News Column

Perrigo Announces FDA Approval for Generic Version of Astepro; Medtronic Announces Promising Results with ALSYNC

May 12, 2014



Below is a look at some of the headlines for companies that made news in the healthcare sector on May 12, 2014. {nfg}Perrigo Company plc (NYSE: PRGO) announced it has received final approval from the U.S. Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for azelastine hydrochloride nasal spray (0.15%). The ANDA involved contributions from both Perrigo and Impax Laboratories, Inc. (Nasdaq: IPXL), who will share certain costs and benefits of this product. Perrigo and Impax continue to be in first to file Hatch Waxman patent litigation with Meda Pharmaceuticals Inc. in the United States District Court for the District of New Jersey. Perrigo has commenced shipment of product to its customers.



Perrigo Company. Astepro® Nasal Spray is a prescription medicine for people 12 years of age and older and is approved to treat nasal symptoms caused by seasonal allergies or environmental irritants. Annual sales were approximately $97 million annually, as measured by Symphony Health Solutions.



Perrigo's Chairman and CEO Joseph C. Papa stated, "This approval is another example of our investment in new products and expansion of our extended topical product portfolio. We are pleased to be the partner of choice with Impax on this important product opportunity. As always, Perrigo is committed to making quality healthcare more affordable for our customers."



President of the Global Pharmaceuticals Division of Impax Dr. Carole Ben-Maimon stated, "We are excited to collaborate with Perrigo on this product as we continue to execute our strategy of diversifying our product base."





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Medtronic, Inc. (NYSE: MDT)
released study findings that show heart failure patients who have limited options for implanted device therapy may benefit from a novel implant technique for cardiac resynchronization therapy (CRT) devices. Data from the ALSYNC (Alternate Site Cardiac Resynchronization) study show that pacing from inside the heart's left ventricle - an alternate site compared to traditional implants - was successful in 89 percent of implant attempts. The data were presented during a Late-Breaking Clinical Trials Session at Heart Rhythm 2014, the Heart Rhythm Society's 35th Annual Scientific Sessions, by Prof. John Morgan, M.D., Southampton University Hospitals Trust, Southampton, U.K. The system evaluated in the ALSYNC study is not available for investigational or commercial use in the United States.



Some heart failure patients are not suitable for, or do not respond to, traditional CRT because of limitations associated with implanting a lead, or thin wire, in veins on the outside of the left ventricle; these limitations may include unique patient anatomy or suboptimal lead placement. As a potential alternative for these patients, the system evaluated in the study implants a lead placed inside the left ventricle by crossing the atrial septum, the wall that divides the two top chambers of the heart.



"There is a significant need for a new way to pace the left ventricle in patients unable to receive the clinical benefits of standard CRT therapy, and this study suggests left ventricular endocardial pacing is a feasible option," said Prof. Morgan, lead investigator of the ALSYNC study. "These findings will elevate this new approach from something that is investigational to one that is closer to the mainstream."



The ALSYNC study, the first of its kind to evaluate the safety and performance of a new delivery system and left ventricular endocardial (LVE) pacing lead for CRT implantation, included 138 patients at 18 centers in Europe and Canada, all of whom were indicated for CRT but were unable to receive a conventional system or did not respond to the therapy at least six months post-implant. LVE pacing was successful in 118 out of 133 (89 percent) implant attempts.



The ALSYNC study assessed the safety and performance of the system and implant procedure. The primary objective was to demonstrate that the complication rates were less than 30 percent at six months in patients with an implant attempt. The objective was met with an observed rate of 17.7 percent (upper confidence bound 24.2 percent), which is comparable to the complication rates of conventional CRT implants^1.



"As the leader in CRT, we are committed to continued innovations in heart failure treatment and bringing renewed hope to the many patients who have previously had limited options," said David Steinhaus, M.D., vice president and general manager, heart failure, and medical director for the Cardiac Rhythm Disease Management business at Medtronic.



In collaboration with leading clinicians, researchers and scientists worldwide, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers around the world.





Also Monday:






Apricus Biosciences, Inc. (Nasdaq: APRI)
, a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today provided a corporate update and reported financial results for the first quarter 2014.



Apricus Biosciences, Inc. (Nasdaq:APRI)
, a pharmaceutical company focusing on the development and commercialization of novel therapeutics for men's and women's health, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application allowing the Company to initiate clinical testing of RayVa™, Apricus' product candidate for the treatment of Raynaud's phenomenon.



Argos Therapeutics, Inc. (Nasdaq:ARGS)
, a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer and infectious diseases using its Arcelis™ technology platform, today announced that the company will present updates from two research studies involving AGS-003, the company's investigational fully personalized immunotherapy for cancer, at the American Society of Clinical Oncology (ASCO) Annual Meeting being held at the McCormick Place Exhibition Center in Chicago, IllinoisMay 30June 3, 2014.



Cara Therapeutics, Inc. (Nasdaq:CARA)
, a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain by selectively targeting kappa opioid receptors, today announced financial results for the first quarter ended March 31, 2014.



Cesca Therapeutics Inc. (Nasdaq:KOOL)
, an autologous cell-based regenerative medicine company, today announced the formation of the Company's Clinical and Scientific Advisory Board ("CSAB") and the appointment of Solomon Hamburg MD, Ph.D.



KYTHERA Biopharmaceuticals, Inc. (Nasdaq:KYTH)
today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ATX-101 (deoxycholic acid) as an injectable treatment for the reduction of submental fat, which commonly presents as a double chin.



LipoScience, Inc. (Nasdaq:LPDX)
, a diagnostic company pioneering a new field of personalized nuclear magnetic resonance (NMR) diagnostics to advance the quality of patient care in cardiovascular, metabolic and other diseases, today announced its financial results for the first quarter ended March 31, 2014.



NuVasive®, Inc. (Nasdaq:NUVA)
, an innovative global medical device company that is changing spine surgery with minimally disruptive surgical products and procedurally integrated solutions for the spine, will visit the NASDAQ MarketSite in Times Square.



Onconova Therapeutics, Inc. (Nasdaq:ONTX)
, a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today provided a corporate update and reported financial results for the first quarter ended March 31, 2014.



Premier, Inc. (Nasdaq:PINC)
today reported financial results for the fiscal 2014 third quarter ended March 31, 2014.



Repros Therapeutics Inc.® (Nasdaq:RPRX)
today announced financial results for the first quarter ended March 31, 2014.



Revance Therapeutics, Inc. (Nasdaq:RVNC)
, a specialty biopharmaceutical company that develops botulinum toxin products for use in aesthetic and therapeutic indications, today announced that Mark A. Prygocki has been appointed to its Board of Directors and as the Chair of its Audit Committee, effective immediately.



Rockwell Medical, Inc. (Nasdaq:RMTI)
, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, reported results for the first quarter ended March 31, 2014.



Surgical Care Affiliates, Inc. (Nasdaq:SCAI)
today announced financial results for the first quarter ended March 31, 2014. Total net operating revenues, which exclude revenues from facilities in which SCA owns a noncontrolling interest, increased 2.1% in the first quarter of 2014 (from $192.0 million to $196.0 million).



Swisher Hygiene Inc. (Nasdaq:SWSH)
, a leading service provider of essential hygiene and sanitizing solutions, announced today first quarter results for the period ended March 31, 2014.



TG Therapeutics, Inc. (Nasdaq:TGTX)
, an innovative clinical-stage biopharmaceutical company focused on the acquisition, development, and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs, today announced its results for the first quarter ended March 31, 2014 and recent company developments.



Xenetic Biosciences, Inc. (OTCBB:XBIO)
, a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, today announced positive results from a Phase 1 clinical trial of PSA-Oxyntomodulin for the treatment of Type II Diabetes, a highly prevalent and often debilitating disorder, and obesity.



XOMA Corporation (Nasdaq:XOMA)
, a leader in the discovery and development of therapeutic antibodies, announced today Paul Rubin, the Company's Senior Vice President, Research and Development & Chief Medical Officer, is scheduled to present at the Bank of America Merrill Lynch 2014 Health Care Conference on May 14, 2014, at 3:40 p.m. PT.






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Source: BioMed Reports


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