Collegium Pharmaceutical Inc. Announces Notice of Allowance for U.S. Patent for its DETERx Abuse Deterrent Sustained Release Technology

Feb 14, 2008 - 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 "Abuse-Deterrent Pharmaceutical Compositions of Opioids and Other Drugs", US Patent Application Number 10/614,866. 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, the patent will provide broad coverage for Collegium's abuse-deterrent, sustained-release, orally administered formulation platform, trademarked "DETERx(TM)". The DETERx(TM) platform consists of a multiparticulate matrix formulation in a capsule. While developed primarily to provide tamper resistant properties, the multiparticulate design has the potential to enable patients with difficulty swallowing to open the capsule and administer the contents on food or with water, while maintaining the desired sustained release properties of the product.

Collegium's lead DETERx(TM) product candidate, COL-003, a formulation of sustained release oxycodone, will be covered by the patent. As previously reported, COL-003 is currently under clinical development pursuant to an active investigational new drug application on file with the United States Food and Drug Administration ("FDA"). Based on in vitro testing and previously reported pharmacokinetic results, COL-003 is expected to provide adequate plasma concentrations to effectively treat pain over a 12 hour period while deterring abuse by oral administration (e.g. chewing, crushing), intravenous injection and nasal administration. Collegium recently reported receipt of Fast Track Designation for the product from the FDA.
"This is an important patent in that it provides coverage for our lead DETERx(TM) product candidate, COL-003, and the DETERx(TM) platform technology in general. Since the patent is for the delivery platform, it will cover any scheduled drug that we incorporate into DETERx including COL-171 (treatment of ADHD) and COL-172 (management of moderate to severe pain), both of which are in pre-clinical development. We plan to continue to strengthen the patent portfolio around the DETERx(TM) technology platform and we look forward to the allowance of complementary and specific product related IP," said Dr. Alison Fleming, Director of Product Research & Development, Collegium Pharmaceutical and one of the inventors of the technology.