Friday, March 22 12:49:47
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.
Today's decision by the European Medicines Agency 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.
Tecfidera and Sanofi's Aubagio were both endorsed for treating relapsing remitting multiple sclerosis (MS). Aubagio was approved by the U.S. Food and Drug Administration for the same use in September.
The London-based agency also gave a green light to Gilead Sciences's four-drug combination pill to treat HIV/AIDS, called Stribild, and recommended wider use of Bayer and Johnson & Johnson's anti-clotting drug Xarelto for treating acute coronary syndromes.
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.
Biogen's Tecfidera is one of the most highly anticipated approvals of 2013. 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.
Sales of the Biogen product 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.
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.