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Transcept Pharmaceuticals Granted First
U.S. Patent Covering Intermezzo® Formulation
POINT RICHMOND, Calif., Feb 09, 2010 /PRNewswire via COMTEX News
Network/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) today
announced that the first patent covering the composition and
method of use of Intermezzo® (zolpidem tartrate sublingual
tablet), the lead Transcept product candidate, has been issued
by the United States Patent and Trademark Office. Transcept
announced the issuance of a Notice of Allowance for claims under
the application for this patent, U.S. Patent Application Serial
No. 11/060,641, on December 14, 2009. The newly issued patent,
U.S. Patent No. 7,658,945, titled "Compositions for Delivering
Hypnotic Agents Across the Oral Mucosa and Methods of Use
Thereof," will expire no earlier than February 2025.
About Transcept
Transcept Pharmaceuticals, Inc. is a specialty pharmaceutical
company focused on the development and commercialization of
proprietary products that address important therapeutic needs in
neuroscience. The most advanced Transcept product candidate is
Intermezzo® (zolpidem tartrate sublingual tablet), for which a
New Drug Application (NDA) was submitted to the U.S. Food and
Drug Administration (FDA) in September 2008 seeking approval as
a prescription sleep aid for use in the middle of the night at
the time a patient awakens and has difficulty returning to
sleep. In October 2009, Transcept received a Complete Response
Letter from the FDA on the Intermezzo® NDA and is working to
respond to issues raised in the letter. Transcept and Purdue
Pharmaceutical Products, L.P. have entered into a collaboration
agreement for the development and commercialization of
Intermezzo® in the United States. For further information,
please visit the company's website at:
www.transcept.com.
Forward Looking Statements
This press release contains forward looking statements for
purposes of the Private Securities Litigation Reform Act of 1995
(the Act). Transcept disclaims any intent or obligation to
update these forward-looking statements, and claims the
protection of the safe harbor for forward-looking statements
contained in the Act. Examples of such statements include, but
are not limited to, the expiration date of the newly issued
patent; the ability of patents to provide important intellectual
property protection for Intermezzo®; and Transcept efforts with
respect to regulatory issues concerning 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, whether Transcept
is able to satisfy concerns expressed by FDA in its October 28,
2009 Complete Response Letter and otherwise satisfy FDA that the
Intermezzo® NDA is sufficient to approve Intermezzo® for its
intended indication and any further delays in, and the final
form of, any FDA approval of Intermezzo®; possible claims of
patent invalidity; maintaining adequate patent protection and
successfully enforcing such patent claims against third parties.
Contact
Transcept Pharmaceuticals, Inc.
Greg Mann
Director, Corporate Communications
(510) 215-3567
gmann @transcept.com
Source
Transcept Pharmaceuticals, Inc.
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