Biogen's Tecfidera expected to hit the MS market running

In a big bang for Biogen Idec's ($BIIB) pocketbook, the FDA gave its final blessing to the much-anticipated multiple sclerosis pill Tecfidera. It's the third oral MS treatment to hit a market long limited to injectable drugs. But Biogen believes--and many analysts agree--that Tecfidera can surpass its oral competitors, and quickly.

Few details about the launch are available yet. Even the price is under wraps till next week. But as Biogen spokeswoman Monique da Silva points out, the company already has a strong foundation in MS, with its IV treatment Tysabri and self-injected Avonex. "Our sales structure is definitely in place," da Silva says.

That sales force will be in for an intense period of training. Reps will need to be educated about Tecfidera's final FDA label, which recommends testing for white blood cell count before treatment begins and annually thereafter. And then there's the study data that supported Tecfidera's FDA approval. "We want to ensure that everyone talking about the product understands the data behind it very clearly," da Silva says.

That's because the data on Tecfidera--and its "excellent" FDA label, according to one analyst--give it an advantage over its oral competitors. Sanofi's ($SNY) new MS pill Aubagio carries a black-box warning about an increased risk of liver problems. The first pill to market, Novartis' ($NVS) Gilenya, carries new safety recommendations against use in patients with heart disease. On the efficacy side, Gilenya cut patients' relapse rate by about 54% in trials, the New York Times points out, while Tecfidera reduced that rate by 44% in one trial and 53% in another. Aubagio reduced the frequency of relapses by about 30%, the NYT states.

"Tecfidera is the third oral on the market, but an important advance, because it has strong efficacy in a broad range of patients with favorable safety and tolerability," da Silva says. "And that's a great choice for patients."

So, with strong efficacy and a better safety profile, Tecfidera could capture as much as 20% of the MS market in its first year, Cowen & Co. analyst Eric Schmidt figures. In fact, some patients have been waiting around for Tecfidera approval, so they can start therapy with the new drug. "We expect a solid launch of Tecfidera, and our sense is that there is a bolus of patients in the queue ready to transition to therapy," J.P. Morgan's Geoff Meacham said in a note to investors (as quoted by Reuters).

The near-term sales estimates are quite impressive, even at the low end of the range. Sanford Bernstein's Geoffrey Porges figures Tecfidera will bring in $1.7 billion by 2015 and $2.6 billion by 2017. Marko Kozul of Leerink Swann is more bullish, with global sales at around $4 billion by 2018. According to EvaluatePharma, the consensus estimate is $3.8 billion.

- see the release from Biogen
- get more from the FDA
- read the NYT article
- check out the Reuters news
- find the Bloomberg piece

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