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Collegium Pharmaceutical, Inc. Announces Notice of Allowance for U.S. Patent Covering Oxycodone DETERx®, a Tamper-Resistant, Extended-Release Opioid Product  
2/12/2013 9:00:17 AM

CANTON, Mass., Feb. 12, 2013 /PRNewswire/ -- Collegium Pharmaceutical, Inc., a specialty pharmaceutical company, today announced that it has received Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for its patent application "Abuse-Deterrent Drug Formulation" US Patent Application Number 12/823,628. 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. This will be the third issued patent related to the DETERx® drug delivery technology.

The allowed patent claims cover the Company's lead development program Oxycodone DETERx®(COL-003), a tamper-resistant, extended-release oxycodone product utilizing its proprietary DETERx®technology. The Oxycodone DETERx® formulation was specifically designed to provide and preserve extended release of the active ingredient following the most common methods of product tampering employed by drug abusers (e.g., crushing, chewing, heating for IV injection, etc.). The product is currently in the final stage of clinical development and has been designated Fast Track Status by the FDA due to its potential to address the problem of prescription drug abuse, a major public health issue in the U.S.

"These newly allowed, product specific claims strengthen and expand our overall patent coverage for COL-003. We are continuing to focus on filing new patent applications that support COL-003 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 tamper-resistant 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 gastronomy 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. COL-003 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 tamper-resistant properties, and flexible dose administration options. For more information, visit the Company's website at www.collegiumpharma.com.

Contact:

Michael Heffernan, President
Collegium Pharmaceutical, Inc.
781-713-3699
mheffernan@collegiumpharma.com

SOURCE Collegium Pharmaceutical, Inc.


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