While several Massachusetts biotechs have been tripped up by US regulators in recent weeks, Europe has been providing a more welcoming environment for drug makers.
European authorities Friday cleared the way for Cambridge’s Biogen Idec Inc. to enjoy a decade of patent protection on its multiple sclerosis pill Tecfidera. At the same time, they recommended continued use in Europe of the potent leukemia drug Iclusig — developed by Ariad Pharmaceuticals Inc. — even though the Cambridge company has been forced to suspend sales in the United States because of safety concerns.
Investors on this side of the Atlantic were cheered by the news. Shares of Biogen Idec climbed $33.19 to $285.62, a gain of 13.1 percent on the Nasdaq exchange Friday, while Ariad’s pummeled stock rose 99 cents to $3.78, a 35.5 percent gain.
Friday’s actions by the European Medicine Agency’s Committee for Medicinal Products for Human Use, an influential regulatory committee that makes recommendations to the European Commission on prescription medicines, underscore what some analysts say has become a more independent, if not laissez-faire, attitude among overseas regulators.
“The European Union in recent years has given the green light sooner than the FDA for some new drugs,” said Kevin Gorman, chairman emeritus of life sciences consulting firm Putnam Associates in Burlington. “In the US, they may be more risk averse. They don’t want to be hauled before a congressional committee if something they approved turns out to have dangerous side effects. They don’t have quite the same equivalent in the EU system.”
European regulators were first to approve Lemtrada, a multiple sclerosis pill developed by Cambridge-based Genzyme, which is owned by French pharmaceutical giant Sanofi SA. Genzyme’s bid to market Lemtrada in the United States is now before the Food and Drug Administration. But a recent FDA staff report warned of toxic side effects, and a medical advisory panel last week sent mixed signals about whether the drug should be sold here.
By contrast, Tecfidera, the Biogen Idec pill, was approved for US sale by the FDA in March. Demand has exceeded analysts’ expectations in the US market, which is still viewed by drug makers as the most attractive place to sell because they find it easier to charge higher prices to recoup their research and development outlays. Unlike their US counterparts, regulators in Europe focus not only on the effectiveness and safety of new medicines, but on keeping costs down.
“Even if the clinical bar is the same, you have to prove cost effectiveness in Europe or you can’t get past the system,” said Harry Glorikian, managing partner at Scientia Advisors, a life sciences consulting firm in Cambridge.
Biogen Idec’s approval in Europe was delayed in May while it sought increased market protection for Tecfidera. On Friday, the European advisory committee ruled one of the drug’s ingredients, dimethyl fumarate, qualified as an active substance. That means rivals cannot use it to produce cheaper generic drugs for 10 years. The company has equivalent protection in the United States.
“This is a great day for MS patients,” said Biogen Idec chief medical officer Al Sandrock, contending the patent protection would enable the company to generate enough cash to accelerate its drug development. “We want to keep investing in MS. We have a very deep pipeline for MS, but patients need better therapies. Until we get a cure, we’re not going to stop.”
The European advisory committee’s vote of support for Ariad's drug, Iclusig, came with a caveat that it not be given to patients who have had heart attacks or strokes unless doctors determined the potential benefits outweighed risks. Blood clots and heart-related side effects were responsible for sidelining the drug in the United States last month, forcing Ariad to eliminate 160 jobs, or 40 percent of its staff, to conserve cash.
Ariad executives are currently negotiating with FDA officials about revising the warning label for Iclusig so it can return to the US market — most likely for a smaller population of patients.
Both of the European votes are expected to be ratified by the European Commission, the executive body of the European Union, which signs off on drug recommendations.