Antares Announce FDA Acceptance of NDA for OTREXUP; Mylan to Acquire Agila Print E-mail
By Staff and Wire Reports   
Wednesday, 27 February 2013 19:57
Below is a look at some of the headlines for companies that made news in the healthcare sector on February 27, 2013

Antares Pharma, Inc. (NASDAQ: ATRS)
announced that the New Drug Application (NDA) for OTREXUP™, a potential new product for the subcutaneous delivery of methotrexate (MTX) using Medi-Jet™ technology, has been accepted by the U.S. FDA indicating that the application is sufficiently complete to permit a substantive review. OTREXUP is being developed for self-administration of MTX to enhance the treatment of rheumatoid arthritis (RA), poly-articular-course juvenile RA and psoriasis.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of October 14, 2013, ten months from the official NDA filing. The PDUFA date is the target date for the FDA to complete its review of the NDA.

“The FDA's acceptance of the OTREXUP NDA is an important start to the review process and a significant milestone for our shareholders,” said Paul K. Wotton Ph.D., President and Chief Executive Officer. “We look forward to working closely with the FDA during their review of the application.”


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Mylan Inc. (Nasdaq: MYL)
announced it has signed a definitive agreement to acquire Agila Specialties Private Limited, a developer, manufacturer and marketer of high-quality generic injectable products, from Strides Arcolab Limited (BSE: 532531, NSE: STAR) for $1.6 billion in cash. The acquisition of Agila will create a global injectables leader, significantly expanding and strengthening Mylan's global injectables platform and providing Mylan entry into new high-growth geographic markets. The acquisition is expected to be immediately accretive to Mylan's adjusted diluted earnings per share following closing. The transaction is expected to close in the fourth quarter of 2013, subject to regulatory approvals and certain closing conditions.

Mylan CEO Heather Bresch commented, "The addition of Agila to our existing injectables platform will immediately create a new, powerful global leader in this fast-growing, attractive market segment and accelerate our target of becoming a top-three global player in injectables. Further, the acquisition of this unique asset delivers on several of Mylan's strategic growth drivers by further expanding and diversifying our product portfolio and geographic reach, strengthening our presence in the institutional channel, and positioning us to maximize our generic biologics portfolio. Agila's broad product portfolio and pipeline, which is very complementary to Mylan's, is the result of best-in-class research and development and an industry-leading track record of securing product approvals. Importantly, Agila will bring us one of the most state-of-the-art, high quality injectables manufacturing platforms in the industry. Our significantly expanded manufacturing capacity will allow us to vertically integrate our injectables platform and fast-track our ability to pursue additional product opportunities and partnerships to facilitate long-term growth. We are excited to welcome the Agila employees to our growing global team and anticipate a seamless and rapid integration of the Agila business."

Agila, headquartered in Bangalore, India, will bring Mylan a broad product portfolio of more than 300 filings approved globally and marketed through a network covering 70 countries, including 61 abbreviated new drug applications (ANDAs) approved by the U.S. Food and Drug Administration (FDA). Agila has a global pipeline of approximately 350 filings pending approval, including 122 ANDAs pending FDA approval. Agila's research and development and regulatory track record are reflected in its industry-leading number of approvals and fast approval timeframes. The company currently produces products across nine high-quality manufacturing facilities in India, Brazil and Poland, eight of which have been approved by the FDA. Agila's manufacturing capabilities include vials, pre-filled syringes, ampoules, lyophilization, cytotoxics, and antibiotics. Agila's manufacturing base represents one of the largest steriles capacity in India and one of the largest lyophilization capacities in the world. In addition to its established presence in developed markets, Agila has a strong position in high-growth emerging markets, including Brazil.

Agila's capabilities complement Mylan's existing injectables platform of more than 500 products marketed globally, including 55 ANDAs, and its high quality sterile manufacturing facilities in Ireland and India.



Also Wednesday:



AbbVie (NYSE: ABBV)
will present at the Barclays Global Health Care Conference on Wednesday, March 13, 2013.

BioSpecifics Technologies Corp. (NASDAQ: BSTC)
, a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S., announced today that BioSpecifics' President, Tom Wegman, will present at the following upcoming investor conferences.

Cerus Corporation (NASDAQ:CERS)
announced today that William “Obi” Greenman, president and chief executive officer, is scheduled to present a corporate update at the Cowen and Company 33rd Annual Health Care Conference in Boston at 9:20 AM ET on Wednesday, March 6, 2013.

EnteroMedics Inc., (NASDAQ: ETRM)
, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced the closing of its previously announced public offering of 13,770,000 shares of its common stock and warrants to purchase 5,508,000 shares of its common stock.

ExamWorks Group, Inc. (NYSE: EXAM)
, a leading provider of independent medical examinations ("IMEs"), peer reviews, bill reviews and related services, today reported financial results for the fourth quarter and the full year of 2012.

Hansen Medical, Inc. (NASDAQ: HNSN)
, a global leader in intravascular robotics, today reported recent business highlights and financial results for the full year and fourth quarter ended December 31, 2012.

Insulet Corporation (NASDAQ: PODD)
, the leader in tubeless insulin pump technology with its OmniPod® Insulin Management System, today announced financial results for the fourth quarter and full year ended December 31, 2012.

Bioassociate has initiated coverage on KaloBios Pharmaceuticals, Inc. (NASDAQ: KBIO).  

M*Modal, a leading provider of clinical documentation services and Speech Understanding™ solutions, today announced it has expanded its strategic relationship with imaging leader Merge Healthcare (NASDAQ: MRGE) to an extensive reseller partnership.

mPhase Technologies, Inc. (OTCBB: XDSL)
announced today that on the heels of filing a US letter patent application for automatic dispensing of preset dosages for a drug delivery system that the Nanodermatology Society declared 2013 the year of Topical Delivery.

Neurocrine Biosciences, Inc. (Nasdaq: NBIX)
announced today that Tim Coughlin, Chief Financial Officer of Neurocrine Biosciences, will be presenting at the Cowen and Company 33rd Annual Health Care Conference in Boston.  

Onyx Pharmaceuticals, Inc. (NASDAQ: ONXX)
will host an Analyst Day on Thursday, March 14, 2013, from 8:30 a.m. to 11:30 a.m. ET (5:30 a.m. to 8:30 a.m. PT).

The Board of Directors of Optimer Pharmaceuticals (NASDAQ: OPTR) (the "Company" or "Optimer") today announced the appointment of its Chairman, Dr. Henry McKinnell, as Chief Executive Officer.

Sangamo BioSciences, Inc. (Nasdaq: SGMO)
announced today that Geoff Nichol, M.B., Ch.B., Sangamo's executive vice president, research and development, will provide an update on the progress of Sangamo's ZFP Therapeutic®development programs and an overview of the company's business strategy at 10:40 am ET on Wednesday, March 6, 2013, at the 33rd Annual Cowen and Company Health Care Conference which will be held in Boston.

Synergetics USA, Inc. (NASDAQ: SURG)
announced today that it will host a conference call on Wednesday, March 13, 2013 at 9:30 a.m. Central Time (10:30 a.m. Eastern) to review the Company's results for the fiscal second quarter ended January 31, 2013.

TelVue® Corporation (PINKSHEETS: TEVE)
, the innovation leader in Television and Internet Broadcasting for communities, cable operators, and media companies, today launched The Rutgers Channel on Roku®, the most popular Internet-powered TV set top box on the market today.

Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT)
, a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, today announced financial results for the three and twelve months ended December 31, 2012.

Viratech Corp. (PINKSHEETS: VIRA)
, the first open source biotech research social network platform, announced today that it has published its e-Book on open source biotech research.

ViroPharma Incorporated (Nasdaq: VPHM) reported today its financial results for the fourth quarter and year ended December 31, 2012.



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