By GlobeNewswire, October 22, 2013, 08:03:00 AM EDT
- No Change to Program Timelines and No Change to REMOXY Deal Economics -
- Commercial Rights to Three Drug Assets Revert to Pain Therapeutics -
AUSTIN, Texas, Oct. 22, 2013 (GLOBE NEWSWIRE) -- Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported Pfizer Inc. (NYSE:PFE) has informed us that, having achieved technical milestones related to manufacturing, they will continue the development program for REMOXY® (oxycodone) Extended-Release Capsules CII.
We also were informed that, following guidance received from the U.S. Food and Drug Administration (FDA) earlier this year, Pfizer will proceed with the additional clinical studies and other actions required to address the Complete Response Letter received in June 2011. These new clinical studies will include, in part, a pivotal bioequivalence study with the modified REMOXY formulation to bridge to the clinical data related to the original REMOXY formulation, and an abuse-potential study with the modified formulation.
The FDA did not require any further drug efficacy trials. As previously disclosed, the complete response submission is not expected to occur prior to mid-2015.
REMOXY DEAL ECONOMICS ARE UNCHANGED
Pfizer is our exclusive, worldwide partner for REMOXY (except as to Australia/New Zealand). We are eligible to receive from Pfizer a $15.0 million payment upon FDA approval of REMOXY. After commercial launch, we will receive from Pfizer a royalty of 20% of net sales of REMOXY in the United States, except as to the first cumulative $1.0 billion in net sales, which royalty is set at 15%. The royalty rate outside the U.S. is 10%.
In addition, we will also receive from Pfizer a supplemental payment of 6% to 11.5% of net sales, depending on the range of total dollar sales in each year. This supplemental payment is tied to the full amount of our financial obligations to Durect Corporation (Nasdaq:DRRX), our exclusive supplier of certain excipients.
THREE ASSETS REVERT BACK TO US
Pfizer has returned to us all rights with respect to abuse-resistant formulations of hydrocodone, hydromorphone and oxymorphone. These drug assets now vest exclusively in PTI without any royalty or other obligation to Pfizer. We are now free to develop and commercialize these assets on our own or with a licensee of our choice, and may do so without notice or approval from Pfizer. Investigational New Drug (IND) applications for all three drug assets are in place with FDA. We have not yet made a decision to develop or to out-license the three drug assets.
Our lead drug candidate, REMOXY, is an extended-release oral 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 designed REMOXY to discourage common methods of tampering and misuse. We developed REMOXY using technology from DURECT Corporation (Nasdaq:DRRX).
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, any statements relating to our projected timeline, potential future milestone payments and royalties based on revenue from REMOXY, the potential development of other abuse resistant drug candidates, and funding obligations of 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 obtaining regulatory approval of REMOXY and in development, testing and pursuit of regulatory approval of our other drug candidates, unexpected adverse side effects or inadequate therapeutic efficacy of our drug candidates, difficulties or delays in commercialization efforts with respect to our products, if any are approved for marketing, or failure of such products to gain market acceptance, the uncertainty of patent protection for our intellectual property or trade secrets, unanticipated additional research and development and other costs, the timing and receipt of funds from Pfizer, potential diversion of resources from the pursuit of development and commercialization of drug candidates subject to our strategic alliance with Pfizer as a result of the acquisition of King by Pfizer, and the potential for abuse resistant pain medications or other competing products or therapies to be developed by competitors and potential competitors or others. For further information regarding these and other risks related to the Company's business, investors should consult the Company's filings with the Securities and Exchange Commission.
CONTACT: For More Information Contact:
Peter S. Roddy
Vice President and Chief Financial Officer
Pain Therapeutics, Inc.email@example.com
Source: Pain Therapeutics, Inc.