Teva Petitions FDA To Delay Biogen MS Drug

In the latest gambit by a drugmaker to derail a looming competitive threat, Teva Pharmaceuticals recently filed a citizen’s petition to ask the FDA not to approve a forthcoming multiple sclerosis treatment from Biogen Idec without first holding an advisory committee meeting. For those who may not recall, Teva sells Copaxone, an injectable medicine that accounts for roughly 20 percent of revenue. This explains why the Israeli drugmaker – which is best known for selling generics, but wants to build a bigger brand-name business – is worried about Biogen and its BG-12 pill, which Wall Street thinks will be a blockbuster. In an investor note today, Leerink Swann analyst Marko Kozul looks for $3.2 billion in sales by 2017. In its petition, Teva (TEVA) tells the FDA there is “troubling information” on a publicly accessible website about the safety of BG-12 that showed that kidney changes were seen after mice, rats, dogs and monkeys were given repeated dosages. Teva suggests “there is a substantial probability the risk is applicable to humans as well” (here is the petition). Biogen has previously noted that in late-stage trials, adverse renal events were comparable among all study groups (see this). One such trial showed that 21 percent of patients taking a placebo experienced kidney problems, compared with 22 percent of patients taking BG-12 twice a day and 25 percent of patients taking BG-12 three times a day, a Biogen spokeswoman tells Re...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized Biogen Idec Gilenya MS Multiple Sclerosis Novartis Teva Pharmaceuticals Tysabri Source Type: blogs