Just days ahead of a big-time FDA decision on its oral multiple sclerosis pill, Biogen Idec grabbed the endorsement of a European Union authority for approval of Tecfidera as a first-line therapy. Biogen ($BIIB) was among a crew of biopharma outfits to gain positive opinions from the key EU committee, including one for Sanofi's ($SNY) rival oral MS drug Aubagio.
The biotech world is abuzz about the highly anticipated FDA decision for Biogen's Tecfidera (f.k.a. BG-12), which many analysts expect to become the top seller among a blockbuster slate of new oral MS therapies. Arguably, Weston, MA-based Biogen hasn't faced a regulatory decision as important as this since the agency's approval of Tysabri in 2004. And with the recommendation from the EU's Committee for Medicinal Products for Human Use (CHMP), the biotech heavyweight can expect a regulatory decision from the European Commission in the coming months.
If approved as expected, Tecfidera would follow Novartis' ($NVS) Gilenya and Sanofi's Aubagio onto the growing market for MS pills. However, the safety and efficacy profile of the Biogen pill have raised expectations that the drug could take the top spot in this class, and a poll of analyst estimates from Bloomberg puts annual sales of the product at $3.25 billion by 2017, which would build on Biogen's dominance in the MS market with existing treatments Avonex and Tysabri, for which the company bought full rights from Elan to solidity its hold on the franchise.
Yet Novartis and Sanofi, whose Genzyme unit handles its MS franchise, have blockbuster ambitions of their own. As Reuters reported, annual sales of Gilenya and Aubagio could reach $2.5 billion and $1.1 billion respectively by 2017, according to analyst forecasts. The lofty projections reflect the anticipated demand from MS patients and their doctors preferring the convenience of pills over injected drugs that dominate the market today.
Aside from the action from CHMP on the MS front, the committee handed down several positive opinions on therapies with major market expectations.
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Gilead Sciences ($GILD) snagged a nod from the committee for its four-drug combo therapy for HIV, Stribild, which the FDA approved last year and is a crown jewel in the Foster City, CA-based biopharma powerhouse's world-leading HIV franchise.
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Ariad Pharmaceuticals ($ARIA) grabbed the committee's endorsement for approval of Iclusig (ponatinib) for patients with forms of chronic myeloid leukemia and acute lymphoblastic leukemia. The company, which operates main offices in Cambridge, MA, and Lausanne, Switzerland, has blockbuster ambitions for the targeted drug, which the FDA approved in December for patients with the rare leukemias.
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Johnson & Johnson ($JNJ) and partner Bayer also scored a positive opinion from CHMP for expanding the use of their next-gen clot-buster Xarelto in treating patients with acute coronary syndromes.
- here's the Biogen release
- and the Sanofi/Genzyme release
- read Gilead's release
- get Ariad's release
- check out Bloomberg's article
- and Reuters' report