teva pharmaceutical-sp adr (TEVA) Key Developments
Teva Pharmaceutical Industries Ltd. and Active Biotech Announce First Patient Enrolled in Phase II Study Evaluating Laquinimod for Primary Progressive MS
Apr 23 15
Teva Pharmaceutical Industries Ltd. and Active Biotech announced the first patient has been enrolled in the study ARandomized Placebo-controlled Trial Evaluating Laquinimod in PPMS, Gauging Gradations In MRI and Clinical Outcomes, a Phase II study to evaluate laquinimod, an investigational, oral, immune modulator, for the treatment of primary progressive multiple sclerosis. Currently there are no approved treatments for PPMS, representing a condition with a high unmet need. PPMS affects approximately 15% of all MS patients and is characterized by the worsening of neurologic function without distinct relapses. Unlike patients with relapsing-remitting MS, those with PPMS tend to have more lesions in the spinal cord than in the brain and these brain lesions usually contain fewer inflammatory cells. In addition, all studies evaluating RRMS treatments in patients with PPMS have failed to prove effective for this condition. ARPEGGIO is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study of once-daily, oral laquinimod in patients with PPMS. The study’s primary endpoint is percent brain volume change through MRI analysis. The trial will enroll approximately 375 patients in the U.S., Canada, and Europe. Additional details on the study design will be presented at the AAN Annual Meeting in Washington, D.C. on April 23, 2015 during Poster Session 7.
Teva Pharmaceutical Industries Limited Announces New 36-Month Data from the Placebo-Controlled and Open-Label Extension Phases of the Glatiramer Acetate
Apr 23 15
Teva Pharmaceutical Industries Limited announced new 36-month data from the placebo-controlled and open-label extension phases of the Glatiramer Acetate Low-frequency Administration (GALA) study evaluating the efficacy and safety of three-times-a-week COPAXONE (glatiramer acetate injection) 40 mg/mL in patients with relapsing forms of multiple sclerosis. The study compared early start (ES) patients (n=834) who received three-times-a-week COPAXONE 40 mg/mL for 36 months versus delayed start (DS) patients (n=419), who started COPAXONE after the 12-month placebo-controlled phase of the trial. The data show the adjusted mean annualized relapse rate was significantly lower for ES over 36 months (0.23 vs 0.30, risk ratio RR =0.770; P=0.0052). In addition, early treatment with three-times-a-week COPAXONE 40 mg/mL resulted in a sustained reduction in lesion activity and the evolution of active lesions to chronic black holes. Adverse events observed in the trial were consistent with the established COPAXONE 40 mg/mL safety profile.
Teva Pharmaceutical Industries to Pay $512 Million in Settlement over Generic Provigil
Apr 20 15
Teva Pharmaceutical Industries announced that it will pay $512 million to resolve lawsuits accusing its Cephalon division of making illegal payments that kept cheaper generic versions of its sleep disorder drug Provigil off the market, boosting Cephalon's sales. The class action lawsuit dates to 2006, five years before Teva bought Cephalon. Teva said it is pleased with the terms of settlement but had no further comment because other litigation is pending. The company set aside $495 million in 2013 to cover potential settlements. Provigil is used to treat tiredness caused by narcolepsy, obstructive sleep apnea, and changes in work schedule. In 2005 and 2006, Cephalon struck deals with four generic drug companies that resolved lawsuits challenging Provigil's patent protection. Cephalon made payments to the companies, which dropped their challenges, and said they could start selling generic versions of the drug in 2011 or 2012.
Federal Circuit Upholds Mylan's U.S. Patents on Perforomist Inhalation Solution Which Prevents Approval of Teva Anda
Apr 17 15
Mylan N.V. announced the United States Court of Appeals for the Federal Circuit upheld the validity and infringement of all four patents asserted by Mylan Specialty, L.P. protecting its Perforomist (formoterol fumarate) Inhalation Solution. The Court summarily affirmed the previous decision by the district court against Teva. The decision prevents Teva from receiving final approval of its ANDA from the U.S. Food and Drug Administration (FDA) prior to expiration of U.S. Patent Nos. 6,667,344; 6,814,953; 7,348,362; and 7,462,645. Those patents cover Perforomist until they expire in June 2021.
VIVUS, Inc. Files Lawsuit Against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd for Infringement of Qsymia Patents
Apr 15 15
VIVUS, Inc. announced that it has filed a lawsuit in the U.S. District Court for the District of New Jersey against Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd., collectively referred to as Teva. The lawsuit was filed in response to an Abbreviated New Drug Application, or ANDA, filed by Teva. In its application, Teva seeks to market and sell generic versions of the currently approved doses of Qsymia (phentermine and topiramate extended-release) capsules CIV prior to the expiration of U.S. Patents 7,056,890, 7,553,818, 7,659,256, 7,674,776, 8,580,298, 8,580,299, 8,895,057 and 8,895,058, which are listed in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. VIVUS filed the lawsuit on the basis that Teva's proposed generic products infringe each of these patents held by VIVUS.