Teva Cites BG-12 Safety in Asking FDA to Add MS Reviews

Teva Pharmaceutical Industries Ltd. (TEVA) asked U.S. regulators for more scrutiny before they approve any new multiple sclerosis drugs as it tries to block Biogen Idec Inc. (BIIB)s BG-12 oral treatment from entering the market.

Teva, whose best-selling Copaxone injection controls about 40 percent of the MS market, requested that the U.S. Food and Drug Administration seek expert advice from the Peripheral and Central Nervous System Advisory Committee prior to clearing a treatment for the illness, according to a filing Dec. 31 on the U.S. governments Citizen Petition website.

Safety issues with approved drugs, such as Biogens older treatment Tysabri and Novartis AG (NOVN)s Gilenya, show that the FDA must ensure that the risks and benefits of the drug are thoroughly evaluated, Teva said. In addition, Biogen recently posted some troubling information about the safety and effectiveness of Panoplin capsules, also known as BG-12, suggesting risks for renal adverse events.

For now, Teva is playing defense against BG-12, said Asthika Goonewardene, a Bloomberg Industries pharmaceutical analyst in London. BG-12 is a direct threat to Tevas market share. Any delay, be it for an AdCom panel or merely administrative, is a big deal for Teva.

A lag to the approval of the BG-12 pill would be a boon for Petach Tikva, Israel-based Teva, which depends on Copaxone for about 20 percent of sales. Teva, which boosted the treatments price by 9.9 percent this year, is seeking to preserve sales of its main brand to allow time for Chief Executive Officer Jeremy Levin to bring in new products as he revamps the worlds largest maker of generic drugs.

Teva rose 1.1 percent to 145.5 shekels at 4:26 p.m. in Tel Aviv. That pared the stocks decline in the past 12 months to 15 percent.

This is Tevas fifth Copaxone-related petition, with every filing taking on a new element against competitors experimental drugs. While Tevas last four petitions targeted generics for Copaxone, which loses its last patent protection in 2015, the new petition focuses on novel drugs. The FDA plans to decide on BG-12 this year.

BG-12 has been studied in more than 2,600 patients and we have the utmost confidence in the FDA, and other regulators for that matter, to objectively evaluate a new treatment, Kate Niazi-Sai, a spokeswoman for Weston, Massachusetts-based Biogen, said by telephone. Safety for BG-12 has been favorable, and in well-controlled human trials the overall incidence of renal events were similar between placebo and BG-12 treated patients.

To contact the reporter on this story: David Wainer in Tel Aviv at dwainer3@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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Teva Cites BG-12 Safety in Asking FDA to Add MS Reviews