Hydro Med Sciences Accelerates Phase III Trials of 12-Month Implant For Prostate Cancer.

Business Editors & Health/Medical Writers

CRANBURY, N.J.--(BW HealthWire)--March 1, 2002

Targets Large Market Dominated by Shorter Acting LHRH Therapies

Including Lupron Depot(R) and Zoladex(R)

Hydro Med Sciences (HMS) today announced it has accelerated Phase III development of its Histrelin (histrelin acetate) implant for the continuous 12-month administration of this LHRH agonist for treating prostate cancer, the most prevalent form of cancer afflicting American men.

The annual U.S. market for LHRH treatments of prostate cancer is estimated at over $1 billion. However, this market is dominated by 4-month and shorter duration depot injections or implants, led by Lupron Depot(R) (leuprolide acetate) from TAP Pharmaceutical Products Inc. (a joint venture of Abbott Laboratories (NYSE:ABT) and Takeda Chemical Industries Ltd) and includes Zoladex(R) (goserelin acetate implant) from AstraZeneca PLC (NYSE:AZN, LSE:AZN.L).

The Histrelin implant utilizes Hydro Med's innovative Hydron(TM) Implant technology, representing potentially significant benefits arising from administering small, but potent amounts of a therapeutic at a controlled rate for up to a year or more. Additionally, the Histrelin implant is compact, highly flexible and a retrievable subcutaneous implant that can be inserted in a physician's office with a local anesthetic.

HMS has added 11 additional urology clinical sites. To date, 40 patients have completed over 12 months of therapy in the Histrelin arm of the study with all reaching a critical clinical marker, i.e., drug induced castration within 4 weeks. Moreover, among patients evaluated at week 52, all satisfied the criteria of induced castration based on monthly blood analyses. LHRH agonists inhibit testosterone production and such hormonal deprivation is an established treatment option to surgical castration.

Dr. David Tierney, President and CEO of HMS, said, "Given the very encouraging results of the clinical studies and success of our recent financing, we accelerated the Histrelin studies to conclude the trials and launch the implant as soon as possible."

While recognizing that the outcome of any clinical study can never be guaranteed, HMS anticipates completing the studies during the second-half 2003. Also, these are open label trials, so data can be entered as the study progresses and documentation for submission to the Food and Drug Administration (FDA) should be substantially ready with the completion of the trials.

Assuming FDA clearance around mid-year to the third-quarter 2004, HMS intends to market the Histrelin implant itself in the U.S., but plans to out-license rights in other geographic areas to a well positioned partner.

Hydro Med Sciences is committed to extending the possibilities of pharmaceutical health care. The company focuses on developing, acquiring and commercializing specialty pharmaceuticals and, through internal R&D and strategic partnerships, is advancing the state-of-art of drug delivery with its innovative Hydron(TM) Implant technology. Additional information is available on the Internet at: http://www.hydromed.com/