Pfizer Ends Deal To Develop Remoxy, To Return Full Rights To Pain Therapeutics

(RTTNews) - Pharmaceutical giant Pfizer Inc. (PFE) said Monday that it has informed Pain Therapeutics Inc. (PTIE) of its decision to discontinue their agreement to develop and commercialize Remoxy, or oxycodone Extended-Release Capsules CII, an investigational extended-release oral formulation of oxycodone for patients with moderate-to-severe chronic pain.

Pfizer will return all rights, including responsibility for regulatory activities of Remoxy, to Pain Therapeutics, a biotechnology company based in Austin, Texas. Shares of Pain Therapeutics are down 60 percent following the announcement, while Durect Corp.'s (DRRX) shares are down almost 46 percent.

As a result, Pain Therapeutics now has the rights to develop and commercialize Remoxy on its own or with an alternative licensee. Pain Therapeutics had the rights to develop and commercialize this product candidate under a license from Cupertino, California-based specialty pharmaceutical company Durect Corp. (DRRX).

James Brown, President and CEO of Durect said in a statement, "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."

Pfizer's decision to discontinue development and commercialization of Remoxy came after it concluded an internal review of the top-line results of five recently completed clinical studies required to address the Complete Response Letter received in June 2011 from the U.S. Food and Drug Administration or FDA.

Remoxy is an oral, long-acting oxycodone gelatin capsule that was licensed by Durect to Pain Therapeutics in December 2002. Subsequently, Pain Therapeutics has sublicensed the commercialization rights of Remoxy to King Pharmaceuticals, which in turn was acquired by Pfizer in February 2011.

Remoxy is formulated with Durect's ORADUR technology, which combines properties designed to resist common methods of prescription drug misuse and abuse with the convenience of twice-a-day dosing of oxycodone.

In June 2011, Pfizer received a Complete Response Letter from the FDA. The issues raised in the letter related primarily to manufacturing. Pfizer said at that time that it was trying to resolve these issues.

In October 2013, Pfizer said that having achieved technical milestones related to Remoxy's manufacturing, it will continue the development program for Remoxy. Following guidance received from the FDA, Pfizer said it will proceed with the additional clinical studies and other actions required to address the Complete Response Letter that was received in June 2011.

However, Pfizer said Monday that it will now work for an orderly transition of Remoxy to Pain Therapeutics. Pfizer will continue ongoing activities under the agreement for the next six months, until the scheduled termination date.

Pfizer said it supports the appropriate use of opioid pain medications, and believes that abuse-deterrent products are important to help address the growing public health problem of opioid abuse in the U.S.

PFE is trading at $29.10, down $0.01 or 0.03 percent on a volume of 1.31 million shares.

PTIE is trading at $1.66, down $2.49 or 60.00 percent on a volume of 1.67 million shares, while DRRX is down $0.64 or 45.83 percent to $0.75.