Teva Provides Update on COPAXONE® Litigation; Gentium Receives Positive Opinion for Defitelio Print E-mail
By Staff and Wire Reports   
Friday, 26 July 2013 19:10
Below is a look at some of the headlines for companies that made news in the healthcare sector on July 26, 2013.

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced the U.S. Court of Appeals for the Federal Circuit has affirmed the judgment of the U.S. District Court for the Southern District of New York in the appeal filed by Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals regarding the validity and infringement of four patents for Teva's relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE® (glatiramer acetate injection) that expire in May 2014. The appellate court, however, reversed the trial court and declared other patents expiring in May 2014 and one patent expiring in September 2015 to be invalid. The appellate court specifically ruled that asserted claims of these patents are invalid for being indefinite.

Teva Pharmaceuticals Ltd. filed suit against Momenta Pharmaceuticals Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals for infringement of multiple patents covering the chemical composition of COPAXONE®, methods of using the product and processes for manufacturing the product, the latest of which expires on September 1, 2015. Today's decision maintains exclusivity for COPAXONE® until May 24, 2014.

Teva is disappointed with the court's decision with respect to four of the 2014 patents and the 2015 patent and will appeal today's decision. Importantly, any purported generic version of COPAXONE® needs to obtain the Food and Drug Administration's (FDA's) approval prior to being made available to the public. At this point, it is unclear what the requirements would be for approval of complex synthetic peptides.

Given the complexity of COPAXONE®, Teva believes unpredictable differences between a proposed generic product and COPAXONE® could lead to immunogenic effects in patients. The inability to fully characterize the active ingredients of the product leads many experts to believe that the only way to ensure the safety, efficacy and immunogenicity of any purported generic version of COPAXONE® would be through full-scale, placebo-controlled clinical trials with measured clinical endpoints (such as relapse rate) in RRMS patients.


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Gentium S.p.A. (Nasdaq: GENT) announced following its request for re-examination, the European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted a positive opinion for Defitelio recommending a Marketing Authorization Application ("MAA") under exceptional circumstances, for the treatment of severe hepatic veno-occlusive disease ("VOD") in adults and children undergoing hematopoietic stem cell transplantation therapy.

The European Commission ("EC") will review the positive opinion from the CHMP, as they have the authority to grant marketing authorization. The EC generally follows the recommendations of the CHMP and delivers its final decision within three months, which will be applicable to all European Union (EU) countries. Upon approval, each member state will then determine the individual country price and the level of reimbursement.

Dr. Khalid Islam, Chairman and Chief Executive Officer of Gentium S.p.A., welcomed the decision saying "We are delighted for this positive recommendation for Defitelio. This outcome from the CHMP meeting is an important milestone for the Company and represents the culmination of a great deal of work by many people. If approved, Defitelio would become the first drug for VOD in the current treatment setting. We look forward to the ratification of the CHMP recommendation by the European Commission."

Dr. Paul Richardson, RJ Corman Professor Of Medicine, Harvard Medical School, Clinical Director of the Jerome Lipper Multiple Myeloma Center, Dana Farber Cancer Institute, Boston, MA (USA) and principal investigator stated, "We believe that Defitelio will represent a very important therapeutic option for patients undergoing hematopoietic stem-cell transplantation. It provides a potentially life-saving treatment for severe VOD, a complication with both a very high mortality rate and for which there are no other approved therapies."

Dr. Alejandro Madrigal, President of the European Group for Blood and Morrow Transplantation ("EBMT"), the largest professional body in field of Hematopoietic Stem Cell transplantation, said "The EBMT guidelines, prepared by over 30 leading experts, recommend Defitelio as a therapy proven to be of value in the treatment of severe VOD. The EBMT considers that the published evidence of efficacy and safety, and also the extensive clinical experience, support the value of Defitelio in the treatment of VOD."



Also Friday:



ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP), an emerging biopharmaceutical company, will host an investor call to update investors on recent company developments.

Align Technology, Inc. (NASDAQ: ALGN)
today provided an update regarding the International Trade Commission (ITC) release issued on July 25, 2013 stating that it has decided to review the Administrative Law Judge (ALJ) Rogers' final Initial Determination (ID), which was issued back on May 6, 2013.

CytoSorbents Corporation (OTCBB: CTSO)
, a critical care focused company working to save lives through blood purification, announced that it has been selected to make a presentation of its HemoDefend™ blood purification technology at the Military Health System Research Symposium (MHSRS), the premier U.S. scientific meeting focused on medical advances that address the unique medical needs of the warfighter.

EnteroMedics Inc. (NASDAQ: ETRM)
, the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that it will host a conference call on Wednesday, July 31, 2013 at 11:00 AM Eastern Time to discuss financial results for the second quarter ended June 30, 2013 and to provide a business update.

Gentium S.p.A. (Nasdaq:GENT)
announced that today, Friday, July 26, 2013, it will provide update on Defibrotide Marketing Authorization and hold a conference call and live webcast at 8:00 a.m. US ET / 14:00 p.m. CET.

In the summer of 2000, INSCOR, Inc.'s (PINKSHEETS: IOGA) new CEO, Kenny Andam, was sprinting in the Sydney Summer Olympics for his homeland, the Republic of Ghana.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND)
announced that the U.S. Food and Drug Administration (FDA) has granted orphan-drug designation for its proprietary Captisol-enabled™ Topiramate Injection for the treatment of partial onset or primary generalized tonic-clonic seizures in hospitalized epilepsy patients who are unable to take oral topiramate.

Liberator Medical Holdings, Inc. (OTCQB: LBMH) today announced that on July 18, 2013 Morgan Duke resigned from the board of directors.

Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) partner GlaxoSmithKline (NYSE: GSK) announced that today, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorization for GSK’s REVOLADE™ (eltrombopag) as a treatment for low platelet counts (thrombocytopenia) in adult patients with chronic hepatitis C infection, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy.

Lipocine, Inc. (OTCBB:MBARD)
, a specialty pharmaceutical company, announced today that it has entered into securities purchase agreements with gross proceeds of $38.0 million for the issuance and sale of approximately 6.3 million shares of its common stock at $6.00 per share to institutional investors.

Novus International, Inc. and Verenium Corporation (Nasdaq: VRNM) today announced the name of their new phytase enzyme product, CIBENZA® PHYTAVERSE™.

Orexigen® Therapeutics, Inc. (Nasdaq: OREX)
, a biopharmaceutical company focused on the treatment of obesity, will announce financial results for the second quarter ended June 30, 2013, on Tuesday, August 6, 2013 after the markets close.

OxySure Systems, Inc. (OTCQB: OXYS)
, based in Frisco, Texas, manufactures and markets the FDA-approved OxySure Model 615, a low cost, lightweight portable catalytic oxygen generator for medical emergency use.

Nova Mining Corporation
announced today that effective as of the opening of business on Friday, July 26, 2013 the Company's name has been changed to The Radiant Creations Group, Inc. trading under the symbol (OTCBB: RCGP), to more clearly reflect the nature of its business operation.

PDI, Inc. (Nasdaq: PDII)
today announced that it will release its second quarter 2013 financial results on Monday, August 5, 2013 after the market close and host a conference call beginning at 4:30 pm Eastern time to discuss the results.

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 that the underwriters have exercised in full their option to purchase an additional 855,000 shares of common stock.



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