Transcept cuts workforce following FDA news on Intermezzo NDA
Following the notification from the U.S. Food and Drug Administration (FDA) that the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet) cannot be approved, Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today announced the company’s plan to reduce its workforce strength by almost half. Intermezzo® is the lead product candidate that helps in patients with insomnia for the treatment of difficulty to fall asleep after a middle of the night awakening. Glenn A. Oclassen, President and Chief Executive Officer commented, “Our staffing needs have changed after the recent news from the FDA on the regulatory status of Intermezzo®. We are therefore phasing out certain positions that are non-essential to our plan to pursue potential paths forward with the FDA on the Intermezzo® NDA, and to continue development of our TO-2061 program. This cost containment step is consistent with our long standing principle of conservative cash management.”
Mr. Oclassen also stated, “This decision was a difficult one for all of us and was made all the more challenging by the high quality of the people affected. We are extremely grateful to our all employees for their significant efforts and contributions to Transcept.”
As previously stated in media by Transcept, the company had cash, cash equivalents and marketable securities of approximately $59.6 million at the end of June this year. The cash spend during the quarter ending June 30, 2011 was approximately $1.2 million per month.
SOURCE Transcept Pharmaceuticals, Inc.
One thought on “Transcept cuts workforce following FDA news on Intermezzo NDA”
FDA is currently approving more drugs than ever and in recent years there have been lapses by this authority. It is good to see some approvals being denied. This will help in more confidence gain in FDA.