Healthcare Industry News:  central precocious puberty 

Biopharmaceuticals Drug Delivery

 News Release - April 6, 2006

Valera Pharmaceuticals Completes Phase III Study of Its Twelve-Month Implant for Treating Central Precocious Puberty

CRANBURY, N.J.--(HSMN NewsFeed)--April 6, 2006--Valera Pharmaceuticals, Inc. announced today the successful completion of the active clinical portion of its Phase III study of Supprelin® LA, a 12-month implant for treating central precocious puberty (CPP), or the early onset of puberty. This multi-center, open-label study involved 36 patients, primarily female, who ranged in age from four to eleven years.

Valera said that, in line with its previously stated milestone goal for the submission of a New Drug Application (NDA), it anticipates finalizing the preparation of documentation necessary to submit the NDA to the Food and Drug Administration (FDA) by the end of the second quarter of 2006. Meanwhile, interim data will be presented at the 2006 annual meeting of the Pediatric Academic Societies to be held in San Francisco from April 29 through May 2, 2006.

CPP, which is more prevalent in girls, is characterized by the premature development of secondary sexual characteristics due to an increase in secretion of the sex hormones. Additionally, if left untreated, the disorder limits a child from attaining full adult height, thus, resulting in short stature. The standard of care of CPP involves the use of LHRH agonists to suppress this hormonal production to delay the onset of puberty. A treatment regimen can generally run three to five years depending upon the age of a child at the time of diagnosis.

Supprelin LA would target a U.S. therapy market currently estimated at over $75 million annually. This market is dominated by Lupron Depot-PED® (leuprolide acetate for depot suspension) from TAP Pharmaceutical Products, Inc. which involves intramuscular injections of leuprolide administered every 4 weeks.

The Supprelin LA implant employs the Company's patented Hydron technology to provide the continuous twelve-month administration of a controlled dose of histrelin acetate. Histrelin acetate was previously approved by the FDA and marketed during the 1990's, under the brand name Supprelin, as a daily injection for treating CPP. In February 2006, Valera acquired the Supprelin brand name for use with the Company's long-acting implant.

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. VANTAS®, 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:

This press release contains forward-looking statements that are not historical facts but rather are based on current expectations, estimates and projections about the Company'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 the Company'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 the Company's Form 10-K as filed with the Securities and Exchange Commission on March 20, 2006. You are cautioned not to place undue reliance on these forward-looking statements. You should read the Company's Form 10-K, and the documents that the Company refers to therein and have filed as exhibits with the understanding that actual future results and events may be materially different from what the Company currently expects. The forward-looking statements included in this press release reflect the Company's views and assumptions only as of the date of this press release. Except as required by law, the Company undertakes no obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Source: Valera Pharmaceuticals

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