The license is extended to register, manufacture and commercialise Tapentadol in additional regions, including selected Asia Pacific, Latin American, African, and New European countries including Turkey and Greece, under Grunenthal’s Nucynta /Palexia /Palexis trademark for both the immediate and prolonged release (IR and PR) formulations.
Ortho-McNeil-Janssen Pharmaceuticals licenses marketing rights for Tapentadol from Grunenthal for the US, Canada and Japan.
Johnson and Johnson Pharmaceutical Research and Development has submitted Tapentadol extended/prolonged-release in the US and Canada for the management of moderate to severe chronic pain in patients 18 years of age or older.
Grunenthal has submitted decentralised marketing authorisation applications to the European health authorities as well as marketing authorisation applications to other non-European health authorities for Tapentadol IR/PR tablets for severe acute and chronic pain.
As per the terms of the expanded agreement, Janssen has the right to market Nucynta /Palexia /Palexis in more than 80 additional countries. Janssen and Grunenthal are expected to manufacture the IR and PR/ER formulation for certain regions. Janssen is expected to be responsible for marketing, distributing, promoting and selling the product in the entire licensed territory.
Husseini Manji, head of global therapeutic area of neuroscience at Johnson and Johnson Pharmaceutical Research & Development, said: “Despite great advances in recent years, many people still suffer from inadequately treated acute or chronic pain, a disease of high unmet medical need.
“With this agreement, Janssen is expected to help ensure that Nucynta /Palexia /Palexis is available to the many patients with moderate to severe acute and chronic pain as a new option and alternative to older pain medications such as strong opioids.”