With $4 billion of Copaxone revenue on the line, it's no surprise to find Teva ($TEVA) waving a red flag to the FDA as Biogen Idec ($BIIB) gets down to the regulatory wire with its closely watched competitor BG-12. The big generics company--which has been beefing up the R&D side of the branded business under new CEO Jeremy Levin--filed a petition with the FDA demanding an advisory committee meeting to inspect what it has called potentially "serious safety risks."
After accusing Biogen Idec of posting "unlawful, pre-approval promotion of an unapproved drug product" on the web, Teva adds that the big biotech also revealed a possible Achilles' heel, tearing into data pointing to renal toxicity signs found in animal studies.
The citation: "Kidney changes were observed after repeated oral administration of dimethyl fumarate in mice, rats, dogs, and monkeys. Renal tubule epithelia regeneration, suggestive of tubule epithelial injury, was observed in all species. Renal tubular hyperplasia was observed in rats with life time dosing (2 year study). Cortical atrophy was observed in dogs and monkeys, and in monkeys, single cell necrosis and interstitial fibroses were observed in animals that received daily oral doses of dimethyl fumarate for 12 months at six times the RHD based on AUC."
Many of the big MS drugs have presented serious safety threats, says Teva's Michael Nicholas, helpfully pointing to Biogen's Tysabri. So "the need for a preapproval advisory committee meeting is particularly acute for new drugs products containing active ingredients that have not previously been approved in the United States."
Teva is playing an end game with Copaxone, boosting prices and revenue as it faces a 2015 patent expiration. So a delay on BG-12, for any reason, could be worth a fortune.
For its part, Biogen is largely shrugging off the affair. Just days ago CEO George Scangos acknowledged the chatter about safety. But with analysts projecting blockbuster revenue and top status for BG-12 in the therapeutic area, he didn't sound very concerned. "We're very confident in the safety," he said at J.P. Morgan, according to a Dow Jones report. "I kind of take it as a compliment that the competition is worried about BG-12."
- here's the Dow Jones story