Pfizer plays intermediate?.... Merck and OSI can cross-license, but Sibia and KDUS couldn't reach an agreement. Comer and Levin wound one good biotech and kill another, over chump change.......
Monday June 12, 7:30 am Eastern Time
Company Press Release
SOURCE: OSI Pharmaceuticals, Inc.
OSI Pharmaceuticals Announces Cross-Licensing of
its Gene Transcription Patent Estate With Merck &
Co., Inc.
- OSI Accesses Former SIBIA Neurosciences' Patents -
UNIONDALE, N.Y., June 12 /PRNewswire/ -- OSI Pharmaceuticals, Inc. (Nasdaq: OSIP - news) announced today that it
has signed a worldwide, non-exclusive, cross-licensing agreement with Merck & Co., Inc. (NYSE: MRK - news) involving
OSI's gene transcription patent estate and Merck's family of patents referred to as the Transcription Based Assay (TBA)
patents, that were previously owned by SIBIA Neuroscience, Inc. prior to their acquisition by Merck & Co., Inc. in
November 1999. Financial terms of the agreement have not been disclosed.
``Today's agreement concludes OSI's strategy to fully enable an outstanding platform of yeast-based technologies for GPCR
based drug discovery which we acquired from Cadus last year,'' stated Colin Goddard, Ph.D., President and Chief Executive
Officer of OSI Pharmaceuticals, Inc.
OSI's licensing of Merck's patents complements the portfolio of intellectual property which OSI acquired through its purchase
of the research assets of Cadus Pharmaceutical Corporation in July 1999; its subsequent licensing of patented yeast screening
technology from American Cyanamid Company in January, 2000; and the licensing of additional yeast assets from Cadus in
February, 2000. The TBA patents were the subject of a patent dispute between SIBIA and Cadus, which resulted in a
judgment against Cadus and an injunction blocking them from using their core yeast-based G-protein coupled receptors
(GPCR) technology.
The agreement allows OSI to fully utilize a comprehensive platform of functional genomics and drug discovery technologies for
GPCRs. GPCRs are an important class of targets in drug discovery, comprising over 40 percent of currently marketed
pharmaceuticals. This agreement enhances OSI's capacity to rapidly identify small molecule ligands for both known and
so-called ``orphan'' GPCRs. The technology platform comprises proprietary bio-informatics; cloning and expression of orphan
GPCRs in yeast; and high throughput screening of OSI's chemical and natural product libraries.
Merck joins American Home Products, Pharmacia & Upjohn, R.W. Johnson Research Institute, a Johnson & Johnson
Company, and Aurora Biosciences as licensees of OSI's gene transcription patent estate.
OSI's patent estate results from the Company's pioneering application of gene transcription approaches for drug discovery. The
principal patent, U.S. Patent No. 5,776,502, issued July 7, 1998, covers the use of low molecular weight compounds for
pharmaceutical, agricultural or veterinary purposes to modulate gene transcription in vivo. A second patent, U.S. Patent No.
5,665,543, issued September 1997, covers methods of discovering compounds which modulate gene transcription using
reporter gene technology. The patent estate includes other associated patents and patent applications.
The TBA patents consist of claims that cover assay systems designed to identify compounds that bind to cell-surface receptors
and are commonly referred to as transcription based assays or TBA. Taken together the two estates comprise an impressive
and comprehensive intellectual property estate for drug discovery in the gene transcription area.
``The ability to establish freedom-to-operate in various drug discovery technologies is becoming an important competitive
advantage within the biotechnology sector,'' added Dr. Goddard. ``OSI is now in a very strong position to conduct discovery
activities in two important technology areas: gene transcription and yeast-based approaches to GPCR drug discovery and
functional genomics.''
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.
This press release may contain so-called ``forward-looking statements'', all of which are subject to risks and uncertainties. One
can identify these forward-looking statements by the fact that they do not relate strictly to historical or current facts. These
statements are likely to address Merck's growth strategy, financial results, product approvals and development programs. One
must carefully consider any such statement and should understand that many factors could cause actual results to differ from
Merck's forward-looking statements. These factors include inaccurate assumptions and a broad variety of other risks and
uncertainties, including some that are known and some that are not. No forward-looking statement can be guaranteed and
actual future results may vary materially. Merck does not assume the obligation to update any forward-looking statement. One
should carefully evaluate such statements in light of factors described in Merck's filings with the Securities and Exchange
Commission, especially on Forms 10-K, 10-Q and 8K (if any). In Item 1 of Merck's annual report on Form 10-K for the year
ended December 31, 1999, Merck discusses in more detail various important factors that could cause actual results to differ
from expected or historic results. One should understand that it is not possible to predict or identify all such factors.
Consequently, the reader should not consider any such list to be a complete statement of all potential risks or uncertainties.
Additional information on OSI Pharmaceuticals is available on the World Wide Web at: osip.com.
Functional Genomics at OSI Pharmaceuticals
G-protein coupled receptors or GPCRs, are one of the largest families of targets for drug discovery in the pharmaceutical
industry, with approximately 40% of the currently marketed pharmaceutical products effecting their function through modulation
of GPCR activity. While novel members of this class of proteins continue to be identified through advances in molecular biology
and bio-informatics, the physiological role played by these ``orphan'' receptors remains obscured due to a disappointing lack of
agonists and antagonists. Thus a wealth of potential targets for drug discovery has, for the most part, remained untapped. OSI
has established a powerful methodology by which this class of orphan genomic sequences may be converted into targets for
therapeutic intervention by its functional genomics program. This scientific platform relies upon the yeast, Saccharomyces
cerevisiae , in which the pheromone response signal transduction pathway has been modified to allow the coupling of genetically
engineered human GPCRs with humanized G-protein subunits. Activation of the receptor signaling pathway is then detected by
reporter gene expression. This provides a means by which small molecule, natural product libraries, and biological extracts can
be rapidly screened in a high-throughput mode to detect synthetic and natural ligands to the receptor. One of the major
advantages of this approach is the absence of other GPCR subtypes, which can greatly obscure ligand identification in
mammalian cell systems. Ligand-receptor pairs can subsequently be used to identify/develop additional agonists as well as
antagonists that are utilized for physiological studies. Once potential therapeutic value is identified, compounds can be advanced
for further clinical study.
SOURCE: OSI Pharmaceuticals, Inc. |
