New Orleans, LA, May 23, 2000. - PRAECIS PHARMACEUTICALS INCORPORATED (NASDAQ: PRCS) today announced the results of two Phase III studies for its lead compound, abarelix depot-M, for the treatment of prostate cancer. PRAECIS is developing this product globally with its corporate collaborators. These two studies, which included 520 prostate cancer patients, showed the intended benefits of abarelix depot-M when compared head to head with leuprolide acetate depot or leuprolide acetate depot and bicalutamide, two drugs commonly used for treating prostate cancer. The data were presented at the 36th annual meeting of the American Society of Clinical Oncology (ASCO) in New Orleans by David McLeod, M.D., Director of Urologic Oncology at Walter Reed Army Medical Center.
Prostate cancer is one of the most commonly diagnosed cancers in men. According to the American Cancer Society, approximately 180,000 new diagnoses of, and 32,000 deaths from, prostate cancer will occur in the United States this year. Current prostate cancer therapies include surgery, radiation therapy, hormonal therapy or a combination of these. Hormonal therapies reduce the male hormone, testosterone, to low levels and are used because approximately 85% of newly-diagnosed prostate cancers are hormone-dependent tumors that require testosterone for their continued growth. Shutting off the body's normal production of testosterone, therefore, is the primary goal of hormonal treatment.
Available hormonal therapies may cause an initial surge or increase in the level of testosterone before the desired effect of lowering testosterone occurs. In the studies reported today, zero percent of the patients treated with abarelix depot-M experienced a testosterone surge compared to more than 80% of patients treated with leuprolide acetate depot, or a combination of leuprolide acetate depot plus bicalutamide. Further, abarelix depot-M suppressed testosterone levels more rapidly, achieving suppression by day 8 in 70% of patients compared to zero percent of patients treated with either leuprolide, or leuprolide plus bicalutamide. Each treatment therapy studied achieved and maintained testosterone suppression from day 29 through day 85 in more than 90% of patients. Reported side effects, such as hot flashes, were similar for all three hormonal treatment regimens.
"The studies show that abarelix depot-M represents a potentially new prostate cancer treatment which acts rapidly without causing a testosterone surge when therapy is initiated," said Marc B. Garnick, M.D., PRAECIS' Chief Medical Officer. "Based on the results of these trials, PRAECIS plans to continue clinical evaluation of abarelix depot-M and plans to file a New Drug Application with the United States Food and Drug Administration by fourth quarter, 2000."
"These positive clinical results validate PRAECIS' core technology for drug discovery and our ability as a company to bring pharmaceuticals through the drug development process. We look forward to advancing our other clinical programs which are aimed at treating patients suffering from other serious human diseases," said Malcolm L. Gefter, PRAECIS' President and Chief Executive Officer.
PRAECIS PHARMACEUTICALS INCORPORATED is a fully integrated drug discovery and development company that commercializes pharmaceuticals through integration of proprietary gene and chemistry-based combinatorial evolution technologies and drug delivery strategies.
This news release contains forward-looking statements. Such statements are subject to certain factors and uncertainties that may cause actual results to differ materially from expected results. These include, but are not limited to, unexpected results in further clinical trials, the need for additional research and testing, delays in manufacturing, access to capital and funding, and the timing and content of decisions made by the US Food and Drug Administration, as well as the risks set forth from time to time in PRAECIS' filings with the Securities and Exchange Commission, including but not limited to the risks discussed in PRAECIS' Registration Statement on Form S-1 (Registration No. 333-96351).
EDITOR'S NOTE: This release may be accessed via PRAECIS' web site at: http://www.praecis.com.
Abstract # 101680, D. McLeod: May 23, 2000 Abstract # 102719, D. McLeod: May 23, 2000
CONTACT:
PRAECIS PHARMACEUTICALS INCORPORATED Malcolm Gefter, President & CEO 617-494-8400 Noonan/Russo Communications, Inc. Renee Connolly (Media Relations) 212-696-4455 Ext. 227 or 917-930-8471 Patricia Dimond, Ph.D. (Investor Relations) 212-696-4455 Ext. 245