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Collegium Pharmaceutical Inc. Announces U.S. Patent Issued Covering its DETERx Abuse Deterrent Sustained Release Technology

Wednesday, July 16, 2008

Patent will cover lead sustained release opioid product, COL-003 until 2025

Cumberland, RI -- Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that a new patent has been issued by the U.S. Patent and Trademark Office (USPTO) relating to its tamper resistant, abuse-deterrent formulation platform. US Patent Number 7,399,488 contains claims that cover orally administrable compositions comprising Collegium’s proprietary micro-particle formulations. The formulations are designed to be more resistant to physical methods of tampering than currently available sustained release dosage forms. US Patent No. 7,399,488 will provide protection for DETERx™ and products incorporating the DETERx™ technology into the year 2025.

The patent will provide broad coverage for Collegium’s abuse-deterrent, sustained-release, orally administered DETERx™ formulation platform. The DETERx™ platform consists of a multi-particulate matrix formulation in a capsule. While developed primarily to provide tamper resistant properties, the multi-particulate design potentially allows patients with difficulty swallowing to open the capsule and administer the contents on food or with water, while maintaining the sustained release properties of the product.

Collegium’s lead DETERx™ 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. The abuse-deterrent properties of DETERx™ are the result of the formulation itself, which protects the drug from dose dumping, as demonstrated in a variety of laboratory tampering simulations, without relying on aversive agents or pharmacological approaches that could have harmful effects in legitimate patients. The product received Fast Track Designation from the FDA.

"We are pleased to announce the issuance of the first patent that broadly covers our DETERx™ technology. Since the claims cover the DETERx™ technology, we are not limited to one specific drug candidate. This patent will protect a variety of active ingredients incorporated into DETERx™, in addition to our lead product COL-003. We intend to continue to prosecute additional patents that will strengthen our intellectual property for this technology." said Michael Heffernan, President and CEO, Collegium Pharmaceutical.

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 ( 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

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