Biogen wins EU backing for big new MS drug hope
March 22nd, 2013 by admin

By Ben Hirschler

LONDON | Fri Mar 22, 2013 12:02pm EDT

(Reuters) – European regulators have recommended approval of two new multiple sclerosis pills from Biogen Idec and Sanofi, both of which are expected to become major sellers.

Friday’s decision by the European Medicines Agency (EMA) was particularly significant for Biogen, since the U.S. biotech company is still awaiting a verdict on Tecfidera, or BG-12, in the United States.

Shares in Biogen, which have more than trebled in the last three years on rising hopes for Tecfidera, hit a new all-time high of $178.66 on Friday and stood 1 percent up on the day by 11.40 a.m. ET.

Tecfidera is one of the most highly anticipated new drug approvals for the pharmaceuticals industry in 2013, with analysts predicting billions of dollars a year in sales.

It will compete in the oral MS drug market against Novartis’s existing Gilenya and Aubagio, but many investors already see it as best in class.

“We believe Tecfidera will raise expectations for what people living with MS can achieve with their therapy,” Biogen CEO George Scangos said in a statement welcoming the news.

Oral drugs are changing the MS market dramatically, by offering patients a highly effective alternative to traditional injections, which can be painful and may cause flu-like symptoms.

Tecfidera and Sanofi’s Aubagio were both endorsed for treating relapsing remitting multiple sclerosis (MS), though the EMA decision still needs to be finalized before the drugs can be launched.

Aubagio was approved by the U.S. Food and Drug Administration (FDA) for the same use in September, while an FDA decision on the Biogen product is due by March 28.

Mark Schoenebaum, an analyst with ISI Group, said the European decision on Tecfidera was reassuring since the EMA only flagged up two safety issues.

The agency’s press release merely highlighted as side effects flushing, or redness of the skin, and gastrointestinal events, such as diarrhea and nausea.


The London-based agency also gave a green light to Gilead Sciences’s four-drug combination pill to treat HIV/AIDS, called Stribild. Gilead shares rose 2 percent.

The flurry of positive recommendations for new medicines, each of which analysts believe will become multibillion-dollar-a-year sellers, underscores a recent pick-up in research productivity by the pharmaceutical industry.

Sales of the Biogen MS drug are expected to reach $3.0 billion a year by 2017, outstripping revenues by the same time of $2.5 billion for Gilenya and $1.1 billion for Aubagio, according to consensus forecasts compiled by Thomson Reuters Pharma.

Tecfidera will add an important new leg to Biogen’s multiple sclerosis business, which already includes the injectable drugs Avonex and Tysabri.

Ariad Pharmaceuticals also won a recommendation for its drug Iclusig for chronic myeloid leukemia, while Baxter International and Halozyme Therapeutics secured EMA backing for HyQvia as a treatment for immunodeficiencies, lifting their stock 1 percent and 15 percent respectively.


Bayer and Johnson & Johnson, which together sell the anti-clotting drug Xarelto, had something to cheer about as well, with the EMA recommending the medicine for treating acute coronary syndrome (ACS).

That decision was in contrast to the position adopted by the FDA, which denied approval to expand use of Xarelto to reduce the risk of heart attacks and strokes in ACS patients earlier this month.

Deutsche Bank analysts said the EU stance was “an incremental positive” that would provide a modest uplift to peak sales forecasts.

Patients with ACS have suffered blood clots blocking blood supply to the heart.

Recommendations for marketing approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, are normally endorsed by the European Commission within a couple of months.

(Editing by Elaine Hardcastle)