SOURCE: Collegium Pharmaceutical, Inc.

October 17, 2013 07:30 ET

Collegium Pharmaceutical Announces Issuance of U.S. Patent and Allowance of New Claims Covering Oxycodone DETERx®, an Abuse-Deterrent, Extended-Release Opioid Product

CANTON, MA--(Marketwired - Oct 17, 2013) - Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that U.S. Patent No. 8,557,291 has been issued by the U.S. Patent and Trademark Office (USPTO). Additionally, Application No. 13/870,690 has been allowed for issuance as a new patent by the USPTO. Both patents relate to Collegium's Oxycodone DETERx® formulation and contain claims that cover the Company's lead product, an abuse-deterrent, extended-release oxycodone product utilizing its proprietary DETERx® technology. These are the fourth and fifth U.S. patents related to the DETERx® drug delivery technology. The five patents are part of the Company's larger portfolio of U.S. and international filings.

Oxycodone DETERx® is nearing completion of enrollment in its Phase 3 clinical program with a planned NDA filing in the first half of 2014. The product has been designated Fast Track Status by the FDA. In addition to the Phase 3 study to establish the safety and efficacy of the product, Collegium has executed a comprehensive development program for evaluation of the product's abuse-deterrent properties consistent with the FDA's recently-issued Guidance, "Abuse-Deterrent Opioids -- Evaluation and Labeling."

"These newly issued claims covering our platform technology continue to strengthen and expand our overall patent coverage for Oxycodone DETERx®. We are continuing to focus on the prosecution of additional patents that support our lead product and the DETERx® technology in both the U.S. and internationally," states Michael Heffernan, CEO of Collegium.

About DETERx® Technology
The DETERx® drug delivery platform consists of a multi-particulate matrix formulation in a capsule. While developed primarily to provide abuse-deterrent properties to protect against common methods of tampering such as chewing, crushing, insufflation and extraction for IV injection, the multi-particulate design is expected to enable patients with difficulty swallowing to open the capsule and administer the contents on food or via a gastrostomy tube, while maintaining the extended-release properties of the product. DETERx® technology can be used with drugs that are commonly abused such as opioids and amphetamines, as well as drugs that have narrow therapeutic windows that would benefit from protection against misuse such as breaking, crushing, grinding or dissolving the product. The formulation platform is covered by U.S. and international patents and patent applications. Oxycodone DETERx® is the first of a number of product candidates using the DETERx® platform.

About Collegium Pharmaceutical, Inc.
Collegium Pharmaceutical, Inc. is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its patent-protected DETERx® formulation platform for the treatment of chronic pain. The DETERx® oral drug delivery technology provides extended release delivery, unique abuse-deterrent properties, and flexible dose administration options. For more information, visit the Company's website at www.collegiumpharma.com.

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