Mylan Sues FDA Seeking Ruling On Provigil® Rights; Sanofi Colon-Cancer Drug on FDA Fast Track

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By Staff and Wire Reports   
Thursday, 05 April 2012 18:40
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 5, 2012.

Mylan Inc. (NASDAQ:MYL) announced its subsidiary, Mylan Pharmaceuticals Inc., has filed suit against the U.S. FDA in the U.S. District Court for the District of Columbia seeking to overturn a decision by FDA, which awarded Teva sole 180-day exclusivity for the generic version of its affiliate Cephalon's Provigil®.

The Complaint alleges that Teva did not maintain valid paragraph IV (PIV) certifications as a result of its acquisition of Cephalon. The Complaint states that, once Teva became the owner of Cephalon, Teva could no longer infringe its own patents through a PIV certification and that Teva therefore is not entitled to exclusivity based on patent certifications. Mylan also alleges that FDA should have found that Mylan is the sole first filer on one of the Orange Book Patents for Provigil, that Teva abandoned its abbreviated new drug application (ANDA), and that FDA should have approved Mylan's ANDA for this product. Mylan is seeking an immediate order from the Court entitling it to exclusivity and immediate approval for its ANDA.

The Complaint also alleges that FDA's decision, which blocks Mylan and other generic entrants from launching their generic Provigil products, is unlawful. Mylan believes the Federal Trade Commission did not contemplate the current outcome when it imposed its conditions on the Teva/Cephalon merger. As a result of FDA's decision, only one party--Teva/Cephalon--controlling 100% of the supply of product in the marketplace. This is despite the fact that Cephalon previously agreed to a Mylan launch of its generic product no later than April 6, 2012.

Mylan is seeking immediate equitable relief from the Court requiring FDA to approve Mylan's ANDA.


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Sanofi SA (NYSE:SNY)
U.S.-based partner Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said their experimental drug Zaltrap missed targeted goals in a late-stage clinical trial for treating prostate cancer, but that U.S. regulators are giving it a fast-track review for use in treating colon cancer.

Sanofi said the Phase III VENICE trial involving 1,226 prostate cancer patients "did not meet the pre-specified criterion of improvement in overall survival."

The French drug maker added that the U.S. Food and Drug Administration had granted a priority review to the companies to examine Zaltrap in the treatment of colon cancer. That filing is based on a late-stage study, called VELOUR, in patients with colorectal cancer, whose disease has spread to other parts of the body and who have been previously treated with an oxaliplatin-containing regimen.

A fast-track priority review is given to drugs if preliminary estimates indicate that the product, if approved, has the potential to provide a treatment where no adequate therapy exists or a it shows significant improvement compared with marketed products.

The FDA is due to give a decision on its Zaltra priority review by Aug. 4.



Also Thursday:



Advaxis, Inc., (OTCBB: ADXS)
, a leader in developing the next generation of immunotherapies for cancer and infectious diseases, announced that it has entered into a research collaboration with Professor Marianne van Hage, research group leader and Head of the Clinical Immunology and Allergy Unit and Vice Head of the Department of Medicine at Karolinska Institutet in Stockholm, Sweden.

Avita Medical Ltd. (ASX:AVH) (OTCQX:AVMXY)
, the regenerative medicine company, has been granted European patent EP1357922B1 “Cell Suspension Preparation Technique and Use” by the European Patent Office.

CONMED Corporation (NASDAQ: CNMD) announced today that it expects to report first quarter 2012 financial results before the market opens on Thursday, April 26, 2012, and will also hold a conference call live over the Internet at 10:00 a.m. Eastern Time that same day.

GenMark Diagnostics, Inc., (NASDAQ: GNMK) and Advanced Liquid Logic, Inc. (ALL) announced today that they have entered into a Heads of Agreement defining the key terms of a collaboration to develop an all-electronic, fully integrated in-vitro diagnostic platform bringing together ALL’s proprietary electrowetting technology and GenMark’s proprietary electrochemical detection.

HP (NYSE: HPQ)
today announced it is helping medical professionals and organizations meet their business technology needs through a collaboration with the American Medical Association (AMA), the nation's largest physician organization.

Intuitive Surgical, Inc. (NASDAQ: ISRG)
, the leader in operative surgical robotics, will hold its quarterly conference call to discuss First Quarter 2012 results, Tuesday, April 17, at 4:30 p.m. Eastern Time.

Medgenics, Inc. (NYSE Amex: MDGN and AIM: MEDU, MEDG)
(the “Company”), the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announces that all resolutions proposed at the Company’s Annual Meeting of Stockholders held yesterday were duly passed.

Rite Aid Corporation (NYSE: RAD) today announced sales results for March.

Spectrum Pharmaceuticals (NasdaqGS: SPPI)
, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that the two double blind, randomized, placebo controlled, Phase 3 clinical trials for apaziquone did not meet their primary endpoint of a statistically significant difference in the rate of tumor recurrence at 2 years between the two arms.

Spectrum Pharmaceuticals (NASDAQ: SPPI)
and Allos Therapeutics, Inc. (NASDAQ: ALTH) today announced that they have signed a definitive agreement under which Spectrum will acquire all of the outstanding shares of Allos for $1.82 per share in cash plus one Contingent Value Right (CVR).

Sucampo Pharmaceuticals, Inc. (NASDAQ: SCMP) today announced positive top-line results from an open-label phase 3 clinical trial designed to evaluate the long-term safety and efficacy of lubiprostone in opioid-induced bowel dysfunction (OBD) patients with chronic, non-cancer-related pain.

Taro Pharmaceutical Industries Ltd. (NYSE: TARO)
(“Taro,” or the “Company”), today announced that in view of the unusual market activity in the Company’s stock, the New York Stock Exchange (“NYSE”) has contacted the Company in accordance with its usual practice.

Tonix Pharmaceuticals Holding Corp. (OTCBB:TNXP)
(“TONIX” or the “Company”), a specialty pharmaceutical company developing therapies for challenging disorders of the central nervous system (“CNS”) completed a pharmacokinetic (PK) study of the first formulation of its lead drug, TNX-102, for the treatment of fibromyalgia syndrome (“FM”).

Waters Corporation (NYSE:WAT) will webcast its Q1 2012 financial results conference call live on Tuesday, April 24th at 8:30 a.m. eastern time.

Zalicus Inc. (NASDAQ: ZLCS) today announced the publication of new preclinical data in Molecular Cancer Therapeutics, a Journal published by the American Association for Cancer Research.



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