Teva files citizen petition over Copaxone
JERUSALEM — Teva Pharmaceutical Industries has filed a citizen petition with the Food and Drug Administration, hoping to keep purported generic versions of its multiple sclerosis treatment off the market, the company said Sunday.
Teva said its petition, concerning the drug Copaxone (glatiramer acetate), is based on what it called the inability to establish acceptable “sameness” due to the active ingredient’s complexity.
Similar to Sanofi-Aventis’ blood-thinning drug Lovenox (enoxaparin), the FDA approved Copaxone as a pharmaceutical drug, but its chemical complexity has led many analysts to say it should be considered more akin to a biotech drug.
Teva said it urged the FDA to require any follow-on version of the drug to undergo preclinical testing and clinical trials before winning approval, as follow-on biologics already must do.
Shire attempts to block generic Intuniv
DUBLIN — Drug maker Shire has filed a patent infringement suit against Watson Pharmaceuticals and Impax Labs in response to their attempt to win approval from the Food and Drug Administration for a generic version of a Shire drug.
Shire announced that it had filed the suit in the U.S. District Court for the Northern District of California following the two generic drug makers’ filing of an approval application for guanfacine hydrochloride, a version of Shire’s Intuniv, used to treat hypertension.
Shire alleged that the filing infringes on three patents covering Intuniv, the last of which expires in July 2022, according to the FDA. Intuniv’s regulatory exclusivity period runs through September 2012.
Genzyme (again) turns down Sanofi-Aventis
CAMBRIDGE, Mass. — Biotech company Genzyme still is saying “no thanks” to French drug maker Sanofi-Aventis’ tender offer of $18.5 billion, or $69 per share, to acquire it, saying the offer “substantially undervalues” the company.
The offer has been extended until Jan. 11, Genzyme said.
Sanofi has sought to buy Genzyme since August. Genzyme, based in Cambridge, Mass., specializes in treatments for rare genetic disorders, such as Fabry disease and Gaucher disease.