Generic versions of Copaxone hit roadblock
NEW YORK Efforts by two generic drug makers to market a generic version of a drug for multiple sclerosis hit an obstacle this week in a U.S. District Court.
The U.S. District Court for the Southern District of New York denied a motion for summary judgment filed by Sandoz and Momenta Pharmaceuticals that patents covering Teva Pharmaceutical Industries’ drug Copaxone (glatiramer acetate) are invalid due to indefiniteness.
“Teva is very pleased with today’s decision, which reaffirms our belief that the patents are valid and enforceable,” Teva corporate VP and chief legal officer Richard Egosi said. “We remain committed to vigorously defending Copaxone [intellectual property] rights against infringement wherever they are challenged.”
The court has yet to set a trial date. The patents covering Copaxone are set to expire in 2014, according to Food and Drug Administration records.
Perrigo gets approval for generic Aldara
ALLEGAN, Mich. The Food and Drug Administration has approved Perrigo’s generic drug for treating skin diseases, the drug maker said Wednesday.
The FDA approved Perrigo’s imiquimod cream in the 5% strength. The drug is a generic version of Graceway Pharmaceuticals’ Aldara.
The drug is used to treat actinic keratoses on the face and scalp, superficial basal cell carcinoma and external genital and perianal warts in patients ages 12 years and older.
GSK inks deal with Lonza, announces CFO’s exit
LONDON Swiss drug maker Lonza will help British drug maker GlaxoSmithKline manufacture five biotech drugs in early- and mid-stage clinical trials, the two companies said Wednesday.
Lonza will manufacture clinical trial batches of the drugs, all monoclonal antibodies in phase-1 and phase-2 testing, and provide additional access to manufacturing capacity so GSK can fulfill future demands. The two companies said other details of the agreement remain confidential.
“We believe this is a critical step in the ongoing and future success of GSK in biopharmaceuticals,” GSK head of biopharmaceutical research and development Ian Tomlinson said.
Tomlinson said the company’s goal was to have a biopharmaceutical portfolio that consistently exceeded 20% of its research and development pipeline by 2015.
In other news, the company said that CFO and executive director Julian Heslop would retire at the end of March 2011. Goldman Sachs executive Simon Dingemans will be appointed CFO designate and executive director in January.