Janssen Pharmaceutica NV (Janssen) has expanded its licensing agreement with the Grünenthal Group (Grünenthal) to register, manufacture and commercialize Tapentadol in additional regions, including selected Asia Pacific, Latin American, African, and New European countries including Turkey and Greece, under Grünenthal's Nucynta /Palexia /Palexis trademark for both the immediate- and prolonged-release (IR and PR) formulations.
Currently, Ortho-McNeil-Janssen Pharmaceuticals, Inc licenses marketing rights for Tapentadol from Grünenthal for the United States, Canada and Japan. Johnson & Johnson Pharmaceutical Research & Development, LLC has submitted Tapentadol extended/prolonged-release in the United States and Canada for the management of moderate to severe chronic pain in patients 18 years of age or older, and PriCara, a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc, is already marketing Tapentadol IR as Nucynta in the United States for the relief of moderate to severe acute pain in patients 18 years of age or older. Grünenthal has submitted decentralized marketing authorization applications to the European health authorities as well as marketing authorization applications to other non-European health authorities for Tapentadol immediate-and prolonged-release (IR/PR) tablets for severe acute and chronic pain.
Under the terms of this expanded agreement, Janssen has the right to market Nucynta /Palexia /Palexis in more than 80 additional countries. Janssen and Grünenthal will each manufacture the IR and PR/ER formulation for certain regions. Janssen will be responsible for marketing, distributing, promoting and selling the product in the entire licensed territory.
"Despite great advances in recent years, many people still suffer from inadequately treated acute or chronic pain, a disease of high unmet medical need," said Husseini K. Manji, Global Therapeutic Area Head, Neuroscience, Johnson & Johnson Pharmaceutical Research & Development. "With this agreement, Janssen will help to ensure that Nucynta /Palexia /Palexis is available to the many patients with moderate to severe acute and chronic pain as an important new option and alternative to older pain medications such as strong opioids."
Tapentadol is a centrally-acting analgesic with a dual mechanism of action: mu-opioid receptor agonist and norepinephrine reuptake inhibitor in a single molecule. These two mechanisms are thought to work in concert to provide pain relief via two different physiologic pathways involved in pain transmission.