Teva Pharmaceutical Industries ($TEVA) is very proud of its multiple sclerosis drug Copaxone. And no wonder: The injectable treatment, one of the company's few branded products, brought in almost $3 billion in 2011, with a forecast for 2012 of almost $4 billion. That's a hefty chunk of the company's overall sales, and analysts have estimated its share of the company's profits at upwards of 40%.
Thing is, Copaxone goes off patent in 2015. And in the meantime, it's facing new competition, including oral treatments that are obviously easier to use than Copaxone injections. Because of that competition, the company expects 2013 sales to drop at least slightly from 2012 levels. So, Teva has been fighting tooth and nail to fend off competition--first from proposed generics, and now, from new branded rivals.
Perhaps, then, it should come as no surprise that the Israeli company has petitioned the FDA, demanding that all prospective MS treatments be subject to review by the agency's expert advisors. Patient safety is at stake, Teva says. After all, safety questions have cropped up for marketed MS drugs such as Biogen Idec's ($BIIB) Tysabri and Novartis' ($NVS) Gilenya.
It's no accident that the petition comes as Biogen's new pill, BG-12, comes ever closer to FDA approval. That product poses a threat to Copaxone that's potentially bigger than competition from Gilenya or Sanofi's ($SNY) new Aubagio pill. According to Teva's petition, BG-12 "may be associated with other serious safety risks," including kidney problems.
Teva's Denise Bradley told Dow Jones that the the company wants to make sure "that appropriate safeguards are implemented to maintain an acceptable risk-benefit profit" for any new MS treatment.
At least one analyst, RBC's Michael Yee, figures Teva's petition won't delay BG-12's market debut. And Biogen CEO George Scangos told the news service, "We're very confident in the safety. I kind of take it as a compliment that the competition is worried about BG-12."
Drugmakers have been petitioning the FDA at an increasing rate in recent months, as generic competition looms for some of their biggest products. Companies have cited everything from bioequivalence testing questions to pill design in their attempts to delay cheaper rivals.
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