CANTON, Mass., July 1, 2015 (GLOBE NEWSWIRE) -- Collegium Pharmaceutical, Inc. (Nasdaq:COLL) today announced that John (Jack) Weet, Ph.D., has joined the company as its Vice President of Regulatory Affairs and Quality Assurance. Dr. Weet will oversee Collegium's Regulatory Affairs and Quality Assurance, providing oversight for all U.S. and international filings and interactions with regulatory authorities.
Prior to joining Collegium, Dr. Weet was Vice President of Regulatory Affairs at Durata Therapeutics, Vertex Pharmaceuticals, and Bausch and Lomb, where he was closely involved with the submissions of Dalvance® (dalbavancin), Incivek® (telaprevir), and Besivance® (besifloxicin), respectively. In addition, Dr. Weet was on the faculty of the Pharmaceutical Education and Research Institute (PERI), a guest lecturer at Georgia Institute of Technology, a member of the Long Island University Curriculum Planning Committee of the Arnold and Marie Schwartz College of Pharmacy, and has authored various papers and presentations at industry conferences. Dr. Weet is a graduate of St. Lawrence University and holds his Ph.D. in Medical Physiology from the Ohio State University.
"Jack brings to Collegium over two decades of experience and a proven track record of leading regulatory affairs for global pharmaceutical franchises in diverse therapeutic areas," said Michael Heffernan, Collegium's CEO. "His expertise in supporting novel therapeutics through the FDA approval process will be invaluable to Collegium as we approach the PDUFA date for our lead product, Xtampza ER® later this year. We look forward to his contributions as a key member of our growing leadership team."
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 a Current Report on Form 8-K, which was filed with the Securities and Exchange Commission ("SEC") on June 19, 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 [email protected]