Oramed Granted Key Patent From Japanese Patent Office; Mylan Launches First Generic Version of Zovirax® Ointment Print E-mail
By Staff and Wire Reports   
Wednesday, 03 April 2013 19:53
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 3, 2013.

Oramed Pharmaceuticals (NASDAQ: ORMP)
, a developer of oral drug delivery systems, announced it has received approval for a key patent by the Japanese Patent Office. The patent, titled "Methods and Compositions for Oral Administrations of Proteins," covers a core concept of the company's technology. The patent has also been approved in Israel and Australia. Oramed's portfolio now consists of seven issued patents and 28 patents pending.

According to a report by the European Federation of Pharmaceutical Industries and Associations, Japan constitutes 12% of the global sales of new medicines launched in the period from 2006 to 2010.

Nadav Kidron, CEO of Oramed, commented, "We are very excited to add the Japanese patent to our international portfolio. The Japanese patent approval represents a great success in further establishing the global standing of Oramed's innovative oral delivery technology."


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Mylan Inc. (Nasdaq: MYL)
announced its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Acyclovir Ointment USP, 5%. This product is the first generic version of Valeant International's Zovirax® Ointment, which is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients.

Acyclovir Ointment USP, 5% had U.S. sales of approximately $230 million for the 12 months ending Dec. 31, 2012, according to IMS Health (RX). Mylan is shipping this product immediately.

Currently, Mylan has 178 ANDAs pending FDA approval representing $78.4 billion in annual sales, according to IMS Health.  Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $20.3 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.



Also Wednesday:



Antares Pharma, Inc. (NASDAQ: ATRS)
today announced the first shipment of commercial-ready VIBEX™ auto-injector devices to Teva at the end of the first quarter 2013.

Celgene Corporation (NASDAQ: CELG)
senior management will host a conference call and live audio webcast on Thursday, April 25, 2013 at 9 a.m. ET to discuss the company’s first quarter 2013 financial and operational results.

Cytomedix, Inc. (OTCQX: CMXI)
, a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, today announced the appointment of Steven A. Shallcross, CPA, as Executive Vice President, Chief Financial Officer, Secretary and Treasurer, effective as of May 10, 2013.

DARA BioSciences, Inc. (NASDAQ: DARA)
, a specialty pharmaceutical company focused on oncology and oncology supportive care products, announced today that it has signed an agreement with Prime Therapeutics Specialty Pharmacy LLC for distribution of its two lead proprietary products, Gelclair® (oral bioadhesive gel) for patients with oral mucositis and Soltamox® (tamoxifen citrate) oral solution to treat breast cancer patients.

Diagnostic Imaging International Corp. (OTCQB:DIIG)
announced today that it has filed its 2012 10-K report and provided an update on its financial results for 2012.

The Board of Elan Corporation, plc (NYSE:ELN) (the Company) welcomes this morning's imposition by the Irish Takeover Panel of an expected May 10, 2013 deadline on Royalty Management LLC (Royalty Pharma) (following their original indication of interest announcement of February 25, 2013) by which Royalty Pharma must either announce an offer for Elan under Rule 2.5 of the Irish Takeover Rules or announce that it will not proceed with an offer for Elan.

Entia Biosciences (OTCQB: ERGO)
, a food science biotechnology company and emerging leader in the field of Nutrigenomics, has now received three Patent Notices of Allowance covering the use of Ergothioneine and its genetic transporter in the treatment of a wide variety of diseases, including those affecting the immune and central nervous systems.

Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT)
today commented on the results of the meeting of the Company`s stockholders held on March 28, 2013.

Impax Laboratories, Inc. (NASDAQ: IPXL)
announced today that the Company will release its first quarter 2013 financial results on Wednesday, May 1, 2013, after the close of the U.S. financial markets.

Ingen Technologies, Inc.'s (PINKSHEETS: IGNT)
is pleased to announce that on April 1, 2013, Ingen and ATMC Inc. have executed the "Letter of Intent" to merge the two companies. Ingen has moved forward to acquire ATMC Inc.

La Jolla Pharmaceutical Company (OTCBB: LJPC)
("La Jolla"), a leader in the development of therapeutics targeting galectin proteins, announced today that its common stock started quotation on the OTC Bulletin Board ("OTCBB").

MDxHealth SA (EURONEXT BRUSSELS: MDXH)
, a leading molecular diagnostic company that develops and commercializes epigenetic tests to support cancer treatment, today announced the publication of the clinical utility of epigenetic diagnosis to improve the management of prostate cancer.

Mylan Inc. (Nasdaq: MYL)
today announced that its subsidiary Mylan Pharmaceuticals has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Acyclovir Ointment USP, 5%.

Obagi Medical Products, Inc. (NASDAQ: OMPI)
today announced that Obagi and Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) have executed an amendment to their Agreement and Plan of Merger, dated March 19, 2013.

OrganovoHoldings, Inc. (OTCQX: ONVO)
("Organovo"), a three-dimensional biology company focused on delivering breakthrough 3D bioprinting technology, announced today that the Company's Board of Directors has approved a fiscal year-end change from December 31st to March 31st, beginning on March 31, 2013.

Quture International, Inc. (OTCQB: QUTR)
announced today that real-time clinical data was recently collected for approximately 800 perioperative patients at the University of Miami/Jackson Memorial Hospital (UoM).

PAREXEL International Corporation (NASDAQ: PRXL)
will release financial results for the Third Quarter of Fiscal Year 2013 on Tuesday, April 30, 2013 after the close of the stock market.  

PE INTERNATIONAL, a global sustainability software and services firm, today announced it has been selected by Kimberly-Clark (NYSE: KMB) to help manage their corporate-wide sustainability initiatives.

Perceptive Informatics, a leading eClinical solutions provider and a subsidiary of PAREXEL International Corporation (NASDAQ: PRXL), today released an enhanced version of its comprehensive IMPACT® clinical trial management system (CTMS).

Quture International, Inc. (OTCQB: QUTR)
announced today that real-time clinical data was recently collected for approximately 800 perioperative patients at the University of Miami/Jackson Memorial Hospital (UoM).

Bioassociate has released valuation coverage on RedHill Biopharma, Ltd. (NASDAQ: RDHL) (TASE:RDHL.TA).  

Rosetta Genomics Ltd. (NASDAQ: ROSG)
, a leading developer and provider of microRNA-based molecular diagnostics, announces that two posters related to the Company's microRNA-based diagnostic assays will be featured at the American Association for Cancer Research (AACR) Annual Meeting 2013, to be held April 6-10 at the Walter E. Washington Convention Center in Washington, D.C.

Thermo Fisher Scientific Inc. (NYSE: TMO)
, the world leader in serving science, announced that it will release its financial results for the first quarter 2013 before the market opens on Wednesday, April 24, 2013, and will hold a conference call on the same day at 8:30 a.m. EDT.

ZELTIQ® Aesthetics, Inc. (Nasdaq: ZLTQ)
, a medical technology company focused on developing and commercializing products utilizing its proprietary controlled-cooling technology platform, today announced CoolSculpting, its non-surgical, clinically proven procedure designed to selectively reduce fat in treated areas using a patented cooling technology, will be featured in several podium presentations and e-posters at the American Society for Laser Medicine and Surgery annual conference (ASLMS) in Boston, April 3-7, 2013.



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