Shares of Transcept Pharmaceuticals Inc (TSPT) are on a roll Monday following news about the licensing agreement related to its sleep drug candidate Intermezzo that was released on Sunday. Shares rose as much as 80% and set a new 52-week intraday high of $10.49 and after a pull back are currently trading at $8.08, up 39.31%.
On Sunday, Transcept crafted a license and collaboration agreement with privately-held Purdue, under which Purdue and its associated company will have an exclusive license to sell Intermezzo in the United States and also have the right to negotiate for the commercialization of the product in Canada and Mexico. Transcept has retained an option to co-promote Intermezzo to psychiatrists in the United States and has retained rights to commercialize the drug in the rest of the world.
The terms of the agreement also call for Purdue to pay Transcept near-term milestones that include an upfront cash payment of $25 million and an additional payment of up to $30 million upon FDA approval of Intermezzo. Transcept is eligible to receive up to an additional $90 million upon reaching future milestones related to achievement of intellectual property and U.S. net sales targets.
Purdue will pay double-digit royalties to Transcept ranging up to the mid-twenty percent level on U.S. net sales of Intermezzo. If Transcept elects to exercise its psychiatrist co-promotion option, Transcept will receive an additional double-digit royalty on the portion of U.S. net sales generated by psychiatrists.
Intermezzo, which is at the altar awaiting FDA decision, will get to know its fate on October 30, 2009. Transcept had filed a New Drug Application with the FDA seeking approval for Intermezzo as a treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep on September 30, 2008. The regulatory agency had originally set a decision date of July 30, 2009. However on June 10, the FDA notified the company that an additional three months would be needed to complete the review of Intermezzo and hence extended the original deadline to October 30.
If approved, Intermezzo will be the first commercially available sleep aid designed specifically for use in the middle of the night when patients awaken and have difficulty returning to sleep. Reports indicate that middle of the night awakening is the most frequently reported insomnia symptom.
As part of the NDA submission, Transcept had requested that the FDA grant three years of Hatch-Waxman marketing exclusivity to Intermezzo. The Hatch-Waxman Act permits applicants to rely in part on clinical and non-clinical data generated by third parties. Specifically, the company is relying in part on third party data with respect to zolpidem, which is the active ingredient in Intermezzo and the previously approved insomnia products Ambien and Ambien CR.
Transcept is also actively pursuing patents to cover Intermezzo in the United States and key non-U.S. markets.
In clinical trials, Intermezzo when used at the time of a middle of the night awakening, significantly shortened the time for patients to return to sleep as compared to placebo, and there was no evidence of next day residual sedative effects.
Transcept Pharmaceuticals was a privately-held company until it merged with Novacea Inc. (NOVC) on February 2, 2009 and the combined company began trading under the new ticker 'TSPT' on the Nasdaq.
The company has incurred losses in each year since its inception in 2002 and as of March 31, 2009, had an accumulated deficit of $73.6 million. Cash, cash equivalents and marketable securities were $81.0 million as of March 31, 2009 and the company believes that the amount will be sufficient to fund planned expenditures for at least the next twelve months.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.