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Biogen’s Tecfidera Approved as Expected; Launch in ‘Days’

By Jennifer Boggs
Managing Editor

Just days after winning a thumbs-up from the European Committee for Medicinal Products for Human Use, Biogen Idec Inc.’s much-lauded Tecfidera  (dimethyl fumarate) was approved by the FDA, and analysts have said the drug has a good shot going up against the two oral multiple sclerosis (MS) therapies already on the market.

The Weston, Mass.-based biotech said it expects to have the oral capsule available to patients with relapsing forms of MS “in the coming days.” Pricing has not yet been released, but analysts are expecting Tecfidera to cost between $50,000 and $60,000 annually, with most estimates on the lower end.

RBC Capital analyst Michael Yee expects a price tag of $50,000 to $55,000, to give it a pricing advantage over the tougher competitor, Novartis AG’s Gilenya (fingolimod), which costs about $58,000 per year, but higher than the $45,000 for Sanofi SA’s Aubagio (teriflunomide), which was saddled with a black box warning when approved last fall. (See BioWorld Today, Sept. 14, 2012.)

“We believe this in an attractive level of pricing given Tecfidera’s combined efficacy and safety profile,” Yee wrote.

The approval application, submitted last year, was based on data from two Phase III studies – DEFINE and CONFIRM – showing that twice-daily Tecfidera (formerly called BG-12) reduced the annualized relapse rate and cut disability progression. (See BioWorld Today, April 12, 2011.)

Its safety profile, however, might prove the biggest advantage for the immune modulator. The FDA did not disclose detailed labeling Wednesday, though ISI Group analyst Mark Schoenebaum said he’d seen the label and wrote in a research note that it was relatively clean, with “no black box or onerous monitoring requirements,” seeing the requirement to monitor white blood cell counts, which Tecfidera has been shown to decrease in some patients, as a “yawn.”

The most common side effects associated with Tecfidera are flushing and gastrointestinal events.

Shares of Biogen (NASDAQ:BIIB) gained $5.59 Wednesday to close at $182.69, though approval of Tecfidera had been close to a foregone conclusion by the street. As Cowen and Co. analyst Eric Schmidt said in a January research note, “Tecfidera is one thing we do not worry about.”

Wall Street also saw a positive omen in the fact that the FDA declined to schedule an advisory committee meeting to discuss Tecfidera’s risk/benefit profile, despite public pressure from MS competitor Teva Pharmaceutical Industries Ltd. The Jerusalem-based big pharma, which markets Copaxone (glatiramer acetate), had filed citizen petitions seeking an advisory meeting for Biogen’s drug. (See BioWorld Today, Jan. 11, 2013.

Tecfidera, along with Gilenya and Aubagio, are expected to cut into sales of the current MS blockbusters – Copaxone, Avonex (interferon beta-1a, Biogen), Betaseron (beta interferon 1b, Bayer AG), Copaxone (glatiramer acetate, Teva Pharmaceuticals Inc.) and Rebif (interferon-beta-1a, Merck Serono) ‑ though how quickly the oral therapies gain market share remains to be seen.

In a research note on Teva, analyst Shibani Malhotra, of RBC Capital Markets, said he will “wait to see the pick up in the market and how quickly and robustly doctors and patients adopt Tecfidera” to determine the impact on Copaxone sales.

Overall, analysts are projecting a successful launch for Tecfidera, with the drug estimated to pull in about $330 million in revenue for 2013.

The drug marks the latest addition to Biogen’s MS franchise, which includes Avonex. It pulled in sales of $2.9 billion for 2012. The company recently reported positive data from a pivotal study of pegylated version of Avonex, which would offer patients more convenient dosing. (See BioWorld Today, Jan. 25, 2013.)

Biogen also has Tysabri (natalizumab), which recorded 2012 sales of $1.6 billion.