Healthcare Industry News:  allergic rhinitis 

Biopharmaceuticals

 News Release - August 15, 2007

Collegium Pharmaceutical Provides Update on Development of its Nasal Inhaled Steroid for Allergic Rhinitis

Expects to file for FDA Approval by the end of 2007

CUMBERLAND, R.I.--(HSMN NewsFeed)--Collegium Pharmaceutical, Inc., a specialty pharmaceutical company with a focus on respiratory and CNS disorders, today announced an update on the development of its most advanced prescription product candidate for the treatment of allergic rhinitis. Collegium previously announced that it had acquired, from Muro Pharmaceutical, Inc., all rights to its Tri-Nasal® (triamcinolone acetonide, USP) Nasal Spray, including the product's approved NDA and the right to market the product. Triamcinolone acetonide is the same active ingredient found in Nasacort® AQ (Aventis) which had 2006 US sales of approximately $350 million according to IMS Health. Tri-Nasal® received FDA approval as a once-daily, intranasal steroid medication for the treatment of seasonal and perennial allergic rhinitis in adults and children over age 12. Tri-Nasal® was then the subject of a Class III voluntary recall for low potency found in certain lots of the product.

Since acquiring Tri-Nasal®, Collegium has initiated a comprehensive development program including the re-formulation of the product to address the recall issue. The Company has met with the FDA on numerous occasions to review the requirements for the approval of this reformulated product. The reformulated product, renamed AllerNase(TM) Nasal Spray, has a pending patent application covering the product formulation. In addition, the Company identified a manufacturing site for the product where numerous scale-up batches of AllerNase(TM) have been produced. Collegium expects to file a supplement to the NDA ("sNDA") by the end of 2007 with approval anticipated in 2008. The Company, in cooperation with Accentia Biopharmaceuticals, Inc. which currently holds the US commercial rights to AllerNase(TM), is exploring options with other potential US partners for commercialization of the product.

AllerNase(TM) competes in the $3 billion a year U.S. market for nasal inhaled steroids for the treatment of allergic rhinitis. allergic rhinitis is the most common allergic condition and is increasing in prevalence. Estimates suggest that as many as 20-25% of the U.S. population are currently affected. The most common treatments include nasal inhaled steroids and antihistamines. Competing inhaled steroid products in this category include Nasonex® (Schering), Nasacort® (Aventis) and Rhinocort Aqua® (AstraZeneca).

"We are very pleased with the progress we have made in moving AllerNase(TM) through the product development process," said Michael Heffernan, President of Collegium. "We believe that the benefits of its novel formulation will provide another alternative to the currently available treatment choices for allergic rhinitis and we intend to focus on identifying the best commercial options for the product."

About Collegium Pharmaceutical

Collegium Pharmaceutical, Inc. is a privately held specialty pharmaceutical company focused on the development of proprietary, late stage pharmaceutical products. These products target market opportunities through product improvement and line extension strategies protected by intellectual property (IP). Collegium applies customized pharmaceutical formulations and IP strategies to active ingredients that have been shown to be safe and effective, creating a portfolio of improved pharmaceutical products with potentially less development risk and shorter times to market. For more information, visit the Company's website at www.collegiumpharma.com.


Source: Collegium Pharmaceutical

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