Valera Pharmaceuticals Announces FDA Approval of Vantas, a 12-Month Implant for Treating Prostate Cancer; Heralds Valera's Transition from a Research Firm to a Specialty Pharma Company.

CRANBURY, N.J. -- Valera Pharmaceuticals today announced that the Food and Drug Administration (FDA) approved the marketing of Vantas(TM), the Company's long-acting implant, indicated for the palliative treatment of advanced prostate cancer. Utilizing Valera's Hydron Implant technology, Vantas(TM) has been designed for the continuous 12-month administration of histrelin, a synthetic nonapeptide agonist of luteinizing hormone-releasing hormone (LHRH).

Valera noted that LHRH agonists have become a mainstay in treating locally advanced and metastatic prostate cancer with the U.S. market for such therapies representing over $1 billion in annual sales. However, this market is dominated by 4-month and shorter duration depot injections or implants, led by Lupron Depot(R) (leuprolide acetate for depot suspension) from TAP Pharmaceutical Products Inc. and includes Zoladex(R) (goserelin acetate implant) from AstraZeneca PLC (NYSE:AZN).

"The Vantas(TM) approval marks a key turning point in a strategy to transition Valera from a research firm to a specialty pharmaceutical company," noted David S. Tierney, MD, Valera's President and CEO. "In the few years since I joined the Company in mid-2000, we broadened and strengthened our team of pharmaceutical professionals. We also established and expanded our drug development program with Vantas(TM) now having the distinction of being the first to emerge from the product pipeline. Our excitement over this landmark event is heightened by the fact that this approval was granted within ten months of our submission of a New Drug Application."

"Moreover, it was only three years ago that our Company - then known as Hydro Med Sciences, an affiliate of GP Strategies (NYSE:GPX) - began shifting its focus from the out-licensing of science and technology to being a product driven specialty pharmaceutical company," continued Dr. Tierney. "To this end, and supported by over $30 million of private equity funding, in early 2002 we reacquired from Shire Pharmaceuticals (NASDAQ:SHPGY) previously out-licensed rights to our 12-month histrelin implant technology and then aggressively advanced that program through clinical development to today's announced approval."

"Furthermore, we have already deployed our own sales force and begun to manufacture Vantas(TM) in our cGMP approved facilities," said Dr. Tierney. "All these key components are coming together smoothly and we expect to begin ramping up product sales in the very near term. With the approval of Vantas(TM) and with other pipeline drugs in late-stage development, we are very optimistic about our future. We look to 2005 as a year of revenue growth and a year during which Valera turns cash-flow positive and profitable."

About Valera Pharmaceuticals

Valera Pharmaceuticals, formerly known as Hydro Med Sciences, has strategically built its pharmaceutical strengths to leverage its historical strengths in polymer biomaterial research. Today, with executive offices, state-of-the-art research laboratories and cGMP manufacturing located in Cranbury, NJ, Valera is a specialty pharma company led by an experienced and strong team of experts in drug development, product licensing, and sales and marketing. The Company focuses on developing, acquiring, and commercializing therapeutics addressing the needs of select niche markets with a focus on urology and endocrine physician specialties. Additionally, through internal R&D and strategic partnerships, Valera is advancing the state-of-art of drug delivery with its innovative Hydron Implant technology. Utilizing specialty blends of hydrogel polymers, this drug delivery platform allows for the formulation of highly compact, light weight, flexible and retrievable subcutaneous implants that can be inserted in a physician's office with a local anesthetic, and which can be designed to provide for the administration of small, but potent amounts of therapeutic at a controlled rate for up to a year or more. Further information is available on the internet at: http://www.ValeraPharma.com