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.
