On January 20, 2010, Transcept (TSPT) management met with the U.S. FDA to discuss the complete response letter issued last October on Intermezzo. The letter brought up issues on potential inadvertent re-dosing in a single night and inadvertent dosing with less than four hours of bedtime remaining. The FDA also requested additional data demonstrating that Intermezzo, when taken as directed in the middle of the night, would not present an unacceptable risk of next-day driving ability (for additional details on the letter, see our November 17, 2009 report).

We do not expect management to comment publically on the meeting until the final minutes have been issued. This is usually a 30 to 45 day process, putting a potential release from the company on the future plans for the drug sometime in late February 2010. Management will probably release fiscal 2009 earnings in March 2010.

Based on our analysis of the complete

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Yesterday, Merck (MRK) updated the status of two of its pipeline candidates, both used to treat migraine. While the company abandoned MK-3207, it will continue to develop telcagepant (MK-0974). Although MK-3207 was found to be effective, it caused liver abnormalities in some patients on discontinuing the drug. Due to this, Merck has decided to abandon any further studies of the drug. The phase III trial conducted by Merck for telcagepant found it to be more effective than placebo for acute treatment of multiple migraine attacks. In another study, the safety of the product was compared to another migraine drug of Merck, Maxalt (rizatriptan). The company presented data from both trials at the International Headache Congress and plans to initiate discussions regarding the next steps with the US Food and Drug Administration (FDA) later this year. The telcagepant trial was carried out on 1677 patients who ...