Based: San Diego, CA
Why It's Fierce: In just two years, Somaxon has pushed a lead compound into Phase III and has two others coming up the pipeline behind it. It's helped that Somaxon started with a compound (doxepin) that had been approved 35 years ago as an antidepressant. A psychiatrist -- Dr. Neil Kavey at Columbia-Presbyterian Medical Center -- noticed that patients taking small doses of doxepin were reporting that they were sleeping through the night. That discovery has helped make Somaxon a contender among the drug developers scrambling to develop new and better sleep drugs in what is projected to be a massive market. Their goal: Show that Silenor can maintain sleep through the night without any of the side effects common to the class. Having a compound with an already well-defined safety profile has made their task much simpler. And their racing form helped attract a whopping $65 million third round just days before starting a pivotal trial for Silenor. Two other pipeline candidates to watch: Oral nalmefene for pathological gambling and a new formulation of acamprosate, a GABA-A agonist and NMDA antagonist, that will increase the bioavailability of the drug. A key member of the development team is Philip Jochelson, M.D., an expert in insomnia drugs who had worked at Neurocrine.
What to look for: Look for a marketing partner to step in somewhere between preliminary Phase III data in the second quarter of next year and an NDA by the end of '06.