This excerpt taken from the NOVC 8-K filed Nov 12, 2009.
REPORTS THIRD QUARTER 2009 FINANCIAL RESULTS
Conference call scheduled for 5:00 PM Eastern time today
Point Richmond, CA November 12, 2009 Transcept Pharmaceuticals, Inc. (NASDAQ: TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in neuroscience, today announced financial results for the three and nine months ended September 30, 2009.
Transcept previously announced that on October 28, 2009, the FDA issued a Complete Response Letter regarding the New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet), the lead Transcept product candidate. The NDA seeks approval to market Intermezzo® for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. Transcept and Purdue Pharmaceutical Products, L.P. have entered into a collaboration agreement for the development and commercialization of Intermezzo® in the United States.
Glenn A. Oclassen, President and Chief Executive Officer commented, Our focus is now on moving Intermezzo® forward through the remainder of the regulatory review process. With $93 million of cash, cash equivalents and marketable securities at September 30, 2009, we believe we have substantial resources on hand to cover a range of potential additional expenses that may be required to address the issues raised by the recent FDA Complete Response Letter. We expect to have more clarity on the FDAs remaining requirements for the Intermezzo® NDA after our planned meeting to discuss the Complete Response Letter. We are working with the FDA to schedule this meeting in early 2010.
Purdue Pharma, our U.S. commercialization partner for Intermezzo®, has been actively engaged in our collaboration since we received the Complete Response Letter. We are working closely with the Purdue clinical, regulatory and packaging teams to address the concerns raised by FDA.
With regard to other key Intermezzo® milestones, we announced last week that the United States Patent and Trademark Office issued a Notice of Allowance for one of our patent applications with claims that cover the use of our low-dose sublingual Intermezzo® formulation. Transcept is actively pursuing additional patents to protect Intermezzo® in the United States and key non-U.S. markets, and, as part of the NDA submission, has requested that the FDA grant three years of Hatch-Waxman marketing exclusivity to Intermezzo®.