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Somaxon Makes Big Entry Into Competitive Arena

San Diego-based Somaxon Pharmaceuticals Inc. didn’t waste any time putting its recently raised $65 million in venture capital financing to use.

The San Diego-based specialty pharmaceutical company announced June 9 it started enrolling patients in a late-stage trial to test Silenor, an experimental insomnia drug it licensed from Dr. Neil Kavey of the New York’s Columbia Presbyterian Medical Center in August 2003.

Ken Cohen, Somaxon’s president and chief executive officer, declined to comment on the terms of licensing deal. He also didn’t give details on the study design and protocol.

“When the results are available, (then) we will discuss the study,” Cohen said.

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Cohen expects to release his first study findings next spring and complete other late-stage trials in the middle or third quarter of 2006.

If the findings are good, Cohen said he’ll file for Silenor’s marketing approval with the Food and Drug Administration by the end of 2006, with a possible launch planned for 2007.

Silenor’s active ingredient doxepin is already approved under the brand names Adapin and Sinequan for treating depression.

Doxepin can cause difficulty sleeping, according to drugs.com, which provides online information on drugs.

Cohen said that Somaxon tests Silenor in lower dosages than being used in the anti-depressants.

He also said that compared to many existing insomnia drugs, doxepin doesn’t have addictive or abusive properties, which would give Silenor an advantage on the marketplace.

In previous two mid-stage trials, one in adults and one in elderly patients, Silenor helped people stay asleep throughout the night and sleep longer, he said.

Insomnia affects more than 70 million Americans with two-thirds of adults aged 55 to 84 reporting sleep problems a few more nights a week, according to the National Sleep Foundation’s Sleep in America Poll, Somaxon said.

Cohen puts the current market opportunity for insomnia drugs at about $2.5 billion, with a growth curve.

Adam Noah, a health care analyst with the Granite Financial Group in San Diego, agreed.

“Insomnia is a large and growing market,” Noah said. “Everyone agrees, when Neurocrine Biosciences Inc., a San Diego-based biotechnology firm, which has a promising insomnia drug started, people thought the market was much smaller.”

Neurocrine’s insomnia drug, indiplon, is up for FDA approval. Analysts see it as one of the highest-profile biopharmaceutical launches in 2005 or 2006.

Neurocrine’s indiplon would rival existing insomnia drugs , Sanofi-Aventis’ Ambien and Marlborough, Mass.-based Sepracor Inc.’s Lunesta, Noah said.

But Silenor is different, Noah noted.

“All three drugs work similarly, whereas Silenor has a different mechanism of action , that’s always good in treating any disease, because it gives doctors and patients options,” he said.

Neurocrine, however, has a powerful partner in the New York-based pharmaceutical giant Pfizer Inc., which has the sales muscle to successfully market the drug to primary care doctors, Noah said. A small company wouldn’t be able to compete.

“They need a big partner,” he said.

Somaxon isn’t betting on insomnia alone.

The firm licensed a second existing drug, nalmefene, from Finnish biotechnology company Bio Tie Therapies Corp. in November 2004, Cohen said.

Nalmefene is approved as an intravenous drug to reverse the effects of opiates, Cohen said. Somaxon plans to test nalmefene this year for use in treating pathological gambling in a Phase II/III trial, and for nicotine addiction in a Phase II trial, Cohen said.

It will be 2008 or 2009 before nalmefene would be up for possible FDA review, he said.

Somaxon’s product candidates are attractive because they address large and growing markets, Cohen said.

“(If you have) products with attractive features, there is a significant opportunity to grow a business around it,” he said.

Cohen was previously president and chief executive of San Diego-based Synbiotics Corp., which makes diagnostics for the veterinary market.

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