Tests dash insomnia drug development

Tests dash insomnia drug development

	Published : Wed, 28 Mar 2007 21:10 By : Agencies Print this Story

TRENTON, N.J. (AP) - Merck & Co. and its Danish partner, pharmaceutical company H. Lundbeck A/S, are putting to rest development of an insomnia drug that was in the final human testing stage after studies found safety problems, including hallucinations.

The companies said Wednesday they have stopped testing the drug, known by the chemical name gaboxadol, after a three-year partnership. Whitehouse Station, N.J.-based Merck and Copenhagen-based Lundbeck had planned this summer to apply for U.S. regulatory approval to sell the drug, which likely would have been the first of a new class of sleeping pills.

Anders Gersel Pedersen, Lundbeck's head of drug development, told The Associated Press about a half-dozen tests had shown gaboxadol met goals of inducing deep sleep and leaving patients rested in the morning. Recent tests found problems, though.

Pedersen said one study found limited effectiveness at low doses; another found it waned over time. A third, conducted on drug addicts taking high doses of gaboxadol -- required by the U.S. Food and Drug Administration because of the risk of addiction with sleeping pills -- found side effects were more common and more severe than in a comparison drug.

Those effects included hallucinations, agitation and dissociation from reality, he said. A handful of regular patients in another study slightly exceeded the regular dose and had the same problems.

Wall Street showed limited reaction to the news, with shares down 33 cents at $43.32 in afternoon trading on the New York Stock Exchange.

Analysts didn't see gaboxadol as a blockbuster, anticipating a 2008 launch and annual sales of $250 million to $575 million by 2011.

'While this presents a clear setback to Merck's late-stage pipeline, the company has other compounds in obesity, cardiovascular health and HIV that should provide revenue growth in the near term,' A.G. Edwards analyst Joseph Tooley wrote in a research note.

James Kelly, a Goldman Sachs analyst, wrote in a research note that Merck's long-range forecasts require significant contributions from drugs in development.

Merck is still committed to its long-term profit forecast, spokeswoman Amy Rose said.

Peter S. Kim, president of Merck Research Laboratories, said Merck is still committed to research in neuroscience and sleep disorders, one of its nine priority areas.

The company halted development of two other drugs late in testing in November 2003, one for diabetes and the other for depression.

Merck sells Singulair for allergies and asthma, Fosamax for osteoporosis and, with Schering-Plough Corp., cholesterol drugs Vytorin and Zetia. The company, which had 2006 sales of $22.6 billion, is beset by more than 27,000 product liability lawsuits over its withdrawn painkiller Vioxx.

Lundbeck makes drugs for central nervous system disorders and has four medicines -- one each for Alzheimer's, Parkinson's disease, schizophrenia and depression -- on sale in other countries. In the United States, its antidepressant is sold as Lexapro under a licensing deal.

Lundbeck had revenues of $1.6 billion last year.