Watson Pharma Sues FDA On Delay Of Generic Version Of Actos; Bristol-Myers Announces Patient Management Programs For Sprycel Print E-mail
By Staff and Wire Reports   
Wednesday, 15 August 2012 17:54
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 15, 2012.

Watson Pharmaceuticals Inc. (NYSE:WPI)
has filed suit against the U.S. FDA challenging the Agency's decision relating to Watson's entitlement to shared exclusivity for its generic version of Actos. Because of FDA's decision, Watson's abbreviated new drug application or ANDA could be delayed for up to six months. Watson said it filed suit after communications with FDA regarding its ANDA failed to resolve the dispute and permit a timely launch.

Watson maintains that FDA improperly denied the company's shared exclusivity despite the company directly following directions received from FDA concerning its Paragraph IV certification to certain patents at the time of its 2003 ANDA filing. Watson's suit would argue that the company properly filed paragraph IV certifications to certain patents for Actos listed in the FDA Orange Book in its original 2003 ANDA filing.

The FDA denied Watson's claim of shared exclusivity based on the timing of Watson's reinstatement of several of its original PIV patent certifications, which the company previously converted from a PIV to a section VIII at FDA's direction, and then reinstated back to a PIV patent certification following the settlement of patent litigation.

Watson planned to introduce its generic version of Actos on August 17, 2012, as per a settlement deal on March 10, 2010 with Takeda Pharmaceutical Company Limited and Takeda Pharmaceuticals North America. According to pre-Medicare Modernization Act Hatch Waxman rules, Watson believes it is entitled to share in the 180 day period of generic marketing exclusivity.


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Bristol-Myers Squibb Company (NYSE: BMY)
and Otsuka America Pharmaceutical, Inc. announced the launch of patient management programs for Sprycel^® (dasatinib) patients with a select group of specialty pharmacy providers.

The specialty pharmacies include Accredo, CuraScript, Diplomat, Biologics and Avella (formerly The Apothecary Shops). The distribution of Sprycel will remain open to other specialty and retail pharmacies.



Also Wednesday:



3SBio Inc. (NASDAQ: SSRX)
, a leading China-based biotechnology company focused on researching, developing, manufacturing and marketing biopharmaceutical products, today announced its unaudited financial results for the second quarter and first half ended June 30, 2012.

Aeterna Zentaris Inc. (NASDAQ:  AEZS) (TSX: AEZ)
, today reported financial and operating results as at and for the second quarter ended June 30, 2012.

Applied DNA Sciences, Inc. (OTCBB: APDN)
, (Twitter: @APDN), a provider of DNA-based anti-counterfeiting technology and product authentication solutions, announced its financial results for the third fiscal quarter ending June 30, 2012, generating revenues of $528,574.

Cambrex Corporation (NYSE: CBM)
announced that it has entered into an agreement to supply an active pharmaceutical ingredient for a customer's Phase 3 program during 2013 and 2014.  Under this non-exclusive supply arrangement, Cambrex will manufacture and deliver Phase 3 and pre-launch quantities of this product candidate.

China Cord Blood Corporation (NYSE: CO)
, the first and largest cord blood banking operator in China, and Cordlife Group Limited (CLGL.SP) ("Cordlife"), a cord blood and tissue banking service provider listed on the Singapore Exchange Securities Trading Limited ("SGX-ST"), are fostering a close strategic partnership to offer umbilical cord blood storage services for expectant parents across Asia.  

Delcath Systems, Inc. (NASDAQ: DCTH)
announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration seeking approval for the Company's proprietary chemosaturation system for use with melphalan hydrochloride in the treatment of patients with unresectable metastatic melanoma in the liver.

Ingen Technologies, Inc. (PINKSHEETS: IGNT)
, an emerging medical device manufacturer with proprietary medical products for the growing $4 billion respiratory markets, announced today that the company has signed a Letter of Intent to acquire SomaLife Consulting LLC.

iSatori, Inc. (OTCQB: IFIT) (OTCBB: IFIT)
, a leader in the development and marketing of scientifically engineered nutritional supplements, announced its second quarter and first half calendar 2012 financial results.

Merus Labs International Inc.("Merus" or the "Company") (TSX:MSL) (NASDAQ:MSLI)
is pleased to announce today its financial results for the third quarter of fiscal 2012. The results from the third quarter of fiscal 2012, for both revenue and earnings, were in line with management's expectations.

MMRGlobal, Inc. (OTCBB: MMRF)
("MMR" or the "Company"), a leading provider of Personal Health Records (PHRs), MyEsafeDepositBox storage solutions and electronic document management and imaging systems for healthcare professionals, today announced that it has filed its quarterly report on Form 10-Q for the period ended June 30, 2012 with the United States Securities and Exchange Commission.

Myrexis, Inc. (NASDAQ: MYRX)
announced today that Richard B. Brewer, 61, its Chief Executive Officer and Board member, has died after a long battle with multiple myeloma, a type of blood cancer.

Omeros Corporation (NASDAQ: OMER)
today announced that it has identified compounds that functionally interact with each of five additional orphan G protein-coupled receptors (GPCRs).

Organovo Holdings, Inc. (OTCQB: ONVO) ("Organovo") a three-dimensional biology company focused on delivering breakthrough 3-D bioprinting technology, today reported unaudited financial results for the period ended June 30, 2012.

Raney & Associates, strategist and project manager of outsourced service providers to create proactive alternative investor relation solutions for US listed PRC and global SMEs and ADRs, announced today that it has secured the first contract since the launch of its ProAltIRâ„¢ solutions with China Forestry Inc. (OTCBB: CHFY), a Chinese forest plantation investor, landscape nursery operator and distributor of landscape plants and trees.

Sinovac Biotech Ltd. (NASDAQ: SVA)
, a leading provider of biopharmaceutical products in China, announced today its unaudited second quarter financial results for the period ended June 30, 2012.

Trovagene, Inc. (Nasdaq:  TROV)
, a developer of transrenal molecular diagnostics, today reported its financial results for the three and six months ended June 30, 2012.

University General Health System, Inc. (OTCQB: UGHS) (PINKSHEETS: UGHS)
, a diversified, integrated multi-specialty health delivery system, today announced significantly improved operating results for the second quarter and first half of 2012.



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