AUSTIN, Texas, April 21, 2015 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported it had recently resumed responsibility for REMOXY® under the terms of a letter agreement with Pfizer. The letter agreement was entered into within the scope of the previously disclosed provisions of the Collaboration Agreement between the two companies relating to the return of REMOXY.
Pfizer has started to transfer to Pain Therapeutics documents, data and regulatory responsibilities related to REMOXY. The two companies have agreed to implement a detailed transition plan involving an orderly transfer of a large amount of data, materials, capital equipment and other assets related to REMOXY. Pain Therapeutics expects the transition will be substantially completed in Q2 2015.
“We’re excited REMOXY is home again,” said Remi Barbier, Chairman, President & CEO. “We’re now reviewing a lot of new information, including results of a Drug Likeability Study. We look forward to communicating with shareholders our findings in the weeks ahead, after we’re done validating key clinical data and development timelines.”
About REMOXY®
Our lead drug candidate, REMOXY Extended-Release Capsules CII, is an oral, twice-a-day formulation of oxycodone for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. We specifically developed REMOXY to discourage certain common methods of drug tampering and misuse. We own world-wide commercial rights to this New Drug Application (NDA) stage drug. The REMOXY NDA is supported by multiple clinical trials, including a successful Phase III efficacy program that was conducted under a Special Protocol Assessment.
About Pain Therapeutics, Inc.
Pain Therapeutics, Inc. is a clinical-stage biopharmaceutical company that develops novel drugs. The FDA has not approved our drug candidates for commercial sale. For more information, please visit www.paintrials.com.
Note Regarding Forward-Looking Statements : This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Pain Therapeutics disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to, potential resubmission of an NDA for REMOXY with the U.S. Food and Drug Administration, or FDA and statements relating to Pfizer’s return to us of rights to REMOXY, including data related to REMOXY, in connection with the termination of our Collaboration Agreement with Pfizer. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in Pfizer’s return of REMOXY to us in connection with the termination of the Collaboration and difficulties or delays in preparing for potential submission of an NDA for REMOXY with the FDA and in obtaining regulatory approval of REMOXY. For further information regarding these and other risks related to our business, investors should consult our filings with the U.S. Securities and Exchange Commission.
CONTACT: Peter S. Roddy Vice President and Chief Financial Officer Pain Therapeutics, Inc. proddy@paintrials.com (512) 501-2450
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