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EXHIBIT 99.1
Contact: Kathy Galante Burns McClellan
Corporate Communications Ethan Denkensohn (investors)
(516) 222-0023 Kathy Jones, Ph.D. (media)
[email protected] (212) 213-0006
OSI PHARMACEUTICALS GAINS FULL DEVELOPMENT AND MARKETING RIGHTS
FOR PFIZER'S ANTI-CANCER COMPOUND, CP-358,774 (OSI-774)
FTC CONSENT DECREE REQUIRES PFIZER TO DIVEST CP-358,774 (OSI-774)
IN MERGER WITH WARNER-LAMBERT
UNIONDALE, NEW YORK - JUNE 19, 2000 -- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP)
announced today that Pfizer Inc. (NYSE: PFE), in order to meet Federal Trade
Commission requirements for its merger with Warner-Lambert Company (NYSE: WLA),
is granting all development and marketing rights to OSI Pharmaceuticals for
CP-358,774 (OSI-774). The compound is the most advanced clinical development
candidate arising from the OSI/Pfizer alliance and is currently in Phase II
trials. Warner-Lambert is also developing an EGFR inhibitor. CP-358,774
(OSI-774) is a potent, selective and orally active inhibitor of the EGFR
oncogene. EGFR inhibitors are considered amongst the most promising new cancer
treatments under development.
Pfizer stated, "that it is taking this action today to meet the requirements of
the FTC resulting from its review of the Pfizer acquisition of Warner-Lambert.
By returning our rights in CP-358,774 to OSI Pharmaceuticals through the
collaborative agreement between the two companies, we can most expeditiously
meet the FTC requirements while minimizing any delay in the development of this
anti-cancer agent."
"This agreement represents a tremendous opportunity for OSI Pharmaceuticals to
accelerate our previously stated plans to develop our own products," stated
Colin Goddard, Ph.D., President and Chief Executive Officer of OSI
Pharmaceuticals. "We believe CP-358,774 (OSI-774) to be an outstanding
competitor in what is increasingly recognized as one of the most exciting areas
of cancer drug development today. Based on our solid financial status and the
encouraging clinical trial data for this compound, we are in a very strong
position to accelerate development of this promising product to the benefit of
both our shareholders and the cancer community."
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OSI Pharmaceuticals, Inc. - Page 2
Under terms of the agreement with Pfizer, OSI Pharmaceuticals will receive a
royalty-free license to all rights for the further development and
commercialization of CP-358,774 (OSI-774). In order to minimize any development
delays and ensure a smooth transition Pfizer continues to coordinate the ongoing
Phase II trials in ovarian, head and neck and non-small cell lung cancer through
a transition period of up to 6 months. Pfizer will also provide OSI
Pharmaceuticals with its inventories of finished product, bulk drug and
production intermediates. Sufficient inventories are available to complete an
extensive clinical development program.
In connection with today's announcement, OSI also disclosed information updating
investors on the progress of the ongoing trials. Enrollment has been completed
for a 30 patient single agent open label salvage study in ovarian cancer and
approximately 45 patients in non-small cell lung cancer and is ongoing for a
similar study involving 100 patients in head and neck cancer. Patients in these
studies have advanced cancer and have failed standard treatment regimens. "Data
continue to indicate that this drug is well tolerated and have shown encouraging
indications of activity, including clinical responses, consistent with our
expectations based upon the experience of competitor compounds," stated Arthur
Bruskin, Ph.D., Executive Vice President, Pharmaceutical Operations of OSI
Pharmaceuticals.
Phase I studies had previously revealed a reversible rash and mild to moderate
diarrhea, treated effectively with Loperamide (Imodium(R)), as side effects from
daily dosing of CP-358,774 (OSI-774) on 150mg. A sub-set of patients in both
Phase I and II studies have now received daily doses of CP-358,774 (OSI-774) for
extended periods (from 6 months to over a year) and over 100 patients have now
received the drug with well managed side effects. Daniel Von Hoff, M.D.,
Director, Arizona Cancer Center and Eric K. Rowinsky, M.D., Director of Clinical
Research, Institute for Drug Development, Cancer Therapy and Research Center,
San Antonio, Texas, were the principal investigators on the daily dosing Phase I
study. Dr. Von Hoff noted that, "Compounds like CP-358,774 (OSI-774) are of
great interest because they hit a specific target (EGFR) that is important in
many cancer patients. In our Phase I study we identified a dose and schedule
that proved to be well tolerated." Dr. Rowinsky added, "Even in this earliest
study we were able to discern objective activity with this agent." Study
investigators will present data from the Phase II clinical trials at the
upcoming European Organization for the Research and Treatment of Cancer (EORTC)
symposium on new drugs in cancer therapy in Amsterdam in November.
OSI Pharmaceuticals will assume planning and management of further clinical
studies immediately, including pivotal studies designed to test the activity of
OSI-774 in combination with existing standard of care therapy. OSI
Pharmaceuticals has appointed Paul I. Nadler, M.D., of Nadler Pharma Associates,
LLC, as Acting Vice President of Medical Affairs on an interim basis to
coordinate the first phase of this program and establish working partnerships
with appropriate Clinical Research Organizations (CROs).
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OSI Pharmaceuticals, Inc. - Page 3
Dr. Nadler's medical training is in oncology and clinical immunology and he has
over 23 years of clinical trial experience. He has served as a clinical
consultant to OSI Pharmaceuticals since September 1999.
The Company also communicated its intent to retain full ownership of OSI-774
through advanced clinical development prior to seeking a marketing partnership
with a major pharmaceutical industry ally. "We believe that this strategy
provides the best vehicle for maximizing both the speed with which we can bring
this product to cancer patients and the value of this asset to our shareholders.
At the same time it recognizes the need for a strong marketing presence in order
to effectively compete in this emerging market," stated Geoff Cooper, Ph.D.,
Vice President, Business Development of OSI Pharmaceuticals.
OSI anticipates a net investment of approximately $25MM in this program over the
next several years. The Company recently concluded a private placement, raising
$56.5MM, and currently has over $83MM in cash. Dr. Goddard added, "We are
fortunate to be in the position to make this investment without negatively
impacting our other programs and we believe this deal greatly strengthens the
Company. OSI is now in the position of owning a strong clinical candidate in an
exciting anti-cancer area, backed by the resources to develop it and an
outstanding pipeline of collaborative and proprietary drug candidates."
OSI Pharmaceuticals is a leading drug discovery company with a substantial
pipeline of product opportunities for commercialization with the pharmaceutical
industry. OSI's research programs are focused in the areas of cancer
therapeutics, cosmeceuticals, diabetes, and GPCR-directed drug discovery. OSI
utilizes a comprehensive drug discovery and development capability to facilitate
the rapid and cost-effective discovery and development of novel, small molecule
compounds in more than 40 research and development programs. OSI is involved in
long-term research alliances with Pfizer, Tanabe, Novartis, Aventis, Sankyo, and
Solvay.
This news release contains forward-looking statements. These statements are
subject to known and unknown risks and uncertainties that may cause actual
future experience and results to differ materially from the statements made.
Factors that might cause such a difference include, among others, uncertainties
related to the identification of lead compounds, the successful pre-clinical
development thereof, the completion of clinical trials, the FDA review process
and other governmental regulation, pharmaceutical collaborators' competition
from other pharmaceutical companies, product pricing and third party
reimbursement, and other factors described in OSI Pharmaceuticals' filings with
the Securities and Exchange Commission.
ADDITIONAL INFORMATION ON OSI PHARMACEUTICALS IS AVAILABLE ON THE WORLD WIDE WEB
AT: HTTP://WWW.OSIP.COM
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