USPTO grants Collegium second patent for tamper-resistant DETERx formulation platform

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 DETERx™ formulation platform. US Patent Number 7,771,707 contains claims that cover Collegium's proprietary extended-release formulations, which are designed to resist dose dumping when subjected to a variety of physical methods of tampering.

US Patent No. 7,771,707 will provide additional protection for the DETERx™ portfolio of products into the year 2025. The DETERx™ platform consists of a multi-particulate matrix formulation in a capsule. While developed primarily to provide tamper resistant properties to protect against common methods of tampering such as chewing, crushing, injecting, snorting and extraction for IV injection, the multi-particulate design also potentially enables 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. The new patent claims, directed at specific aspects of the formulation composition, further broaden the patent coverage provided by the Company's first US Patent relating to the DETERx™ technology (U.S. Patent No. 7,399,488, issued in July of 2008) and are part of the Company's larger portfolio of US and international filings.

The Company's lead DETERx™ product candidate, COL-003, an extended release formulation of oxycodone that is in clinical development, will be covered by the patent. In addition, this patent will also cover other product candidates formulated using the DETERx™ technology, including COL-172, Collegium's second product for the treatment of chronic pain. The Company filed an Investigational New Drug Application for COL-172 in March of 2010. Both COL-172 and COL-003 have been granted Fast Track Designation by the FDA.

"We are pleased to announce the issuance of the second patent related to our DETERx™ formulation platform. It is an important milestone in our continued efforts to obtain the strongest possible IP protection for our lead DETERx™ product candidate, COL-003, as well the other product candidates in our pipeline that utilize this technology", stated Michael Heffernan, President, Collegium Pharmaceutical.


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