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Merck steers top drug prospect to an NDA, analysts ponder R&D weakness

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Merck today says it has the late-stage data it needs to gain an approval for a new insomnia drug, one of 5 treatments the pharma giant believes it can gain an official OK on before the end of 2013. But highlighting plans for a little-known insomnia treatment that would be entering a crowded market may be sending a different kind of message to industry analysts than the one Merck ($MRK) intends.

Merck wasn't talking data points today, but it says the treatment--an orexin receptor antagonist--hit endpoints on a change from baseline in subjective total sleep time and time to sleep onset, wake time after persistent sleep onset, and latency to onset of persistent sleep at one and three months.

"Suvorexant selectively targets an important pathway involved in helping to promote sleep and, if approved, will be a new, first-in-class treatment for patients with insomnia," said Peter Kim, president, Merck Research Laboratories. "We are enthusiastic about the potential of this investigational medicine, and look forward to sharing the results from these studies with the medical community."

Orexin receptor drugs have had their problems. Just a year ago Glaxo and Actelion shuttered a trial on almorexant, which has a similar mechanism.

Suvorexant, which gained little attention while in clinical development, joins osteoporosis drug odanacatib, the anesthesia-reversing Bridion, an anti-hardening of the arteries drug dubbed Tredaptive and a vaccine called V503 as among the pharma giant's brightest hopes, according to a recent AP story. But some analysts see the lineup as a thin front line for a company that needs substantial new revenue. As a result, there's been some buzz recently that Merck may be altering its deal-making game plan and focusing more on drugs in late-stage development to gain some respect.

- here's the press release

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