Pain Therapeutics Tanks As Pfizer Walks Away From Remoxy® Deal
October 27, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Pain Therapeutics said today that biopharma giant Pfizer has terminated its agreement with the company to develop and commercialize the drug Remoxy, an extended-release oxycodone drug, news that caused its stock to plummet 52 percent in Monday trading.
Austin, Texas-based Pain Therapeutics licensed Remoxy from Durect Corp. , the Cupertino, Calif.-based biopharmaceutical company focused on developing a novel way to deliver opioids while preventing their abuse. In the wake of the Pfizer deal termination, share prices of Durect plunged 49 percent today.
The companies differed in their public reactions to the news. Remi Barbier, president and CEO of Pain Therapeutics was quoted in a press release as saying, “We are grateful to Pfizer for their substantial investment in Remoxy over the years and now for this opportunity to regain full control of Remoxy.” Barbier additionally claimed, “It's a privilege to reacquire worldwide rights to an unencumbered Phase III asset that targets a $2 billion market. We look forward to the prospects of resubmitting the Remoxy NDA under our control.” The company is also “enthusiastic” about the prospect of finding new partners with which to work on developing and commercializing Remoxy.
Durect’s Chief Executive Officer James Brown was quoted as saying in a press release from his company that, “We are surprised by Pfizer’s decision given the late stage of this program, and continue to believe that Remoxy could play an important role in serving the needs of chronic pain patients while potentially reducing the misuse and abuse of oxycodone.”
Remoxy is an extended release oral analgesic intended to treat severe pain that requires daily, around the clock management. The drug is based on Durect Corp.’s patent-pending Oradur technology, which is designed to, as described by the company, “discourage common methods of tampering associated with prescription opioid analgesic misuse and abuse.”
The U.S. Food and Drug Administration (FDA) rejected approval of Remoxy in 2011, providing Pfizer with a Complete Response Letter in June of that year. According to the FDA’s web site, a Complete Response Letter, first implemented in 2008, provides a “consistent and neutral mechanism to convey that our initial review of an application is complete and we cannot approve the application in its present form.” A Complete Response letter also informs “applicants of changes that must be made before an application can be approved, with no implication regarding the ultimate approvability of the application.”
Pfizer, in press release issued today, stated that the company reached its decision to terminate the deal with Pain Therapeutics after Pfizer did an internal review of data from five completed studies that were run to address the 2011 Complete Response Letter. Pfizer provided no additional information for its decision.