ST. LOUIS--(BUSINESS WIRE)--Covidien (NYSE:COV), a leading global provider of healthcare products, today announced that one of its Pharmaceutical Products subsidiaries has acquired the licensing rights to drug candidate Exalgo^TM, (hydromorphone HCl) Extended-Release Tablets, a formulation of an opioid analgesic from Neuromed Development Inc., a subsidiary of Neuromed Pharmaceuticals Ltd. The agreement is aimed at expanding Covidien’s presence in the branded pain management market.

Covidien is the largest supplier of controlled pain medications in the United States, based on number of prescriptions. Neuromed is a privately held Canadian biopharmaceutical company working to develop new and improved pain medicines.

Covidien’s subsidiary, Mallinckrodt Inc., has acquired Neuromed’s rights to Exalgo (hydromorphone HCl) Extended-Release Tablets, a formulation of hydromorphone which utilizes the OROS^® Push-Pull™ osmotic delivery system designed to release the opioid at a controlled rate. This formulation of hydromorphone was developed by ALZA Corporation. In April 2007, Neuromed acquired the U.S. marketing rights to Exalgo from ALZA Corporation. Neuromed recently announced that Exalgo met the primary efficacy endpoint in a pivotal phase III trial.

“Building on more than a century of pain treatment experience, Covidien focuses on providing patients with access to advanced medications that expand the limits of pain therapy by combining proven drugs with innovative delivery systems. We are excited about our agreement with Neuromed on Exalgo and expect it will play a major role in helping us achieve this goal,” said Timothy R. Wright, President, Pharmaceutical Products and Imaging Solutions, Covidien. “While we face difficult comparisons in 2010 in our Pharmaceutical business, we are excited about the potential of this product to accelerate our performance in 2011 and beyond.”

On May 22, 2009, Neuromed submitted a Complete Response to an Approvable Letter for the extended release hydromorphone formulation that was issued by the U.S. Food and Drug Administration (FDA) in October 2000. The FDA has assigned a PDUFA date of November 22, 2009, to complete its review of the application. However, issues related to Risk Evaluation & Mitigation Strategy (REMS) with this class of product could delay approval.

Under the agreement, Covidien’s subsidiary Mallinckrodt Inc. will be responsible for all commercialization activities for Exalgo in the United States, including marketing and sales. Neuromed will work to complete the clinical development and the regulatory approval process. Covidien’s subsidiary Mallinckrodt Inc. will be responsible for all regulatory filings post-FDA approval. 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 will be owned by ALZA.

Neuromed has received a one-time upfront payment and could receive additional development and, if Exalgo is approved, regulatory approval milestone payments as well. ALZA will also receive regulatory milestone payments. In addition, Covidien will pay royalties to Neuromed and ALZA Corporation based on commercial sales of Exalgo.

Covidien expects that the upfront payment noted above, in combination with the payment to Nuvo Research announced yesterday, will result in its fiscal third quarter research and development expense being higher than previously anticipated.

About Exalgo

Exalgo is an investigational drug and has not been approved by the FDA. Exalgo has been studied in more than 2,000 pain patients in clinical trials. The most common adverse events seen in clinical trials to date were opioid-related events of constipation, nausea, somnolence, headache, vomiting and dizziness. Respiratory depression is the most important hazard of opioid preparations including Exalgo.

OROS® and Push-Pull™ are trademarks of ALZA Corporation.

About Covidien

Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence. Covidien manufactures, distributes and services a diverse range of industry-leading product lines in four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies. With 2008 revenue of nearly $10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit http://www.covidien.com to learn more about our business.

Forward-Looking Statements

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