AllerNaze

Treatment for Allergic Rhinitis

Update: AllerNaze Now FDA Approved - January 7, 2009

AllerNase sNDA Filed

Collegium Pharmaceutical Announces FDA Filing for AllerNase, a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis

CUMBERLAND, R.I.--(BUSINESS WIRE)--April 8, 2008 - Collegium Pharmaceutical, Inc., a specialty pharmaceutical company with a focus on respiratory and CNS disorders, today announced that it filed a Supplemental New Drug Application (sNDA) with the U.S. Federal Drug Administration (FDA) for the approval of AllerNase (triamcinolone acetonide, USP) Nasal Spray, 50 mcg, an aqueous based intranasal steroid indicated for the once daily treatment of nasal symptoms associated with both seasonal and perennial allergic rhinitis in adults and children twelve years of age and older.

Background:

Collegium acquired the rights, title and interest in Tri-Nasal (triamcinolone acetonide, USP) Nasal Spray, including the product's approved NDA and the right to market the product, from Muro Pharmaceutical, Inc. The efficacy and safety of Tri-Nasal Nasal Spray in both seasonal allergic rhinitis and perennial allergic rhinitis have been well established in 14 clinical trials involving almost 1,200 subjects. 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. The Product was then the subject of two Class III voluntary recalls, one for product leakage and the other for low potency. The product was indefinitely removed from the market in 2002.

Since acquiring Tri-Nasal, Collegium has initiated a comprehensive development program including the re-formulation of the product to address both the recall issues. The reformulated product has been named AllerNase Nasal Spray. It has a pending patent application covering the product's new formulation.

Market Opportunity:

AllerNase competes in the approximately $2.5 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), Rhinocort Aqua (AstraZeneca) and Veramyst (Glaxo).

The Company is in the process of identifying potential strategic marketing partners for both the U.S and international markets.

"We are very pleased to have filed this sNDA and advanced AllerNase Nasal Spray closer to the commercial stage" said Michael Heffernan, President of Collegium. "We believe that the benefits of AllerNase's novel aqueous based solution formulation containing a proven safe and effective active ingredient (triamcinolone acetonide) will provide another alternative to the currently available options for the treatment of allergic rhinitis. We intend to direct our focus on identifying the best commercial marketing partner for the product".

About Collegium Pharmaceutical

Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on the development of proprietary, late stage pharmaceutical products. These products target market opportunities through formulation based product improvements protected by intellectual property (IP). Collegium focuses on product development in respiratory diseases, CNS disorders, and skin and skin related disorders through its subsidiary, Onset Therapeutics (www.onsettx.com). For more information, visit the Company's website at www.collegiumpharma.com.

Contact

Collegium Pharmaceutical, Inc.
Steven N. Tannenbaum, 401-762-2000 Ext. 16
stannenbaum@collegiumpharma.com

Posted: April 2008

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