Novacea, Inc.: Novacea Stockholders Approve Merger With Transcept

Published in Health and Fitness on Tuesday, January 27th 2009 at 11:05 GMT, Last Modified on 2009-01-27 11:06:30 by Market Wire
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SOUTH SAN FRANCISCO, CA--(Marketwire - January 27, 2009) - Novacea, Inc. (NASDAQ: [ NOVC ]) announced today that its stockholders approved the proposals to complete the proposed merger with Transcept Pharmaceuticals, Inc. at a special meeting of stockholders held earlier in the day. The merger is expected to close after satisfaction or waiver of all closing conditions specified in the merger agreement, which is currently expected to occur within the next week. Immediately following completion of the merger, Novacea will change its name to Transcept Pharmaceuticals, Inc. and common stock in the combined company will trade on The NASDAQ Global Market® under the symbol "TSPT".

The merger of Novacea and Transcept will result in a NASDAQ-listed specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the fields of psychiatry and sleep medicine. The lead Transcept product candidate, Intermezzo®, is a sublingual low dose formulation of zolpidem that has been developed for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. Intermezzo® Phase 3 clinical trials have been completed and, on September 30, 2008, Transcept submitted a New Drug Application for Intermezzo® to the U.S. Food and Drug Administration, which was accepted for filing on December 15, 2008. The related Prescription Drug User Fee Act (PDUFA) date is scheduled for July 30, 2009.

John P. Walker, Novacea's Chief Executive Officer and Chairman of the Board, commented, "I appreciate the vote of the Novacea stockholders who share the belief of our board and management team that Transcept represents a compelling opportunity for value creation. The management of Transcept, led by Glenn Oclassen, has a demonstrated track record of success in partnering and commercially launching specialty pharmaceutical products. Intermezzo® potentially represents a significant new opportunity in the insomnia market and, if approved, is positioned to be the first sleep therapeutic for use as-needed at the time of middle of the night awakening. We believe that the capital resources of the merged company give it the potential to reach significant value creating milestones, including the anticipated FDA approval of Intermezzo® in 2009 and corporate collaborations in the U.S. and in other world markets. As a member of the merged company's Board of Directors, I look forward to working with Glenn and his management team as they take Transcept forward to capitalize fully on this opportunity."

About Novacea

Novacea is a biopharmaceutical company that had been focused on in-licensing, developing and commercializing novel cancer therapies. Novacea currently has two product candidates, including Asentar™, which had been in a Phase 3 clinical trial for androgen-independent prostate cancer, and AQ4N, a hypoxia-activated prodrug. There are currently no clinical trials underway or planned for Asentar™ or AQ4N, and both programs are part of current out-licensing efforts by Novacea.

Safe Harbor

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). Novacea disclaims any intent or obligation to update these forward-looking statements, and claim the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include statements about the completion of the merger of Novacea and Transcept Pharmaceuticals, including the business of the combined company, the proposed name change to take place in connection with the consummation of the proposed merger, FDA approval of Intermezzo®, and the commercial opportunity offered by Intermezzo®. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to, Novacea or Transcept inability to satisfy the conditions of the merger, or that the merger is otherwise delayed or ultimately not consummated; and other events and factors disclosed previously and from time to time in Novacea filings with the Securities and Exchange Commission, including the Novacea Annual Report on Form 10-K for the year ended December 31, 2007 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2008.