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Treatment for Precocious Puberty

Update: Supprelin-LA Now FDA Approved - May 3, 2007

Valera Pharmaceuticals Receives PDUFA Date for Supprelin-LA

CRANBURY, N.J., September 7, 2006 - Valera Pharmaceuticals, Inc. announced that the Food and Drug Administration (FDA) has accepted the submission of its New Drug Application (NDA) for Supprelin-LA, a 12-month implant for treating central precocious puberty (CPP) or the early onset of puberty in children. Accordingly, under the Prescription Drug User Fee Act (PDUFA) guidelines, the FDA is expected to complete its review and act upon this NDA submission by the PDUFA date of May 3, 2007.

Valera also noted that its Supprelin-LA manufacturing facilities in Cranbury, New Jersey, successfully passed a recent FDA pre-approval inspection. In November 2005, the FDA granted Supprelin-LA orphan drug designation which provides seven years marketing exclusivity from date of marketing approval as well as certain economic benefits and tax credits.

CPP is characterized by the premature development of secondary sexual characteristics in young children due to increased secretion of sex hormones. The standard of care involves the use of gonadotropin-releasing hormone (GnRH) agonists to suppress hormonal production to delay the onset of puberty. The current standard of therapy involves intramuscular injections administered every three to four weeks. In general, depending on the age of the child at the time of diagnosis, CPP hormonal therapy could run three to five years, or longer.

Supprelin-LA, which utilizes Valera's patented and proprietary Hydron implant technology, has been designed to provide the continuous 12-month administration of a controlled dose of histrelin. The multi-center, open-label Phase III study of Supprelin-LA, which is the basis of Valera's NDA submission, involved 36 patients ranging in age from four to eleven years. The primary endpoint of the study was hormonal suppression below pubertal levels by month three with continued suppression upon GnRH challenge. "All patients in the study were actually suppressed within the first month of treatment," noted Valera's President and CEO David S. Tierney, MD.

"While the outcome of any FDA review can never be assured, we are very encouraged by the clinical data and are optimistic about the prospects for Supprelin-LA," said Dr. Tierney.

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Posted: September 2006

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