Axys Pharmaceuticals Announces Receipt of Proof-of-Concept Research Milestone From Merck in Osteoporosis Collaboration SOUTH SAN FRANCISCO, Calif.--(BW HealthWire)--Dec. 20, 1999--Axys Pharmaceuticals, Inc. (Nasdaq:AXPH - news) announced today the achievement of a research milestone in its collaboration with Merck & Co., Inc. (NYSE:MRK - news) based on the successful testing of a specific, selective cathepsin K inhibitor compound in an animal efficacy model.
Axys and Merck are proceeding to identify a safety assessment candidate for IND-enabling studies scheduled to commence in late 2000.
Axys and Merck entered into a two-year collaboration in November 1996 to develop small molecule inhibitors of cathepsin K as a treatment for osteoporosis. In February 1997 Axys announced it had solved the three-dimensional crystal structure of cathepsin K. In December 1998 Axys and Merck extended the collaboration for an additional year. Most recently in November 1999, the collaboration was extended for another year and research support was increased to Axys.
Cathepsin K is a member of a large family of cysteine proteases, and has been associated with the action of osteoclasts in bone degradation. Increased osteoclast activity after menopause results in bone loss and is characteristic of osteoporosis. Inhibiting this excessive enzyme activity may slow or reverse this condition, providing a new avenue for chronic therapy.
''The successful proof-of-concept study carried out by our colleagues at Merck suggests that inhibition of cathepsin K is a viable treatment modality for osteoporosis,'' commented Dr. Michael C. Venuti, Sr. Vice President, Research and Preclinical at Axys. ''Our focused efforts in the medicinal chemistry of protease inhibition, particularly in the cysteine protease family of enzyme targets originally accessed through our acquisition of Khepri Pharmaceuticals, has once again provided a series of candidate compounds for pivotal animal studies designed to prove the role of this target in disease pathology. As with many targets identified through genomics and functional biology, the connection of cathepsin K to osteoporosis has been postulated for a number of years. Without potent and highly selective inhibitors of enzymes such as cathepsin K, additionally possessing pharmacokinetic properties amenable to chronic dosing schedules, the biological connection of a target to a disease, and the utility of such a target in drug discovery and development, would remain speculative. The extension of our collaboration with Merck will now aim at identification of compounds optimized for safety, delivery and efficacy.''
''We are encouraged that an inhibitor of cathepsin K might provide a real advance in the chronic treatment of osteoporosis,'' said Dr. Gideon Rodan, Head, Bone Biology Research at Merck & Co., West Point, PA. ''The encouraging results obtained from the in vivo efficacy studies carried out using the cathepsin K inhibitor confirm the genetic and biological suggestion that this target is involved in the bone resorption process, and that inhibition of the cathepsin K enzyme may provide a directed way to restore balance to this process, which is in pathologic disequilibrium in osteoporosis.''
Axys Pharmaceuticals is a drug discovery and development company with a proprietary focus in oncology. Axys is building shareholder value through (1) a broad and diversified pipeline of research and development programs partnered with world-class pharmaceutical companies; (2) expansion of a non-partnered research and development franchise in oncology; and (3) the spin out of affiliated businesses that leverage the company's technologies in order to provide capital for Axys' drug discovery and development programs. Axys' technology-leveraging businesses are: Axys Advanced Technologies, a combinatorial chemistry oriented business; PPGx, a majority owned pharmacogenomics company, and Akkadix, an agricultural biotechnology company.
Merck & Co., Inc. is a global research-driven pharmaceutical company that discovers, develops, manufactures and markets a broad range of human and animal health products, directly and through our joint ventures, and provides pharmaceutical benefit services through Merck-Medco Managed Care.
Except for the historical information contained herein, this press release contains forward-looking statements that involve risks and uncertainties which could cause Axys' actual results to differ materially from those discussed here, including the reliance on the efforts of collaborative partners, the risk that this or other Axys collaborations will not be successful, the risk that clinical trials will not proceed as anticipated or may not be successful, the risks inherent in early stage development, the risk that Axys will not be successful in entering into new collaborations, competition and marketing risk, the risk of unexpected difficulties and delays in the development of new technologies and in expanding its manufacturing capabilities, and general economic conditions that may affect Axys' actual results and developments. Additional factors that could cause or contribute to such differences include, but are not limited to, those discussed in the sections entitled ''What Factors Could Cause Our Results to Differ Significantly from Those You Might Expect?'' and ''Additional Risk Factors'' in the Axys' SEC Reports, including Axys' report on Form 10-K for the fiscal year ended December 31, 1998.
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, 1998, Merck discusses in more detail various important factors that could cause actual results to differ from expected or historic results. One should understand that is not possible to predict or identify all such factors. Consequently, the reader should no consider any such list to be a complete statement of all potential risks or uncertainties.
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