Buserelin

Business Editors/Health/Medical Writers

BIOWIRE2K

CRANBURY, N.J.--(BUSINESS WIRE)--Sept. 4, 2003

Valera Pharmaceuticals:

Valera Pharmaceuticals, formerly Hydro Med Sciences, today announced it has adopted its new name - from the Latin root for 'strength' - signifying substantial achievements in its strategy to position itself for long-term growth as a niche specialty pharmaceutical company.

Under the leadership of its President and CEO, David S. Tierney, M.D., who joined the Company in mid-2000, Valera Pharmaceuticals has strategically built its pharmaceutical strengths to leverage its historical strengths in polymer biomaterial research. The latter includes specialty blends of hydrogel polymers, the science that led to the formulation of soft contact lenses, and more recently to the development of Valera's patented Hydron(TM) Implant technology, an innovative drug delivery platform.

Utilizing the Hydron(TM) Implant technology, Valera has custom designed an implant to provide for 12 months of controlled delivery of Histrelin for the palliative treatment of advanced prostate cancer. "We are very excited about this implant, because we expect to file for U.S. approval before year end and the product targets a comparatively huge market," noted Dr. Tierney. The hormonal treatment market for prostate cancer exceeds a billion dollars in the U.S. alone and the 12-month Histrelin implant would represent a definitive alternative to leuprolide, goserelin and buserelin therapies which are currently administered at one, three or four month intervals.

The Company also noted that it has already partnered this product with the Montreal based Paladin Labs (TSX:PLB), and anticipates a filing for the Canadian market early next year. The strength of Valera's development pipeline is further demonstrated by Phase II studies of another Hydron(TM) Implant which has been formulated for the continuous 12-month hormonal treatment of central precocious puberty.

Dr. Tierney, who previously served as President of Biovail Technologies, a division of Biovail Corporation (NYSE:BVF), said "The dramatically enhanced characteristics of Valera Pharmaceuticals have evolved over the past couple of years. During that time, we have substantially bolstered our pharmaceutical resources with highly experienced industry professionals who served in a broad range of functions with companies such as Elan Corp. (NYSE:ELN), Roberts Pharmaceutical Corp., Reed and Carnrick, Shire Pharmaceuticals Group (NASDAQ:SHPGY), Schering-Plough (NYSE:SGP), Pfizer (NYSE:PFE) and Bristol-Myers Squibb (NYSE:BMY)."

"In the absence of such in-house pharmaceutical capabilities, the Company would have little choice except to seek out-licensing opportunities for its technology; thus, forfeiting the much greater returns possible by developing and commercializing its own specialty therapeutics," noted Dr. Tierney.

"For example, despite encouraging data obtained by the Population Council regarding early studies of the 12-month Histrelin implant for prostate cancer, the rights to that product had been out-licensed to Roberts Pharmaceutical in late 1988, at a time when I was that company's Head of Drug Development," said Dr. Tierney. "Roberts was then acquired at year-end 1999 by Shire, and by early 2002 Valera decided to reacquire the rights to the 12-month Histrelin implant and accelerate its Phase III development. We are now on the threshold of recognizing the fruits of our labor as we begin to prepare the data for submission to the Food and Drug Administration."

Dr. Tierney further noted, "We have also been fortunate to have the financial backing of some very knowledgeable healthcare investors, including: Corporate Opportunities Funds, an affiliate of the Houston-based investment management firm of Sanders Morris Harris (NASDAQ:SMHG); plus Wheatley Partners, a New York-based venture capital firm; and Paladin Labs, a specialty pharmaceutical company and our Montreal-based Canadian partner for the 12-month Histrelin implant for prostate cancer."

"We will continue to look at other drug delivery opportunities and entertain the possibility of out-licensing our technology to the appropriate partners," concluded Dr. Tierney. "Moreover, we will also seriously consider product acquisitions, co-promotion deals and other strategic alliances in select therapeutic categories such as the urology and endocrinology markets. While we possess very powerful drug delivery capabilities and plan to leverage the strengths of that technology platform, we intend to grow and evolve into a well integrated specialty pharmaceutical company."

About the Hydron(TM) Implant Technology

The Hydron(TM) Implant technology represents potentially significant benefits arising from the administration of small, but potent amounts of a therapeutic at a controlled rate for up to a year or more. The technology can be custom-designed to fulfill unmet therapeutic delivery needs, thus providing the potential of offering increased bioavailability, enhanced efficacy, reduced drug load and lower side effects. The implants are compact, highly flexible and retrievable subcutaneous devices that can be inserted in a physician's office with a local anesthetic.

About Valera Pharmaceuticals

Valera Pharmaceuticals, with executive offices in Cranbury, N.J., is led by a highly experienced management team, and is committed to extending the possibilities of pharmaceutical healthcare. 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.ValeraPharma.com/.

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