Additional Patent Coverage for Lead Product, Xtampza ER(TM)
CANTON, Mass., June 8, 2015 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced that U.S. Patent No. 9,044,398 was issued by the U.S. Patent and Trademark Office (USPTO) for its patent application entitled, "Abuse-deterrent Pharmaceutical Compositions of Opioids and Other Drugs". The issued patent covers the DETERx technology platform and Collegium's lead product candidate, Xtampza ER (oxycodone extended-release capsules). The claims provide additional coverage for multiple opioid molecules, as well as non-opioid drugs prone to abuse that are developed with the DETERx technology platform. This is the seventh issued U.S. patent related to the DETERx technology platform.
"This newly issued patent expands our patent coverage for our lead product candidate, Xtampza ER, and the DETERx technology platform. We have a number of additional patent applications currently undergoing the patent prosecution process that, if issued, would continue to protect Xtampza ER, the DETERx technology platform, and additional product candidates in the U.S. and internationally," said Michael Heffernan, Chairman and CEO of Collegium.
Collegium's lead product candidate, Xtampza ER, is the first of a number of product candidates utilizing the DETERx technology platform. The FDA set a Prescription Drug User Fee Act, or PDUFA, goal date for completion of its review of the Xtampza ER NDA for October 12, 2015.
About Collegium Pharmaceutical, Inc.
Collegium is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its patent-protected DETERx technology platform for the treatment of chronic pain and other diseases. The DETERx oral drug delivery technology is designed to provide extended-release delivery, unique abuse-deterrent properties, and flexible dose administration options. The new drug application, or NDA, filing for Xtampza ER, the Company's lead product candidate, was accepted by the FDA on February 10, 2015. The FDA set a Prescription Drug User Fee Act, or PDUFA, goal date of October 12, 2015 for completion of its review of the Xtampza ER NDA.
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company's current expectations. For example, there can be no guarantee that we will obtain approval for Xtampza or any of our other product candidates from the U.S. Food and Drug Administration ("FDA") or foreign regulatory authorities; even if Xtampza is approved, we may not be able to obtain the label claims that we are seeking from the FDA. Furthermore, we are subject to patent infringement litigation relating to Xtampza and may, in the future, be subject to additional litigation relating to our other product candidates, which may be expensive to defend and delay the commercialization of Xtampza or our other product candidates. Management's expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: our ability to commercialize our product candidates; the size and growth potential of the markets for our product candidates, and our ability to service those markets; our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of our product candidates; the success, cost and timing of our product development activities, studies and clinical trials; the success of competing products that are or become available; and our expectations regarding our ability to obtain and adequately maintain sufficient intellectual property protection for our product candidates. These and other risks are described under the heading "Risk Factors" in the registration statement on Form S-1 (commission file number 333-203208), which was declared effective by the Securities and Exchange Commission ("SEC") on May 6, 2015. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.
CONTACT: Douglas Carlson
Vice President, Corporate Development