Collegium Pharmaceutical is Granted U.S. Patent on Once Daily, Pulsatile Delivery of Antiarrhythmic Sotalol.

Business Editors/Health/Medical Writers

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HINGHAM, Mass.--(BUSINESS WIRE)--May 21, 2003

Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced the issuance of U.S. Patent No. 6,500,457 B1 entitled "Oral Pharmaceutical Dosage Forms for Pulsatile Delivery of An Antiarrhythymic Agent." The patent relates to methods for novel pharmaceutical dosage forms that provide for once daily, pulsatile delivery of Sotalol HCL, a widely used Class III antiarrhythmic in widespread use. Sotalol is used to treat life-threatening ventricular arrhythmias as well as symptomatic atrial fibrillation/atrial flutter in patients currently in sinus rhythm. The drug is presently available only in a twice daily formulation as Betapace(R) and Betapace AF(TM) (Berlex) as well as generics. Collegium's once daily, pulsatile formulation is designed to mimic the twice daily dosing schedule by combining immediate and delayed release functions resulting in plasma levels consistent with twice daily administration. The Company anticipates that the new formulation may have clinical benefits in addition to greater convenience.

Use of Class III drugs for treating ventricular arrhythmias has grown since the identification of mortalities associated with Class I agents in the early 1990's. The twice daily formulation of Sotalol (Betapace(R)/Betapace AF(TM)) had 2001 U.S. prescription sales in excess of $100 million. "We are very pleased to add this important patent to our growing patent portfolio of proprietary delivery methods and formulations," said Jessica Wolfe, PhD, Vice President, Collegium Pharmaceutical. "Improving existing therapeutic products by addressing medical concerns and patient compliance is an important market area and one where Collegium has extensive expertise. We look forward to further contributions in a number of disease areas." The Company expects to complete initial bioavailability studies in 2003.

A copy of the above patent is available at http://www.uspto.gov.

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.