Collegium Pharmaceutical Inc. receives Notice of Allowance from U.S. Patent and Trademark Office for Novel Anti-Histamine Combination.

CUMBERLAND, R.I. -- Collegium Pharmaceutical, Inc. develops patented products for specialty pharmaceutical companies, today announced that it has received notification from the U.S. Patent and Trademark Office (PTO) allowing the Company's patent application US Patent 20030130263 "Compositions Containing Both Sedative and Non-Sedative Antihistamines." The patent relates to compositions comprising both a sedating and a non-sedating antihistamine in a single dosage form. More particularly the invention relates to a composition to be taken at bedtime containing the sedating antihistamine in immediate release form and the non-sedating antihistamine in delayed-release form, and a composition to be taken during the day containing the non-sedating antihistamine in immediate release form and the sedating antihistamine in delayed-release form.

The U.S. Market for anti-histamine products is currently estimated at $4 billion per year. Products that are currently available include the older anti-histamines which tend to have a sedating effect such as Diphenhydramine (e.g. Benadryl(TM)) and the newer anti-histamines which are considered more non-sedating such as Loratidine (e.g. Claritin(TM)). There are also combination products that include anti-histamines and decongestants. Clinicians estimate that 20-40% of patients with Allergic Rhinitis have a worsening of symptoms at bedtime that cause the potential for difficulties in sleeping. There are currently no available once a day products on the market in the U.S. that capitalize on the unique benefits of each type of anti-histamine in a method described in this patent. Collegium is in the process of developing the final formulation and intends to enter clinical trials in late 2004 with the lead product.

"We are very pleased to add this important patent to our growing patent portfolio" said Michael Heffernan, R.Ph., President, Collegium Pharmaceutical. "The product covered by this patent allows patients to avoid the sedating effects of antihistamines during the day time but takes full advantage of sedating antihistamines during the night time hours, with the added advantage of being a once a day medication."

About Collegium Pharmaceutical, Inc.

Collegium Pharmaceutical, Inc., is a privately held pharmaceutical company focused on the efficient 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 drugs that are safe and effective, creating a portfolio of improved pharmaceutical products with potentially less development risk and shorter times to market. Collegium uses its broad expertise in IP development, drug formulation, manufacturing, basic science (chemistry, biology, bioengineering), marketing and clinical trials management to identify and execute product opportunities for itself and its partners. For more information, visit the Company's website at www.collegiumpharma.com.