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Collegium Pharmaceutical Inc. Announces Notice of Allowance for U.S. Patent Covering its Novel Combination Allergic Rhinitis Product


Tuesday, May 26, 2009

Key patent will expand and extend protection of COL-118 until 2026

Cumberland, RI -- Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its patent application "Compositions containing both sedative and non-sedative antihistamines and sleep aids", US Patent Application Number 10/943,311. The Notice of Allowance is the USPTO’s official communication that the Company’s application has successfully completed examination and that a patent will be issued.

Once issued, this patent along with other previously issued patents will provide broad protection for Collegium’s novel modified release combination antihistamine (COL-118) for the treatment of allergic rhinitis. In addition to the patents that have been issued or allowed to date in the US, international patents have also been allowed in Europe and Canada. These broad patents cover COL-118, Collegium’s lead product candidate, as well as multiple variations of the core product concept.

COL-118 is a fixed dose combination product for the treatment of allergic rhinitis. The product combines both a sedating antihistamine (immediate-release) for symptom relief at night with a non-sedating antihistamine (delayed release) for daytime relief in a novel, patented, once-daily formulation. Collegium’s research suggests that there is an unmet need for an antihistamine with the efficacy of first-generation sedating products and the safety of second-generation non-sedating products, which provides a full 24 hours of coverage for the patient. It is estimated that as many as 20%-40% of patients with allergic rhinitis are reported to have worsening of symptoms at bedtime that often lead to difficulties in sleeping, as well as in the early morning hours.

A clinical proof-of-concept trial was completed for the product. The study demonstrated that in the target population (patients with moderate to severe symptoms as measured by Total Nasal Symptom Score (TNSS)), COL-118 relieved symptoms of allergic rhinitis in both the morning following dosing and at 24 hours after dosing better than a non-sedating antihistamine alone and placebo while also maintaining a safety profile similar to that of the non-sedating antihistamine and placebo. Collegium had a successful End of Phase II meeting with the FDA during which the Phase III protocol was reviewed and the basis for regulatory approval was confirmed. COL-118 will be available as an OTC product upon approval from the FDA.

Allergic rhinitis affects approximately 40 million people in the United States, according to the American Academy of Allergy, Asthma, and Immunology. Annual sales of allergic rhinitis products are currently estimated at more than $4 billion per year in the United States alone. Antihistamine products comprise a significant sector of this market. Antihistamines that are currently available for the treatment of allergic rhinitis include both first generation antihistamines which tend to have a sedating effect, such as diphenhydramine (e.g. Benadryl®), and the newer antihistamines which are considered less sedating, such as loratadine (e.g. Claritin®) and cetirizine (Zyrtec®). The antihistamine market growth is anticipated to be primarily in OTC products in the future.

"This recently allowed patent in conjunction with our existing intellectual property not only provides exclusivity for COL-118, but also extends to other potential variations of this unique combination, including changes in the active ingredients as well as the inclusion of additional drug actives. Our market research suggests that this product has the potential to address a large unmet patient need in the treatment of allergic rhinitis", said Michael Heffernan, R.Ph., President, Collegium Pharmaceutical.

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.

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.



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