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(SPPR) Signs Agreement to Acquire Three Premium-Branded Hotels
Changes Name Effective July 15 to Condor Hospitality Trust Reflecting New Direction
NORFOLK, NE–(July 15, 2015) – Supertel Hospitality, Inc. (NASDAQ: SPPR), a real estate investment trust (REIT), announced today that it has signed agreements to acquire three, premium-branded hotels in an off-market transaction for $42.5 million. The properties are the 116-room SpringHill Suites by Marriott, San Antonio, Texas, the 142-room Hotel Indigo adjacent to the Hartsfield-Jackson Atlanta International Airport in Atlanta, Georgia, and the 120-room Courtyard by Marriott in Jacksonville, Florida.
The acquisitions are subject to completion of satisfactory due diligence and financing. The transactions are expected to close in 2015 during the third quarter and are projected to be accretive to 2015 fourth quarter results.
Changes Name to Condor Hospitality
The company has changed its name from Supertel Hospitality, Inc. to Condor Hospitality Trust, Inc. Upon the completion of Nasdaq procedures, the company’s common stock trading symbol will change from SPPR to CDOR. The trading symbol for the company’s Series A preferred stock will change from SPPRP to CDORP and the trading symbol for the company’s Series B preferred stock will change from SPPRO to CDORO.
“The acquisition of these three hotels aligns perfectly with the new strategy underway at the company and creates a great opportunity for us to announce the renaming of the company to Condor Hospitality,” said Bill Blackham, Condor Hospitality’s CEO. “The name Supertel connotes economy and midscale hotels, segments that are no longer part of our future plans, which was an important part of the consideration behind renaming the company. The recently announced prospective acquisitions and the new name are consistent with the dynamic new direction for the company.
“The Condor is a highly respected bird known for its considerable strength, tenacity and long life, traits that exemplify what we strive to be as a company — a respected industry leader in the premium, select-service, extended-stay and limited service hotel segments operated under high quality, contemporary brands.”
“As previously announced, we have accelerated capital recycling through disposition of much of our economy and economy extended-stay hotel portfolio which has an average age of 30 years and in many cases is located in tertiary markets,” he noted. “We intend to reinvest the capital from those dispositions into a higher quality, significantly newer, upscale portfolio of hotels in order to drive increased shareholder value.”
Blackham said that the hotels under contract are a window into the company’s portfolio of the future. Condor’s acquisition profile will be hotels located primarily in the 20th through 50th MSAs. The hotels under contract are located in Atlanta, the country’s 8th largest MSA; San Antonio, the 25th; and Jacksonville, the 40th. Targeted hotels are expected to have an average investment in the $15 to $20 million range with an average age of 10 years or less. He also pointed out that this off market acquisition is the result of one of several evolving strategic alliances with highly competent management companies, in this case Peachtree Hotel Group and its affiliate Peachtree Hospitality Management (“PHM”). PHM is a Georgia based hotel property management company currently operating 27 hotel properties with more than 3,000 hotel rooms. It is an approved operator of the major, premium hotel brands including Marriott, Starwood, InterContinental, Hilton, Hyatt, Choice and Wyndham.
“Condor is in a state of transition, divesting older properties in the economy segment and investing in newer, contemporary hotels to create a significantly larger hospitality REIT comprised of a higher quality portfolio with greater margins and located in markets with better fundamentals,” he said. “We will remain highly disciplined in our acquisition investment strategy, continuously review our portfolio and, when appropriate, upgrade into properties that we believe will generate more attractive returns. Brand considerations will be important in our portfolio because brand relevancy is critical to meeting evolving guest preferences, particularly the increasingly important Millennial generation.
About the Hotels
The Hotel Indigo Hartsfield Atlanta International Airport was built in 2012 on a 1.76 acre parcel near the world’s busiest airport and is located at 1776 Harvard Ave., in College Park, Ga. The 142-key boutique hotel offers 2,100 square feet of meeting space, a high energy entrance and lobby area, the Harvard & Main Restaurant and bar, fitness room, business center and 93 parking spaces.
The SpringHill Suites Downtown/Riverwalk, San Antonio, Texas, is located on 1.1 acres at 524 S. St. Mary’s Street in the heart of the popular Riverwalk tourist/business district in San Antonio. The property opened in December 2014 following extensive renovations during an upbranding conversion. The city’s convention center, only two blocks away, is expanding to 1.65 million square feet, which will make it the ninth largest in the country. No Property Improvement Plan (PIP) is anticipated due to the recent conversion. The 116-key, all-suite, four-story hotel features 2,100 square feet of meeting space, lobby and breakfast area, business center, swimming pool, fitness center and 34 parking spaces.
The Courtyard by Marriott Jacksonville, Flagler Center is located adjacent to the 1.4 million square foot Flagler Center business park, the Baptist Medical Center South and the Citi Card credit card processing center. Situated on 3.0 acres at 14402 Old St. Augustine Road, the 120-room hotel features 565 square feet of meeting space, lobby and cafe restaurant/lounge, business center, fitness center, swimming pool and 139 parking spaces. Opened in 2007, the property was significantly updated and renovated in 2014, including upgrading to Courtyard’s new Bistro concept. No PIP requirement is anticipated.
“These hotels are in ‘like-new’ condition in very attractive markets and have brand affiliation conducive to future RevPAR expansion, particularly given the recent completion of extensive renovations,” Blackham said.
“Upon completion of the acquisitions, Condor will additionally own premium-branded properties in the Marriott and InterContinental brand families. We have an active pipeline within these brands, as well as with other premium-branded hotel companies such as Hilton and Hyatt.”
ABOUT CONDOR HOSPITALITY
Condor Hospitality Trust is a self-administered real estate investment trust that specializes in the investment and ownership of upper midscale and upscale, premium branded select-service, extended stay and limited service hotels. The company currently owns 48 hotels in 19 states. Condor’s hotels are franchised by a number of the industry’s most well-regarded brand families including Hilton, Choice and Wyndham. For more information or to make a hotel reservation, visit www.condorhospitality.com.
Certain matters within this press release are discussed using forward-looking language as specified in the Private Securities Litigation Reform Act of 1995, and, as such, may involve known and unknown risks, uncertainties and other factors that may cause the actual results or performance to differ from those projected in the forward-looking statement. These risks are discussed in the company’s filings with the Securities and Exchange Commission.
Contact:
Ms. Krista Arkfeld
Director of Corporate Communications
karkfeld@supertelinc.com
(402) 371-2520
(MDGN) First Patient Enrolled in U.S.-Based Phase 2 Clinical Trial of TARGT-EPO
PHILADELPHIA, July 15, 2015 — Medgenics, Inc. (NYSE:MDGN), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that the first patient has been enrolled in its U.S.-based Phase 2 clinical trial of MDGN-201 (TARGTEPOTM), an investigational gene therapy for the treatment of anemia in end stage renal disease (ESRD) patients undergoing peritoneal dialysis.
“Enrolling our first patient in the U.S. represents a significant achievement for the Company,” commented Garry Neil, MD, Chief Scientific Officer of Medgenics. “We look forward to progressing the study and continuing the advancement of this unique gene therapy platform.”
About the Trial (MG-EP-RF-04)
The objective of this Phase 2, open-label study is to evaluate the safety and biologic activity of MDGN-201 TARGTEPO treatment when maintaining hemoglobin levels within the targeted range of 9-12 g/dl. Biological activity assessments will include duration of TARGTEPO secretion as measured by serum EPO levels above baseline. Each patient will be administered with a targeted dose of EPO delivered via TARGTEPO. The targeted doses will be determined according to two cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 IU/Kg/day). Additional details may be found on www.clinicaltrials.gov using identifier NCT02468414.
About Medgenics, Inc.
Medgenics is developing the TARGT™ (Transduced Autologous Restorative Gene Therapy) system, a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides using ex vivo gene therapy and the patient’s own tissue for the treatment of orphan and rare diseases. For more information, visit the Company’s website at www.medgenics.com.
Forward-looking Statements
This 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 as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company’s financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as “estimate,” “project,” “intend,” “forecast,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “will likely,” “should,” “could,” “would,” “may” or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.
CONTACT: Medgenics, Inc.
John Leaman
john.leaman@medgenics.com
Brian Piper
Brian.piper@medgenics.com
Stern Investor Relations
Beth DelGiacco
212-362-1200
Beth@sternir.com
(ITUS) Settlement and License Agreement With eBay, Vendio, & Auctiva
LOS ANGELES, CA–(July 15, 2015) – ITUS Corporation (“ITUS“) (NASDAQ: ITUS), today announced that its wholly owned subsidiary, Auction Acceleration Corporation (“AAC”), has entered into a Settlement and License Agreement with eBay, Inc., Auctiva, LLC, and Vendio Services, LLC.
The Settlement and License Agreement resolves a lawsuit between the parties that was filed on September 8, 2014 in The United States District Court for the Northern District of California, which will be dismissed. AAC owns the rights to patents that cover presentation and cross selling technologies enabling auction sellers to cross-sell and upsell additional items to interested buyers, resulting in incremental sales and higher yields per transaction.
About ITUS Corporation
ITUS funds, develops, acquires, and licenses emerging technologies such as High-Tech, Biotechnology, Life Sciences, and Informatics. The company’s wholly owned subsidiary, Anixa Diagnostics, is developing non-invasive, cancer screening tests, and the company and its other subsidiaries have ongoing development and licensing programs involving encrypted communications, advanced materials, and thin-film, flat panel displays. Additional information is available at www.ITUScorp.com.
Forward-Looking Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect ITUS Corporation’s current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A – Risk Factors” and other sections of our Annual Report on Form 10-K for the fiscal year ended October 31, 2014 as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.
ITUS Corporation: FOCUSED ON INNOVATION™
Contact:
Dean Krouch
310-484-5184
dkrouch@ITUScorp.com
(BGMD) Announces Payoff of Secured Term Loan
WALTHAM, Mass., July 15, 2015 — BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, announced today that it has paid off its secured term loan facility with General Electric Capital Corporation and Comerica Bank.
The secured term loan in the aggregate principal amount of $10 million was funded to BG Medicine in February 2012. BG Medicine has been making monthly principal and interest payments on this loan since August 2013. With today’s payoff, all security interests that had been granted to the secured lenders are now released and discharged.
“The payoff of the secured term loan facility and elimination of the associated cash burn was an important milestone for BG Medicine and will allow us to invest additional operating cash to grow our business,” said Paul R. Sohmer, M.D., President and Chief Executive Officer of BG Medicine. “Fulfilling this key objective was an essential step in our plan to redirect critical resources to support our role in the U.S. market introduction of automated galectin-3 testing, which became available in the U.S. earlier this month.”
About BG Medicine, Inc.
BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, is focused on the development and delivery of diagnostic solutions to aid in the clinical management of heart failure and related disorders. For additional information about BG Medicine, heart failure and galectin-3 testing, please visit www.BG-Medicine.com.
The BG Medicine Inc. logo is available for download here.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the anticipated benefits of the payoff of the secured term loan facility on our ability to grow our business. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond the Company’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. These risks and uncertainties include, among other things, the factors discussed under the heading “Risk Factors” contained in BG Medicine’s annual report and quarterly reports filed with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and BG Medicine disclaims any obligation to update the information contained in this press release as new information becomes available.
CONTACT: Stephen Hall, EVP & Chief Financial Officer
(781) 890-1199
(ONCS) to Participate in Webcast on Advances in Cancer Immunotherapy
SAN DIEGO, July 14, 2015 — OncoSec Medical Inc. (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, announced today that Robert H. Pierce, MD, Chief Scientific Officer, will participate in a BioPharma Dealmakers webcast featuring four companies developing cancer immunotherapies. The webcast is scheduled for 11:00 am ET on July 21, 2015. To register for the webcast, please click here.
The webcast will explore some of the challenges and opportunities of technologies at the cutting edge of cancer immunotherapy. Participants will learn about new approaches that have been developed to:
- Harness the full potential of our immune system
- Screen for novel target and antibody combinations
- Enlist our own immune system to attack cancer cells
- Improve the delivery of cancer-specific therapeutics to tumors
The webcast will include a round table discussion and a Q&A session to enable participants to contribute their own thoughts on this highly innovative area of cancer research. The webcast is sponsored in part by OncoSec. In addition to Dr. Pierce, other webcast participants include:
- Jeremy Graff, PhD, Senior Vice President, Pharmaceutical Research for Biothera. Dr. Graff joined Biothera from Eli Lilly and Company where he was Research Fellow and Group Leader, Oncology Patient Tailoring.
- Björn Frendéus, PhD, Chief Scientific Officer, BioInvent. Dr. Frendéus is an immunologist and graduate of the Swedish Foundation for Strategic Research.
- Harlan Robins, PhD, Adaptive Biotechnologies. Dr. Robins is the Chief Scientific Officer and Co-Founder of Adaptive Biotechnologies.
- Moderator: Gaspar Taroncher-Oldenburg, PhD. Dr. Taroncher-Oldenburg is an independent consultant and former managing editor of SciBX: Science-Business eXchange for Nature Publishing Group and the former scientific editor at Nature Biotechnology.
About OncoSec Medical Inc.
OncoSec Medical Inc. is a biopharmaceutical company developing its investigational ImmunoPulse™ intratumoral cancer immunotherapy. OncoSec’s core technology is designed to enhance the local delivery and uptake of DNA IL-12 and other DNA-based immune-targeting agents. Clinical studies of ImmunoPulse™ IL-12 have demonstrated an acceptable safety profile and evidence of anti-tumor activity in the treatment of various skin cancers as well as the potential to initiate a systemic immune response. OncoSec’s lead program, ImmunoPulse™ IL-12, is currently in Phase II development for several indications, including metastatic melanoma and squamous cell carcinoma of the head and neck. In addition to ImmunoPulse™ IL-12, the company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse™ platform. For more information, please visit www.oncosec.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management’s current preliminary expectations and are subject to risks and uncertainties, which may cause our results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to raise additional funding, our ability to acquire, develop or commercialize new products, uncertainties inherent in pre-clinical studies and clinical trials, unexpected new data, safety and technical issues, competition, and market conditions. These and additional risks and uncertainties are more fully described in OncoSec Medical’s filings with the Securities and Exchange Commission. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. OncoSec Medical disclaims any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
About the Webcast
Biopharma Dealmakers webcasts are dedicated to small and large companies looking for commercial partnerships. Read the quarterly Biopharma Dealmakers supplement in Nature Biotechnology and Nature Reviews Drug Discovery.
CONTACT:
Investor Relations:
Jordyn Kopin
OncoSec Medical Inc.
855-662-6732
investors@oncosec.com
Media Relations:
Mary Marolla
OncoSec Medical Inc.
855-662-6732
media@oncosec.com
(CRNT) Accelerating 4G Service Launch for Large Mobile Operators Across Asia Pacific
IP-20 platform enables simple, quick network upgrades and expansions
PARAMUS, New Jersey, July 14, 2015 —
Ceragon Networks Ltd., (NASDAQ: CRNT), the #1 wireless backhaul specialist, today announced that three leading mobile operators in the Asia Pacific region, including one in India, are deploying its IP-20 platform as means to accelerate 4G services availability. The total value of the three projects is over $43 million.
All three mobile operators are long-standing Ceragon customers and share a common challenge: to quickly and efficiently upgrade and expand their networks to 4G/LTE. In order to provide the most extensive suite of 4G services to their subscribers, they require a wireless backhaul solution that will allow for simple and quick network upgrade, with no service interruption, and rapid network expansion for support of mobile, enterprise and residential subscribers, as well as school districts for bridging the digital divide. The IP-20 platform is uniquely designed to support business objectives such as accelerating transformation to digital services, increasing operational efficiency and enhancing customer experience. With the IP-20 platform, Ceragon’s customers enjoy a simple upgrade of existing wireless backhaul links with new radio technologies, without replacing radios nor antennas on towers and rooftops, such as ultra-high 4G backhaul capacity using the highest modulations, capacity boosting and IP traffic management techniques, better spectrum utilization and management, and state of the art quality of service enforcement & management. The capability to perform a simple upgrade proves to be a major contribution to meeting the operators’ business objectives.
With network expansions required in all three operators’ regions, Ceragon provides the IP-20 platform’s unique wireless backhaul 4×4 MIMO technology for quadrupling capacity over a single narrowband channel over long distances, avoiding the need to opt for wideband short range spectrum. Moreover, in order to meet stringent network availability requirements, Ceragon offers an extensive suite of equipment redundancy capabilities, unique to the IP-20 platform, in order to ensure consistent and reliable network performance.
The IP-20 platform provides all three operators with a unified, simple to deploy & operate solution that fits all network segments, from wireless backhaul for the Radio Access Network, all the way to the backbone.
“We are delighted to continue these key customer relationships by providing value via our advanced turnkey solutions,” said Ira Palti, president and CEO of Ceragon. “Having all three operators choose Ceragon for their individual 4G network expansion and upgrade illustrates the immense benefits our IP-20 platform provides for solving a wide variety of wireless backhaul needs.”
About Ceragon Networks Ltd.
Ceragon Networks Ltd. (NASDAQ: CRNT) is the #1 wireless backhaul specialist. We provide innovative, flexible and cost-effective wireless backhaul and fronthaul solutions that enable mobile operators and other wired/wireless service providers to deliver 2G/3G, 4G/LTE and other broadband services to their subscribers. Ceragon’s high-capacity solutions use microwave technology to transfer voice and data traffic while maximizing bandwidth efficiency, to deliver more capacity over longer distances under any deployment scenario. Based on our extensive global experience, Ceragon delivers turnkey solutions that support service provider profitability at every stage of the network lifecycle enabling faster time to revenue, cost-effective operation and simple migration to all-IP networks. As the demand for data pushes the need for ever-increasing capacity, Ceragon is committed to serve the market with unmatched technology and innovation, ensuring effective solutions for the evolving needs of the marketplace. Our solutions are deployed by more than 430 service providers in over 130 countries.
Join the discussion:
LinkedIn:http://www.linkedin.com/company/14470
Facebook:https://www.facebook.com/ceragonnetworks
Twitter:https://twitter.com/Ceragon
YouTube:http://www.youtube.com/user/CeragonNetworks?featur
Backhaul Forum:http://www.backhaulforum.com/
Ceragon Networks® and FibeAir® are registered trademarks of Ceragon Networks Ltd. in the United States and other countries. CERAGON ® is a trademark of Ceragon Networks Ltd., registered in various countries. Other names mentioned are owned by their respective holders.
This press release contains statements concerning Ceragon‘s future prospects that are “forward-looking statements“ under the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements include: projections of capital expenditures and liquidity, competitive pressures, revenues, growth prospects, product development, financial resources, restructuring costs, cost savings and other financial matters. You can identify these and other forward-looking statements by the use of words such as “may,“ “plans,“ “anticipates,“ “believes,“ “estimates,“ “predicts,“ “expects,“ “intends,“ “potential“ or the negative of such terms, or other comparable terminology. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including risks associated with increased working capital needs; risks associated with the ability of Ceragon to meet its liquidity needs; the risk that Ceragon will not achieve the benefits it expects from its expense reduction and profit enhancement programs; the risk that Ceragon will not comply with the financial or other covenants in its agreements with its lenders; the risk that sales of Ceragon‘s new IP-20 products will not meet expectations; risks associated with doing business in Latin America, including currency export controls and recent economic concerns; risks relating to the concentration of our business in the Asia Pacific region and in developing nations; the risk of significant expenses in connection with potential contingent tax liability associated with Nera‘s prior operations or facilities; and other risks and uncertainties detailed from time to time in Ceragon‘s Annual Report on Form 20-F and Ceragon‘s other filings with the Securities and Exchange Commission, and represent our views only as of the date they are made and should not be relied upon as representing our views as of any subsequent date. We do not assume any obligation to update any forward-looking statements.
Media Contact:
Matthew Krieger
GK Public Relations
Tel: + 914-768-4219
matthew@gkpr.com
Company Contact:
Tanya Solomon
Ceragon Networks
Tel: +972-3-543-1163
tanyas@ceragon.com
Investor Contact:
Claudia Gatlin
Tel. +1-(212)-830-9080
claudiag@ceragon.com
(EPRS) and Polpharma Group Enter Into a Multi-Product, Multi-Region, Profit-Sharing Collaboration
- Profit-sharing collaboration focused on the commercialization of EPIRUS’ biosimilars pipeline in EU, Middle East, Turkey, Russia and CIS territories (“Territories”)
- EPIRUS retains commercial rights to Switzerland, Norway, Austria, Belgium, Denmark, Finland, Luxembourg, the Netherlands and Sweden
- Call to be hosted today at 9 a.m. ET
BOSTON, July 14, 2015 — EPIRUS Biopharmaceuticals, Inc. (Nasdaq:EPRS) and Polpharma Group today announced the signing of a multi-product, multi-region profit-sharing collaboration for select EPIRUS biosimilars, including BOW015(infliximab, reference biologic Remicade®), BOW050 (adalimumab, reference biologic Humira®) and BOW070 (tocilizumab, reference biologic Actemra®), representing $6 billion in innovator sales in the specified territoriesi. Polpharma Group is a leading generics company based in Poland with annual sales of approximately $1 billion and a strong commercial infrastructure, including a salesforce of over 1,700 employees globally.
With EPIRUS leading the global product development and clinical programs, both parties will jointly fund clinical development and collaborate on regulatory filings in the specified territories. EPIRUS will also be responsible for process development, scale-up and manufacturing, with Polpharma Group overseeing commercialization across the territories. Clinical development costs and eventual operating profit will be split 51 percent Polpharma Group and 49 percent EPIRUS. Polpharma Group will contribute approximately $30 million towards clinical development costs, as well as cover product launch costs across all three programs.
“This profit-sharing collaboration with Polpharma Group enables us to better direct our business and retain future value,” said Amit Munshi, president and chief executive officer, EPIRUS Biopharmaceuticals. “We have an aggressive plan to bring our products to markets globally and to build a pure-play, sustainable and profitable biosimilar business. To achieve this goal, we need an equally aggressive partner with aligned objectives. Polpharma Group is rooted in over 80 years of experience in highly competitive global markets with complex generics. They have already made a substantial commitment to the biosimilar space with a vision to expand.”
EPIRUS retains the commercial rights to Switzerland and Norway along with select EU countries including Austria, Belgium, Denmark, Finland, Luxembourg, the Netherlands and Sweden, allowing the Company to build its direct commercial footprint. EPIRUS also retains rights to North America and other global markets not addressed in this agreement. A joint management board will oversee the collaboration.
“Partnering with EPIRUS allows us to combine their technical expertise with our commercial strength,” said Jerzy Starak, chairman of the supervisory board, Polpharma Group. “We are pleased to join the experience of both teams and the potential of these markets to provide patients with more affordable access to modern treatment.”
Conference Call and Webcast Information:
The EPIRUS leadership team will host a conference call and webcast today, July 14, 2015 at 9 a.m. Eastern Time. To access the conference call, please dial 1-855-638-3957 (United States) or 1-224-633-1318 (International).The conference ID is 81626670. The webcast can be accessed on EPIRUS’ website at www.epirusbiopharma.com. Please connect to either the conference call or webcast at least 10 minutes early to ensure adequate time to register. The webcast will be archived on EPIRUS’ website for a period of three months.
About EPIRUS Biopharmaceuticals
EPIRUS Biopharmaceuticals (Nasdaq:EPRS) is a biopharmaceutical company focused on building a pure-play, sustainable, profitable biosimilar business. As such, EPIRUS will be able to improve patient access to important, cost-effective medicines worldwide. EPIRUS’ current pipeline of biosimilar product candidates includes BOW015 (infliximab, reference biologic Remicade®), BOW050(adalimumab, reference biologic Humira®) and BOW070 (tocilizumab, reference biologic Actemra®). The reference products for these candidates together generated $23 billion in global sales for 2014, according to EvaluatePharma®. EPIRUS has developed distinct strategies to penetrate the global market, leveraging partnerships to optimize value retention over the long-term. For more information visit EPIRUS’ website at www.epirusbiopharma.com.
About Polpharma Group
Polpharma Group is a leading generics player based in Poland, operating across Europe, the Caucasus and Central Asia, with manufacturing subsidiaries in Russia and Kazakhstan. Polpharma Group is among the top 20 generic drug manufacturers in the world with annual sales of approximately $1 billion. Polpharma Group’s portfolio includes about 600 products with another 200 in pipeline. It is also one of the leading European API producer delivering products for pharmaceutical companies worldwide. In order to provide patients with more affordable access to modern biologic drugs, Polpharma Group has decided to focus on biosimilar products. It has created a state-of-the-art R&D and production center, and established strategic partnerships in addition to expanding its capabilities in the development and commercialization of biosimilars. For more information visit Polpharma Group’s website atwww.polpharma.pl/en.
Forward-Looking Statements
Various statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this document, the words “may,” “could,” “should,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “plan,” “predict” and similar expressions and their variants, as they relate to EPIRUS or its management may identify forward-looking statements. EPIRUS cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by EPIRUS to secure and maintain relationships with collaborators and single-source contract manufacturers; risks relating to clinical trials; risks relating to the commercialization, if any, of EPIRUS’ proposed product candidates (such as marketing, regulatory, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property; risks related to the loss of any of EPIRUS’ key management personnel; risks that EPIRUS may lack the financial resources and access to capital to fund proposed operations and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of EPIRUS’ annual report on Form 10-K for the fiscal year ended December 31, 2014 which is on file with the SEC and available on the SEC’s website at www.sec.gov. In addition to the risks described above and in EPIRUS’ annual report on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect EPIRUS’ results. There can be no assurance that the actual results or developments anticipated by EPIRUS will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, EPIRUS. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.
All written and verbal forward-looking statements attributable to EPIRUS or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. EPIRUS cautions investors not to rely too heavily on the forward-looking statements EPIRUS makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and EPIRUS undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
i As reported by EvaluatePharma® for 2014 innovator sales; Remicade is a registered trademark of J&J; Humira is a registered trademark of AbbVie; ACTEMRA is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group.
Contact Information:
Jennifer Almond, EPIRUS Biopharmaceuticals, Inc.
+1-617-606-3288
ir@epirusbiopharma.com
Magdalena Rzeszotalska, Polpharma Group
+48 607 696 473
magdalena.rzeszotalska@polpharma.com
(TBIO) Launches Most Comprehensive Genetic Test for Diagnosis of Leukodystrophy
New Test is Most Comprehensive for Definitive Diagnosis of These Devastating Genetic Disorders
Transgenomic, Inc. (NASDAQ: TBIO), a global biotechnology company advancing precision medicine through advanced diagnostic tests and clinical and research services, today announced the launch of the Transgenomic Leukodystrophy NGS Panel for the diagnosis of leukodystrophy, a group of rare progressive genetic disorders that affect the central nervous system by disrupting the growth or maintenance of the myelin sheath insulating nerve cells.
Leukodystrophies have typically been difficult to diagnose, with definitive diagnoses taking years of testing. Previously, brain MRI scans were commonly used, but often provided non-specific results. With the advent of improved genetic testing methods, the Global Leukodystrophy Initiative (GLIA) Consortium has issued diagnostic guidelines that recommend use of a broad spectrum next-generation sequencing (NGS) panel, whole exome sequencing, or whole genome sequencing as the preferred first-line diagnostic tool. The new Transgenomic Leukodystrophy NGS Panel includes 137 genes and incorporates all of the genes GLIA recommends for testing. As the most comprehensive test on the market, it can potentially make definitive diagnoses accessible to patients and their families much earlier in the disease process.
“Leukodystrophy comprises a group of devastating genetic diseases that have been difficult to diagnose and almost impossible to treat,” said Paul Kinnon, President and Chief Executive Officer of Transgenomic. “We accordingly are very pleased to launch our Leukodystrophy NGS Panel, the most comprehensive genetic test for these conditions available today. By enabling clinicians to pinpoint the genetic source of the disorder earlier in the disease, we hope the Leukodystrophy NGS Panel will enable better disease management and facilitate the development of more effective therapies using new technologies, such as stem cells or gene editing techniques. This new test is another example of our commitment to harnessing advanced genetic tools to improve the lives of patients and families.”
The leukodystrophies are a group of about 40 inherited conditions in which the white matter of the brain is abnormal as a result of altered development or degeneration of the myelin sheath, the fatty covering that protects neurons. The condition results in progressive loss of neurologic function. Leukodystrophies often appear during infancy or early childhood, although the disease occasionally first manifests in adults. Diagnosis has typically been made by brain MRI, but many of the findings are non-specific. Most leukodystrophies result in progressive disability and death, often in childhood. Bone marrow transplantation is being performed for a few leukodystrophies, but current treatment is primarily supportive.
Robert Rauner, President of the United Leukodystrophy Foundation, commented, “On average it can take up to a decade to arrive at a definitive diagnosis for a leukodystrophy. Transgenomic’s genetic testing panel may help affected individuals arrive at a definitive diagnosis earlier to guide patient management decisions. This is very positive for those affected by leukodystrophy.”
For more information on the Transgenomic Leukodystrophy NGS Panel, visit http://www.transgenomic.com/product/leukodystrophy-ngs-panel-2/
Transgenomic, Inc. is a global biotechnology company advancing personalized medicine in cardiology, oncology, and inherited diseases through advanced diagnostic technologies, such as its revolutionary ICE COLD-PCR™ and its unique genetic tests provided through its Patient Testing business. Transgenomic also provides specialized clinical and research services to biopharmaceutical companies developing targeted therapies and sells equipment, reagents and other consumables for applications in molecular testing and cytogenetics. Transgenomic’s diagnostic technologies are designed to improve medical diagnoses and patient outcomes.
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements” of Transgenomic within the meaning of the Private Securities Litigation Reform Act of 1995, which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Forward-looking statements include, but are not limited to, those with respect to the expected timing for the availability of additional mutations with the ICEme kits, the potential uses for the ICEme kits, the effectiveness of the ICEme kits and Multiplexed ICE COLD-PCR technology, the availability of the ICEme kits for diagnostic use and expectations regarding the ICEme kits’ and Multiplexed ICE COLD-PCR’s ability to facilitate the development of Transgenomic’s pipeline. The known risks, uncertainties and other factors affecting these forward-looking statements are described from time to time in Transgenomic’s filings with the Securities and Exchange Commission, including in Transgenomic’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on April 15, 2015. Any change in such factors, risks and uncertainties may cause the actual results, events and performance to differ materially from those referred to in such statements. Accordingly, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995 with respect to all statements contained in this press release. All information in this press release is as of the date of the release and Transgenomic does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
For Transgenomic, Inc.
Media Contact
BLL Partners LLC
Barbara Lindheim, 212-584-2276
blindheim@bllbiopartners.com
or
Investor Contact
Argot Partners
Susan Kim, 212-600-1902
susan@argotpartners.com
(OPGN) to Acquire AdvanDx, Closes $6 Million Financing With Merck GHI
Gains Rapid Molecular Diagnostic Tests and Additional Sales Channels
Conference Call to Begin at 10:00 a.m. Eastern Time Today
GAITHERSBURG, Md., July 14, 2015 — OpGen, Inc. (Nasdaq:OPGN), has agreed to acquire AdvanDx, Inc., a Woburn, Mass. developer of advanced molecular diagnostic products. The acquisition will be accounted for as a merger combination. The consummation of the merger provides OpGen with a family of FDA approved and CE marked rapid molecular tests for use with the company’s Acuitas® MDRO Gene tests and bioinformatics for multi-drug resistant organisms.
AdvanDx is a market leader in molecular testing of blood cultures. Its QuickFISH™ products are FDA approved and provide 20 minute identification and differentiation of Gram-negative species and other blood pathogens. AdvanDx had gross revenue of approximately $4.8 million in 2014 (based on unaudited financial statements) and has approximately 20 employees. Its facilities are located in Woburn, Mass. and Vedbaek, Denmark.
“The acquisition of AdvanDx strengthens OpGen’s portfolio of rapid molecular tests for combating drug resistant infections, while providing additional avenues to sell our Acuitas tests,” said Evan Jones, Chairman & CEO. “Combination of the two companies will expand our revenue and customer base and provide rapid testing capabilities to complement our MDRO gene tests. Together we will be able to combine rapid organism ID capabilities with best in class drug resistance testing.”
OpGen issued 681,818 shares of OpGen common stock in the merger transaction. Majority stockholders in AdvanDx include SLS Ventures AB, Merck Global Health Innovation Fund (Merck GHI) and LD Pensions.
David M. Rubin, Ph.D., Managing Director, Merck Global Health Innovation Fund, to Join OpGen Board of Directors
GAITHERSBURG, Md., July 14, 2015 — OpGen, Inc. (NASDAQ:OPGN) today announced the closing of a $6 million financing by the Merck Global Health Innovation Fund (Merck GHI). In connection with this financing, David M. Rubin, Ph.D., Managing Director of Merck GHI, has been appointed to OpGen’s board of directors, effective immediately.
Evan Jones, chairman and chief executive officer of OpGen, said, “Merck is a world leader in antibiotics and infectious disease therapeutics and vaccines. With its strong capabilities and global reach, we see opportunities to accelerate the growth of our business and to improve patient care worldwide. The investment by Merck GHI will help us further develop OpGen’s molecular information business and rapid diagnostics to guide antibiotic therapy. We welcome David Rubin to the OpGen board and look forward to formalizing our collaboration in a number of areas in the coming months.”
Under the agreement Merck GHI will purchase 1,136,364 shares of OpGen common stock at a price of $4.40 per share for an aggregate purchase price of $5 million, and a $1 million senior secured promissory note with 8% interest maturing in July 2017. OpGen has agreed to file a registration statement with the Securities and Exchange Commission covering the resale of the shares of common stock sold in the private placement.
Dr. Rubin is managing director at Merck Global Health Innovation LLC., where he is responsible for identifying investment opportunities in emerging healthcare solutions and services, with a particular emphasis on solutions for precision medicine. Dr. Rubin joined Merck from Cognia Corporation, a bioinformatics company, where he most recently served as President and CEO. Previously he was at The Wilkerson Group/IBM Global Services. Dr. Rubin was a National Institutes of Health and American Cancer Society post-doctoral fellow at Harvard Medical School, where he worked on the ubiquitin-proteasome pathway. He serves as a director of several companies including Electrocore LLC, Daktari Diagnostics and Prophecy Inc., and as a board observer for several others. He received post-graduate business training at Harvard University, a Ph.D. in molecular biology from Temple University and a B.A. in biology from SUNY Binghamton.
Dr. Rubin’s appointment to the OpGen board of directors brings the total to seven directors.
About AdvanDx
AdvanDx develops advanced molecular diagnostic products for the diagnosis and treatment of life-threatening infections. The company has three product families: PNA FISH, 90-minute pathogen ID; QuickFISH, 20 minute pathogen ID; and XpressFISH, 70 minute mecA resistance ID. For more information visit www.AdvanDx.com.
About OpGen
OpGen, Inc. is an early commercial-stage company using molecular testing and bioinformatics to assist healthcare providers in combating multi-drug resistant bacterial infections. The company’s products and services are designed to enable the rapid identification of hospital patients who are colonized or infected with life-threatening MDROs. The company’s products include the Acuitas MDRO Gene Test, CR Elite Test, Resistome Test, Whole Genome Sequence Analysis and the Acuitas Lighthouse MDRO Management System. In addition, the company has more than 10 years of experience mapping microbial, plant and human genomes. Learn more at www.opgen.com.
Conference Call and Webcast
Management will hold a conference call today at 10:00 a.m. Eastern time to discuss recent developments. The call may be accessed by dialing (888) 883-4599 (domestic) or (484) 653-6821 (international) five minutes prior to the start of the call and providing passcode 85034204. The live, listen-only webcast of the conference call may be accessed by visiting the investors section of the company’s website at http://ir.opgen.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website.
A telephone replay also will be available from 1:00 p.m. Eastern time through July 20, 2015 and may be accessed by dialing (855) 859-2056 from within the U.S. or (404) 537-3406 from outside the U.S. All listeners should provide passcode 85034204.
Forward-Looking Statements
This press release includes statements relating to the company’s Acuitas MDRO Gene Test and Acuitas Lighthouse MDRO Management System and commercialization plans for these products and services. These statements and other statements regarding our future plans and goals constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, the successful integration of AdvanDx, the rate of adoption of our products and services by hospitals, the success of our commercialization efforts, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen’s business, please review our filings with the Securities and Exchange Commission (SEC). You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.
CONTACT: OpGen
Michael Farmer
Director, Marketing
(240) 813-1284
mfarmer@opgen.com
InvestorRelations@opgen.com
Investors
LHA
Kim Sutton Golodetz
(212) 838-3777
kgolodetz@lhai.com
or
Bruce Voss
(310) 691-7100
bvoss@lhai.com
Media
Lisa Guiterman
(301) 217-9353
lisa.guiterman@gmail.com
(AXPW) Announces 1-for-35 Reverse Stock Split
Company’s Common Stock to Begin Trading on Split Adjusted Basis at Open of Market on July 14, 2015
NEW CASTLE, Pa., July 14, 2015 — Axion Power International, Inc. (Nasdaq: AXPW) (“AXION “), a developer of advanced lead-carbon PbC® batteries, energy storage systems and frequency regulation systems, today announced that it has effected a 1-for-35 reverse stock split previously approved by the Company’s stockholders at a special meeting held on June 17, 2015. The 1-for-35 reverse stock split was effective as of the close of business on July 13, 2015 and the Company’s common stock will begin trading on a split-adjusted basis on Tuesday, July 14, 2015.
The reverse stock split will reduce the number of shares of the Company’s common stock currently outstanding from approximately 93.9 million shares to approximately 2.7 million shares. Proportional adjustments will be made to the conversion and exercise prices of the Company’s outstanding warrants, convertible notes and stock options, and to the number of shares issued and issuable under the Company’s equity compensation plans.
The number of authorized shares of the Company’s common stock will remain 100 million shares. The reverse stock split is intended to increase the market price per share of the Company’s common stock to allow the Company to maintain the listing of its common stock on The NASDAQ Capital Market. The Company’s common stock will continue to trade on The NASDAQ Capital Market under the symbol “AXPW.”
The new CUSIP number for the common stock following the reverse stock split will be 05460X208. Information for Stockholders: Upon the effectiveness of the reverse stock split, each thirty-five shares of the Company’s issued and outstanding common stock will be automatically combined and converted into one issued and outstanding share of common stock, par value $0.005 per share. The Company will not issue any fractional shares in connection with the reverse stock split. Instead, fractional share interests will be rounded up to the next largest whole number. The reverse stock split will not modify the rights or preferences of the common stock. As a result of the reverse stock split, the Company will today recommence honoring requests for exercise of its derivative securities.
The Company’s transfer agent, Continental Stock Transfer & Trust Company, will act as its exchange agent for the reverse stock split. Continental Stock Transfer & Trust Company will provide stockholders of record holding certificates representing pre-split shares of the Company’s common stock as of the effective date a letter of transmittal providing instructions for the exchange of shares. Registered stockholders holding pre-split shares of the Company’s common stock electronically in book-entry form are not required to take any action to receive post-split shares. Stockholders owning shares via a broker or other nominee will have their positions automatically adjusted to reflect the reverse stock split, subject to brokers’ particular processes, and will not be required to take any action in connect with the reverse stock split. Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on May 28, 2015, a copy of which is available at www.sec.gov or at www.axionpower.com under the SEC Filings tab located on the Investors page.
About Axion Power International, Inc.
Axion Power is an industry leader in lead-carbon energy storage. Its PbC battery technology utilizing proprietary activated carbon electrodes is the only advanced battery that can be assembled on existing lead-acid production lines throughout the world. Axion Power’s primary goal is to become the leading supplier of carbon electrode assemblies for lead-acid battery companies around the world.
For more information, visit www.axionpower.com
Forward-looking Statements
Certain statements in this Press Release are “forward-looking statements” within the meaning of the Private Securities Litigation Act of 1995. These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risk factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include the risk for the Company to complete its development work, as well as the risks inherent in commercializing a new product (including technology risks, market risks, financial risks and implementation risks, and other risks and uncertainties affecting the Company), as well as other risks that have been included in filings with the Securities and Exchange Commission, all of which are available at www.sec.gov. We disclaim any intention or obligation to revise any forward-looking statements, including, without limitation, financial estimates, whether as a result of new information, future events, or otherwise.
Contacts
Axion Power International, Inc.
Charles Trego, CFO
info@axionpower.com
DresnerAllenCaron
Rudy Barrio (Investors)
r.barrio@allencaron.com
(212) 691-8087
(NVGN) Pre-clinical Studies Suggest Anisina May Improve Chemotherapy Effectiveness
– Potential to improve effectiveness of chemotherapy – May reduce the risk of life-long side-effects associated with childhood chemotherapy
NEW YORK, July 13, 2015 — US-Australian drug discovery company, Novogen Limited (NRT: ASX; NVGN: NASDAQ), today announced details of an in vivo proof of concept study that demonstrates their lead anti-tropomyosin drug candidate, Anisina, has the potential to improve the effectiveness of chemotherapy in children and reduce life-long side-effects.
The study results were presented by Dr Timothy Cripe from the Nationwide Children’s Hospital Research Institute, at the Eighth Annual Cancer Molecular Therapeutics Research Association (CMTRA) meeting in Boston, USA. The results demonstrated that Anisina significantly improved the efficacy of standard of care microtubule targeting compound, vincristine, in an animal model of neuroblastoma.
Neuroblastoma is a cancer that is most frequently observed in the young with more than 90% of diagnoses occurring in children under 5 years of age. It is considered to be the most common solid tumour in children outside the brain. Although childhood cancers such as neuroblastoma are relatively rare compared to adult cancers, the potential years of life lost are substantial making it imperative that new clinical strategies are developed to treat this disease.
The importance of this study, from a clinical perspective, is that it shows we can dose animals with a proprietary formulation of Anisina in combination with the standard of care and recapitulate in an animal model of neuroblastoma the same effect as observed in the test tube.
According to Dr Justine Stehn, Novogen Anti-Tropomyosin Program Director, this represents an important milestone in the development of Anisina as a combination therapy for the treatment of neuroblastoma.
The study was done as part of the Children’s Oncology Drug Alliance (CODA) involving Australian charity, The Kids’ Cancer Project (Sydney), The University of New South Wales (Sydney), The Nationwide Children’s Hospital (Columbus, Ohio), and Novogen. The objective of this study was to evaluate the effectiveness of Anisina either alone or in combination with vincristine, in a mouse model of human neuroblastoma (CHLA20).
Animals with tumors were treated with i) no drug (control), ii) Anisina alone (150mg/kg), iii) vincristine alone (0.5mg/kg) or iv) Anisina (150mg/kg) + vincristine (0.5mg/kg). Consistent with existing data, Novogen was able to show that Anisina on its own was effective in reducing tumor growth by about 35%.
Dr Timothy Cripe, principal investigator, Nationwide Children’s Hospital said more importantly, when used in combination, the Anisina/vincristine treatment not only reduced tumor growth but also made tumors “regress”.
“Of the five animals in the combinatorial Anisina/vincristine treatment group, three (60%) reached a complete response – meaning that their tumors were deemed to be too small to be measured, with one animal showing a ‘maintained complete response’ meaning that the tumor had disappeared for more than 60 days after treatment had stopped,” Dr Cripe said.
“What is exciting about this novel drug technology is that Anisina has the potential to improve the effectiveness of the current standard of care chemotherapeutic, vincristine. What this means from a clinical perspective is that chemotherapy may be more effective in treating patients. In some cases doses of vincristine used in the clinic could be lowered thereby minimizing the risk of leaving children with side-effects that have life-long consequences.”
Dr Stehn said the outcome of this study was encouraging.
“Studies are now underway to validate the combinatorial effect of Anisina with a microtubule targeting compound in an animal model of adult cancer with the objective still being to have first-in-man studies commencing by mid-2016 once we have completed the standard battery of toxicology studies that are requisite for any experimental drug prior to entering the clinic,” Dr Stehn said.
About Anisina
Anisina is a small molecule which belongs to a family of compounds termed the anti-tropomyosins or ATMs. Anisina has been designed to inhibit a protein known as Tpm3.1. Tpm3.1 is a structural protein and is a core component of the skeleton, or cytoskeleton of a cancer cell. By binding to Tpm3.1, Anisina impacts the function of this structural protein causing the collapse of the cytoskeleton which results in the death of the cancer cell. Anisina has been shown to be effective against a broad range of cancer types. At Novogen we are focused on the clinical development of Anisina for the treatment of both adult (melanoma and prostate) and pediatric (neuroblastoma) cancers.
About CODA
CODA’s mission is to accelerate development of innovative new therapeutic approaches to the treatment of childhood cancers and to take account of the fact that childhood cancers are different to adult cancers and that the lifelong consequences of cancer drug side-effects can be far more devastating in a child than in an adult.
CODA unites the research and resources of five organizations in Australia and the US.
The Australian members are:
- The charity, The Kids’ Cancer Project
- The originator of the anti-tropomyosin technology, the University of New South Wales and its commercial arm, New South Innovations
- Biotechnology company, Novogen Limited
The US member is:
- Nationwide Children’s Hospital, Columbus, Ohio
Novogen is providing access to both its anti-tropomyosin and super-benzopyran drug technologies. Anisina is being evaluated for its ability to complement the action of standard chemotherapies in childhood cancers. TRXE-009 is being evaluated for its ability to treat brain cancers in children.
Further information on CODA is available at www.childrensoncologydrugalliance.org
About Novogen
Novogen is a public, Australian-US drug development company whose shares trade on both The Australian Securities Exchange (NRT) and NASDAQ (NVGN). The Novogen group includes US-based, CanTx Inc, a joint venture company with Yale University. Novogen has two drug technology platforms (the super-benzopyrans (SBPs) and anti-tropomyosins (ATMs)) yielding drug candidates that are first-in-class with potential application across a range of degenerative diseases. Given the encouraging data from in vitro and in vivo pre-clinical Proof-of-Concept studies in the field of Oncology, our immediate focus is to bring our lead Oncology drug candidates Cantrixil, Anisina and Trilexium into the clinic in 2016 pending successful completion of their respective toxicology programs. Ovarian cancer, colorectal cancer, malignant ascites, prostate cancer, neural cancers (glioblastoma, neuroblastoma in children) and melanoma are the potential clinical indications being pursued, with the ultimate objective of employing both technologies as a unified approach to therapy.
About The Kids’ Cancer Project
The Kids’ Cancer Project is an Australian charity dedicated to funding medical research to find a cure for childhood cancer. Thanks to community support the charity has invested more than $24 million into research and is currently supporting 13 research projects. The independent charity is the largest not-for-profit funder of childhood cancer in Australia. The Kids’ Cancer Project was inspired by one man who promised to find the cure for childhood cancer and make a difference. The Kids’ Cancer Project supports research that will increase a child’s chance of survival and that will eradicate or minimise the toxicity of current treatments children endure. The Kids’ Cancer project supports collaborative research that has the greatest chance of clinical success and is excited about the potential that Anisina presents as a potential improvement in chemotherapy treatment. Visit www.thekidscancerproject.org.au for further information or to donate.
For more information, please visit www.novogen.com
Forward Looking Statement
This press release contains “forward-looking statements” within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as “expects,” “appear,” “intends,” “hopes,” “anticipates,” “believes,” “could,” “should,” “would,” “may,” “target,” “evidences” and “estimates,” and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to any statements relating to the Company’s drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials of the Company’s drug development program, including, but not limited to, Anisina, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to the difficulties or delays in financing, development, testing, regulatory approval, production and marketing of the Company’s drug components, including, but not limited to Anisina, the ability of the Company to procure additional future sources of financing, unexpected adverse side effects or inadequate therapeutic efficacy of the Company’s drug compounds, including, but not limited to, Anisina, that could slow or prevent products coming to market, the uncertainty of patent protection for the Company’s intellectual property or trade secrets, including, but not limited to, the intellectual property relating to Anisina, and other risks detailed from time to time in the filings the Company makes with Securities and Exchange Commission including its annual reports on Form 20-F and its reports on Form 6-K. Such statements are based on management’s current expectations, but actual results may differ materially due to various factions including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on those forward-looking statements as a prediction of actual future results.
(HEAR) Partners With Audiology For Groundbreaking HyperSound Clear™
SAN DIEGO, July 13, 2015 — Turtle Beach Corporation (NASDAQ: HEAR), the leading-edge audio technology company, today announced a new partnership with Audiology Management Group, Inc. (AMG) for HyperSound Clear™, the Company’s groundbreaking hearing healthcare product planned to launch later this year. HyperSound® technology is a fundamentally new approach to sound delivery that generates a highly directional, narrow beam of audio in the air, much like the way a flashlight directs a beam of light. When an individual enters the audio beam created by HyperSound Clear, they hear immersive 3D audio, and as a first-of-its-kind product for the hearing healthcare market, HyperSound Clear has been shown to improve sound clarity and speech intelligibility for people with hearing loss for a crisp, clear home entertainment listening experience. With this new partnership, AMG – a leading audiology services company that provides an extensive range of products and services proven to drive sales for the country’s most elite Ear, Nose & Throat, Retail, Hospital and University Hospital practices – will offer HyperSound Clear as an all-new, entry level hearing healthcare solution to hearing centers and their patients as soon as it becomes available.
“We’re thrilled to partner with AMG to offer HyperSound Clear as a gateway hearing solution product, and a device that we believe will spark broader awareness in hearing healthcare,” said Rodney Schutt, Senior Vice President and General Manager for the HyperSound business at Turtle Beach Corporation. “Researchers estimate that over 48 million Americans suffer from hearing loss. Additionally, approximately 80% of people who go see a hearing healthcare specialist for the first time do so because they’re having trouble hearing and understanding the television, and we think HyperSound Clear will be a great entry-level hearing healthcare device that directly addresses that issue with hearing and enjoying home entertainment.”
Schutt continued, “Currently, the amount of time between a patient’s first visit with their hearing healthcare specialist and when they actually get their first hearing aid is five to six years. Typically, these first-time patients simply don’t want to get a hearing aid, and instead turn to other means to address hearing and understanding the television; whether that means turning-up the volume or turning on closed captioning. What happens from there is that this behavior creates a divide in the household where family members and friends no longer want to sit in the room and watch television with somebody with hearing loss because the volume is too loud. With HyperSound Clear connected to your TV or home theater system, we create an environment where everyone can once again return to the family room and enjoy the latest home entertainment together.”
“HyperSound Clear is a unique and innovative device for hearing healthcare. Why? Because, most importantly, HyperSound Clear has the potential to motivate people with hearing loss to address their hearing issues earlier in life,” said Michael Tease, President, Audiology Management Group. “Addressing hearing loss earlier is not only better for enjoying home entertainment again, but is also important for overall health as well.”
Researchers estimate that one in five Americans, and one in three people over age 65, suffer from hearing loss, and an estimated 360 million people worldwide suffer from some form of hearing loss. Further, hearing loss is the third most common chronic physical condition in the United States after heart disease and arthritis. A nationwide survey1 of nearly 4,000 adults and their significant others show a considerably higher rate of depression, anxiety, and other psychosocial disorders in adults with untreated hearing loss.
To learn more about HyperSound technology and HyperSound Clear, please visit the official website at http://hypersoundhearing.com.
About Audiology Management Group, Inc.
Audiology Management Group, Inc. (AMG) is a leading innovative audiology services company dedicated to improving the business performance of its members and equity partners. AMG’s goal is to support its members and partners in achieving high performance hearing health clinics (HPCs) through a patient centric growth model that creates the possibility for above average ROI. More information on AMG can be found on the company’s website at http://audiologymanagementgroup.com.
About Turtle Beach Corporation
Turtle Beach Corporation (www.turtlebeachcorp.com) designs leading-edge audio products for the consumer, commercial and healthcare markets. Under the Turtle Beach brand (www.turtlebeach.com), the Company markets a wide selection of quality gaming headsets catering to a variety of gamers’ needs and budgets, for use with video game consoles, including officially-licensed headsets for the Xbox One and PlayStation®4, as well as for personal computers and mobile/tablet devices. Under the HyperSound brand (www.hypersound.com), the Company markets pioneering directed audio solutions that have applications in digital signage and kiosks, consumer electronics and healthcare. The company’s shares are traded on the NASDAQ Exchange under the symbol: HEAR.
Forward-Looking Statements
This press release includes forward-looking information and statements within the meaning of the federal securities laws. Except for historical information contained in this release, statements in this release may constitute forward-looking statements regarding assumptions, projections, expectations, targets, intentions or beliefs about future events. Forward looking statements are based on management’s statements containing the words “may”, “could”, “would”, “should”, “believe”, “expect”, “anticipate”, “plan”, “estimate”, “target”, “project”, “intend” and similar expressions constitute forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which could cause actual results to differ materially from those contained in any forward-looking statement. Forward-looking statements are based on management’s current belief, as well as assumptions made by, and information currently available to, management.
While the Company believes that its expectations are based upon reasonable assumptions, there can be no assurances that its goals and strategy will be realized. Numerous factors, including risks and uncertainties, may affect actual results and may cause results to differ materially from those expressed in forward-looking statements made by the Company or on its behalf. Some of these factors include, but are not limited to, the substantial uncertainties inherent in acceptance of existing and future products, the difficulty of commercializing and protecting new technology, the impact of competitive products and pricing, general business and economic conditions, risks associated with the expansion of our business including the implementation of any businesses we acquire, our indebtedness, and other factors discussed in our public filings, including the risk factors included in the Company’s most recent Annual Report on Form 10-K and the Company’s other periodic reports. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the Securities and Exchange Commission, the Company any is under no obligation to publicly update or revise any forward-looking statement after the date of this release whether as a result of new information, future developments or otherwise.
Untreated Hearing Loss in Adults- A Growing National Epidemic, American Speech-Language Hearing Association
(PSDV) Positive Top Line Results From Phase II Study of Medidur™ for Uveitis
Statistically Significant Reduction in Recurrence of Disease and Statistically Significant Improvement in Visual Acuity
pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, today announced positive top line results from a Phase II investigator-sponsored study of pSivida’s Medidur for uveitis affecting the posterior of the eye (posterior, intermediate and pan-uveitis). Dr. Glenn J. Jaffe, Robert Machemer Professor of Ophthalmology at Duke University School of Medicine in Durham, NC, presented the top line results during an oral abstract session at the American Society of Retina Specialists in Vienna, Austria, reporting a statistically significant reduction in recurrence of uveitis and a statistically significant improvement in visual acuity in eyes treated with Medidur.
In the three-year, ongoing study, 11 participants with recurrent non-infectious intermediate, posterior or pan uveitis were randomized to receive a masked low or a high dose of Medidur. (pSivida is studying only the low dose of Medidur in its Phase III clinical trials.) Fellow eyes with uveitis were treated with standard of care, which included steroid eye drops. At the most recent follow-up visit reported, participants have been followed for between 12 and 24 months.
Through the last follow-up visit reported, none of the eyes treated with Medidur had any recurrence of uveitis, while fellow eyes treated with standard of care averaged 2.33 recurrences. The difference between treatment with Medidur and standard of care was statistically significant (p=0.014).
Eyes treated with Medidur experienced a significant improvement in visual acuity, gaining an average of 17 letters from baseline letters at 12 months on the Snellen eye chart (p=0.014 at 12 months). At the last follow-up visit reported, the average gain from baseline in Medidur-treated eyes was over 20 letters, while eyes treated with standard of care declined an average of 10 letters.
The most common adverse event in study eyes was elevated intraocular pressure (IOP). Through the last follow-up visit reported, three study eyes developed elevated IOP and were treated with eye drops, with filtering procedures subsequently performed in two of these eyes. However, those two eyes still gained an average of over 25 letters from baseline at the last observation. The study remains masked as to the dosage so results cannot yet be separated for the low and high doses of Medidur.
pSivida recently announced that at three months in its first Phase III trial, which is testing only the low dose of Medidur, only 4% more study eyes (2/3 of which received Medidur) experienced elevated IOP than the fellow non-study eyes (none of which received Medidur). Initial IOP elevation is an indication of the likelihood of subsequent clinically significant IOP increases. The minimal difference observed in elevated IOP in the assessment suggests highly favorable results for a key safety measure of the trial, the number of eyes that develop clinically significant increases in IOP within 12 months of receiving Medidur relative to control eyes.
“The results in Dr. Jaffe’s study are very dramatic. The efficacy of Medidur in controlling uveitis and restoring visual acuity was spectacular. At the extreme, in addition to completely arresting any recurrence of uveitis, Medidur restored vision to two eyes that were legally blind at baseline, improving from 20:400 to 20:25 and from 20:500 to 20:40 at the last follow-up visit. We look forward to the unmasking of the data to view the results for the low dose of Medidur we are studying,” said Dr. Paul Ashton, President and Chief Executive Officer of pSivida Corp.
About the Phase II Trial. The investigator-sponsored Phase II study is evaluating the tolerability, safety and benefits of high and low dose Medidur in recurrent non-infectious posterior, intermediate or pan-uveitis. Eleven enrolled participants were randomized to receive a masked low or a high dose of Medidur in the worse eye. (Only the low dose is being studied in pSivida’s Phase III trials.) Fellow eyes with uveitis are treated with standard of care. Eyes are observed on the day of injection, on days 1, 7, 14, 28, then monthly for up to six months, then every three months for 18 additional months. For purposes of these results, all participants were followed for a minimum of one year, with a mean follow-up duration of 20.5 months. Because the study is ongoing, the dose remained masked, and the results present aggregate data for the low and high dose. Full top-line results of this Phase II study have been submitted for publication.
About Medidur. Medidur is an injectable micro-insert designed to treat posterior uveitis that provides sustained release of flucinolone acetonide (a corticosteroid) for three years. Medidur comprises the same micro-insert (same design, same polymers, same drug, same dose) as ILUVIEN® for DME. ILUVIEN has been approved in the U.S. and 17 EU countries and is sold in the U.S., the U.K., Germany and Portugal.
About Posterior Uveitis. Posterior uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is a leading cause of blindness in the developed and developing countries. It afflicts people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S. posterior uveitis affects approximately 175,000 people, resulting in approximately 30,000 cases of blindness and making it the third leading cause of blindness in the U.S.
Patients with posterior uveitis are typically treated with systemic steroids but over time frequently develop serious side effects that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an increased risk of cancer. Medidur is designed to provide improved outcomes compared to standard of care but with a significant reduction in side effects.
About the Phase III Trials. pSivida’s two Phase III trials for Medidur are double-blind studies comparing injections of Medidur to sham injections on a two-to-one basis. The first trial is fully enrolled with 129 patients in 16 centers in the U.S. and 17 centers outside the U.S. The primary end point of the first trial is recurrence of posterior uveitis within one year. The last scheduled visit for the last patient in this trial is in March 2016, and top-line data is expected in the second quarter of 2016. The second trial will enroll up to 150 patients in approximately 15 centers in India. The primary endpoint of the second trial is recurrence of posterior uveitis within six months. Patients in both trials will be followed for three years. pSivida plans to seek approval for Medidur for posterior uveitis based on 12-month data from the first Phase III trial, six-month data from the second Phase III trial and data from a utilization study of pSivida’s redesigned proprietary inserter together with data referenced from the Phase III trials of ILUVIEN for DME. With favorable results, pSivida expects to file a New Drug Application in the first half of 2017.
About pSivida Corp.
pSivida Corp. (www.psivida.com), headquartered in Watertown, MA, is a leader in the development of sustained release, drug delivery products for treating eye diseases. pSivida has developed three of only four FDA-approved treatments for back-of-the-eye diseases. The most recent, ILUVIEN®, a micro-insert for diabetic macular edema, is licensed to Alimera Sciences and sold in the U.S. and three EU countries. Retisert®, an implant for posterior uveitis, is licensed to and sold by Bausch & Lomb. pSivida’s lead product candidate, Medidur™, a micro-insert for posterior uveitis, is currently in pivotal phase III clinical trials with an NDA anticipated in the first half of 2017. pSivida’s preclinical development program is focused on using its core platform technologies, Durasert™ and/or Tethadur™, to deliver drugs and biologics to treat wet and dry age-related macular degeneration (AMD), glaucoma, osteoarthritis and other diseases.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: actual final IOP safety results for Medidur Phase III trials; ability to achieve profitable operations and access to capital; fluctuations in operating results; further impairment of intangible assets; decline in Retisert royalties; successful commercialization of, and receipt of revenues from, ILUVIEN for DME; effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; consequences of fluocinolone acetonide side effects; number and cost of clinical trials and data necessary to support an NDA for, approval by Indian regulators of the trial design for, timing of filing the NDA for, and regulatory approval and successful commercialization of, Medidur; delays in completion of clinical trials; increases in cost of clinical trials; changes in, or misunderstandings with respect to, FDA guidance on required clinical trials; development of the Latanoprost Product and any exercise by Pfizer of its option; ability of Tethadur to successfully deliver large biologic molecules and to develop products using it; ability to successfully develop product candidates, complete clinical trials and receive regulatory approvals; ability to market and sell products; success of current and future license agreements; termination of license agreements; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the SEC. You should read and interpret any forward-looking statements together with these risks. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
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For more information on pSivida, visit www.psivida.com
Martin E. Janis & Company, Inc.
Beverly Jedynak
President
T: 312-943-1123
M: 773-350-5793
bjedynak@janispr.com
(AXN) Positive Results of Registration Trial of Buprenorphine/Naloxone for Opioid Dependence
JERSEY CITY, NJ / July 13, 2015 / Aoxing Pharmaceutical Company, Inc. (NYSE MKT: AXN) (“Aoxing Pharma”), a specialty pharmaceutical company focusing on research, development, manufacturing, and distribution of narcotic, pain-management and addiction treatment pharmaceuticals, today announced positive results of its Buprenorphine/Naloxone sublingual tablets as a treatment for opioid dependence. This was a registration clinical study evaluating the safety and efficacy of the sublingual tablets in order to gain the final production and marketing clearance by the China Food and Drug Administration (CFDA).
In this multi-center, placebo-controlled, double-blinded, randomized, and paralleled study, 300 patients with opioid dependence were enrolled in 12-week therapy. The primary endpoints of this study were to evaluate the safety and effectiveness of the sublingual tablets for the opioid dependence patients, by measuring the rate of outpatient service. The secondary endpoints of the study included the negative rate of urine morphine test, and others. In the study, the drug demonstrated statistical significance in the measurements designed in the trial.
“We are very excited and encouraged by the progress of our Buprenorphine/Naloxone sublingual tablets program, which could be the first such therapy available in Chinese market for treating opioid dependence patients. We are working on the final preparation of the registration data package, and look forward to final clearance by the China CFDA,” said Mr. Zhenjiang Yue, the Chairman and CEO of Aoxing Pharma.
Drug abuse has become a profound social problem in China. In 2014 it was estimated that there were 14 million individuals, or 1% of the whole population, with drug abuse or opioid dependence problems. The annual economic loss was estimated at approximately $100 billion USD due to drug abuse problem in China. At present, Methadone is the principal method of treating opioid dependence in China. Industry research has indicated at Buprenorphine/Naloxone is more effective than Methadone and significantly less injurious to the patient’s overall health. For this reason, the Company believes that the product will find a large market when finally introduced in China.
About Aoxing Pharmaceutical Company, Inc.
Aoxing Pharmaceutical Company, Inc. is a US incorporated specialty pharmaceutical company with its operations in China, specializing in research, development, manufacturing and distribution of a variety of narcotics and pain-management products. Headquartered in Shijiazhuang City, outside Beijing, Aoxing has the largest and most advanced manufacturing facility in China for highly regulated narcotic medicines. Its facility is one of the few GMP facilities licensed for the manufacture of narcotic medicines by the China State Food and Drug Administration (CFDA). It has a joint venture collaboration with Johnson Matthey Plc to produce and market narcotics and neurological drugs in China. For more information, please visit: www.aoxingpharma.com.
Safe Harbor Statement from Aoxing Pharmaceutical Company, Inc.
Certain statements made in this press release are forward-looking and are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995. Such statements involve risks and uncertainties that may cause actual results to differ materially from those set forth in these statements. All forward-looking statements included herein are based upon information available to the Company as of the date hereof and, except as is expressly required by the federal securities laws, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. To the extent that any statements made here are not historical, these statements are essentially forward-looking. Undue reliance should not be placed on forward-looking information. The economic, competitive, governmental, technological and other risk factors identified in the Company’s filings with the Securities and Exchange Commission, specifically, Item 1A, “Risk Factors,” in the Form 10-K for the year ended June 30, 2014, may cause actual results or events to differ materially from those described in the forward looking statements in this press release. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events, or otherwise.
CONTACT:
Aoxing Pharmaceutical Company:
646-367-1747
investor.relations@aoxingpharma.com
(ANAC) Positive Top-Line Results, Phase 3 Pivotal Studies of Crisaborole in Atopic Dermatitis
- Crisaborole, a novel non-steroidal topical anti-inflammatory PDE-4 inhibitor, achieved statistically significant results on all primary and secondary endpoints in both studies and demonstrated a safety profile consistent with previous studies
- Anacor expects to submit a New Drug Application for crisaborole to the U.S. Food and Drug Administration in the first half of 2016
Anacor to Host a Conference Call Today at 7:30 a.m. ET / 4:30 a.m. PT to Discuss Results
Anacor Pharmaceuticals, Inc. (NASDAQ:ANAC) today announced preliminary top-line results from its two Phase 3 pivotal studies of Crisaborole Topical Ointment, 2% (formerly AN2728), a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults. In both studies, crisaborole achieved statistically significant results on all primary and secondary endpoints and demonstrated a safety profile consistent with previous studies.
| Summary of Primary and Secondary Phase 3 Pivotal Study Results | ||||
| Study AD-301 | Study AD-302 | |||
| (crisaborole / vehicle) N=503 / 256 |
(crisaborole / vehicle) N=513 / 250 |
|||
| Primary Endpoint | ||||
| % of patients who achieved success in the Investigator’s Static Global Assessment (ISGA), defined as a score of 0 (clear) or 1 (almost clear) with a minimum 2-grade improvement at day 29 | 32.8% / 25.4% (p=0.038) |
31.4% / 18.0% (p<0.001) |
||
| Secondary Endpoints | ||||
| % of patients who achieved an ISGA score of 0 (clear) or 1 (almost clear) at day 29 | 51.7% / 40.6% (p=0.005) |
48.5% / 29.7% (p<0.001) |
||
| Time to Success in ISGA: Time course to success in ISGA between crisaborole and vehicle was statistically significantly different (p<0.001) in each study, with patients treated with crisaborole achieving success earlier than vehicle-treated patients. | ||||
“We are extremely pleased by the top-line results from our Phase 3 pivotal studies of crisaborole. We believe there is a significant unmet medical need for a novel non-steroidal topical anti-inflammatory treatment option for the patients who are affected by mild-to-moderate atopic dermatitis,” said Paul L. Berns, Chairman and Chief Executive Officer of Anacor. “We also want to extend a special thanks to the clinical investigators who conducted the studies and the patients and their families who volunteered to participate in our studies. We currently plan to file a New Drug Application for crisaborole in the first half of 2016 and, if approved, we believe crisaborole could offer an important treatment option for patients with mild-to-moderate atopic dermatitis.”
Atopic dermatitis is a chronic rash characterized by inflammation and itching. Lesions of atopic dermatitis are commonly red, elevated and oozing patches and are often accompanied by pruritus (itching). The lesions’ lichenification, a thickening of the skin with exaggerated skin lines, is considered to be a hypertrophic response to chronic rubbing. Based on available sources, we believe approximately 18 to 25 million people in the United States suffer from atopic dermatitis, and 80% to 90% have mild or moderate disease. Atopic dermatitis can persist into adulthood, but most commonly appears in childhood, with estimates that between 8% and 18% of all infants and children in the United States are affected by the disease.
Patients suffering with the condition often try multiple treatments to treat their atopic dermatitis, yet many are not satisfied with the effectiveness of their medications. Topical corticosteroids are broad anti-inflammatories, which if used inappropriately or for long periods of time may lead to local side effects including skin thinning, acne and stretch marks and systemic side effects, including HPA axis suppression. In addition, patients are often instructed to limit use on thin skin areas such as the face, neck and skin folds. The only non-steroidal topical pharmacologic therapies currently approved for prescription in the U.S. for the treatment of atopic dermatitis are topical calcineurin inhibitors, which have a “boxed warning” on their labels concerning potential cancer risk.
“Mild-to-moderate atopic dermatitis, or eczema, is a chronic, life-altering inflammatory skin disease that can be a constant challenge for patients and family members. Based on the safety and efficacy profile demonstrated by crisaborole in these Phase 3 pivotal studies, crisaborole, if approved, could become a significant first-in-class treatment option for patients suffering from mild-to-moderate atopic dermatitis and the physicians who treat them,” said Amy Paller, M.D., Walter J. Hamlin Professor and Chair of Dermatology, Professor of Pediatrics, Northwestern University Feinberg School of Medicine.
“I’m impressed with the performance of crisaborole on the primary and secondary endpoints in these Phase 3 pivotal studies. Crisaborole represents an innovative non-steroidal topical anti-inflammatory and, if approved, has the potential to offer physicians and patients a new, important therapeutic choice for treating mild-to-moderate atopic dermatitis,” said Lawrence Eichenfield, M.D., Chief of Pediatric and Adolescent Dermatology at Rady Children’s Hospital, San Diego and a Professor of Dermatology and Pediatrics at the University of California, San Diego School of Medicine.
About our Phase 3 Pivotal Studies
Our Phase 3 pivotal studies of crisaborole consisted of two multi-center, double-blind, vehicle-controlled studies of over 750 patients each, aged 2 years and older with mild-to-moderate atopic dermatitis (defined as an ISGA score of 2 (mild) or 3 (moderate)). The ISGA is a 5-point scale ranging from 0 (clear) to 4 (severe). Patients were randomized in a 2:1 ratio (crisaborole:vehicle). Crisaborole or vehicle was applied twice daily for 28 days. The primary efficacy endpoint was success in ISGA at day 29 (defined as the proportion of patients achieving an ISGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline). Secondary endpoints included the proportion of patients achieving an ISGA score of 0 or 1, irrespective of a minimum 2-grade improvement, at day 29 and time to success in ISGA. Our safety evaluation included reported adverse events, safety laboratory tests and vital signs.
The safety results were consistent with previous studies. The majority of adverse events in crisaborole-treated patients were graded as mild in severity. The most common adverse events occurring on a pooled basis across both studies in ≥ 2% of patients were application site pain (4.4% and 1.2% for crisaborole and vehicle, respectively) and upper respiratory tract infections (3.0% and 3.0% for crisaborole and vehicle, respectively). There were no treatment-related serious adverse events among patients treated with crisaborole.
In addition to the Phase 3 pivotal studies, we are conducting an open-label long-term safety study to evaluate the safety of intermittent use of crisaborole for up to 12 months. Patients who completed either pivotal study had the option to enroll in the long-term safety trial. At completion, at least 100 patients will have been enrolled for 12 months and at least 300 patients will have been enrolled for 6 months, during which time patients will have been treated with crisaborole as needed under the direction of the investigator. We currently expect to announce the results of the long-term safety study by the end of 2015.
Conference Call and Webcast
Anacor will host a conference call today at 7:30 a.m. ET / 4:30 a.m. PT, during which management will discuss the top-line results of our Phase 3 pivotal studies. The call may be accessed by dialing (877) 291-1367 (domestic) and (914) 495-8534 (international) five minutes prior to the start of the call. The call will also be webcast live and can be accessed on the Events and Presentations page, under Investors, on Anacor’s website at www.anacor.com and will be available for three months following the call.
About Crisaborole Topical Ointment, 2%
Crisaborole Topical Ointment, 2%, is an investigational non-steroidal topical anti-inflammatory PDE-4 inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis. Crisaborole is a novel boron-containing small molecule and, although the specific mechanism of action is not yet completely defined, we believe that crisaborole inhibits PDE-4 in target cells, which reduces the production of pro-inflammatory cytokines thought to cause the signs and symptoms of atopic dermatitis.
About Anacor Pharmaceuticals
Anacor is a biopharmaceutical company focused on discovering, developing and commercializing novel small-molecule therapeutics derived from its boron chemistry platform. Anacor’s first approved drug, KERYDIN® (tavaborole) topical solution, 5%, is an oxaborole antifungal approved by the U.S. Food and Drug Administration in July 2014 for the topical treatment of onychomycosis of the toenails. In July 2014, Anacor entered into an exclusive agreement with Sandoz Inc., a Novartis company, pursuant to which PharmaDerm, the branded dermatology division of Sandoz, distributes and commercializes KERYDIN in the United States. In September 2014, PharmaDerm launched KERYDIN in the United States. Anacor’s lead product development candidate is Crisaborole Topical Ointment, 2%, an investigational non-steroidal topical PDE-4 inhibitor for the potential treatment of mild-to-moderate atopic dermatitis and psoriasis. Beyond KERYDIN and crisaborole, Anacor has discovered three investigational compounds that it has out-licensed for further development. The first compound is licensed to Eli Lilly and Company for the potential treatment of an animal health indication. The second compound, AN5568, also referred to as SCYX-7158, is licensed to Drugs for Neglected Diseases initiative for the potential treatment of human African trypanosomiasis. The third compound is licensed to GlaxoSmithKline LLC for development in tuberculosis. Anacor also has a pipeline of other internally discovered topical and systemic boron-based compounds in early stages of research and development. These include AN3365, an investigational Gram-negative antibiotic, and certain other wholly-owned investigational product candidates. For more information, visit www.anacor.com.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the progress, timing and results of Anacor’s clinical trials, the safety and efficacy of Anacor’s approved product and product development candidates, the timing of Anacor’s potential regulatory filings and approval of Anacor’s product development candidates, the commercial success of KERYDIN and the timing and potential commercial success of Anacor’s product development candidates. These statements constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words “may,” “might,” “will,” “should,” “estimate,” “project,” “plan,” “anticipate,” “expect,” “intend,” “outlook,” “believe” and other similar expressions are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Anacor undertakes no obligation to update any forward-looking statement except as required by law. These forward-looking statements are based on estimates and assumptions by Anacor’s management that, although believed to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. The following represent some, but not necessarily all, of the factors that could cause actual results to differ from historical results or those anticipated or predicted by Anacor’s forward-looking statements: the successful commercialization of KERYDIN pursuant to Anacor’s distribution and commercialization agreement with Sandoz Inc.; any issues, delays or failures arising during the course, or as a result, of Anacor’s studies relating to crisaborole; any delay by Anacor in filing for regulatory approval or failure by the U.S. Food and Drug Administration to approve crisaborole; Anacor’s ability to timely and successfully launch, either alone or with a partner, crisaborole, if approved; the impact of general economic, industry, market or political conditions; and the other risks and uncertainties identified in Anacor’s periodic filings, including Anacor’s Annual Report on Form 10-K for the year ended December 31, 2014 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2015.
Anacor Pharmaceuticals, Inc.
DeDe Sheel, 650-543-7575
Senior Director, Investor Relations and Corporate Communications
(OHRP) Positive Results of a Phase II Clinical Study for OHR-102 in Retinal Vein Occlusion
OHR-102 Combination Therapy Enhances Visual Recovery in Macular Edema Secondary to Retinal Vein Occlusion
NEW YORK, July 13, 2015 — Ohr Pharmaceutical, Inc. (Nasdaq:OHRP), an ophthalmology research and development company, today announced positive final results from a Phase II investigator sponsored clinical trial of OHR-102 (0.2% Squalamine lactate ophthalmic solution) in patients with macular edema secondary to branch (BRVO) and central retinal vein occlusion (CRVO). The results demonstrated that, following an initial 10 week combination therapy treatment period, patients who continued to receive a combination of topical OHR-102 BID plus Lucentis® achieved greater visual acuity gains than the control group who received Lucentis alone. At week 38, the mean gain in visual acuity from baseline for patients randomized (at week 10) to treatment with OHR-102 + Lucentis PRN was +27.8 letters compared with +23.3 for patients randomized to treatment with Lucentis plus PRN alone (control group), a clinically meaningful difference of +4.5 letters. The data were presented by John Wroblewski, MD, a retina specialist at Cumberland Valley Retina Consultants on Saturday, July 11 at the 2015 Annual Meeting of the American Society of Retina Specialists (ASRS) in Vienna, Austria.
“These very promising final results demonstrate a clinically meaningful treatment effect of OHR-102 combination therapy for the treatment of macular edema secondary to retinal vein occlusion,” said John Wroblewski, MD, principal investigator of this Phase II study. “The 38 week data confirm a positive and meaningful effect on both visual acuity and macular edema. Importantly, continued treatment with OHR-102 combination therapy for the full 38 weeks of the study resulted in further improvements in visual gains over those patients that only received combination therapy for the first 10 weeks of the study.”
This investigator-sponsored trial was designed to determine the effect of OHR-102 in eyes with macular edema secondary to retinal vein occlusion. The data presented at ASRS included the final analysis of patients that, following a 10 week initial combination treatment period, were randomized to receive either continued OHR-102 + LucentisPRN therapy or only Lucentis monotherapy PRN through week 38. After the initial combination therapy phase, the mean gain in visual acuity from week 10 to week 38 was +7.4 letters for patients who continued treatment with OHR-102 + Lucentis PRN compared with +3.1 letters in those receiving Lucentis PRN alone. Furthermore, at week 38, 80% of patients in the OHR-102 + Lucentis treated group had a gain in visual acuity, compared with 50% of patients treated with Lucentis alone. Additionally, at week 38, none of the patients in the OHR-102 + Lucentis treated group lost any vision. Patients treated with OHR-102 + Lucentis PRN required a mean of 2.0 Lucentis injections between weeks 10 and 38, compared with a mean of 3.3 Lucentis injections for the monotherapy group over the same time period.
“The positive results of this Phase II study demonstrates the role of OHR-102 combination therapy in RVO and represent an important milestone for the development of OHR-102 in the treatment of this disease,” said Dr. Jason Slakter, Chief Medical Officer of Ohr. “This trial constitutes the second clinical study in a retinal vascular disorder which has shown a positive and clinically meaningful benefit in visual acuity using OHR-102 combination therapy versus an intravitreal anti-VEGF injection alone. The consistency of the efficacy data in this study, combined with the favorable safety profile of OHR-102, we believe warrants further study in a large controlled clinical trial.”
Study Design
The 38 week, investigator sponsored, Phase II clinical trial enrolled 20 treatment naïve patients with macular edema due to retinal vein occlusion. All patients received OHR-102 topically for the first 10 weeks of treatment, with two injections of Lucentis given at week 2 and week 6. The week 10 results were presented at ASRS 2014, and demonstrated that the combination of topical OHR-102 eye drops and intravitreal Lucentis led to a mean gain in visual acuity of 20.3 letters and resolution of the foveal edema in 95% of the patients. In the extension stage of the study (weeks 10 to 38), patients were randomized 1:1 at week 10 to either continue administering OHR-102 eye drops or discontinue drops for the remainder of the study. Retreatment with Lucentis injections were administered monthly as needed (PRN) through week 38 based on OCT criteria.
About Ohr Pharmaceutical, Inc.
Ohr Pharmaceutical, Inc. is an ophthalmology research and development company whose lead product, Squalamine, is being studied as an eye drop formulation (OHR-102) in several company-sponsored and investigator sponsored Phase II clinical trials for various back-of-the-eye diseases. These diseases include wet-AMD, retinal vein occlusion, and proliferative diabetic retinopathy. In addition, Ohr has a sustained release micro fabricated micro-particle ocular drug delivery platform with several preclinical drug product candidates in development for glaucoma, steroid-induced glaucoma, ocular allergies, and protein drug delivery. Additional information on the company may be found at www.ohrpharmaceutical.com.
Lucentis® is a registered trademark of Genentech, Inc.
CONTACT: Ohr Pharmaceutical Inc.
Investor Relations
888-388-2327
ir@ohrpharmaceutical.com
LifeSci Advisors, LLC
Michael Wood
646-597-6983
mwood@lifesciadvisors.com
(IIN) Signs Supplier Agreement for AudioNova’s Smartsound Listening Devices
IntriCon Corporation (NASDAQ: IIN), a designer, developer, manufacturer and distributor of miniature and micro-miniature body-worn devices, today announced it has signed a two-year manufacturing agreement with AudioNova International B.V. for their smartsound brand of listening devices. AudioNova is one of Europe’s leading hearing aid providers, operating more than 1,300 retail stores in 11 countries.
Through the program, AudioNova will offer technically advanced hearing devices, manufactured by IntriCon. AudioNova’s smartsound brand is based on IntriCon’s Audion™ amplifier, which includes proven value-added features such as wide-dynamic-range compression, patented adaptive feedback cancelling and layered noise reduction, at value hearing health price points.
“We are thrilled to work with AudioNova to deliver high-quality, low-cost hearing devices to the European market,” said Mark S. Gorder, president and chief executive officer of IntriCon. “AudioNova is one of the largest and most well-respected hearing aid retailers in Europe—and this is a great opportunity for both organizations. Furthermore, we believe our value hearing health vision is closely aligned with their focus on removing barriers to hearing device use.”
AudioNova has begun rollout of the smartsound brand in the Netherlands and intends to expand the program to other targeted European countries in the future. IntriCon expects to begin shipping product in the third quarter. Revenue from this program is included in the company’s growth estimate for 2015.
Concluded Gorder, “This is another meaningful milestone in our strategy to drive business in the growing value hearing health market. And we are very pleased to be expanding our European presence, especially with a partner of AudioNova’s stature. As a company, we are well-positioned to serve their needs and we look forward to our partnership.”
About AudioNova International B.V.
Headquartered in Rotterdam, Netherlands, AudioNova International B.V. is one of the largest retail hearing aid companies on the world. The company operates over 1,300 retail stores in 11 European countries. The company is focused on providing their customers with the selection of the best hearing solution for their needs, improving quality of life through better hearing. AudioNova is owned and supported by HAL Investments, an active long term investor who is fully committed to assist and finance AudioNova’s strategy. For more information about AudioNova, visit http://www.audionova.com.
About IntriCon Corporation
Headquartered in Arden Hills, Minn., IntriCon Corporation designs, develops, manufactures and distributes miniature and micro-miniature body-worn devices. The company is focused on three key markets: medical, hearing health, and professional audio communications. IntriCon has facilities in the United States, Asia and Europe. The company’s common stock trades under the symbol “IIN” on the NASDAQ Global Market. For more information about IntriCon, visit www.intricon.com.
Forward-Looking Statements
Statements made in this release and in IntriCon’s other public filings and releases that are not historical facts or that include forward-looking terminology are “forward-looking statements” within the meaning of the Securities Exchange Act of 1934, as amended. These forward-looking statements may be affected by known and unknown risks, uncertainties and other factors that are beyond IntriCon’s control, and may cause IntriCon’s actual results, performance or achievements to differ materially from the results, performance and achievements expressed or implied in the forward-looking statements. These risks, uncertainties and other factors are detailed from time to time in the company’s filings with the Securities and Exchange Commission, including the Annual Report on Form 10-K for the year ended December 31, 2014. The company disclaims any intent or obligation to publicly update or revise any forward-looking statements, regardless of whether new information becomes available, future developments occur or otherwise.
At IntriCon:
Scott Longval, CFO, 651-604-9526
slongval@intricon.com
or
At PadillaCRT:
Matt Sullivan, 612-455-1700
matt.sullivan@padillacrt.com
(WPPGY) Wins Two Communique Awards
PARSIPPANY, NJ–(Jul 8, 2015) – Ogilvy CommonHealth Worldwide (www.ochww.com), the health behavior change specialists of Ogilvy & Mather (www.ogilvy.com), and a WPP company (NASDAQ: WPPGY) (www.wpp.com), today announced one of the network’s UK-based agencies, Ogilvy HealthPR, achieved double honors at this year’s Communiqué Awards, announced last week in London. Ogilvy HealthPR received an award in the category of Excellence in Digital Communications – Prescription Products/Patient Health and was Highly Commended in the Excellence in Corporate Communications category.
“Our clients continuously challenge us to create innovative and memorable PR campaigns to help them stand out from the crowd,” commented Antonia Betts, Managing Director of Ogilvy HealthPR. “Our success at the Communiqué Awards is yet another recognition of our strategic thinking and careful campaign execution that enables effective healthcare communications across the globe.”
Despite working in a highly regulated industry, Ogilvy HealthPR has been leading the field in the use of social media for healthcare education. Winning the Excellence in Digital Communications Communiqué Award for the fourth time in five years is testament to the agency’s innovative approach to social media and its vital role in integrated multi-stakeholder communications.
Earlier this year, Ogilvy CommonHealth Worldwide published a new report entitled Connecting the Dots: Which Pharma Companies Are Succeeding in the Social Media Space?, which was the first of its kind to provide insights into which pharma companies are leading the way in integrated social media marketing strategies. To find out more about the report, please visit: http://bit.ly/1P5R5Ws.
About Ogilvy CommonHealth Worldwide
Ogilvy CommonHealth Worldwide is committed to creativity and effectiveness in healthcare communications, everywhere. Our global headquarters are in Parsippany, NJ, with additional hubs in New York, London, Paris and Singapore. We maintain multiple additional offices in markets critical to our clients’ global aspirations. Ogilvy CommonHealth Worldwide provides marketing services including behavioral insights, content strategy and management, digital, interactive and new media services, marketing analytics and research, media planning and buying, medical education, payer marketing and market access, professional advertising and promotion, public affairs and relations, relationship marketing, sales training development, social media and social listening, and wellness and consumer advertising and promotion. The network also offers scientific communications and publications planning services through a wholly owned separate legal entity. The organization houses and maintains individual Ogilvy CommonHealth and Ogilvy Healthworld brand identities within the marketplace.
About WPP
WPP is the world’s largest communications services group with billings of US$76 billion and revenues of US$19 billion. Through its operating companies, the Group provides a comprehensive range of advertising and marketing services including advertising & media investment management; data investment management; public relations & public affairs; branding & identity; healthcare communications; direct, digital, promotion & relationship marketing and specialist communications. The company employs over 189,000 people (including associates and investments) in over 3,000 offices across 111 countries. For more information, visit http://www.wpp.com. WPP was named Holding Company of the Year at the 2015 Cannes Lions International Festival of Creativity for the fifth year running. WPP was also named, for the fourth consecutive year, the World’s Most Effective Holding Company in the 2015 Effie Effectiveness Index, which recognizes the effectiveness of marketing communications.
Contact:
Beth Paulino
Kerianne Slattery
Ogilvy CommonHealth Worldwide
973.352.1000 tel
(QLGC) Approves Grant of Equity-Based Award
ALISO VIEJO, Calif., July 10, 2015 — QLogic Corp (Nasdaq:QLGC), a leading supplier of high performance network infrastructure solutions, today announced that on July 9, 2015, the Compensation Committee of the Board of Directors of QLogic Corporation approved a grant of an equity-based award to one individual in connection with his commencing employment with the company and its subsidiaries and as an inducement material to his accepting such employment. The grant consisted of an award to this newly-hired non-executive employee of 40,000 restricted stock units that will vest over a four-year period, subject to his continued employment with the company. The grant was not individually negotiated and was made in accordance with Nasdaq Listing Rule 5635(c)(4).
Follow QLogic @ twitter.com/qlogic
QLogic – the Ultimate in Performance
QLogic (Nasdaq:QLGC) is a global leader and technology innovator in high performance server and storage networking connectivity products. Leading OEMs and channel partners worldwide rely on QLogic for their server and storage networking solutions. For more information, visit www.qlogic.com.
Disclaimer – Forward-Looking Statements
This press release contains statements relating to future results of the company (including certain beliefs and projections regarding business and market trends) that are “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected or implied in the forward-looking statements. The company advises readers that these potential risks and uncertainties include, but are not limited to: potential fluctuations in operating results; gross margins that may vary over time; unfavorable economic conditions; the stock price of the company may be volatile; the company’s dependence on the networking markets served; the company’s ability to compete effectively with other companies; the company’s dependence on a small number of customers; the ability to maintain and gain market or industry acceptance of the company’s products; the company’s dependence on sole source and limited source suppliers; the company’s dependence on relationships with certain third-party subcontractors and contract manufacturers; uncertain benefits from strategic business combinations, acquisitions and divestitures; the ability to attract and retain key personnel; the complexity of the company’s products; declining average unit sales prices of comparable products; sales fluctuations arising from customer transitions to new products; seasonal fluctuations and uneven sales and purchasing patterns with our customers and suppliers; changes in the company’s tax provisions or adverse outcomes resulting from examination of its income tax returns; international economic, currency, regulatory, political and other risks; facilities of the company and its suppliers and customers are located in areas subject to natural disasters; the ability to protect proprietary rights; the ability to satisfactorily resolve any infringement claims; a reduction in sales efforts by current distributors; declines in the market value of the company’s marketable securities; changes in and compliance with regulations; difficulties in transitioning to smaller geometry process technologies; the use of “open source” software in the company’s products; system security risks, data protection breaches and cyber-attacks; and the company’s ability to borrow under its credit agreement is subject to certain covenants.
More detailed information on these and additional factors that could affect the company’s operating and financial results are described in the company’s Forms 10-K, 10-Q and other reports filed, or to be filed, with the Securities and Exchange Commission. The company urges all interested parties to read these reports to gain a better understanding of the business and other risks that the company faces. The forward-looking statements contained in this press release are made only as of the date hereof, and the company does not intend to update or revise these forward-looking statements, whether as a result of new information, future events or otherwise.
QLogic and the QLogic logo are registered trademarks of QLogic Corporation. Other trademarks and registered trademarks are the property of the companies with which they are associated.
CONTACT: Media Contact:
Jess Page
QLogic Corporation
949.542.1455
jess.page@qlogic.com
Investor Contact:
Doug Naylor
QLogic Corporation
949.542.1330
doug.naylor@qlogic.com
(TSYS) Receives $11.3 Million Contract to Support State of Maryland
Represents First TCS Contract under Maryland’s Consulting and Technical Services+ (CATS+) IDIQ
ANNAPOLIS, Md., July 10, 2015 — TeleCommunication Systems, Inc. (TCS) (NASDAQ: TSYS), a world leader in secure and highly reliable wireless communication technology, today announced that it has been awarded a contract to provide the State of Maryland Department of Human Resources (DHR) with statewide Technical Operations Support Services (TOSS). The contract base-award term is three years with two 1-year option terms, which if exercised have a total contract value of $11.3 million.
News Facts:
- CATS+ enables State of Maryland agencies to purchase Professional and Technical Services in 17 primary areas, including software engineering, information system security, geographical information systems and IT management consulting.
- TCS and its team members will work with the DHR personnel to collectively develop, enhance, maintain and support the department’s IT needs.
- Representing one category of TCS’ comprehensive TotalCom® portfolio, IT services are administered by highly qualified on-site TCS program managers and staff to provide reliable solutions with expert service.
- TCS’ Government Solutions Group delivers information and communication services to private enterprises and federal, state and local government clients. Services include network and server support, and premium services such as enterprise architectural design and implementation, information assurance, knowledge management, IT governance, and visual information and video teleconferencing. TCS has a 28-year track record as a proven, trusted provider of government communication technology solutions under conditions that demand the highest level of reliability, availability and security.
TCS Government Solutions Group President Michael Bristol said: “The Department of Human Resources is an innovator in advancing the critical assistance and services that Maryland families and individuals need for healthy, stable environments. TCS is dedicated to delivering the technology expertise necessary to achieve their objectives. For the TOSS project, we have teamed with leading IT small businesses BITHGROUP Technologies, Realistic Computing and Serigor. These premier TCS partners have played integral roles in other TCS Maryland-based contracts for the past 14 years, and we are now applying our proven collaboration and experience to ensure success for DHR.”
About TeleCommunication Systems, Inc.
TeleCommunication Systems, Inc. (TCS), headquartered in Annapolis, Maryland, is a world leader in secure and highly reliable wireless communications. Our patented solutions, global presence, operational support and engineering talent enable 9-1-1, commercial location-based services and deployable wireless infrastructure; cybersecurity; defense and aerospace components; and applications for mobile location-based services and messaging. Our principal customers are wireless network operators, defense and public safety government agencies, and Fortune 150 enterprises requiring high reliability and security. Learn more at www.telecomsys.com.
Except for the historical information contained herein, this news release contains forward-looking statements as defined within Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. These statements are subject to risks and uncertainties and are based upon TCS’ current expectations and assumptions that if incorrect would cause actual results to differ materially from those anticipated. Risks include the possibility that future period funding will not be received, and those detailed from time to time in the Company’s SEC reports, including the Annual Report on Form 10-K for the year ended December 31, 2014 and on Form 10-Q for the quarter ended March 31, 2015.
Existing and prospective investors 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 update or revise the information in this press release, whether as a result of new information, future events or circumstances, or otherwise.
| Company Contact: | Investor Relations: |
| TeleCommunication Systems, Inc. | Liolios Group, Inc. |
| Meredith Allen | Scott Liolios |
| 410-295-1865 | 949-574-3860 |
| PR@telecomsys.com | info@liolios.com |
(ICLD) Next Gen Wireless Professional Services Contracts in Excess of $1.5 Million
SHREWSBURY, N.J., July 10, 2015 — InterCloud Systems, Inc. (Nasdaq:ICLD), a leading provider of cloud networking orchestration and automation solutions and services, announced today that it was recently awarded a series of contracts from new and existing clients valued at over $1.5 million to provide engineering, design and implementation of next generation wireless networks. Further details are withheld due to the nature of the project and associated critical infrastructure.
Mark Munro, CEO of InterCloud Systems stated: “InterCloud continues to win new business from our growing pipeline of sales opportunities. Contracts such as these are indicative of our continued growth and the confidence we enjoy from our customers. This opportunity is expected to be completed over the next several months.”
About InterCloud Systems, Inc.
InterCloud Systems, Inc. is a single-source provider of end-to-end information technology (IT) and next-generation network solutions including Software Defined Networking (SDN) and Network Function Virtualization (NFV) to the telecommunications service provider (carrier) and corporate enterprise markets through cloud solutions and professional services. Additional information regarding InterCloud may be found on InterCloud’s website at www.intercloudsys.com.
Forward-looking statements:
The above news release contains forward-looking statements. The statements contained in this document that are not statements of historical fact, including but not limited to, statements identified by the use of terms such as “anticipate,” “appear,” “believe,” “could,” “estimate,” “expect,” “hope,” “indicate,” “intend,” “likely,” “may,” “might,” “plan,” “potential,” “project,” “seek,” “should,” “will,” “would,” and other variations or negative expressions of these terms, including statements related to expected market trends and the Company’s performance, are all “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and involve a number of risks and uncertainties. These statements are based on assumptions that management believes are reasonable based on currently available information, and include statements regarding the intent, belief or current expectations of the Company and its management. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performances, and are subject to a wide range of external factors, uncertainties, business risks, and other risks identified in filings made by the company with the Securities and Exchange Commission. Actual results may differ materially from those indicated by such forward-looking statements. The Company expressly disclaims any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based except as required by applicable law and regulations.
CONTACT: Investor Relations
InterCloud Systems, Inc.
Telephone 561-988-1988
Website www.intercloudsys.com
(MSLI) Announces Filing of Preliminary Base Shelf Prospectus
TORONTO, July 10, 2015 – Merus Labs International Inc. (“Merus” or the “Company“) [TSX: MSL, NASDAQ: MSLI], announced today that it has filed a preliminary short form base shelf prospectus with the securities commissions in all provinces in Canada, other than Quebec, Nova Scotia and Newfoundland, and a corresponding shelf registration statement on Form F-10 with the U.S. Securities and Exchange Commission (the “SEC”) under the U.S./Canada Multijurisdictional Disclosure System.
The base shelf prospectus and corresponding shelf registration statement, when made final or effective, will allow Merus to offer up to $250,000,000 of common shares, warrants, preferred shares, subscription receipts and units, or any combination thereof, from time to time over a 25-month period. The specific terms of any offering of securities will be set forth in a shelf prospectus supplement. The Company filed this base shelf prospectus to maintain financial flexibility but has no immediate intentions to undertake an offering.
The shelf registration statement filed today with the SEC has not yet become effective. No securities may be sold, nor may offers to buy be accepted, prior to the time the registration statement becomes effective. This news release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualifications under the securities laws of any such jurisdiction.
A copy of the preliminary short form base shelf prospectus can be found on SEDAR at www.sedar.com and on EDGAR at www.sec.gov.
About Merus Labs International Inc.
Merus Labs is a specialty pharmaceutical company focused on acquiring established products. The Company leverages its expertise in European and North American markets to optimize the value of underdeveloped pharmaceutical assets.
Cautionary Statement
Certain statements contained in this press release may constitute “forward-looking statements” within the meaning of Section 21E (i) (1) of the United States Securities Exchange Act of 1934. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Merus’ actual results to be materially different from any future results expressed or implied by these statements. Such factors include the following: general economic and business conditions, changes in demand for Merus’ products, changes in competition, the ability of Merus to complete future acquisitions and to integrate these acquisitions into its business, Merus’ ability to complete future debt and/or equity financings required to complete future acquisitions, interest rate fluctuations, currency exchange rate fluctuations, dependence upon and availability of qualified personnel and changes in government regulation. In light of these and other uncertainties, the forward-looking statements included in this press release should not be regarded as a representation by Merus that Merus’ plans and objectives will be achieved. These forward-looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise the statements.
(SLTD) Congratulates Clients Chosen for Inclusion in the Russell Microcap® Index
SANTA MONICA, Calif., July 9, 2015 — IRTH Communications, a provider of Investor Relations, Financial Marketing, and Strategic Consulting services to high-growth small-cap companies, congratulates three of its clients, IDI Inc., Solar3D Inc., and Vuzix Corporation, on being selected for inclusion in the Russell Microcap® Index. IDI, Inc. (NYSE MKT: IDI) is an information solutions provider. Solar3D, Inc. (NASDAQ: SLTD) provides solar power solutions and is the developer of a proprietary high efficiency solar cell. Vuzix® Corporation (NASDAQ: VUZI) is a leading supplier of Video Eyewear and Smart Glasses products in the consumer, enterprise and entertainment markets.
The Russell Microcap Index measures the performance of the microcap segment of the U.S. equity market, a select group of small-cap U.S. equity shares. It includes approximately 1000 of the smallest companies by market capitalization in the small-cap Russell 2000® Index. The Russell 2000 is reconstituted each year to maintain an accurate representation of the small capitalization universe, with membership in the Index conferred for one year.
IRTH Communications provides investor and media relations, financial communications and strategic consulting services to select companies with exciting new technologies, processes, products and services within their respective industries. Its client industries include intellectual property (IP), technology, alternative energy, energy efficiency, green and sustainable products, clean-tech, telecommunications & mobile engagement, entertainment, healthcare, consumer goods, and food products industries and others. IRTH Communications’ team of seasoned professionals has decades of public market experience focused on small cap companies.
Andrew Haag, Managing Partner of IRTH Communications, commented, “We have worked with client companies as they have gone through the uplisting process to move from the OTC market to a NASDAQ or NYSE listing. We are pleased to see them continue to move forward, broaden their shareholder composition and gain greater visibility, as a result of inclusion in the Russell Index.”
About IRTH Communications
Founded in 2008, IRTH Communications assists entrepreneurs, corporate executives and investors in realizing their visions and achieving their goals by delivering effective Investor Relations, Financial Marketing, and Strategic Consulting services. IRTH supports companies focused on alternative energy, clean and renewable technology, natural and organic products, and socially responsible activities by providing advisory services and direct access to investment funds and other industry professionals. The result provides clients better access to capital and more time to focus on their mission. Over the past 12 months, IRTH Communications has expanded its operations and client base and continues to strategically grow its offerings. To learn more about IRTH Communications visit, www.irthcommunications.com.
(WPRT) Completes HPDI Technology Program with Daimler AG
~Westport HPDI 2.0 Meets Challenging Performance Targets~
VANCOUVER, July 9, 2015 – Westport Innovations Inc. (TSX:WPT / NASDAQ:WPRT), engineering the world’s most advanced natural gas engines and vehicles, announced today that it has completed an engineering program with Daimler AG to develop and assess Westport High Pressure Direct Injection (HPDI) system for a Daimler heavy duty engine. The prototype HPDI engine met all technical targets resulting in a payment of 2.4 million Euro (approximately $2.7 million USD) by Daimler to Westport. For competitive reasons, further terms of the program have not been disclosed.
About Westport™ HPDI 2.0
Westport™ HPDI 2.0 is the only natural gas technology capable of delivering performance and fuel economy equivalent to that of current high performance diesel-fueled engines, but with diesel substitution of over 90%. This combination of high performance and high efficiency is critical for heavy-duty engines in demanding commercial applications. In addition to delivering performance and fuel economy, Westport™ HPDI 2.0 is designed to meet the latest in stringent emission regulations, including Euro VI and EPA 2014.
About Westport
Westport engineers the world’s most advanced natural gas engines and vehicles. More than that, we are fundamentally changing the way the world travels the roads, rails and seas. We work with original equipment manufacturers (OEMs) worldwide from design through to production, creating products to meet the growing demand for vehicle technology that will reduce both emissions and fuel costs. To learn more about our business, visit westport.com, subscribe to our RSS feed, or follow us on Twitter @WestportDotCom.
(CLNE) Refuse Business Continues to Drive Growth
Clean Energy Fuels Corp. (NASDAQ:CLNE) today announced that it has completed 14 station construction projects for refuse customers in the first six months of the year and expects to complete another 22 by the end of 2015, which will enable new or expanding refuse fleets to fuel with clean, less-expensive natural gas. These stations support the country’s largest waste companies such as Waste Management, Republic Services and Progressive Waste Solutions, as well as regional companies like Knight Waste and municipalities like the City of Medicine Hat in Alberta, Canada.
Clean Energy’s refuse business continues to steadily expand, providing a significant portion of the company’s revenues now through three sources. In addition to revenue received from the construction of new stations and expansion of existing stations and the recurring revenues from fuel sales and operating and maintaining stations for long-term refuse customers, more and more companies are now taking advantage of Clean Energy’s Facility Modification Services unit. Clean Energy has been contracted by Waste Management, Republic Services and others to upgrade vehicle maintenance facilities to comply with all local and national code requirements for a number of refuse customers.
“Despite being the first market to fully adopt natural gas years ago, the refuse industry continues to provide Clean Energy with very healthy growth,” said Andrew J. Littlefair, president and CEO of Clean Energy. “The second half of each year typically provides the most robust activity in station construction for our refuse customers as this is when their new trucks arrive and we believe 2015 will be no exception.”
Over 60% of the new refuse trucks sold in the United States today are powered by natural gas with some companies reaching 90%. Clean Energy has relationships with over 125 individual waste companies and municipality waste divisions in North America, and over 9,400 refuse trucks fuel at a Clean Energy built or maintained station daily.
“It has become almost a requirement for refuse companies to convert at least part of their fleets to natural gas in order to stay economically and environmentally competitive,” said Raymond Burke, vice president of Clean Energy for business development (solid waste). “Clean Energy works with each of our customers to assess their individual needs to make the transition or expansion to natural gas seamless so that they can begin to enjoy the benefits of natural gas fueling without a hiccup.”
Watch a short video about Clean Energy’s refuse business at: https://www.youtube.com/watch?v=zTOkYcXlVds
Natural gas fuel costs up to $1.00 less than gasoline or diesel, depending on local market conditions. The use of natural gas fuel not only reduces operating costs for vehicles, but also reduces greenhouse gas emissions up to 30% in light-duty vehicles and 23% in medium- to heavy-duty vehicles. In addition, nearly all natural gas consumed in North America is produced domestically.
About Clean Energy
Clean Energy Fuels Corp. (NASDAQ:CLNE) is the leading provider of natural gas fuel for transportation in North America. We build and operate compressed natural gas (CNG) and liquefied natural gas (LNG) fueling stations; manufacture CNG and LNG equipment and technologies for ourselves and other companies; develop renewable natural gas (RNG) production facilities; and deliver more CNG, LNG and Redeem RNG fuel than any other company in the U.S. For more information, visit www.cleanenergyfuels.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks, uncertainties and assumptions, including without limitation statements about the station construction activity for refuse customers in the second half of 2015, the anticipated revenue associated with construction of new stations and expansion of existing stations and the benefits of natural gas relative to gasoline and diesel. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors, including without limitation the price of natural gas relative to gasoline and diesel, the cost and operating experience associated with natural gas vehicles, and permitting and other factors affecting construction. The forward-looking statements made herein speak only as of the date of this press release and, unless otherwise required by law, the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances. Additionally, the reports and other documents the Company files with the SEC (available at www.sec.gov) contain risk factors, which may cause actual results to differ materially from the forward-looking statements contained in this news release.
Clean Energy Media Contact:
Gary Foster, 949-437-1113
gfoster@cleanenergyfuels.com
or
Clean Energy Investor Contact:
Tony Kritzer, 949-437-1403
tkritzer@cleanenergyfuels.com
(RARE) Positive Interim Bone Treatment Data From Ongoing Pediatric Phase 2 Study
8 of 11 Patients Showed Improvement in Rickets Bone Disease, Including 5 of 5 in Biweekly Dosing Group
NOVATO, Calif., July 9, 2015 — Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE), a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, today announced positive interim data from the first 12 patients in the ongoing pediatric Phase 2 study for its recombinant human monoclonal antibody KRN23 against fibroblast growth factor 23 (FGF23) for the treatment of X-linked hypophosphatemia (XLH). An improvement in mean rickets score was observed after 40 weeks of treatment with investigational KRN23 in these patients. Ultragenyx is conducting the Phase 2 study under a collaboration and license agreement with Kyowa Hakko Kirin to develop and commercialize KRN23.
Bone Disease Efficacy
Eleven of the first 12 patients enrolled had been on standard of care oral phosphate/Vitamin D therapy for an average of 6 years (3.3–9.4 years) prior to the baseline assessment. The mean rickets score was 1.4 at baseline using the Thacher Rickets Severity Scoring method as evaluated by a blinded expert reader and decreased to 0.6 after 40 weeks of treatment with KRN23, a 58% reduction. Eight out of 11 patients with rickets at baseline demonstrated an improvement in rickets, of which three patients no longer exhibited radiographic evidence of rickets at week 40. One patient in the biweekly dosing group did not present with radiographic evidence of rickets at baseline and was excluded from the analysis.
Of the 12 patients, 6 received biweekly dosing and 6 received monthly dosing of KRN23. Of the 5 patients with rickets at baseline in the biweekly dosing group, 100% demonstrated improvement in rickets from a mean baseline rickets score of 1.5 to a mean score of 0.3 at week 40, representing an 80% reduction in rickets score. Of the 6 patients in the monthly dosing group, 50% demonstrated improvement in rickets from a mean baseline score of 1.3 to a mean score of 0.8 at week 40, representing a 38% reduction in rickets score. Two patients in the monthly dosing group did not show a change and one patient in the monthly dosing group worsened by 0.5 points.
“These interim data are encouraging as they are the first indication that KRN23 may improve rickets beyond what can be achieved with standard of care,” commented Sunil Agarwal, M.D., Chief Medical Officer of Ultragenyx. “We look forward to discussing these data with the U.S. and European Union regulatory agencies to determine appropriate next steps for the pediatric development program.”
Metabolic Measures
In the biweekly dosing group (n=6), mean serum phosphorus increased by 0.70 mg/dL, from 2.78 mg/dL at baseline to 3.48 mg/dL, which is in the normal range (3.2–6.1 mg/dL). In the monthly dosing group (n=6), mean serum phosphorus at peak increased by 1.06 mg/dL, from 2.42 mg/dL at baseline to 3.48 mg/dL. The monthly dosing patients showed a decrease to the trough level before the next dose, unlike the biweekly regimen which showed stable phosphate levels.
Increases in renal phosphate reabsorption (TmP/GFR) and in serum 1,25 dihydroxy vitamin D levels were observed in all 12 patients.
Safety and Tolerability
No serious adverse events have been reported in the study to date and there have been no discontinuations from the study for any reason. For the 12 patients who had reached 40 weeks at the time of the interim analysis, the most common adverse events considered to be treatment related were injection site reactions. All of the treatment-related adverse events were considered mild in severity.
No significant changes were observed in serum calcium, urinary calcium, or serum intact parathyroid hormone (iPTH) in the 12 patients. None of the patients had serum phosphorus levels above the upper limit of normal in either dosing group. Safety data on renal ultrasounds, echocardiograms, or immune response to KRN23 are not yet available.
All patients in the study continue to receive KRN23. An additional 40-week analysis for 36 patients is planned for the fourth quarter of 2015.
FDA Fast Track Designation
Ultragenyx also announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the KRN23 program in XLH. Fast Track Designation is intended to facilitate the development and expedite the review of drugs for serious and life-threatening conditions that have the potential to address an unmet medical need. The designation allows for more frequent interaction with the FDA review team. It also enables eligibility for priority review and the potential for a rolling review of the Biologics License Application, when and if filed.
About X-Linked Hypophosphatemia (XLH)
XLH is a disorder of phosphate metabolism caused by phosphate wasting in the urine leading to severe hypophosphatemia. XLH is the most common heritable form of rickets (the softening and weakening of bones) that is inherited as an X-linked dominant trait affecting both males and females, though some reports indicate that the disease may be more severe in males. XLH is a distinctive bone disease characterized by inadequate mineralization of bone that leads to a spectrum of abnormalities, including rickets, progressive bowing of the leg, osteomalacia, bone pain, waddling gait, short stature, gross motor impairment, muscle weakness, frequent/poorly healing pseudofractures, spinal stenosis, enthesopathy, and osteoarthritis.
Most pediatric patients and some adult patients are managed using oral phosphate replacement and vitamin D (calcitriol) therapy, which requires frequent divided doses and careful medical monitoring. It is partially effective at reducing rickets in pediatric patients, but it does not improve growth and can be challenging to optimize the dose without increasing the risk of depositing phosphate-calcium precipitates in the kidneys (nephrocalcinosis).
Phase 2 Study Design
The randomized, open-label, dose-finding Phase 2 study is evaluating safety and efficacy in approximately 50 pediatric XLH patients ages 5 to 12. The study consists of a 16-week individual dose-titration period followed by a 48-week treatment period, for a total of 64 weeks. Patients are divided into three cohorts of escalating starting dose levels of KRN23 with either monthly or biweekly dosing regimens. Patients can continue to have their dose increased throughout the duration of the study to reach an individually-optimized dose.
The evaluation of rickets in the study is done via radiographs of the wrists and knees. The scoring was done using the Thacher Rickets Severity Score, a pre-specified 10-point scale that measures knee and wrist irregularities. Each radiograph is scored by one central independent reviewer who is blinded to the subject’s adherence, dose, dose regimen, and radiographic sequence.
Safety, changes in serum phosphorus, and other pharmacodynamic parameters were evaluated at the 16-week analysis. The current interim analysis includes the first 12 patients enrolled in the study by the lead investigator Thomas Carpenter, M.D. Additional safety, tolerability, and efficacy data, including radiographic evidence of rickets severity, will be evaluated for all patients at the 40-week and 64-week analyses.
About KRN23 and FGF23
KRN23 is an investigational recombinant fully human monoclonal IgG1 antibody, discovered by Kyowa Hakko Kirin, against the phosphaturic hormone fibroblast growth factor 23 (FGF23). It is being developed by Ultragenyx to treat XLH, a disease characterized by excess activity of FGF23. FGF23 is a hormone that reduces serum levels of phosphorus and vitamin D by regulating phosphate excretion and vitamin D production by the kidney. Phosphate wasting in XLH is caused by excessive levels and activity of FGF23. KRN23 is designed to bind to and thereby inhibit the excessive biological activity of FGF23. By blocking excess FGF23 in patients with XLH, KRN23 is intended to restore normal phosphate reabsorption from the kidney and increase the production of vitamin D, which enhances intestinal absorption of phosphate and calcium.
Multiple clinical studies of KRN23 in adult patients with XLH have been completed and Ultragenyx intends to continue development of KRN23 in adults with XLH. In addition, a Phase 2 study in pediatric patients with XLH is ongoing.
KRN23 is also being developed for tumor-induced osteomalacia (TIO), a disease characterized by typically benign tumors that produce excess levels of FGF23, which can lead to severe osteomalacia, fractures, bone and muscle pain, and muscle weakness.
About Ultragenyx
Ultragenyx is a clinical-stage biotechnology company committed to bringing to market novel products for the treatment of rare and ultra-rare diseases, with a focus on serious, debilitating genetic diseases. Founded in 2010, the company has rapidly built a diverse portfolio of product candidates with the potential to address diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapies.
The company is led by a management team experienced in the development and commercialization of rare disease therapeutics. Ultragenyx’s strategy is predicated upon time and cost-efficient drug development, with the goal of delivering safe and effective therapies to patients with the utmost urgency.
For more information on Ultragenyx, please visit the company’s website at www.ultragenyx.com.
About Kyowa Hakko Kirin
Kyowa Hakko Kirin is a leading biopharmaceutical company in Japan focusing on its core business area of oncology, nephrology, and immunology/allergy. Kyowa Hakko Kirin leverages antibody-related leading-edge technologies to discover and develop innovative new drugs aiming to become a global specialty pharmaceutical company which contributes to the health and well-being of people around the world.
For more information, please visit www.kyowa-kirin.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding timing of release of additional data and analysis of same, discussions with regulatory authorities, and the potential benefits of Fast Track Designation, are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of our regulatory filings, and other matters that could affect the availability or commercial potential of our drug candidates. Ultragenyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see Ultragenyx’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 12, 2015, and its subsequent periodic reports filed with the Securities and Exchange Commission.
CONTACT: Ultragenyx Pharmaceutical Inc.
Investors & Media
Robert Anstey
844-758-7273
(VNET) Announces Appointment of Financial Advisor and Legal Counsels
BEIJING, July 9, 2015 — 21Vianet Group, Inc. (Nasdaq:VNET) (“21Vianet” or the “Company”), a leading carrier-neutral Internet data center services provider in China, today announced that the special committee of its board of directors (the “Special Committee”) has retained Morgan Stanley Asia Limited as its financial advisor, K&L Gates LLP as its international and U.S. legal counsel and Conyers Dill & Pearman as its Cayman legal counsel in connection with its review and evaluation of a preliminary non-binding proposal dated June 10, 2015 from Mr. Josh Sheng Chen, the Chairman and Chief Executive Officer of the Company, Kingsoft Corporation Limited and Tsinghua Unigroup International Co., Ltd. (the “Proposal”).
In addition, Skadden, Arps, Slate, Meagher & Flom LLP will act as the Company’s legal counsel in connection with the Proposal.
21Vianet’s board of directors cautions the Company’s shareholders and others considering trading in its securities that the Special Committee is continuing its evaluation of the Proposal and no decisions have been made by the Special Committee with respect to 21Vianet’s response to the Proposal. There can be no assurance that any definitive offer will be made, that any agreement will be executed or that the Proposal or any other transaction will be approved or consummated.
About 21Vianet
21Vianet Group, Inc. is a leading carrier-neutral internet data center services provider in China. 21Vianet provides hosting and related services, managed network services, cloud services, content delivery network services, last-mile wired broadband services and business VPN services, improving the reliability, security and speed of its customers’ internet infrastructure. Customers may locate their servers and networking equipment in 21Vianet’s data centers and connect to China’s internet backbone through 21Vianet’s extensive fiber optic network. In addition, 21Vianet’s proprietary smart routing technology enables customers’ data to be delivered across the internet in a faster and more reliable manner. 21Vianet operates in more than 30 cities throughout China, servicing a diversified and loyal base of more than 2,000 customers that span numerous industries ranging from internet companies to government entities and blue-chip enterprises to small- to mid-sized enterprises.
Safe Harbor Statement
This announcement contains forward-looking statements. These forward-looking statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. 21Vianet may also make written or oral forward-looking statements in its reports filed with, or furnished to, the U.S. Securities and Exchange Commission, in its annual reports to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about 21Vianet’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. All information provided in this press release and in the attachments is as of the date of this press release, and 21Vianet undertakes no duty to update such information, except as required under applicable law.
CONTACT: Investor Relations Contact:
21Vianet Group, Inc.
Eric Chu, CFA
+1(908)7072062
IR@21Vianet.com
Joseph Cheng
+861084562121
IR@21Vianet.com
ICR, Inc.
Calvin Jiang
+1(646)405-4922
IR@21Vianet.com
(RMGN) Awarded Multimillion Dollar Contract to Provide Transformational Retail Solution
Represents One of the Largest Project Wins in RMG’s History
DALLAS, TX–(Jul 9, 2015) – RMG Networks Holding Corporation (NASDAQ: RMGN), or RMG Networks™, a leading provider of technology-driven visual communications, today announced the signing of a multimillion agreement to support one of the world’s largest telecommunication companies. Initial purchases under the award total $1.1 million, a majority of which will be recognized as margin for accounting purposes. Significant future orders representing up to an additional $4 million are likely as the solution continues to roll out in 2016 across the customer’s retail footprint. The opportunity represents one of the largest awards in RMG Networks’ history.
RMG Networks will provide multiple stores with interactive and non-interactive video walls, LED displays and interactive Smart Screens that allow customers to learn about product and service options with multi-language support. The project is in direct support of the international telecommunications provider’s recently unveiled new store concept designed to transform its retail experience and drive sales with a contemporary, fully digital environment for its customers.
“Built on a cutting-edge digital strategy, this retail transformation will elevate our customer’s in-store environment,” said Robert Michelson, Chief Executive Officer and President of RMG Networks. “Working in close collaboration, we are deploying a solution that will deliver a modern retail experience for shoppers. Together we are implementing the concept of connecting people’s lives to the company by improving opportunities to engage with staff, products and services.”
RMG Networks was awarded this tender through a rigorous selection process including multiple competitors from around the globe.
For additional information, visit: http://www.rmgnetworks.com/
© 2015 RMG Networks Holding Corporation. RMG Networks and its logo are trademarks and/or service marks of RMG Networks Holding Corporation.
About RMG NETWORKS
RMG NETWORKS (NASDAQ: RMGN) is a worldwide leader in intelligent visual communications that help businesses increase productivity, efficiency and engagement through digital messaging. By combining best-in-class software, hardware, business applications and services, RMG Networks offers a single point of accountability for integrated data visualization and real-time performance management. The company, who values 70% of the Fortune 100 as clients, is headquartered in Dallas, Texas, with additional offices in the United States, United Kingdom, Singapore and the United Arab Emirates. For more information, visit www.rmgnetworks.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. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, compensation and other benefits derived from the sale of the Airline Media Network business, guidance relating to future financial performance and expected operating results, such as revenue growth, our ability to achieve profitability, our position within the markets that we serve, efforts to grow our business and the impact of litigation.
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. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the following: the company’s ability to raise additional capital on satisfactory terms, or at all; success in retaining or recruiting, or changes required in, its management and other key personnel; the limited liquidity and trading volume of the company’s securities; the competitive environment in the markets in which the company operates; the risk that the anticipated benefits of acquisitions that the company may complete may not be fully realized; the risk that any projections, including earnings, revenues, margins or any other financial items are not realized; changing legislation and regulatory environments; business development activities, including the company’s ability to contract with, and retain, customers on attractive terms; the general volatility of the market price of the company’s common stock; risks and costs associated with regulation of corporate governance and disclosure standards (including pursuant to Section 404 of the Sarbanes-Oxley Act); and general economic conditions.
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.
Media Contact:
Ashley Knapp
TallGrass Public Relations
Ashley.Knapp@tallgrasspr.com
605-275-4075
Investor Contact:
Hayden IR
Brett Maas/Rob Fink
rmgn@haydenir.com
646-536-7331/646-415-8972
(CRV) To Be Acquired By (LKQ)
CHICAGO, July 09, 2015 — LKQ Corporation (Nasdaq:LKQ) and The Coast Distribution System, Inc. (NYSE MKT:CRV) today announced that they have signed a definitive agreement for LKQ to acquire Coast for $5.50 per share in cash. Coast is a leading distributor of replacement parts, supplies and accessories for recreational vehicles (RVs) primarily to retail parts and supplies stores, service and repair establishments, and new and used RV dealers in North America. Under the terms of the definitive agreement, a subsidiary of LKQ will commence a tender offer to acquire all outstanding shares of Coast’s common stock for $5.50 per share in cash. The tender offer is required to be commenced within 10 business days and to remain open for at least 20 business days after launch. The consummation of the tender offer is subject to satisfaction of customary conditions, including that the holders of at least a majority of Coast’s outstanding shares accept the offer. Any shares not tendered in the offer will be acquired, following consummation of the tender offer, in a second step merger at the same cash price as in the tender offer. The acquisition is currently expected to close in the third quarter of 2015. Coast’s Board of Directors has unanimously recommended that Coast stockholders accept the offer and tender their shares. Total cash consideration payable for Coast’s outstanding shares is approximately $29 million. As of June 30, 2015 Coast had $19.5 million outstanding under its long-term revolving bank line of credit.
“The combination of Coast with our Specialty segment and RV business presents tremendous distribution and logistics synergies with our existing network, and expands our RV business with the addition of unique product offerings and brands,” stated Robert L. Wagman, President and Chief Executive Officer of LKQ Corporation.
Robert W. Baird & Co. Incorporated and Duff & Phelps, LLC are acting as financial advisors to The Coast Distribution System, Inc. in this transaction.
About LKQ Corporation
LKQ Corporation (www.lkqcorp.com) is a leading provider of alternative and specialty parts to repair and accessorize automobiles and other vehicles. LKQ has operations in North America, the United Kingdom, the Netherlands, Belgium, France, Scandinavia, Australia and Taiwan. LKQ offers its customers a broad range of replacement systems, components, equipment and parts to repair and accessorize automobiles, trucks, and recreational and performance vehicles.
About The Coast Distribution System, Inc.
The Coast Distribution System, Inc. (www.coastdistribution.com) is one of North America’s largest wholesale aftermarket suppliers of replacement parts, supplies and accessories for the recreational vehicle (RV) and outdoor recreation markets. Coast supplies more than 14,000 products through 17 distribution centers located in the United States and Canada. Coast’s customers consist of independently-owned RV dealers, supply stores and service centers.
Additional Information
The tender offer described in this news release has not yet commenced. This news release and the description contained herein is neither an offer to purchase nor a solicitation of an offer to sell shares of Coast Distribution System, Inc. At the time the tender offer is commenced, LKQ and its wholly owned subsidiary, KAO Acquisition Sub, Inc., intend to file with the Securities and Exchange Commission (the “SEC”) a Tender Offer Statement on Schedule TO containing an offer to purchase, a form of letter of transmittal and other documents relating to the tender offer, and Coast intends to file with the SEC a Solicitation/Recommendation Statement on Schedule 14D-9 with respect to the tender offer. LKQ, KAO Acquisition Sub and Coast intend to mail these documents to the stockholders of Coast. These documents will contain important information about the tender offer and stockholders of Coast are urged to read them carefully when they become available. Stockholders of Coast will be able to obtain a free copy of these documents (when they become available) and other documents filed by Coast, LKQ or KAO Acquisition Sub with the SEC at the website maintained by the SEC at www.sec.gov. In addition, stockholders will be able to obtain a free copy of these documents (when they become available) from the information agent named in the offer to purchase or from LKQ.
Forward Looking Statements
Certain statements in this press release that are not historical facts are forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward looking statements generally include expectations, beliefs, hopes, intentions or strategies regarding our future, including with respect to the proposed transaction described and statements or assumptions regarding the expected timetable for completing the transaction, financial and operating results, benefits and synergies of the transaction, and other statements that are based on management’s current beliefs and expectations of the company and the combined businesses. Forward looking statements are subject to risks, uncertainties and other factors some of which are not currently known to us. Actual events or results may differ materially from those expressed or implied in the forward looking statements as a result of various factors. Some of such risks, uncertainties and other factors are described in LKQ’s and Coast’s annual reports on Form 10-K for the year ended December 31, 2014 and in subsequently filed quarterly reports on Form 10-Q. We assume no obligation to publicly update any forward looking statement to reflect events or circumstances arising after the date on which it was made, except as required by law.
Contacts: Joseph P. Boutross-LKQ Corporation Director, Investor Relations (312) 621-2793 jpboutross@lkqcorp.com James Musbach, President and CEO – The Coast Distribution System, Inc. (408) 782-6686 jmusbach@coastdist.com
(STXS) First Procedure With Stereotaxis Niobe(R) ES Technology in Japan
ST. LOUIS, July 8, 2015 — Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, announced today that the first procedure with its Niobe® ES magnetic navigation system has been performed in Japan. Dr. Kohei Yamashiro of Takatsuki General Hospital completed a cardiac ablation on a patient with ventricular tachycardia, noting, in particular, the improved navigation of the ablation catheter and ease of mapping with the Niobe system compared to manual methods for lesion creation.
“We are excited to be the first institution in Japan to offer this unique, innovative approach to treating complex cardiac arrhythmias, which continue to rise in prevalence at a rapid rate with our aging population,” said Dr. Yamashiro. “The Niobe system provides greater visibility and precise control of the ablation catheter, as well as significantly increased safety, which I expect to translate into improved outcomes for my patients.” Dr. Yamashiro has more than 10 procedures scheduled for the Niobe system’s first two weeks of operation.
Takatsuki General Hospital is located near Osaka, Japan and recently underwent a complete renovation to support the latest medical advances and provide higher quality, more integrated patient services. Installation of the Niobe system was completed in the second quarter, as Dr. Yamashiro, its primary operator, received comprehensive training at Stereotaxis sites in the U.S. The hospital held a grand opening lecture on the Niobe system lab July 3, featuring presentations by Dr. Yamashiro and Dr. Hiroshi Nakagawa, a prominent electrophysiologist, who has educated Japanese physicians and government officials on the use of Stereotaxis technologies.
“We have envisioned this day for some time and are very pleased to see it come to fruition,” said William C. Mills, Stereotaxis’ Chief Executive Officer. “Our momentum continues to build in Japan as we set our sights on becoming the region’s first choice in the treatment of complex electrophysiology cases.”
About Stereotaxis
Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis’ core Epoch® Solution includes the Niobe® magnetic navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management solutions, and the Vdrive® robotic navigation system and consumables.
The core components of Stereotaxis’ systems have received regulatory clearance in the U.S., European Union, Canada, China, Japan, and elsewhere. The V-Sono™ ICE catheter manipulator, V-Loop™ variable loop catheter manipulator, and V-CAS™ catheter advancement system have received U.S. clearance. For more information, please visit www.stereotaxis.com.
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to raise additional capital on a timely basis and on terms that are acceptable, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness on acceptable terms, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the U.S., including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period or at all because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.
CONTACT: Press Contact:
Martin Stammer
Chief Financial Officer
314-678-6155
Investor Contact:
Todd Kehrli / Jim Byers
MKR Group, Inc.
323-468-2300
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