05.12.2007 12:00:00
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Pfizer and Adolor Enter into Exclusive Worldwide Collaboration to Develop and Commercialize Novel Pain Compounds
Pfizer Inc (NYSE: PFE) and Adolor Corporation (Nasdaq: ADLR) announced
today an exclusive worldwide collaboration to develop and commercialize
novel compounds, ADL5859 and ADL5747, for the treatment of pain. Both
compounds are proprietary Delta opioid receptor agonist candidates with
the potential to treat a wide range of inflammatory, neuropathic and
acute pain conditions.
The companies will form a Joint Steering Committee to guide the
development and commercialization of products resulting from the
collaboration. Pfizer will be responsible for securing regulatory
approvals and commercialization on a worldwide basis.
The terms of the agreement provide for Pfizer and Adolor to share
revenues and expenses 60/40 percent in the United States. Outside the
U.S., Pfizer will fund development activities and, on commercialization,
Adolor will receive royalties on Pfizer net sales. Adolor will receive
an upfront, non-refundable payment of $30 million, plus $1.9 million
reimbursement for prior Phase 2 development costs. Adolor may also
receive payments of up to $232.5 million upon the achievement of
development and regulatory milestones for its Delta compounds. More than
50 percent of these milestones may be earned prior to regulatory
approval of the compounds, with the first milestone payment available to
be earned on commencement of Phase 2b clinical studies.
"We are pleased to be partnering with Pfizer
in this very exciting program,” said Michael
R. Dougherty, president and chief executive officer of Adolor
Corporation. "Our vision for the Delta
agonists has been to develop a new class of opioids, delivering
analgesia without some of the complicating side effects of traditional
mu agonists. Pfizer brings extensive pain management development and
commercial expertise to this collaboration and we look forward to
working with Pfizer in the pursuit of this vision.”
ADL5859 is in a Phase 2 development program exploring its analgesic
efficacy in inflammatory pain associated with rheumatoid arthritis and
acute post-dental surgery pain. Additional programs are planned to
evaluate ADL5859 in patients with diabetic peripheral neuropathy and
osteoarthritis. All future development work is subject to a Joint
Development Committee. Adolor expects to begin Phase 1 clinical testing
of ADL5747 in the first quarter of 2008.
"This collaboration demonstrates our
commitment to executing against the R&D plan we outlined, including
expanding our Phase 2 portfolio with a strong focus in our key
therapeutic areas,” said Dr. Martin Mackay,
president of Pfizer Global Research and Development. "Pfizer
has a strong history in bringing to market novel pain solutions
including Lyrica, Neurontin and Celebrex. However, there still remains a
significant unmet medical need for patients suffering from a variety of
debilitating pain conditions.”
One of three opioid receptors, the Delta receptor has potential utility
in a variety of indications, including the modulation of pain. Through a
proprietary research platform based on cloned, human opioid receptors,
Adolor has identified a series of novel, orally active Delta agonists -
compounds that selectively stimulate the Delta opioid receptor. Delta
compounds may have a number of potential advantages, including an
improved side effect profile, as compared to mu opioid receptor
agonists. On the basis of preclinical evaluation in animal models of
human conditions, a Delta agonist may show effect in inflammatory pain,
among other pain conditions. In addition, Delta agonists are thought to
modulate other biological processes that may manifest themselves in
disease states or conditions such as cardio-protection, overactive
bladder, and depression. There are currently no selective Delta agonists
approved by the FDA.
For more information on Pfizer Inc or Adolor Corporation, please visit www.pfizer.com
or www.adolor.com.
Conference Call Information
Adolor will be hosting a conference call and webcast on December 5, 2007
at 8:30 a.m. Eastern Time, 5:30 a.m. Pacific Time to discuss this
collaboration. To participate in the audio portion and have the
opportunity to pose questions, dial 1-800-561-2693 for domestic callers
and 1-617-614-3523 for international callers, and provide the Passcode
21232614. Slides accompanying the call, as well as a webcast of the
audio portion of the call, will be available on the Investor Relations
section of Adolor’s website, www.adolor.com.
A replay of the conference call will be available beginning at 10:30
a.m. Eastern Time on December 5, 2007. To listen to a replay of the
conference call, dial 1-888-286-8010 (domestic callers) or
1-617-801-6888 (international callers) with a Passcode of 56334480 or
listen via Adolor’s website. The replay will
be available for one week.
Adolor Forward-Looking Statement
This release, and oral statements made with respect to information
contained in this release, constitute forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995.
Such forward-looking statements include those which express plan,
anticipation, intent, contingency, goals, targets or future development
and/or otherwise are not statements of historical fact. These statements
are based upon management's current expectations and are subject to
risks and uncertainties, known and unknown, which could cause actual
results and developments to differ materially from those expressed or
implied in such statements. Such known risks and uncertainties relate
to, among other factors: the risks associated with collaboration
arrangements; the risk that milestone payments are not achieved under
the Delta collaboration; the risk that our Delta product candidates
ADL5859 and ADL5747 will show adverse safety findings that make them
unsuitable for further development; the risk that our Delta product
candidates do not show utility in treating pain or any other clinical
indications; the risk that we do not initiate further clinical studies
for our product candidate ADL5859 or initiate clinical studies for our
product candidate ADL5747; the risk that filing targets for regulatory
filings are not met; the costs, delays and uncertainties inherent in
scientific research, drug development, clinical trials and the
regulatory approval process; Adolor's history of operating losses since
inception and its need for additional funds to operate its business;
Adolor's reliance on its collaborators, including Pfizer in connection
with the development and commercialization of Adolor’s
Delta product candidates; the risks associated with Adolor’s
ability to obtain, maintain and successfully enforce adequate patent and
other intellectual property protection of its Delta product candidates;
market acceptance of Adolor's products, if regulatory approval is
achieved; reliance on third party manufacturers; product liability
claims; competition; and securities litigation.
Further information about these and other relevant risks and
uncertainties may be found in Adolor's Reports on Form 8-K, 10-Q and
10-K filed with the U.S. Securities and Exchange Commission. Adolor
urges you to carefully review and consider the disclosures found in its
filings which are available in the SEC EDGAR database at http://www.sec.gov
and from Adolor at http://www.adolor.com.
Given the uncertainties affecting pharmaceutical companies in the
development stage, you are cautioned not to place undue reliance on any
such forward-looking statements, any of which may turn out to be wrong
due to inaccurate assumptions, unknown risks, uncertainties or other
factors. Adolor undertakes no obligation to (and expressly disclaims any
such obligation to) publicly update or revise the statements made herein
or the risk factors that may relate thereto whether as a result of new
information, future events, or otherwise.
Pfizer Forward-Looking Statement
The information contained in this release is as of December 5, 2007.
Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or future
events or developments.
This release contains forward-looking information about a collaboration
between Pfizer and Adolor with respect to certain product candidates,
including their potential benefits, that involves substantial risks and
uncertainties. Such risks and uncertainties include, among other things,
the uncertainties inherent in research and development; decisions by
regulatory authorities regarding whether and when to approve drug
applications that have been and may be filed for any such product
candidates as well as their decisions regarding labeling and other
matters that could affect the availability or commercial potential of
such product candidates; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2006
and in its reports on Form 10-Q and Form 8-K.
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