FDA Approves AllerNaze

Collegium Pharmaceutical Announces FDA Approval of AllerNaze, a Nasal Inhaled Steroid for the Treatment of Allergic Rhinitis

CUMBERLAND, R.I.--(BUSINESS WIRE)--Jan 8, 2009 - Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved AllerNaze (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 allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and children twelve (12) years of age and older.

AllerNaze will compete 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. Allergic rhinitis is the medical term for the inflammation of the nasal membranes and is characterized primarily by a runny nose, which is the most common allergy symptom. Seasonal allergic rhinitis is the most common allergic disease. Approximately 35 million Americans suffer from this condition. The ailment's classic symptoms are watery nasal discharge, fits of sneezing, and itching that can affect not just the nasal passage but also the roof of the mouth, throat and the Eustachian tubes which connect the middle ear to the back of the throat.

The safety and efficacy of AllerNaze Nasal Spray in both SAR and PAR have been well established in 14 controlled clinical trials involving almost 1,200 subjects. The studies assessed the safety and effectiveness of AllerNaze in treating the symptoms (runny nose, nasal itching, sneezing, and nasal congestion) in patients with allergic rhinitis.

The Company intends to launch the product with a marketing partner and is actively discussing the opportunity with potential partners for both the U.S. and international markets.

"We are very pleased to have received FDA approval for AllerNaze Nasal Spray" said Michael Heffernan, President of Collegium. "We believe that the benefits of AllerNaze'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 in both the US and select international markets."

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 is focused on building a portfolio of pain products that incorporate its patent protected DETERx formulation platform that provides for sustained release and tamper resistance. The Company through its subsidiary, Onset Therapeutics (www.onsettx.com) develops and commercializes products for skin and skin related disorders using its novel DELEVO Foam Technology. For more information, visit the Company's website at www.collegiumpharma.com.

About Allergic Rhinitis

Allergic rhinitis, known as nasal allergies, is an inflammatory reaction of the nasal passages to allergens, such as dust mites, animal dander, mold spores, and pollens. One of the most prevalent and chronic diseases in the United States, nasal allergies affect up to 40 million people, including 10 to 30 percent of adults and up to 40 percent of children. Within minutes of exposure to an allergen, immune response cells release chemicals such as histamine and leukotrienes that lead to inflammation and may produce symptoms including nasal congestion, sneezing and runny or itchy nose. Seasonal allergic rhinitis, triggered by pollens, occurs during certain seasons and lasts a few weeks to a few months. Perennial allergic rhinitis, triggered by dust mites, animal dander and mold, occurs year-round.

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

Posted: January 2009

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AllerNaze (triamcinolone acetonide) FDA Approval History

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