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– 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.