Healthcare Industry News:  VP004 

Biopharmaceuticals Drug Delivery

 News Release - November 6, 2006

Valera Pharmaceuticals Commences Clinical Studies of a Long-Acting Naltrexone Implant for Opioid Addiction

CRANBURY, NJ--(Healthcare Sales & Marketing Network)--Nov 6, 2006 -- Valera Pharmaceuticals, Inc. (NASDAQ:VLRX ) today announced it has finalized all administrative arrangements with Johns Hopkins necessary to begin clinical studies for VP004, a subcutaneous implant utilizing Valera's Hydron technology to deliver naltrexone, over an extended period of time, for the treatment of opioid addiction.

An Investigational New Drug Application (IND) for VP004 was submitted by Valera to the Food and Drug Administration (FDA) in late June 2006 and that filing has been accepted by the agency.

Valera said proof-of-concept studies, including patient screening, will commence November 8, 2006. This initial clinical trial will involve an open label study of Valera's naltrexone implant in approximately a dozen healthy volunteers with a history of opioid abuse. A primary objective of the study is to investigate the extent of opiate blockade following morphine challenges. The lead investigator is the pioneering addiction researcher and renowned authority on naltrexone, Donald Jasinski, M.D., Professor of Medicine, Chief Center for Chemical Dependence, Johns Hopkins Bayview Medical Center.

As noted in a previous press release of June 27, 2006, Valera believes that at this early stage of development it is not possible to predict with certainty the duration of time over which its naltrexone implant will deliver an effective therapeutic dose of the active agent. "Our goal is a three to six month implant," said David S. Tierney, M.D., Valera's President & CEO. "We believe an implant that can provide a controlled release of naltrexone for that length of time would offer significant compliance advantages over the currently approved daily oral dosing of naltrexone for treating opioid dependence."

Naltrexone was approved by the FDA in the early 1980s as a daily oral medication for treating heroin addiction. It is a potent opioid receptor antagonist that binds to receptors in the brain, thus, blocking the euphoric effects produced by opioids. However, as an oral tablet administered once daily, this treatment for drug abuse has faced a serious patient compliance issue, because most patients forget or deliberately choose not to take their medicine.

About Valera Pharmaceuticals

Valera Pharmaceuticals is a specialty pharmaceutical company focused on developing, acquiring, and commercializing products to treat urology and endocrinology diseases and disorders. Utilizing its innovative Hydron technology, Valera is developing soft, compact and flexible hydrogel-based implants which can be designed to release therapeutic agents at a controlled rate for up to twelve months. VANTASĀ®, a patent protected once-per-year implant currently marketed by Valera for the palliative treatment of advanced prostate cancer, employs this drug delivery technology. Additional information about Valera Pharmaceuticals is available at: http://www.valerapharma.com.

This press release contains forward-looking statements that are not historical facts but rather are based on current expectations, estimates and projections about Valera's industry, beliefs and assumptions. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks" and "estimates," and variations of these words and similar expressions, are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and other factors, some of which are beyond Valera's control, are difficult to predict and could cause actual results to differ materially from those expressed, implied or forecasted in the forward-looking statements. In addition, the forward-looking events discussed in this press release might not occur. These risks and uncertainties include, among others, those described in "Risk Factors'' contained in Valera's Form 10-K as filed with the Securities and Exchange Commission (SEC) on March 20, 2006, and as updated in Valera's Form 10-Q, as filed with the SEC on August 9, 2006, and as may be further updated from time to time. You are cautioned not to place undue reliance on these forward-looking statements. You should read Valera's filings with the Securities and Exchange Commission, including Forms 10-K and 10-Q, and the documents that Valera refers to therein and have filed as exhibits with the understanding that actual future results and events may be materially different from what Valera currently expects. The forward-looking statements included in this press release reflect Valera's views and assumptions only as of the date of this press release. Except as required by law, Valera undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.


Source: Valera Pharmacuticals

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.



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