Blog & Resources Camargo Blog September 2nd, 2008

Transcept and Novacea to Merge

Transcept Pharmaceuticals (formerly TransOral) announced today (9/2/2008) that it is merging with Novacea. Transcept is a privately held company while Novacea is NASDQ-listed, so the merged company will be a public company. Novacea had 2 cancer therapies that didn’t meet expectations. Transcept has a 505(b)(2) strategy which we have reviewed in this blog before. The lead Transcept product candidate is zolpidem tartrate sublingual lozenge, is a low dose formulation of zolpidem for the as-needed treatment of insomnia in patients who awaken in the middle of the night and have difficulty returning to sleep. According to the company, “Phase 3 clinical trials have been completed for Intermezzo® and Transcept plans to submit an NDA to the FDA via the 505(b)(2) pathway prior to the end of 2008.” Transcept is also developing two fixed dose combination product candidates, TO-2060 (olanzapine/ondansetron) and TO-2061 (risperidone/ondansetron), for the treatment of dopamine associated psychiatric disorders.

Categories: 505(b)(2) Development

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