Covidien’s pharmaceutical products subsidiary Mallinckrodt Inc. has acquired the licensing rights to a drug candidate from Neuromed Pharmaceuticals Ltd in Canada.
Mallinckrodt bought the licensing rights for ExalgoTM, a formulation of an opioid analgesic, for an undisclosed sum.
This formulation of hydromorphone was developed by Mountain View, Calif.-based ALZA Corp. In 2007, Neuromed acquired the U.S. marketing rights to Exalgo from ALZA.
Mallinckrodt 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.
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 based on commercial sales of Exalgo.
Covidien expects that the upfront payment noted above, in combination with the payment to Nuvo Research announced Tuesday, will result in its fiscal third quarter research and development expense being higher than previously anticipated.
Covidien plc, formerly known as Tyco Healthcare, operates Covidien Imaging Solutions and Pharmaceutical Products, also known as Mallinckrodt Inc., which is located in St. Louis and provides medical imaging technology and pharmaceuticals. Covidien was spun off from Tyco International Ltd. in 2007.
With 2008 revenue of nearly $10 billion, Covidien has 3,000 employees in the St. Louis area and more than 41,000 employees worldwide.
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