VALERA PHARMACEUTICALS, INC.
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Valera Pharmaceuticals, Inc. is a US-based specialty pharmaceutical company that focuses on the development and commercialization of urology and endocrinology products. The company, with registered head office located in Cranbury, New Jersey, was founded in 1972. Formerly known as Hydro Med Sciences, Inc., the company changed its name to Valera Pharmaceuticals, Inc. in 2003.
Valera Pharmaceuticals develops implants that continuously deliver drugs directly to the bloodstream for a year or more. Its FDA-approved Vantas administers histrelin to patients with advance prostate cancer. In addition, Valera is developing several drug candidates to treat acromegaly (giantism), bladder disorders, addictive disorders, and other conditions. The company sells its products primarily to urologists in the United States. In 2007, Valera Pharmaceuticals was acquired by the Massachusetts-based Indevus Pharmaceuticals, Inc., which is a specialty pharmaceutical company engaged in the acquisition, development and commercialization of products to treat conditions in urology and endocrinology.
Valera Pharmaceuticals, Inc. (Valera) is a specialty pharmaceutical company concentrating on the development, acquisition and commercialization of products for the treatment of urological and endocrine conditions, diseases and disorders, including products that use its drug delivery technology. The Company’s first product, Vantas, was approved by the United States Food and Drug Administration (FDA) in October 2004. Other product candidates include Supprelin-LA, VP003 (Octreotide), VP004 (Naltrexone), VP005 (Anti-inflammatory), VP006 (rapid dissolve desmopressin), Valstar (Valrubicin) and Endoureteral Stent. In April 2007, Indevus Pharmaceuticals, Inc. and Valera completed their merger. Valera was acquired by Indevus Pharmaceuticals, Inc.
Description and history
Valera Pharmaceuticals, Inc. (Valera), incorporated on May 30, 2000, is a specialty pharmaceutical company concentrating on the development, acquisition and commercialization of products for the treatment of urological and endocrine conditions, diseases and disorders, including products that use its drug delivery technology. The Company’s first product, Vantas, was approved by the United States Food and Drug Administration (FDA) in October 2004. Other product candidates include Supprelin-LA, VP003 (Octreotide), VP004 (Naltrexone), VP005 (Anti-inflammatory), VP006 (rapid dissolve desmopressin), Valstar (Valrubicin) and Endoureteral Stent. In April 2007, Indevus Pharmaceuticals, Inc. and Valera completed their merger. Valera was acquired by Indevus Pharmaceuticals, Inc.
Vantas is a soft and flexible 12-month hydrogel implant based on the Company’s Hydron Technology indicated for the palliative treatment of advanced prostate cancer that delivers histrelin, a luteinizing hormone-releasing hormone (LHRH) agonist, over a 12-month period. In November 2005, Valera announced that it received approval to market Vantas in Denmark, and in July 2006, an application for regulatory approval in Germany, Ireland, Italy, Spain and the United Kingdom was submitted. In July 2006, a partnership with Spepharm Holding B.V (Spepharm) to market Vantas in Denmark and throughout Europe was announced. As of December 31, 2006, Vantas was submitted for regulatory approval in Thailand, Singapore, Malaysia, Taiwan, Korea Hong Kong and China.
Valera competes with TAP Pharmaceutical Products, Sanofi-Aventis, Watson Pharmaceuticals, AstraZeneca and Bayer Pharmaceuticals.
Supprelin-LA is an implant using the Hydron Technology to deliver histrelin over a 12-month period for the treatment of central precocious puberty. In June 2006, the Company submitted a new drug application (NDA) to the FDA for Supprelin-LA. In September 2006, Valera announced that its Supprelin-LA manufacturing facilities in Cranbury, New Jersey successfully passed an FDA pre-approval inspection.
Valera competes with TAP Pharmaceutical Products.
VP003 is an implant using Hydron Technology to deliver octreotide over a six-month period for the treatment of acromegaly, or giantism. The has Company initiated and completed a Phase I/II pharmacokinetic clinical trial with 11 acromegalic patients to evaluate the release characteristics of VP003 and examine safety and efficacy parameters. In August 2006, the FDA requested an additional Phase I/II pharmacokinetic study for the Octreotide implant. In September 2006, Valera submitted an investigational new drug application (IND) with the FDA for the Octreotide implant.
Valera competes with Novartis and Pfizer.
VP004 is an implant using the Hydron Technology to deliver naltrexone for the treatment of opioid addiction over a 3 to 6-month period. In May 2006, the Company submitted an IND application for VP004 to the FDA and that filing has been accepted by the agency. In November 2006, all administrative arrangements with Johns Hopkins Bayview Medical Center were finalized and clinical studies for VP004 commenced.
VP005 is a polymer solution instillation for the treatment of symptoms associated with interstitial cystitis (IC), a chronic inflammatory condition of the bladder. The Company may license the drug delivery technology used in VP005 and apply for patent protection for this application of that technology. A Phase I/II protocol has been drafted to evaluate VP005 in humans.
VP006 (Rapid Dissolve Desmopressin)
VP006 is a modified release oral formulation of desmopressin for the treatment of nocturnal enuresis, commonly referred to as bed-wetting. It has been evaluated in bio-availability studies and has shown a good pharmacodynamic response.
In March 2006, Valera completed the acquisition of certain assets from Anthra Pharmaceuticals, Inc. associated with its valrubicin business in the United States and Canada. The valrubicin product is a bladder instillation approved to treat bladder cancer that is no longer responsive to conventional treatments. In January 2006, the FDA agreed to the Company’s plan to reintroduce the product in the United States. The Company has engaged a third-party manufacturer to produce the finished version of Valstar.
On November 8, 2006, the Company completed studies on a flexible, biodegradable polymer-based ureteral stent for draining urine from the kidney to the bladder. In February 2007, it initiated a porcine model study to establish safety and effectiveness necessary to support the submission of a 510k device application for the polymer-based flexible biodegradable ureteral stent.
Formerly known as Hydro Med Sciences, Inc
A US-based specialty pharmaceutical company that focuses on the development and commercialization of urology and endocrinology products
ERNST & YOUNG LLP
US SIC Code
7, Clarke Drive
City province or state postal code
08512, CRANBURY, NJ
Phone: +1 609 235 3000
Fax: +1 609 409 1650
Country address: UNITED STATES OF AMERICA
Website url: www.valerapharma.com