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Transcept Pharmaceuticals Receives
Notice of Allowance for U.S. Patent Application on Intermezzo®
Patent to Cover Low-Dose Formulation of Zolpidem for
Transmucosal Absorption
POINT RICHMOND, Calif., Nov 04, 2009 /PRNewswire-FirstCall via
COMTEX News Network/ -- 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. 11/833,323, which
covers the use of Intermezzo® (zolpidem tartrate sublingual
tablet), the lead Transcept product candidate. Once issued, this
patent will expire in February 2025.
"This Notice of Allowance represents a significant
accomplishment for Transcept and is an important event in our
Intermezzo® product development program," commented Glenn A.
Oclassen, President and Chief Executive Officer. "Once issued,
this patent is expected to provide an important layer of
intellectual property protection covering our proprietary
low-dose sublingual Intermezzo® formulation. This patent
allowance is a testament to the scientific talent of its
inventor, Nikhilesh Singh, Ph.D., Transcept Co-Founder and Chief
Scientific Officer."
Mr. Oclassen continued, "In addition to this formulation patent,
there are other key elements to our program to protect
Intermezzo®. These include the three years of Hatch-Waxman
regulatory exclusivity which we have requested that the U.S.
Food and Drug Administration (FDA) grant to Intermezzo®, and
additional patent applications under review by the USPTO that
include a second formulation patent application and another
family of patent applications for 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 a $10 million milestone payment
from Purdue after the listing of the issued patent subject to
the Notice of Allowance 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 Purdue electing to
continue with the alliance after its review of the terms of such
FDA approval, if such approval is received.
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 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;
obtaining and maintaining Hatch-Waxman exclusivity for
Intermezzo®; 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 of Corporate Communications
(510) 215-3675
gmann @transcept.com
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