FDA endorses Covidien's REMS program for EXALGO tablets

Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that it presented information to members of a U.S. Food and Drug Administration (FDA) Advisory Committee on the New Drug Application and proposed Risk Evaluation and Mitigation Strategy (REMS) program for EXALGO^TM (hydromorphone HCl extended release) tablets, an opioid formulation. At a meeting held today in Gaithersburg, Md., committee members also heard public comments about the analgesic. Covidien will now await FDA’s decision on EXALGO approval.

“We are pleased that the committee endorsed the REMS program as proposed by Covidien and Neuromed,” said Timothy R. Wright, President, Pharmaceuticals, Covidien. “The committee has asked us to look at the possibility of a phased rollout, and we look forward to discussing this input with the agency and other pain management experts.”

If approved, EXALGO will offer around-the-clock relief for opioid tolerant patients with moderate to severe pain for an extended period of time. EXALGO utilizes a unique, extended-release technology that allows for once-a-day dosing. This technology is the OROS® Push-Pull™ oral osmotic delivery system that is designed to release the hydromorphone at a consistent rate. This proven technology has been used for 20 years in 13 other products. For physicians, EXALGO provides a well-known therapy used in the treatment of chronic pain for more than 80 years – hydromorphone HCl, in an extended-release formulation.

During the meeting, information was provided on Exalgo Alliance – the proposed REMS for EXALGO, which is a comprehensive program that combines education, controlled access and ongoing surveillance. Combined with EXALGO’s proposed labeling, Exalgo Alliance will help ensure the appropriate access, prescribing, dispensing and use of EXALGO.

On May 22, 2009, a Complete Response was submitted to an Approvable Letter for EXALGO that was issued by the FDA in October 2000. The FDA assigned a Prescription Drug User Fee Act date of November 22, 2009, to complete its review of the application. The meeting held today is another step in the approval process.

In June 2009, Covidien, through its Mallinckrodt Inc. subsidiary, acquired the licensing rights to EXALGO Tablets from Neuromed Development Inc., a subsidiary of Neuromed Pharmaceuticals Ltd. Neuromed acquired the U.S. marketing rights to EXALGO from ALZA Corporation in April 2007.

Under the agreement, Covidien is responsible for all commercialization activities for EXALGO in the U.S., including marketing, sales and all regulatory filings post-FDA approval. Neuromed completed the clinical development and oversees the regulatory approval process. For a specified period, ALZA will remain responsible for the manufacturing, packaging and supply of EXALGO. The intellectual property covering the hydromorphone formulation under review is owned by ALZA.