Healthcare Industry News:  Xtampza 

Biopharmaceuticals Litigation

 News Release - February 2, 2016

Collegium Provides Litigation Update

CANTON, Mass., Feb. 02, 2016 -- (Healthcare Sales & Marketing Network) -- Collegium Pharmaceutical, Inc. (COLL) today provided an update regarding its ongoing litigation with Purdue Pharma L.P. (“Purdue”). On February 1, 2016, the U.S. Court of Appeals for the Federal Circuit rendered its decision to uphold a prior ruling from the U.S. District Court of the Southern District of New York that invalidated four patents associated with OxyContin OP, including Purdue’s three Orange Book-listed patents asserted against the Company. The three patents are the cause of the 30 month stay currently imposed on the launch of Xtampza™ ER.

On December 23, 2015, the District Court of Massachusetts issued an order staying proceedings in relation to the three Orange Book-listed patents asserted against Collegium until February 25, 2016, which is the date scheduled by the Court for a status conference. The Court reserved the decision to grant Collegium’s motion for judgment on the three Orange Book-listed patents to be taken up again at the February 25th status conference, at which time the Court indicated it may grant Collegium’s motion for judgment or may consider extending the stay. The Court further indicated that it will consider an earlier hearing if the Court of Appeals for the Federal Circuit issues a decision on the appeal of the New York judgment of invalidity prior to the February 25th status conference.

Upon dismissal of the Massachusetts lawsuit, the Company intends to file a request for Final approval with the U.S. Food and Drug Administration.

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.

Forward-Looking Statements

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 final approval for Xtampza ER or any of our other product candidates from the FDA or foreign regulatory authorities; even if Xtampza ER obtains final approval, 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 ER 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 ER 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 333-208641), which was declared effective by the Securities and Exchange Commission ("SEC") on January 7, 2016, and those risks described from time to time in other reports which we file with the SEC. 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.

Source: Collegium Pharmaceutical

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