Drug Makers Seek Antiobesity Blockbuster
By JASON DOUGLAS
July 29, 2008; Page D2
LONDON -- A handful of drug companies are testing new ways to treat obesity after years of research into the condition have failed to produce a blockbuster for big pharma.
These firms are hoping their drugs, most of which are at midstage phase II trials, will prove more successful. But after the disappointments of the past, investors remain cautious and are demanding data robust enough to convince them and the world's regulators that the drugs have what it takes to safely and effectively fight the flab.
The stakes are high. According to World Health Organization figures from 2005, there are 1.6 billion overweight adults in the world and at least 400 million who are classified as obese. That is forecast to rise to 2.3 billion overweight and 700 million obese by 2015.
"There's a huge market there," said Gareth Powell, manager of London-based Polar Capital Partners' Healthcare Opportunities fund.
Drugs to treat obesity have been around since early in the 20th century, but none have become true blockbusters. Figures from IMS Health show the handful of approved antiobesity medications posted combined world-wide sales of $1.76 billion in the 12 months to the end of the second quarter this year. That is tiny by pharmaceutical standards.
"The basic answer is we don't have the right benefit-to-risk ratio with any of the products on the marketplace," said Mads Krogsgaard Thomsen, chief science officer of Denmark's Novo Nordisk AS. In June, Novo Nordisk reported results from a phase II trial that found 75% of patients on its drug liraglutide lost more than 5% of their weight.
Another drug, Amylin Pharmaceuticals Inc.'s combination of pramlintide, also for diabetes, and metreleptin, an analogue of a hormone, reduced body weight on average 12.7% in a phase II study of 177 patients last year. The U.K.'s Alizyme PLC is developing Cetilistat, a drug that prevents the absorption of fat in a similar way to Roche Holding AG's Xenical. It too showed a statistically significant weight loss in a phase II trial, but fewer of the side effects seen with the Roche drug, the company said.
Arena Pharmaceuticals Inc. is recruiting about 7,000 patients into three phase III trials to test its antiobesity agent, lorcaserin, while Denmark's NeuroSearch AS is developing tesofensine. But all of these companies -- and they are not the only ones with products in the clinic -- have yet to convince physicians and investors that their drugs will do much better financially than previous weight-loss drugs.
Only three drugs have been approved for long-term use in the U.S.: Wyeth's Redux, pulled off the market in 1997 after being linked to heart-valve problems; Abbott Laboratories' Meridia, sales of which don't meet Abbott's threshold for publishing figures; and Roche's Xenical, which despite a roaring start has failed to reach blockbuster sales, a failure blamed on its embarrassing gastrointestinal side effects. Acomplia, a weight-loss pill from France's Sanofi-Aventis SA, was refused marketing approval by the U.S. Food and Drug Administration in 2007 after reports of psychiatric side effects including suicidal feelings among users. It is approved in Europe.
Side effects might still be an issue for some of the new agents being tested. Arena's lorcaserin targets a receptor in the brain that is also affected by fenfluramine, a drug withdrawn in 1997 after being linked to heart-valve damage. NeuroSearch reported a slight increase in heart rate and blood pressure among some patients in its tesofensine trials, though it said these effects weren't clinically significant, and Arena said its drug is far more selective than fenfluramine and won't cause the same cardiovascular effects. That has so far been backed up by an independent review board, which has scrutinized data from patients in the first of its trials, the company said.
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