EU patent call sets stage for Tecfidera launch in Europe

Biogen Idec's ($BIIB) new multiple sclerosis drug Tecfidera has been tearing it up in the U.S., stealing market share from competitors and outperforming analyst forecasts. But the company has yet to launch the drug in the EU, even though it has been recommended for approval there. It wanted to get all of its patent protections firmly in place before it did. The European Medicines Agency (EMA) Friday granted the drug just what Biogen has been waiting for--a "new active substance" (NAS) designation, paving the way to even greater sales for the hot product.

The drug already had patent protection in the EU through 2028 at a 480 mg dose, but the NAS label gives it data protection, securing a decade of regulatory exclusivity from generics. "We are heartened by the CHMP's NAS determination, which brings us closer to our goal of providing this important new treatment to multiple sclerosis (MS) patients in Europe," said Douglas Williams, executive vice president of R&D at Biogen Idec. "We are ready to introduce Tefidera in EU countries shortly after anticipated approval."

Biogen had been working with regulators in Europe to secure the NAS label. As Reuters pointed out, without today's designation, it would have had to rely on less potent patent protections there that analysts believed would have made it vulnerable to generics in some markets. Now, it can launch the drug there with the full protection it was waiting for.

It will compete in the EU against Sanofi's ($SNY) Aubagio and Novartis' ($NVS) Gilenya, but if it mirrors its U.S. results, they will not pose a big hurdle. In the U.S., Tecfidera already has a reported 13% of the market share, compared with 12.3% for those two combined. It also does not have the liver and heart-rate concerns that have plagued those two drugs, respectively. While the drug was priced in the U.S. at $54,900 per patient per year, a Biogen executive recently indicated it may be priced at half that in Europe, where price controls have given drugmakers less pricing power.

Released in the U.S. in April, Tecfidera's third-quarter sales reached $286 million, well beyond the $205 million or so that analysts forecast. That was up from $192 million in the second quarter. The third-quarter sales pushed the company's net profit up 22% to $488 million from $398 million last year. They also helped Biogen raise its outlook, and the company now predicts $8.65 to $8.85 a share rather than the $8.25 to $8.50 a share it announced in July. Biogen expects revenue growth of 23% to 25% for the year.

- here's the Biogen release
- more from Reuters

Special Report: Top 15 Drug Launch Superstars - Tecfidera

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