Transcept Pharmaceuticals Receives Notice of Allowance for Second U.S. Patent Application Covering Intermezzo(R)
December 14 2009 - 3:35PM
PR Newswire (US)
POINT RICHMOND, Calif., Dec. 14 /PRNewswire-FirstCall/ -- Transcept
Pharmaceuticals, Inc. (NASDAQ:TSPT) today announced that it has
received a Notice of Allowance from the United States Patent and
Trademark Office (USPTO) for claims under U.S. patent application
no. 11/060,641, which covers the composition and use of Intermezzo®
(zolpidem tartrate sublingual tablet), the lead Transcept product
candidate. Once issued, this patent will expire no earlier than
February 2025. "This is the second USPTO Notice of Allowance issued
to Transcept to cover our proprietary low-dose sublingual
Intermezzo® formulation. We are pleased with the continued progress
of our patent prosecution efforts," commented Glenn A. Oclassen,
President and Chief Executive Officer. "Other key elements in our
program to protect Intermezzo® include a request to the U.S. Food
and Drug Administration (FDA) to grant three years of Hatch-Waxman
regulatory exclusivity to Intermezzo®, and multiple applications on
file with the USPTO related to an additional family of patents to
cover methods of treating middle of the night awakenings." Under
the terms of the exclusive license and collaboration agreement
between Transcept and Purdue Pharmaceutical Products, L.P. to
commercialize Intermezzo® in the United States, Transcept is
eligible to receive one $10 million milestone payment from Purdue
after either of the two formulation patents, once issued, is listed
in the FDA's Approved Drug Products with Therapeutic Equivalence
Evaluations, or Orange Book. The obligation of Purdue to make this
milestone payment is subject to an FDA approval of Intermezzo® and
to Purdue electing to continue with the alliance after its review
of the terms of such FDA approval. This single $10 million
milestone payment is part of the previously announced $90 million
of potential milestones which Transcept is eligible to receive upon
the achievement of certain intellectual property and U.S. net sales
targets. 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: http://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 ability of patents to provide important intellectual property
protection for Intermezzo®; expectations with regard to
Hatch-Waxman regulatory exclusivity; expectation of patent issuance
and Orange Book listing after a Notice of Allowance is published by
the USPTO; the potential favorable outcome of additional patent
prosecution and issuance efforts in favor of Intermezzo®;
expectations with respect to the activities of Transcept and Purdue
and the satisfaction of conditions and obligations under the
parties' United States License and Collaboration Agreement (the
Collaboration Agreement); expectations regarding potential
milestone payments under the Collaboration Agreement; the ability
of Transcept to satisfy the issues raised by the FDA in the
Complete Response Letter; and the timing of regulatory submissions
and decisions with respect to the NDA for Intermezzo® with the FDA.
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; obtaining patent issuance, maintaining adequate patent
protection and successfully enforcing such patent claims against
third parties; commercializing Intermezzo® without violating the
intellectual property rights of others; a decision by Purdue to
terminate the Collaboration Agreement, even if the Intermezzo® NDA
is approved; obtaining and maintaining Hatch-Waxman exclusivity for
Intermezzo® and other difficulties or delays in, clinical
development, market acceptance and commercialization of
Intermezzo®. Contact: Transcept Pharmaceuticals, Inc. Greg Mann
Director, Corporate Communications (510) 215-3567 DATASOURCE:
Transcept Pharmaceuticals, Inc. CONTACT: Greg Mann, Director,
Corporate Communications of Transcept Pharmaceuticals, Inc.,
+1-510-215-3567, Web Site: http://www.transcept.com/
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