Collegium Pharmaceutical Inc. Announces Notice of Allowance for Second DETERx™ Technology Patent

- U.S. Patent will cover lead tamper resistant, extended release, opioid product, COL-003

CUMBERLAND, R.I.--(BUSINESS WIRE)-- 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 Formulations", US Patent Application Number 11/149,867. 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, this will be the second patent covering the Company’s DETERx™ platform drug delivery technology.

The allowed patent claims will cover products that utilize the Company’s tamper-resistant, extended release, orally administered formulation platform, trademarked “DETERx™”. The DETERx™ platform consists of a multiparticulate matrix formulation in a capsule. The new patent claims, directed at specific aspects of the formulation design, add to the patent coverage provided by the Company's first US Patent relating to the DETERx™ technology, issued in July of 2008 (U.S. Patent No. 7,399,488) 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, will be covered by the patent. As previously reported, COL-003 has been granted Fast Track Designation and is currently in clinical development pursuant to an active Investigational New Drug (“IND”) application on file with the United States Food and Drug Administration ("FDA"). Based on previously reported pharmacokinetic results, COL-003 is expected to provide adequate plasma concentrations to effectively treat pain over a 12-hour period. COL-003 is also designed to resist common methods of tampering (e.g. crushing, chewing, dissolving in water for IV injection) that typically defeat the time-release mechanism of conventional formulations. In addition to COL-003, this patent will cover other of the Company’s product candidates formulated using its DETERx™ technology, including COL-172. The Company filed an IND application with the FDA for COL-172 in March of 2010 and the product is in the process of being moved into clinical development.

“These newly allowed claims continue to broaden our overall intellectual property portfolio and strengthen our patent position in the area of novel extended-release, tamper resistant formulations of opioids. Additionally, this allowance provides complementary patent coverage for our lead DETERx™ product candidate, COL-003, as well the other product candidates in our pipeline that utilize this technology”, states Michael Heffernan, President, 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 extended release and tamper resistance. The Company, through its subsidiary, Onset Therapeutics (www.onsettx.com), 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 www.collegiumpharma.com.



CONTACT:

Collegium Pharmaceutical, Inc.
Steven N. Tannenbaum, 401-762-2000 Ext. 216
[email protected]

KEYWORDS:   United States  North America  Rhode Island

INDUSTRY KEYWORDS:   Health  Biotechnology  Pharmaceutical  FDA

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