By Peter Loftus Of DOW JONES NEWSWIRES Big drug makers will likely continue to steer clear of weight-loss drugs as long as regulatory and commercial hurdles remain in place, and despite the market potential, industry executives said Tuesday. Several drug companies have tried and failed to bring successful new antiobesity drugs to market in recent years, including large drug makers like Sanofi-Aventis SA (SNY) and Merck & Co. (MRK). Recently, U.S. regulators prompted Abbott Laboratories (ABT) to withdraw diet drug Meridia from the market due to safety concerns, and they have declined to approve experimental drugs developed by tiny drug makers Arena Pharmaceuticals Inc. (ARNA) and Vivus Inc. (VVUS) partly for safety-related reasons. Roche Holding AG (RHHBY) has decided not to pursue obesity drugs because of clinical setbacks and disappointments in the marketplace, Anders Svensson, head of metabolism clinical development, said at a Cleveland Clinic conference focusing on obesity and diabetes. "I think a lot of other companies are thinking the same way, that pure obesity and weight reduction is probably not that attractive of an area," Svensson said during a panel discussion about diet drugs. Sanofi-Aventis Chief Executive Chris Viehbacher called the rising incidence of obesity "the greatest health-care challenge" because it leads to serious diseases such as diabetes and hypertension. But he isn't convinced drug makers have the answer. "I don't think right now we have the regulatory environment or risk-benefit environment to foster development of obesity drugs," he said before an audience at the conference. "It's quite a graveyard," he said of past efforts to bring new diet drugs to market. Sanofi's own rimonabant is one of the corpses. It was once viewed as a potential blockbuster in the middle of the last decade, but it was never approved in the U.S. and was pulled from the European market on safety concerns. Some experts think drug makers will have to demonstrate that antiobesity drugs not only help people lose weight but also can produce solid health outcomes, such as reducing the risk of diabetes, to sway drug regulators. Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic, said regulators shouldn't focus on the magnitude of weight loss a drug can trigger but rather on its health benefits. He also thinks programs that control patient access to diet drugs could make them more palatable to regulators. Another potential spur to new diet-drug development could be an extension of market exclusivity periods for drugs that treat certain serious unmet medical needs, Nissen said, which would require action by Congress. Vivus is still hopeful it can gain Food and Drug Administration approval next year after submitting new information about its pill, Qnexa, said President Peter Tam. The company has proposed to conduct a post-approval study testing the drug's effects on health outcomes, he said. Vivus has put off finding a large pharmaceutical partner to help commercialize the drug. Arena has partnered with Eisai Co. (ESALY) for its drug, while another small diet-drug developer, Orexigen Therapeutics Inc. (OREX), has partnered with Takeda Pharmaceutical Co. (4502.TO), for its experimental drug, which is still under FDA review. Meanwhile, one prospect for a new antiobesity weapon lies in a new diabetes drug, Victoza from Novo Nordisk A/S (NVO). The company is conducting late-stage studies of Victoza as an antiobesity agent. "I see use of Victoza ultimately for obesity with complications," said Alan Moses, Novo's chief medical officer. -Peter Loftus, Dow Jones Newswires; +1-215-656-8289; peter.loftus@dowjones.com
