Market Overview

UPDATE: Teva Provides Update on COPAXONE® Litigation

Share:
Related TEVA
Teva Announces Positive Results for TEV-48125 in Phase IIb Chronic Migraine Study Meeting Primary and Secondary Endpoints
Stocks Hitting 52-Week Highs
FDA imposes limits on testosterone drugs and labeling changes to warn of potential heart risks (Seeking Alpha)

Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced that 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.

About Teva Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's leading generic drug maker, with a global product portfolio of more than 1,000 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $20.3 billion in net revenues in 2012.

Indication COPAXONE® (glatiramer acetate injection) is indicated for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (RRMS), including patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis.

Posted-In: News FDA

 

Related Articles (TEVA)

Around the Web, We're Loving...

Get Benzinga's Newsletters