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Purdue Pharmaceutical Products L.P. and
Transcept Pharmaceuticals, Inc. Sign Exclusive Agreement to
Commercialize Intermezzo® in the United States
Transcept Retains Option to Co-Promote to
Psychiatrists
Intermezzo® under FDA review for
use as needed for the treatment of insomnia when a
middle-of-the-night awakening is followed by difficulty
returning to sleep
STAMFORD, Conn. and PT. RICHMOND, Calif., Aug 02, 2009
/PRNewswire-FirstCall via COMTEX News Network/ -- Purdue
Pharmaceutical Products L.P. and Transcept Pharmaceuticals, Inc.
(Nasdaq: TSPT) today announced entry into an exclusive license
and collaboration agreement to commercialize Intermezzo® (zolpidem
tartrate sublingual tablet) in the United States. If approved by
the U.S. Food and Drug Administration (FDA), Intermezzo® has
the potential to be the first prescription sleep aid
specifically approved for use in the middle of the night at the
time a patient awakens and has difficulty returning to sleep.
The FDA has established October 30, 2009 as the Prescription
Drug User Fee Act (PDUFA) action date for the Intermezzo®
New Drug Application (NDA).
In the agreement announced today, Transcept has granted Purdue
and a Purdue associated company an exclusive license to market,
sell and distribute Intermezzo® in the United States and the
right to negotiate for the commercialization of the product in
Canada and Mexico. Transcept has retained an option to
co-promote Intermezzo® to psychiatrists in the United States
and has retained rights to commercialize Intermezzo® in the
rest of the world.
Under the terms of the agreement, Purdue will pay Transcept
near-term milestones that include an upfront cash payment of $25
million and an additional payment of up to $30 million based
upon the timing of an FDA approval of Intermezzo®, which
approval and payment are subject to review and acceptance by
Purdue. Transcept is eligible to receive up to an additional $90
million upon reaching future milestones related to achievement
of intellectual property and U.S. net sales targets.
Purdue will pay double-digit royalties to Transcept ranging up
to the mid-twenty percent level on U.S. net sales of
Intermezzo®. If Transcept elects to exercise its
psychiatrist co-promotion option, Transcept will receive an
additional double-digit royalty on the portion of U.S. net sales
generated by psychiatrists. Under the agreement, Transcept can
enter the market under the co-promotion option as early as the
first anniversary of the commercial launch of Intermezzo® by
Purdue.
Glenn A. Oclassen, President and Chief Executive Officer of
Transcept, said, "This agreement is a transforming event for
Transcept. Purdue has an established and growing primary care
marketing and sales capability that we believe is ideally
positioned to introduce Intermezzo® to physicians. Purdue
has a demonstrated track-record in the key disciplines needed to
drive the awareness and acceptance of Intermezzo®, including
successful experience marketing to national distributors,
managed care organizations and primary care physicians. We
believe that Intermezzo® has the potential to occupy an
important position in the substantial worldwide market for
prescription sleep aids, and that our U.S. partnership with
Purdue is a key step toward the commercial success of
Intermezzo®."
Mr. Oclassen continued, "This agreement further increases our
substantial cash reserves and aligns us with a powerful partner
that will make a significant U.S. primary care sales and
marketing investment. Our agreement with Purdue establishes the
potential for a substantial Transcept revenue stream, and now
enables us to focus increasing attention on prospective
Intermezzo® commercialization partners in other parts of the
world. The increased resources Transcept receives from this
collaboration will also support our continued product pipeline
expansion efforts. Finally, our option to co-promote
Intermezzo® in the United States provides a foundation for
achieving our long-term goal of becoming a fully integrated
specialty pharmaceutical company and creating even greater value
for our shareholders."
Purdue's President and Chief Executive Officer, John H. Stewart
commented, "We are excited to be working with Transcept towards
the launch of this potential new entry into the prescription
sleep aid market. This agreement is part of Purdue's plan to
diversify our product portfolio and broaden our commercial focus
into therapeutic areas that complement our leadership position
in pain management." Mr. Stewart added, "We are confident that
prescribers will find Intermezzo® to be a valuable
therapeutic option for managing patients with
middle-of-the-night sleep disorders that fall within the
proposed indication for the product's use."
About Intermezzo®
Intermezzo® (zolpidem tartrate sublingual tablet) has the
potential to be the first prescription sleep aid specifically
approved for use in the middle of the night at the time a
patient awakens and has difficulty returning to sleep.
Intermezzo® is a sublingual low dose formulation of zolpidem,
the active agent most commonly prescribed in the United States
for the treatment of insomnia. Intermezzo® uses
approximately one-quarter to one-third of the dose of active
drug contained in currently marketed zolpidem-based sleep aids,
in a formulation designed to promote rapid sublingual
absorption. Transcept believes that Intermezzo®, by
combining the reduced zolpidem dose with administration only on
those nights when a middle of the night awakening actually
occurs, has the potential to reduce unnecessary
sedative-hypnotic exposure.
Two Phase 3 clinical studies evaluated 376 patients receiving
either Intermezzo® or placebo. In the first study, a sleep
laboratory trial using an objective polysomnographic endpoint,
Intermezzo® demonstrated a statistically significant
decrease versus placebo in the time it took patients to return
to sleep as measured by Latency to Persistent Sleep. In the
second study, an outpatient trial, Intermezzo® demonstrated
a statistically significant decrease in Latency to Sleep Onset,
a subjective patient reported endpoint. The most common adverse
event seen in these trials was headache (2.7 percent active
versus 1.4 percent placebo in the outpatient study).
The FDA has established October 30, 2009 as its target date
under PDUFA to take action on its review of the NDA. Transcept
is actively pursuing patents to protect Intermezzo® in the
United States and key non-U.S. markets, and, as part of the NDA
submission, has requested that the FDA grant three years of
Hatch-Waxman marketing exclusivity to Intermezzo®.
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. For further information, please visit the
company's website at:
www.transcept.com.
About Purdue
Purdue Pharma L.P. and its associated U.S. companies are
privately-held pharmaceutical companies known for pioneering
research on persistent pain. Headquartered in Stamford, CT,
Purdue is engaged in the research, development, production, and
distribution of both prescription and over-the-counter medicines
and hospital products. Additional information about Purdue can
be found at
www.purduepharma.com.
Transcept Conference Call
Transcept will host a conference call at 8:30 a.m. ET on Monday,
August 3, 2009, to discuss the agreement. The conference call
will be simultaneously web cast on the Investor Relations
section of the Transcept website at
www.transcept.com. A replay
of the call will be available on the website shortly after the
conclusion of the call until Monday, September 7, 2009.
Date: Monday, August 3, 2009
Time: 8:30 a.m. ET
Dial-in (U.S.): 877-545-1490
Dial-in (International): 719-325-4864
A telephone replay of the conference call will be available
beginning August 3, 2009 at 11:30 a.m. ET and ending on August
17, 2009. The replay telephone number is 888-203-1112 (U.S.) or
719-457-0820 (International), Replay Passcode: 5541799.
Transcept Forward-Looking Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. All statements,
other than statements of historical facts, included in this
press release regarding our strategy, future operations, future
financial position, future revenues, projected costs, prospects,
plans and objectives of management are forward-looking
statements. Examples of such statements include, but are not
limited to, statements relating to expectations with respect to
the launch and market potential of Intermezzo®; expectations
with respect to the activities of Transcept and Purdue and the
satisfaction of conditions under the United States License and
Collaboration Agreement (Collaboration Agreement); expectations
regarding potential milestone payments and royalties under the
Collaboration Agreement; the timing of regulatory decisions with
respect to the NDA for Intermezzo® with the FDA;
expectations for use of proceeds that may be obtained pursuant
to the Collaboration Agreement; plans of Transcept to exercise
the option to co-promote Intermezzo® and to develop a
specialty sales force; plans of Purdue to make a significant
U.S. primary care marketing investment and prioritize
Intermezzo® commercialization; Intermezzo® being the
first commercially available sleep aid in the United States in
its target indication; the potential reduction of hypnotic sleep
aid dosing through use of Intermezzo®; and the ability of Transcept to achieve its goal of becoming a fully integrated
specialty pharmaceutical company. Transcept may not actually
achieve the plans, intentions or expectations disclosed in our
forward-looking statements and you should not place undue
reliance on these forward-looking statements. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements we
make. Various important factors could cause actual results or
events to differ materially from the forward-looking statements
that Transcept makes, including risks related to: the opinion of
the FDA on the sufficiency of the NDA to support marketing
approval of Intermezzo®; the grant by the FDA and
maintenance of exclusivity to Intermezzo® under
Hatch-Waxman; a decision by Purdue to terminate the
Collaboration Agreement, even if the Intermezzo®NDA is
approved; commercial acceptance of Intermezzo®, if approved;
competition for Intermezzo®, if approved; unforeseen
expenses related to FDA approval and the business of Transcept
generally; dependence on third parties to manufacture
Intermezzo®; a decision by Purdue to not devote sufficient
time or resources to commercialization of Intermezzo®;
obtaining, maintaining and protecting the intellectual property
incorporated into Intermezzo®; other difficulties or delays
in the commercialization of Intermezzo®, carrying out
activities or obtaining payments under the Collaboration
Agreement and clinical development of, and obtaining regulatory
approval for, Transcept product candidates; the ability of
Transcept to expand its product candidate portfolio; and the
ability of Transcept to obtain additional funding, if needed, to
support its business activities. These and other risks are
described in greater detail in the "Risk Factors" section of
Transcept periodic reports filed with the SEC. Forward-looking
statements do not reflect the potential impact of any future
in-licensing, collaborations, acquisitions, mergers,
dispositions, joint ventures, or investments Transcept may enter
into or make. Transcept does not assume any obligation to update
any forward-looking statements, except as required by law.
Contacts
Purdue Pharma L.P.
James Heins
Senior Director, Public Affairs
(203) 588-8069
james.heins @pharma.com
Libby Holman
Associate Director, Public Affairs
(203) 588-7670
libby.holman @pharma.com
Transcept Pharmaceuticals, Inc.
Greg Mann
Director of Corporate Communications
(510) 215-3567
gmann @transcept.com
The Ruth Group
Investors / Media
Sara Ephraim Pellegrino / Jason Rando
(646) 536-7017 / 7025
spellegrino @theruthgroup.com
jrando @theruthgroup.com
Source
Transcept Pharmaceuticals, Inc.; Purdue Pharmaceutical
Products L.P.
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