase 2 and Phase 3 clinical studies are in progress and Vertex has an ongoing research program focused on discovering new CF medicines.

“In 1998, Vertex and the CF Foundation embarked on a scientific challenge that many believed would be impossible – to discover medicines that treat the cause of CF,” said Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation. “Today’s approval is a milestone for the CF community. We congratulate Vertex for their success in developing new CF medicines and are pleased with their continuing commitment to help all eligible patients get access to these medicines.”

Helping Patients Access ORKAMBI

The people who work at Vertex understand that medicines can only help patients who can get them. The Vertex Guidance & Patient Support (Vertex GPS™) program provides a dedicated team of Vertex employees who help eligible patients who have been prescribed our medicines within their labeled indications understand their insurance benefits and the resources that are available to help them.

Vertex also offers a co-pay assistance program for patients with commercial insurance coverage and a free medicine program for qualifying patients who are uninsured and who meet certain income and other eligibility criteria. More information is available by visiting www.VertexGPS.com or by calling 1-877-752-5933.

About CF and ORKAMBI

Cystic fibrosis is a rare genetic disease that is caused by defective or missing cystic fibrosis transmembrane conductance regulatory (CFTR) proteins resulting from mutations in the CFTR gene. The defective or missing proteins result in poor flow of salt and water into or out of the cell in a number of organs, including the lungs. In people with two copies of the F508del mutation, the CFTR protein is not processed and trafficked normally within the cell, resulting in little to no CFTR protein at the cell surface. Patients with two copies of the F508del mutation are easily identified by a simple genetic test.

ORKAMBI is a combination of lumacaftor, which is designed to increase the amount of mature protein at the cell surface by targeting the processing and trafficking defect of the F508del CFTR protein, and ivacaftor, which is designed to enhance the function of the CFTR protein once it reaches the cell surface. ORKAMBI is taken every 12 hours – once in the morning and once in the evening.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR ORKAMBI™ (lumacaftor/ivacaftor) TABLETS

ORKAMBI is a combination of lumacaftor and ivacaftor indicated for the treatment of cystic fibrosis (CF) in patients age 12 years and older who are homozygous for the F508del mutation in the CFTR gene. The efficacy and safety of ORKAMBI have not been established in patients with CF other than those homozygous for the F508del mutation.

Worsening of liver function, including hepatic encephalopathy, in patients with advanced liver disease has been reported in some patients with CF while receiving ORKAMBI. ORKAMBI should be used with caution in patients with advanced liver disease and only if the benefits are expected to outweigh the risks. If ORKAMBI is used in these patients, the patients should be closely monitored and the dose reduced.

Serious adverse reactions related to elevated transaminases have been reported in patients with CF receiving ORKAMBI and, in some instances, associated with concomitant elevations in total serum bilirubin. It is recommended that ALT, AST, and bilirubin be assessed prior to initiating ORKAMBI, every 3 months during the first year of treatment, and annually thereafter. For patients with a history of ALT, AST, or bilirubin elevations, more frequent monitoring should be considered. Patients who develop increased ALT, AST, or bilirubin should be closely monitored until the abnormalities resolve. Dosing should be interrupted in patients with ALT or AST greater than 5x upper limit of normal (ULN) when not associated with elevated bilirubin. Dosing should also be interrupted in patients with ALT or AST elevations greater than 3x ULN when associated with bilirubin elevations greater than 2x ULN. Following resolution of transaminase elevations, consider the benefits and risks of resuming dosing.

Respiratory events (e.g., chest discomfort, shortness of breath, and chest tightness) were observed more commonly in patients during initiation of ORKAMBI compared to those who received placebo. Clinical experience in patients with percent predicted FEV1 <40 is limited, and additional monitoring of these patients is recommended during initiation of therapy.

Co-administration of ORKAMBI with sensitive CYP3A substrates or CYP3A substrates with a narrow therapeutic index is not recommended as ORKAMBI may reduce their effectiveness.

ORKAMBI may substantially decrease hormonal contraceptive exposure, reducing their effectiveness and increasing the incidence of menstruation-associated adverse reactions. Hormonal contraceptives, including oral, injectable, transdermal, and implantable, should not be relied upon as an effective method of contraception when co-administered with ORKAMBI.

Co-administration with strong CYP3A inducers (e.g. rifampin, rifabutin, phenobarbital, carbamazepine, phenytoin and St. John’s wort) is not recommended as they may reduce the therapeutic effectiveness of ORKAMBI.

ORKAMBI has the potential to affect other drugs. For additional information regarding drug interactions, see full Prescribing Information.

Abnormalities of the eye lens (cataracts) have been reported in pediatric patients treated with ivacaftor, a component of ORKAMBI. Baseline and follow-up ophthalmological examinations are recommended in pediatric patients initiating treatment with ORKAMBI.

Serious adverse reactions that occurred more frequently in patients treated with ORKAMBI included pneumonia, blood in sputum, cough, increased muscle enzyme levels, and liver enzyme elevations. The most common adverse reactions associated with ORKAMBI include shortness of breath, sore throat, nausea, diarrhea, upper respiratory tract infection, fatigue, chest tightness, increased blood creatinine phosphokinase, rash, flatulence, runny nose, and influenza.

Please see full prescribing information for ORKAMBI available at www.ORKAMBI.com.

Global Regulatory Submissions for ORKAMBI

Outside of the U.S., Vertex has submitted ORKAMBI for regulatory approval in the European Union, Australia and Canada. A decision by the European Medicines Agency (EMA) is anticipated by the end of 2015. Reviews by Health Canada and Australia’s Therapeutic Goods Administration (TGA) are also ongoing.

Investor Conference Call

Vertex will host an investor conference call and webcast on Thursday, July 2, at 2:15 p.m. ET. To listen to the live call on the telephone dial (866) 501-1537 (United States and Canada) or (720) 545-0001 (International). The conference ID number for the live call and replay is 76077705. In addition, the conference call will be webcast live, and a link to the webcast may be accessed through Vertex’s website at www.vrtx.com in the “Investors” section under the “Events & Presentations” page.

The call will be available for replay via telephone and webcast. The replay phone number in the United States and Canada is (855) 859-2056. The international replay number is (404) 537-3406. The archived webcast will be available at www.vrtx.com.

About Cystic Fibrosis

Cystic fibrosis is a rare, life-threatening genetic disease affecting approximately 75,000 people in North America, Europe and Australia.

CF is caused by a defective or missing CFTR protein resulting from mutations in the CFTR gene. Children must inherit two defective CFTR genes — one from each parent — to have CF. There are approximately 2,000 known mutations in the CFTR gene. Some of these mutations, which can be determined by a genetic test, lead to CF by creating defective or too few CFTR proteins at the cell surface. The defective or missing CFTR protein results in poor flow of salt and water into or out of the cell in a number of organs, including the lungs. This leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median predicted age of survival for a person with CF is 41 years, but the median age of death is 27 years.

Collaborative History with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT)

Vertex initiated its CF research program in 1998 as part of a collaboration with CFFT, the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation. Both of our approved CF medicines were discovered by Vertex as part of this collaboration.

About Vertex

Vertex is a global biotechnology company that aims to discover, develop and commercialize innovative medicines so people with serious diseases can lead better lives. In addition to our clinical development programs focused on cystic fibrosis, Vertex has more than a dozen ongoing research programs aimed at other serious and life-threatening diseases.

Founded in 1989 in Cambridge, Mass., Vertex today has research and development sites and commercial offices in the United States, Europe, Canada and Australia. For five years in a row, Science magazine has named Vertex one of its Top Employers in the life sciences. For additional information and the latest updates from the company, please visit www.vrtx.com.

Special Note Regarding Forward-looking Statements

This press release contains forward-looking statements, as defined in the Private Securities Litigation Reform Act of 1995, as amended, including the statements by Dr. Leiden in the third paragraph of this press release and statements regarding (i) the timing of the availability of ORKAMBI for shipment to specialty pharmacies in the United States; (ii) Vertex’s commitment to continuing its significant investment in research and development programs in cystic fibrosis; and (iii) the anticipated timing of the completion of regulatory reviews in international markets. While the company believes the forward-looking statements contained in this press release are accurate, there are a number of factors that could cause actual events or results to differ materially from those indicated by such forward-looking statements. Those risks and uncertainties include, among other things, risks related to commercializing ORKAMBI in the United States, obtaining approval and commercializing ORKAMBI in international markets, developing additional medicines to treat cystic fibrosis and the other risks listed under Risk Factors in Vertex’s annual report and quarterly reports filed with the Securities and Exchange Commission and available through Vertex’s website at www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

© 2015 Vertex Pharmaceuticals Incorporated I VRX-US-02-01002 I 07/2015

Vertex Pharmaceuticals Incorporated
Investors:
Michael Partridge, 617-341-6108
or
Eric Rojas, 617-961-7205
or
Kelly Lewis, 617-961-7530
or
Media: mediainfo@vrtx.com
US: 617-341-6992
Europe & Australia: +41 22 593 6066

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(SAND) Provides Asset Update

VANCOUVER, July 2, 2015  – Sandstorm Gold Ltd. (“Sandstorm” or the “Company”) (NYSE MKT: SAND, TSX: SSL) is pleased to provide an update at various projects underlying the Company’s streams and royalties.

LUNA GOLD ANNOUNCES CLOSING OF RESTRUCTURING AND FINANCING
Luna Gold Corp. (“Luna”) has closed the previously announced $30 million financing with Pacific Road Resources Funds, as part of which Luna’s gold steam and debt facility with Sandstorm were restructured (“Luna Restructuring”).

Concurrently with closing of the Luna Restructuring, Luna repaid and settled its debt facility with Société Générale (Canada Branch) and Mizuho Corporate Bank. Luna expects to use the remainder of the proceeds from the Luna Restructuring to commence an infill drilling program, prepare engineering studies and submit updated permits at its Aurizona project in Brazil (“Aurizona”) and for general working capital and corporate purposes.

Sandstorm has a sliding scale net smelter returns royalty (“NSR”) on Aurizona based on the price of gold. At gold prices less than or equal to US$1,500 per ounce the royalty is a 3% NSR. Sandstorm also holds a 2% NSR on Luna’s 200,000 hectares of greenfields exploration ground.

For more information, visit the Luna website at www.lunagold.com and see the press release dated June 30, 2015.

METANOR RESOURCES ANNOUNCES POSITIVE DRILL RESULTS
Metanor Resources Inc. (“Metanor”) has released positive drill results from its exploration activities at the Bachelor Lake Mine in Quebec, Canada (“Bachelor Lake”). A diamond drilling program has been underway in the west sector of Bachelor Lake between underground levels 6 and 8. The assay results have included 22.85 grams per tonne (“g/t”) Au over 4.04 metres, 12.8 g/t Au over 10.8 metres as well as 6.82 g/t Au over 8.7 metres. In addition, Metanor recently intersected mineralization in an unknown sector on level 12. The assay results returned 18 g/t Au over 1.5 metres.

Sandstorm has a gold stream agreement with Metanor to purchase 20% of the gold produced from Bachelor Lake at a per ounce price of US$500 per ounce.

For more information, visit the Metanor website at www.metanor.ca and see the press releases dated June 22, 2015, June 25, 2015, June 30, 2015 and July 2, 2015.

CANADIAN ZINC DISCOVERS NEW VEIN SYSTEM DURING UNDERGROUND DRILL PROGRAM
Canadian Zinc Corporation (“Canadian Zinc”) recently provided assay results from five diamond drill holes from the ongoing underground exploration program at the Prairie Creek Mine in the Northwest Territories, Canada (“Prairie Creek”). Highlights included:

  • Drill hole PCU-15-62 which intercepted a previously unknown quartz vein fault structure 75 metres into the footwall of the Main Quartz Vein (MQV) structure, and graded 8.3% Pb, 19.8% Zn and 150 g/t Ag across an estimated true width of 5.4 metres;
  • PCU-15-65, drilled on the next section 50 metres north, 95 metres to the west of the MQV structure which graded 4.9% Pb, 22.7% Zn and 164 g/t Ag across 1.2 metres of estimated true width, also intercepted the second quartz vein structure and graded 4.6% Pb, 13.8% Zn, 92 g/t Ag across 2.9 metres of estimated true width;
  • Diamond drilling of the lower portion of the MQV structure in hole PCU-15-64 intersected two veins side by side (separated by approximately 8 metres but both interpreted to be the MQV) grading 22.7% Pb, 9.7% Zn, 226 g/t Ag across 8.4 metres estimated true width and 14.0% Pb, 3.5% Zn 194 g/t Ag across 5.1 metres estimated true width, respectively;
  • Multiple intercepts of stockwork mineralization were also returned in all stockwork targeted holes including hole PCU-15-65 which graded 24.7% Pb, 32.7% Zn, and 311 g/t Ag across an estimated true width of 2.4 metres and further down the hole 9.5% Pb, 38.1% Zn, 381 g/t Ag across an estimated true width of 1.5 metres.

Canadian Zinc has completed over 5,000 metres of exploration drilling since the beginning of 2015 from three drill stations. The drilling program was completed at the end of June and the geological data is being incorporated into a newly interpreted geological block model. This data will be further interpreted, modelled and incorporated into the future resource and reserve calculations and a revised mine plan.

Sandstorm holds a 1.2% NSR royalty on the Prairie Creek project.

For more information, visit the Canadian Zinc website at www.canadianzinc.com and see the press release dated June 23, 2015.

QUALIFIED PERSONS
Pascal Hamelin, P. Eng., is Metanor’s Vice President of Operations and a Qualified Person as defined by NI 43-101. Mr. Hamelin has reviewed and approved the technical information related to Bachelor Lake in this press release.

Alan Taylor, P. Geo., is Canadian Zinc’s Chief Operating Officer & Vice President Exploration and is a Qualified Person as defined by NI 43-101. Mr. Taylor has reviewed and approved the technical information related to Prairie Creek in this press release.

ABOUT SANDSTORM GOLD

Sandstorm Gold Ltd. is a gold streaming and royalty company. Sandstorm provides upfront financing to gold mining companies that are looking for capital and in return, receives the right to a percentage of the gold produced from a mine, for the life of the mine. Sandstorm has acquired a portfolio of 72 streams and royalties, of which 14 of the underlying mines are producing. Sandstorm plans to grow and diversify its low cost production profile through the acquisition of additional gold streams and royalties.

For more information visit: www.sandstormgold.com

CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION

This press release contains “forward-looking statements”, within the meaning of the U.S. Securities Act of 1933, the U.S. Securities Exchange Act of 1934, the Private Securities Litigation Reform Act of 1995 and applicable Canadian securities legislation, concerning the business, operations and financial performance and condition of Sandstorm Gold Ltd. (“Sandstorm”). Forward-looking statements include, but are not limited to, statements with respect to the future price of gold, the estimation of mineral reserves and resources, realization of mineral reserve estimates, and the timing and amount of estimated future production. Forward-looking statements can generally be identified by the use of forward-looking terminology such as “may”, “will”, “expect”, “intend”, “estimate”, “anticipate”, “believe”, “continue”, “plans”, or similar terminology.

Forward-looking statements are made based upon certain assumptions and other important factors that, if untrue, could cause the actual results, performances or achievements of Sandstorm to be materially different from future results, performances or achievements expressed or implied by such statements. Such statements and information are based on numerous assumptions regarding present and future business strategies and the environment in which Sandstorm will operate in the future, including the price of gold and anticipated costs. Certain important factors that could cause actual results, performances or achievements to differ materially from those in the forward-looking statements include, amongst others, gold price volatility, discrepancies between actual and estimated production, mineral reserves and resources and metallurgical recoveries, mining operational and development risks relating to the parties which produce the gold Sandstorm will purchase, regulatory restrictions, activities by governmental authorities (including changes in taxation), currency fluctuations, the global economic climate, dilution, share price volatility and competition.

Forward-looking statements are subject to known and unknown risks, uncertainties and other important factors that may cause the actual results, level of activity, performance or achievements of Sandstorm to be materially different from those expressed or implied by such forward-looking statements, including but not limited to: the impact of general business and economic conditions, the absence of control over mining operations from which Sandstorm will purchase gold and risks related to those mining operations, including risks related to international operations, government and environmental regulation, actual results of current exploration activities, conclusions of economic evaluations and changes in project parameters as plans continue to be refined, risks in the marketability of minerals, fluctuations in the price of gold, fluctuation in foreign exchange rates and interest rates, stock market volatility, as well as those factors discussed in the section entitled “Risks to Sandstorm” in Sandstorm’s annual report for the financial year ended December 31, 2014 available at www.sedar.com. Although Sandstorm has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements. Sandstorm does not undertake to update any forward looking statements that are contained or incorporated by reference, except in accordance with applicable securities laws.

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(AGTC) & (BIIB) Enter Collaboration to Develop Gene Therapies in Ophthalmology

Companies to advance a potentially transformative treatment approach for genetic diseases of the eye

AGTC to receive $124M upfront, with potential future milestone payments and royalties

AGTC to host conference call today at 8 a.m. EDT

Biogen (NASDAQ: BIIB) and AGTC (NASDAQ: AGTC) today announced a broad collaboration and license agreement to develop gene-based therapies for multiple ophthalmic diseases. The collaboration will focus on the development of a portfolio of AGTC’s therapeutic programs, including both a clinical stage candidate and a pre-clinical candidate for orphan diseases of the retina that can lead to blindness in children and adults. The agreement also includes options for early stage discovery programs in two ophthalmic diseases and one non-ophthalmic condition, as well as an equity investment in AGTC by Biogen and a license agreement for manufacturing rights.

“With this collaboration, we hope to advance gene therapies to open possibilities for patients who suffer from diseases that are well understood, but have no adequate treatment,” said Olivier Danos, Ph.D., senior vice president, cell & gene therapy at Biogen. “AGTC is an exceptional partner to help us advance our gene therapy capabilities by targeting diseases of the eye – an organ that provides an ideal setting for the localized, selective delivery of gene-based therapies.”

“We expect this collaboration will further validate our novel adeno-associated virus (AAV) gene therapy platform and support the development of new therapies that may allow for transformative treatments for these rare inherited eye diseases and other clinical indications,” added Sue Washer, president and CEO of AGTC. “Biogen’s significant commitment to advancing gene therapies and demonstrated success in developing innovative therapies to treat complex diseases, combined with our proprietary manufacturing technology and extensive gene therapy experience, makes this an ideal partnership.”

The lead development programs in the collaboration include a clinical candidate for X-linked Retinoschisis (XLRS) and a pre-clinical candidate for the treatment of X-Linked Retinitis Pigmentosa (XLRP). XLRS, a disease affecting young males beginning during the teenage years, can lead to serious complications such as vitreous hemorrhage or retinal detachment during adulthood. XLRP usually causes night blindness by the age of ten and progresses to legal blindness by an individual’s early forties. Both conditions represent significant unmet needs that may be addressed by replacing the single, faulty gene causing each disease.

Collaboration Overview
Biogen will make an upfront payment in the amount of $124 million to AGTC, which includes a $30 million equity investment in AGTC at a price equal to $20.63 per share and certain prepaid research and development expenditures. Biogen will be granted a license to the XLRS and XLRP programs and the option to license discovery programs for three additional indications at the time of clinical candidate selection.

Under the collaboration, AGTC is eligible to receive upfront and milestone payments exceeding $1 billion. This includes up to $472.5 million collectively for the two lead programs, which also will carry royalties in the high single digit to mid-teen percentages of annual net sales. In addition, Biogen will make payments up to $592.5 million across the discovery programs, along with royalties in the mid single digits to low teen percentages of annual net sales.

Biogen obtains worldwide commercialization rights for the XLRS and XLRP programs. AGTC has an option to share development costs and profits after the initial clinical trial data are available, and an option to co-promote the second of these products to be approved in the United States. AGTC will lead the clinical development programs of XLRS through product approval and of XLRP through the completion of first-in-human trials. Biogen will support the clinical development costs, subject to certain conditions, following the first-in-human study for XLRS and IND-enabling studies for XLRP. Under the manufacturing license, Biogen will receive an exclusive license to use AGTC’s proprietary technology platform to make AAV vectors for up to six genes, three of which are in AGTC’s discretion, in exchange for payment of milestones and royalties.

The transaction is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 in the United States, and is expected to close in the third calendar quarter of 2015.

AGTC will host a live webcast presentation and conference call on July 2 at 8:00 a.m. EDT to discuss the collaboration. The webcast can be accessed at ir.agtc.com/events.cfm or by dialing (888) 427-9419 (US) or (719) 325-2491 (outside of the US) fifteen minutes prior to the start of the call. The passcode is 6785007. The webcast will be archived on the AGTC website.

About Gene Therapy
Gene therapy is an evolving field of medicine in which faulty genes are corrected in cells. Genes control heredity and provide the basic biological code for determining a cell’s specific functions. The most common form of gene therapy involves using DNA that encodes a functional, therapeutic gene to replace a defective gene. In gene therapy, the healthy copy of a defective gene is packaged within a vector, a biological delivery mechanism which is used to transport the genetic information into the diseased cells within the body. Once the gene is delivered into the correct cell, a therapeutic protein is naturally made by the cell from the therapeutic gene.

About Adeno-Associated Virus (AAV) Vectors
AAV vectors have emerged as an attractive approach for gene therapy since they can deliver the genes for therapeutic proteins to accessible tissues in the body. Several AAV gene therapy products are in late-stage clinical development, and one product is approved in the EU.

About Biogen
Through cutting-edge science and medicine, Biogen discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hematologic conditions and autoimmune disorders. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies, 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 www.biogen.com.

About AGTC
AGTC is a clinical-stage biotechnology company that uses its proprietary gene therapy platform to develop products designed to transform the lives of patients with severe diseases in ophthalmology. AGTC’s lead product candidates focus on X-linked retinoschisis, achromatopsia and X-linked retinitis pigmentosa, which are inherited orphan diseases of the eye, caused by mutations in single genes that significantly affect visual function and currently lack effective medical treatments. AGTC is also using its gene therapy expertise to expand into disease indications with large market opportunity such as wet AMD and other ophthalmology and orphan indications.

Biogen Safe Harbor
This press release contains forward-looking statements, including statements about the potential benefits and advancements that may be achieved through the collaboration with AGTC and the expected timing of the closing the transactions. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on Biogen’s current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include, among others: uncertainty inherent in the regulatory review process and satisfaction of other closing conditions relating to the transactions; uncertainty regarding the ability to achieve the expected benefits from the proposed collaboration, including as a result of risks and uncertainties associated with drug development and commercialization, reliance on third parties over which Biogen may not always have full control and other risks associated with collaborations; and other risks and uncertainties that are described in the Risk Factors section of Biogen’s 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 Biogen assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

AGTC Safe Harbor
This release contains forward-looking statements that reflect AGTC’s plans, estimates, assumptions and beliefs. Forward-looking statements include information concerning the expected timing of the closing of the transactions contemplated by the proposed collaboration, possible or assumed future results of operations, business strategies and operations, preclinical and clinical product development and regulatory progress, potential growth opportunities, potential market opportunities and the effects of competition. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “seeks,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions and the negatives of those terms. Actual results could differ materially from those discussed in the forward-looking statements, due to a number of important factors. Risks and uncertainties that may cause actual results to differ materially include, among others: uncertainty inherent in the regulatory review process and satisfaction of other closing conditions relating to the transactions; uncertainty regarding the ability to achieve the expected benefits from the proposed collaboration, including as a result of risks and uncertainties associated with drug development and commercialization, reliance on third parties over which AGTC may not always have full control and other risks associated with collaborations; and other risks and uncertainties that are described under the heading “Risk Factors” in AGTC’s Annual Report on Form 10-K for the fiscal year ended June 30, 2014, as filed with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent management’s plans, estimates, assumptions and beliefs only as of the date of this release. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

MEDIA CONTACTS:
Biogen:
Todd Cooper, +1 781-464-3260
public.affairs@biogen.com
or
Lazar Partners Ltd. for AGTC
Danielle Lewis, 212-843-0211
dlewis@lazarpartners.com
or
INVESTOR CONTACTS:
Biogen
Carlo Tanzi, Ph.D., +1 781-464-2442
IR@biogen.com
or
Lazar Partners Ltd. for AGTC
David Carey, 212-867-1768
dcarey@lazarpartners.com

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(RADA) Awarded UAV Avionic Unit Upgrade & Production Contract

NETANYA, Israel, July 1, 2015  — RADA Electronic Industries of Netanya, Israel (Nasdaq:RADA) announced today that it was awarded a contract from a leading Israeli defense contractor to upgrade a previously designed UAV (unmanned aerial vehicle) avionics unit and to supply additional production units. The total order value is $1.5 million with deliveries expected during the next 24 months.

During the last 10 years, UAV avionics have been one of the established areas of expertise at RADA, and the company is active in this market both in Israel and overseas.

For this new order, RADA will upgrade and modify the design of a previously developed unit, qualify the upgraded unit to the UAV environment and supply production units.

Zvi Alon, RADA’s CEO, commented: “This contract evidences the long-term recognition by a leading defense contractor of our avionics design and production capabilities, and we expect to maintain our presence in this advanced avionics market.”

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 radar systems 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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(RCPI) Human Proof of Principle Study with Lead Compound in Anti-inflammatory Role

SARASOTA, Fla., July 1, 2015 — Rock Creek Pharmaceuticals, Inc., (NASDAQ: RCPI), a drug development company focused on chronic inflammatory disease and neurologic disorders, announced today the results of a human proof of principle study with anatabine citrate, the Company’s lead compound. Results from the study show that a single oral dose of anatabine citrate can significantly inhibit the activation of inflammatory proteins in the blood of human subjects. The Company is developing this compound in a Phase 1 clinical trial under a Medicines and Healthcare Products Regulatory Agency (MHRA) regulatory protocol in the United Kingdom.

New Zealand Study

In December of 2014, the Company received a New Zealand Ministry of Health Ethics Committee approval to conduct a single-site, single dose, open-label human study, entitled “Determination of the Blood Pharmacodynamic Effects following a Single Dose of Oral Anatabine Citrate in Normal, Healthy Volunteers.”

The primary objective of the study was to determine whether a single dose of orally administered anatabine citrate could reduce the activation of inflammatory proteins in human white blood cells. Blood samples were taken from ten healthy human subjects, collected before and after oral administration of anatabine citrate. The blood samples were immediately challenged with lipopolysaccharide (LPS), a well-known potent stimulator of inflammation. The blood samples were then evaluated to measure the activation of two proteins, NF-kB and STAT3, which are known to be central to inflammation. The study compared the amount of LPS-induced activation of NF-kB and STAT3 in the white blood cells before and after the administration of anatabine citrate. Activated NF-kB and STAT3 protein levels were measured by two different, well-established molecular biology methods.

Data analysis showed that there were statistically significant (p<0.05) reductions in LPS stimulated levels of both NF-kB and STAT3 in human white blood cells after a single oral dose of anatabine citrate. These data are consistent with several peer reviewed scientific papers showing that anatabine can reduce NF-kB and STAT3 activation in animal models of inflammatory diseases, as well as in several human cell lines as shown by in vitro studies. Additionally, evaluation of safety data showed that anatabine citrate was well tolerated by the study participants and there were no safety concerns.

Ryan Lanier, PhD, Rock Creek Pharmaceuticals’  Chief Scientific Officer remarked, “This is the first time that anatabine citrate taken orally by human subjects has been shown to oppose the activation of these known inflammatory proteins in white blood cells. The data are entirely consistent with our proposed mechanism of action of anatabine citrate which forms the basis for our advancement of this compound into clinical trials for human inflammatory diseases.”

About Anatabine Citrate:
Rock Creek Pharmaceuticals’ Anatabine Citrate is a small molecule, cholinergic agonist which exhibits anti-inflammatory pharmacological characteristics, distinct from other anti-inflammatory drugs available such as biologics, steroids and non-steroidal anti-inflammatories. The Company has sponsored extensive pre-clinical (in vitro and in vivo) studies resulting in peer reviewed and published scientific journal articles, covering models of Multiple Sclerosis, Alzheimer’s Disease, and Auto-Immune Thyroiditis. All these studies demonstrated the anti-inflammatory effects of Anatabine Citrate. In addition, the Company’s compilation of human exposure, safety and tolerability data, derived primarily from human clinical studies and post-marketing data collection of the previously marketed nutraceutical product, has provided important insights for clinical development.

About Rock Creek Pharmaceuticals, Inc.:
Rock Creek Pharmaceuticals, Inc. is an emerging drug development company focused on the discovery, development and commercialization of new drugs, formulations and compounds that provide therapies for chronic inflammatory disease, neurologic disorders and behavioral health.

For more information, visit: http://www.rockcreekpharmaceuticals.com

Forward Looking Statements:
Certain statements contained in this release constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to statements identified by words such as “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “targets,” “projects” and similar expressions. The statements in this release are based upon the current beliefs and expectations of our company’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, failure to obtain sufficient capital resources to fund our development program and operations, results of clinical trials and/or other studies, the challenges inherent in new product development initiatives, including the continued development and approval of anti-inflammatory drug candidates, the effect of any competitive products, our ability to license and protect our intellectual property, our significant payables, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and/or regulation, potential litigation by or against us, any governmental review of our products or practices, pending litigation matters, as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our annual report on Form 10-K for the fiscal year ended December 31, 2014 filed on March 12, 2015. We undertake no duty to update any forward-looking statement or any information contained in this press release or in other public disclosures at any time.

CONTACT:

Stephanie Carrington
Investors
Integrated Corporate Relations, Inc. (ICR): Redefining Strategic Communications
685 Third Avenue, 2nd Floor,
New York, NY 10017
(646) 277-1282
stephanie.carrington@icrinc.com

Ted Jenkins
Vice President, Corporate Strategy and Development,
Rock Creek Pharmaceuticals
2040 Whitfield Avenue, Suite 300
Sarasota, FL  34243
Direct: 941-251-0488
tjenkins@rockcreekpharmaceuticals.com

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(LJPC) Lakhmir S. Chawla, M.D. Receives the International Vicenza Award

La Jolla Pharmaceutical Company (Nasdaq: LJPC) (the Company or La Jolla), a leader in the development of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases, today announced that Lakhmir “Mink” S. Chawla, M.D., the Company’s Chief Medical Officer, received the International Vicenza Award for Critical Care Nephrology at the 33rd Course on Critical Care Nephrology in June 2015. This award recognizes individuals who have made seminal clinical research advancements that have significantly improved the care of critically ill patients with acute kidney injury (AKI) and have been adopted worldwide.

Dr. Chawla was selected as the recipient of the Vicenza Award for his contributions to the development of the renal angina model, the development and standardization of the furosemide stress test, the link between AKI and chronic kidney disease (CKD), and the use of angiotensin II in the treatment of high-output shock. Dr. Chawla is the tenth recipient to receive the Vicenza Award.

Prior to his appointment at La Jolla, Dr. Chawla was an Associate Professor of Medicine at the George Washington University, where he had dual appointments in the Department of Anesthesiology and Critical Care Medicine and in the Department of Medicine, Division of Renal Diseases and Hypertension. Dr. Chawla was also the Chief of the Division of Intensive Care Medicine at the Washington D.C. Veterans Affairs Medical Center.

Dr. Chawla has been an active investigator in the field of critical care nephrology since 2002. His research has focused on shock, inflammation, AKI epidemiology and outcomes, the link between AKI and CKD, and AKI risk assessment. He is also a leading researcher in the field of AKI biomarkers and functional kidney testing.

“On behalf of the entire La Jolla team, I would like to congratulate Mink on receiving this prestigious award,” said George F. Tidmarsh, M.D., Ph.D., President and Chief Executive Officer of La Jolla. “Mink has made many valuable contributions to the field of medicine, and we are honored to have him on our team.”

Professors Claudio Ronco, M.D. and Rinaldo Bellomo, MBBS, M.D., FRACP, FCICM, PGDipEcho presented the award. Professor Ronco founded the International Renal Research Institute of Vicenza that has hosted more than 100 fellows from all over the world and is renowned for the interdisciplinary nature of the research carried out in its many laboratories. Professor Bellomo is the Director of Intensive Care Research at the Austin Hospital in Melbourne, the Founding Chair of the Australian and New Zealand Intensive Care (ANZIC) Society Clinical Trials Group and the current Co-Director of the ANZIC Research Centre.

About La Jolla Pharmaceutical Company

La Jolla Pharmaceutical Company is a biopharmaceutical company focused on the discovery, development and commercialization of innovative therapies intended to significantly improve outcomes in patients suffering from life-threatening diseases. The Company has several product candidates in development. LJPC-501 is La Jolla’s proprietary formulation of angiotensin II for the potential treatment of catecholamine-resistant hypotension and hepatorenal syndrome. LJPC-401 is La Jolla’s novel formulation of hepcidin for the potential treatment of conditions characterized by iron overload, such as hereditary hemochromatosis and beta thalassemia. LJPC-30Sa and LJPC-30Sb are La Jolla’s next-generation gentamicin derivatives for the potential treatment of serious bacterial infections and rare genetic disorders, such as cystic fibrosis and Duchenne muscular dystrophy. For more information on La Jolla, please visit www.ljpc.com.

 

La Jolla Pharmaceutical Company
George F. Tidmarsh, M.D., Ph.D.
President & Chief Executive Officer
858-207-4264
gtidmarsh@ljpc.com
or
Dennis M. Mulroy
Chief Financial Officer
858-433-6839
dmulroy@ljpc.com

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(WPCS) Suisun City Opens Fiscal 2016 by Signing $3.6 Million in New Contracts

SUISUN, CA–(Jul 1, 2015) – WPCS International Incorporated (NASDAQ: WPCS), which specializes in contracting services for communications infrastructure, today announced that it was awarded $3.6 million in new contracts during the first two months of fiscal year 2016.

According to Sebastian Giordano, Interim CEO of WPCS, “With Suisun City Operations having just completed a profitable fiscal year end 2015, this is a very good start to the new year.”

These new projects include a significant $2.4 million technology cabling and technology room build-out for all network cabling at the new California Pacific Medical Center, St. Luke’s Campus Hospital, located in the Mission District of San Francisco. The new hospital will be a 215,000 square foot acute health care facility providing 120 new patient beds.

About WPCS International Incorporated
WPCS provides contracting services to the public services, healthcare, energy and corporate enterprise markets in the United States. For more information, please visit www.wpcs.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements with respect to the Company’s future growth opportunities and strategic plan. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

INVESTOR CONTACT:
WPCS International Incorporated
David Allen
Chief Financial Officer
Phone: 707.759.6008
Email: Email Contact

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(VSTA) FDA, NIH Clearance for NIH-Funded AV-101 Phase 2 Study in MDD

Phase 2 Clinical Study in Major Depressive Disorder Expected to Commence at NIH in 3Q 2015

SOUTH SAN FRANCISCO, CA–(Jul 1, 2015) – VistaGen Therapeutics, Inc. (OTCQB: VSTA), a clinical-stage biopharmaceutical company committed to developing and commercializing innovative product candidates for patients with depression, other diseases and various disorders related to the central nervous system as well as cancer, has received clearance from the U.S. Food and Drug Administration (FDA) and the U.S. National Institutes of Health (NIH) to initiate an NIH-funded Phase 2 clinical study of its orally active AV-101 in subjects with treatment-resistant Major Depressive Disorder (MDD) under protocol number 15-M-0151. The Principal Investigator of the study will be Dr. Carlos Zarate, Jr., Chief of the Section on the Neurobiology and Treatment of Mood Disorders and Chief of the Experimental Therapeutics and Pathophysiology Branch at the U.S. National Institute of Mental Health (NIMH), which is part of the NIH. The Phase 2 study will be a randomized, double-blind, placebo-controlled, crossover clinical trial conducted at the NIMH and designed to evaluate the efficacy and safety of a single oral dose of AV-101 administered once per day for 14 days to approximately 25 patients with MDD. VistaGen and the NIMH expect to initiate enrollment of subjects in the study in 3Q 2015.

AV-101 is an orally active, clinical-stage prodrug candidate that readily gains access to the central nervous system (CNS) after systemic administration and is rapidly converted in vivo to its active metabolite, 7-chlorokynurenic acid (7-Cl-KYNA), a well-characterized, potent, and highly-selective antagonist of the glycine-binding co-agonist (GlyB) site of the N-methyl-D-aspartate receptor (NMDAR). Current evidence suggests that AV-101’s antagonism of NMDAR signaling may provide fast-acting antidepressant effects in the treatment of MDD. In addition, as confirmed in two Phase 1 clinical studies, using AV-101 to target the GlyB site of the NMDAR may bypass potential adverse effects that occur with ketamine, while activating similar pathways resulting in the “glutamate surge” that has been associated with increased neurogenesis and the rapid-acting antidepressant effects of ketamine observed in previous clinical studies.

“The NIMH and several key leaders in the field with clinical experience using ketamine to treat MDD provided valuable expert advice on the design of our Phase 2 MDD study. We are grateful for their assistance. With their help, we have now achieved an important regulatory milestone for our AV-101 clinical development program,” said H. Ralph Snodgrass, the Company’s President and Chief Scientific Officer. “The pharmacology and existing clinical safety data and preclinical efficacy data point to AV-101’s potential to provide a transformative advancement in the treatment of MDD, in a manner fundamentally different from all currently approved antidepressants.”

About MDD

While most people will experience episodic depressed mood at multiple points during their life, MDD is different. MDD is the chronic, pervasive feeling of utter unhappiness, hopelessness and suffering, which impairs daily functioning. Symptoms of MDD include diminished pleasure in activities, changes in appetite that result in weight changes, insomnia or oversleeping, psychomotor agitation, loss of energy or increased fatigue, feelings of worthlessness or inappropriate guilt, difficulty thinking, concentrating or making decisions, and thoughts of death and attempts at suicide. Suicide is estimated to be the cause of death in up to 15% of individuals with MDD. MDD is one of the most common mental disorders in the United States. According to the NIMH, about 6.7% of U.S. adults experience MDD each year.

About Current Antidepressants

Current medications available in the multi-billion dollar global antidepressant market, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs), have limited effectiveness. Because of their mechanism of action, SSRIs and SNRIs must be taken for several weeks before patients experience significant therapeutic benefit. Approximately two-thirds of depression sufferers do not benefit from initial treatment with SSRIs and SNRIs. Although approximately two-thirds patients may find an antidepressant drug or drug combination that induces remission of their depressive symptoms after several different drug treatment attempts, this trial and error process and the systemic effects of the various antidepressant medications involved increases the risks of patient tolerability issues and serious side effects, including the potential of increased suicidal thoughts and behaviors during the time period before the therapeutic effects of the drugs are obtained.

About Ketamine for MDD

Ketamine hydrochloride (ketamine) is an FDA-approved, rapid-acting general anesthetic. The use of ketamine to treat MDD has been studied in several clinical trials conducted by depression experts, including Dr. Carlos Zarate and others at the NIMH. In randomized, placebo-controlled, double-blind clinical trials reported by Dr. Zarate and others at the NIMH, a single subanaesthetic intravenous dose of ketamine (0.5 mg/kg over 40 minutes) produced robust and rapid antidepressant effects in MDD patients who had not responded to currently-approved medications. These results were in contrast to the slow onset of currently FDA-approved antidepressant medications, which usually require many weeks or months of chronic usage to achieve similar antidepressant effects. The potential for widespread therapeutic use of ketamine is severely limited by its potential for abuse, dissociative and psychosis-like side effects, and by practical challenges associated with its intravenous administration in a medical center. Notwithstanding these limitations the discovery of ketamine’s fast-acting antidepressant effects revolutionized thinking about the MDD treatment paradigm. The discovery also increased interest in the development of a new generation of antidepressants with a fast-acting mechanism of action similar to ketamine’s.

About AV-101 for MDD
AV-101’s fundamentally novel mechanism of action places it among a new generation of glutamatergic antidepressants with potential to treat millions of MDD sufferers worldwide who are poorly served by SSRIs, SNRIs and other current depression therapies. Like ketamine, AV-101 modulates (down-regulates) NMDAR activity. However, unlike ketamine’s antagonistic activity, which results from its blocking the NMDAR ion channel, AV-101’s antagonistic activity results from its selective binding to, and blocking of, the functionally-required GlyB site of the NMDAR. In addition, AV-101 is orally available and has a much longer half-life than ketamine and mechanistically similar peptides currently under development for MDD.

About the U.S. National Institute of Mental Health

The U.S. National Institute of Mental Health (NIMH), part of the U.S. National Institutes of Health (NIH), is the largest scientific organization in the world dedicated to mental health research. NIMH is one of 27 Institutes and Centers of the NIH, the world’s leading biomedical research organization. The mission of NIMH is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For more information, visit www.nimh.nih.gov.

About VistaGen Therapeutics

VistaGen Therapeutics, Inc. is a clinical-stage biopharmaceutical company committed to developing and commercializing innovative product candidates for patients with depression, other diseases and various disorders related to the central nervous system as well as cancer. VistaGen’s AV-101 is a new generation orally-available NMDAR GlyB antagonist in Phase 2 clinical development for Major Depressive Disorder. Based on preclinical studies, AV-101 may also have potential as a treatment for other CNS-related conditions, including chronic neuropathic pain and epilepsy, as well as neurodegenerative diseases such as Parkinson’s disease and Huntington’s disease. VistaGen is also developing and using pluripotent stem cell technology and clinically-predictive bioassay systems, CardioSafe 3D™ and LiverSafe 3D™, for drug rescue applications focused on producing proprietary new chemical entities (NCEs) for its internal development pipeline.

Visit VistaGen at http://www.VistaGen.com
Follow VistaGen on Twitter at http://www.twitter.com/VistaGen
Connect to VistaGen’s Facebook page at http://www.facebook.com/VistaGen

Cautionary Statement Regarding Forward-Looking Statements

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the VistaGen’s and the NIH’s successful completion of the NIH-sponsored Phase 2 clinical study of AV-101 in MDD, its stem cell technology-based drug rescue activities, protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the foregoing activities. These and other risks and uncertainties are identified and described in more detail in VistaGen’s filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC’s website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

For more information:

Shawn K. Singh, J.D.
Chief Executive Officer
VistaGen Therapeutics, Inc.
www.VistaGen.com
650-577-3613
Investor.Relations@VistaGen.com

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(KEYW) Strategic Executive Changes Prepare Company for Growth

HANOVER, Md., June 30, 2015  — Hexis Cyber Solutions, Inc. (Hexis), a wholly-owned subsidiary of The KEYW Holding Corporation (NASDAQ:KEYW), and a provider of advanced cybersecurity solutions for commercial companies and government agencies, today welcomes Jan Manning as the company’s Vice President of IT Operations. The company is also pleased to appoint Chris Carlson as its new Vice President of Product Management, HawkEye G. These organizational changes, coupled with strong industry demand for innovative cybersecurity solutions, help to position Hexis for growth and demonstrate the company’s commitment to innovation and customer success in combating sophisticated threats.

Jan Manning joins the Hexis team after having served as CIO for SafeNet-Gemalto, where she was responsible for defining and implementing corporate application and infrastructure standards across the company’s entire technology footprint. A security industry veteran, Manning will drive Hexis overall IT strategy, IT based services and ensure the company is well-positioned for expansion.

“Working in a field as fast-paced as IT security, I was eager to join a team willing to break industry boundaries and offer next-generation, innovative solutions like automated threat removal,” said Jan Manning, Vice President, Information Technology and Operations, Hexis Cyber Solutions. “This is an exciting time for Hexis as it emerges as a leader in the cybersecurity market. I am thrilled to be part of the team that will help drive the company forward, focusing on enhancing our internal infrastructure and processes to allow us to take advantage of new opportunities and serve a growing customer base.”

Hexis is equally pleased to announce that its former Senior Director of Product Management, Chris Carlson, has been promoted to Vice President of Product Management, HawkEye G. Having joined the Hexis team in September of 2014, Carlson’s talents as a security expert were exemplified by his leadership in the recent launch of HawkEye G 3.0, the company’s flagship solution. Carlson played a major role in the development of HawkEye G’s new ThreatSync™ capability for evidence-based detection and verification of unknown and known threats, and integration with popular third-party security technologies for increased threat intelligence.

“Given our current rate of success it’s clear that the time is right for a solution like HawkEye G that accelerates time to detection and removes advanced threats before damage is done,” said Chris Fedde, President, Hexis Cyber Solutions. “The addition of Jan to our team and Chris’ promotion will allow us to take Hexis to the next level. Their expertise and experience will help ensure we continue to execute in the way we need to build on our momentum and solidify our position as a leader in the cybersecurity market.”

About Hexis Cyber Solutions

Hexis Cyber Solutions, Inc. is a team of cybersecurity experts delivering solutions that enable organizations to defend against and remove cyber threats at machine speeds before they do damage. Hexis’ advanced security solutions use real-time endpoint sensors, network detection, and threat analytics to provide organizations with an intelligent and automated threat detection and response solution. Hexis’ solutions deliver improved visibility into the network and endpoints, threat verification, and automated threat removal capabilities for organizations of all sizes.

Hexis Cyber Solutions, Inc. is a wholly-owned subsidiary of The KEYW Holding Corporation (KEYW), based in Hanover, Maryland with engineering offices in Columbia, Maryland and San Mateo, California. Hexis’ solutions were developed leveraging KEYW’s expertise in supporting our nation’s cybersecurity missions. For more information contact Hexis Cyber Solutions, 7740 Milestone Parkway, Suite 400, Hanover, Maryland 21076; Phone 443-733-1900; Fax 443-733-1901; E-mail info@hexiscyber.com; or on the Web at www.hexiscyber.com.

Follow Hexis on Twitter: @hexis_cyber

About KEYW

KEYW provides agile cyber superiority, cybersecurity, and geospatial intelligence solutions for U.S. Government intelligence and defense customers and commercial enterprises. We create our solutions by combining our services and expertise with hardware, software, and proprietary technology to meet our customers’ requirements. For more information contact KEYW Corporation, 7740 Milestone Parkway, Suite 400, Hanover, Maryland 21076; Phone 443-733-1600; Fax 443-733-1601; E-mail investors@keywcorp.com; or on the Web at www.keywcorp.com.

For Media Inquiries:
Nina Korfias - MSLGROUP
781.684.6543
hexis@mslgroup.com

For Investor Relations:
Chris Donaghey - Hexis
443.733.1600
cdonaghey@hexiscyber.com
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(AMRS) Announces Total’s Decision to Proceed With Jet Fuel Joint Venture

EMERYVILLE, Calif., June 30, 2015  — Amyris, Inc. (Nasdaq:AMRS), the industrial bioscience company, today announced that it has agreed on key business terms with Total Energies Nouvelles Activités USA (a wholly owned subsidiary of Total S.A.) (“Total”) for restructuring its fuels joint venture to open the way for proceeding with commercialization of its jet fuel technology over the coming years. Following the restructuring, Total would own 75% of the joint venture with Amyris.

In conjunction with this transaction, Amyris has also agreed on key business terms with Total and Temasek, another major stockholder of Amyris, under which, and as part of a plan to strengthen the balance sheet, these stockholders would exchange an aggregate of $138 million of convertible debt for Amyris common stock at a price of $2.30 per share, with an additional $37 million of outstanding convertible debt being restructured to eliminate Amyris’s repayment obligation at maturity and provide for mandatory conversion to Amyris common stock. The terms of the restructuring include provisions related to the note conversions for these participating stockholders, including to maintaining pro rata holdings. The closing of the exchange transactions would be subject to customary closing conditions, including any required Board of Directors or other internal approvals, and regulatory approvals or notices.

These joint venture and exchange transactions are subject to the execution of definitive agreements between Amyris and the parties, the terms of which may vary from those described above.

About Amyris

Amyris is the integrated renewable products company that is enabling the world’s leading brands to achieve sustainable growth. Amyris applies its innovative bioscience solutions to convert plant sugars into hydrocarbon molecules, specialty ingredients and consumer products. The company is delivering its No Compromise® products in focused markets, including specialty and performance chemicals, fragrance ingredients, and cosmetic emollients. More information about the company is available at www.amyris.com.

Forward-Looking Statements

This release contains forward-looking statements, and any statements other than statements of historical facts could be deemed to be forward-looking statements. These forward-looking statements include, among other things, statements regarding future events (such as Amyris’ expectation of entering into agreements to restructure its fuels joint venture with Total to encompass the commercialization of jet fuel and agreements for the conversion of certain outstanding convertible debt into common stock through a pricing mechanism currently resulting in a price of approximately $2.30 per share and restructuring of certain other outstanding convertible debt) that involve risks and uncertainties. These statements are based on management’s current expectations and actual results and future events may differ materially due to risks and uncertainties, including risks that Amyris, Total and Temasek will not be able to agree to final terms for the completion of the completed agreements and that required consents and approvals for the entry into these agreements may not be obtained, that consummation of the restructuring of the fuels joint venture and the conversion agreements will be subject to numerous conditions to be negotiated by the parties, certain of which are likely to be outside of Amyris’s control, as well as risks detailed in the “Risk Factors” section of Amyris’s annual report on Form 10-Q filed on May 5, 2015. Amyris disclaims any obligation to update information contained in these forward-looking statements whether as a result of new information, future events, or otherwise.

Amyris is a registered trademark of Amyris, Inc.

CONTACT: Peter DeNardo
         Director, Investor Relations and Corporate Communications
         Amyris, Inc.
         +1 (510) 740-7481
         investor@amyris.com
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(TLOG) Announces Update on MDS Clinical Program

MALVERN, Pa., June 30, 2015  — TetraLogic Pharmaceuticals Corporation (NASDAQ:TLOG), a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, today announced preliminary data from the ongoing Phase 2A study of birinapant in combination with azacitidine in first line higher risk myelodysplastic syndromes (MDS). The study is being conducted as a precursor to the ongoing randomized Phase 2B study.

In this study, birinapant was administered, at 13 mg/m2 twice a week, three weeks out of four, during a four week cycle in combination with the approved dose of azacitidine. The primary assessment of efficacy was the response rate using the modified International Working Group criteria (Cheson 2006) at the end of cycle four. Of the nine patients who entered the study, six completed four cycles of therapy and underwent a repeat bone marrow assessment. Three patients experienced a complete response, one patient experienced a bone marrow complete response, one patient experienced a partial response and underwent a stem cell transplant and one patient had stable disease. Three patients discontinued the study prior to receiving four cycles of treatment. The regimen was generally well tolerated, the most common side effects being fatigue, neutropenia and thrombocytopenia.

“While acknowledging the small number of patients involved in the study, we find these data encouraging,” said Dr. Lesley Russell, TetraLogic’s Chief Medical Officer. “We plan to conduct an interim analysis of the ongoing randomized trial around the end of the year and look forward to reviewing those results.”

About TetraLogic Pharmaceuticals Corporation

TetraLogic is a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases. TetraLogic has two clinical-stage product candidates in development: birinapant and SHAPE. Birinapant is currently being evaluated for the treatment of solid and liquid tumors and certain intracellular pathogens.   SHAPE is being evaluated for the treatment of early-stage cutaneous T‑cell lymphoma.

Forward Looking Statements

Some of the statements in this release are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events or TetraLogic’s pre-clinical and clinical development of birinapant, SHAPE and other clinical programs, future expectations, plans and prospects. Although TetraLogic believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. TetraLogic has attempted to identify forward looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 26, 2015 and in our Form 10-Q filed with the SEC on May 14, 2015.  Any forward looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

CONTACT: Pete A. Meyers
         Chief Financial Officer and Treasurer
         TetraLogic Pharmaceuticals Corporation
         (610) 889-9900, x103
         pete.meyers@tlog.com
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(AST) Added To Russell Indexes

MENLO PARK, Calif., June 30, 2015  — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company focused on the emerging field of regenerative medicine, today announced that it has been added to the Russell 2000®, Russell 3000®, Russell Global and Russell Microcap® indexes following Russell Investments’ (“Russell”) reconstitution of its comprehensive set of U.S. and global equity indexes after the close of the U.S. markets on June 26, 2015. Each June, Russell completely rebalances its indexes, known as a reconstitution, to reflect market changes in the past year.

The Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for passive and active investment strategies. Approximately $5.7 trillion in assets are currently benchmarked to Russell indexes and more than $800 billion in assets are invested in products based on them. The most well-known index of the series is the Russell 2000®, a subset of the Russell 3000® Index that measures the performance of the small-cap segment of the U.S. equity market.

Russell determines membership for its equity indexes, which remains in place for one year, primarily by objective, market-capitalization rankings and style attributes. The Russell 3000® captures the 3,000 largest U.S. stocks as of the end of May of each year, ranking them by total market capitalization. The largest 1,000 companies in this ranking make up the Russell 1000® and the next largest 2,000 companies comprise the Russell 2000®. The Russell 3000® also serves as the U.S. component to the Russell Global Index. The Russell Microcap® consists of the smallest 1,000 securities in the small-cap Russell 2000 Index, plus the next 1,000 smallest eligible securities by market cap.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. (NYSE MKT: AST) is a leading biotechnology company in the emerging field of regenerative medicine. The Company’s proprietary, industry leading platforms are based on its pluripotent stem cell and allogeneic dendritic cell technologies. Pluripotent stem cells are characterized by the ability to become all cell types in the human body. Asterias is focused on developing therapies based on pluripotent stem cells to treat conditions in several medical areas where there is high unmet medical need and inadequate available therapies. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) has demonstrated promise in a Phase 2 study in acute myelogenous leukemia. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic approach to dendritic cell vaccines.  Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.

FORWARD-LOOKING STATEMENTS

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias’ filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.

Tuesday, June 30th, 2015 Uncategorized Comments Off on (AST) Added To Russell Indexes