Morphine Oral - Elan Corporation: Avinzaâ„¢

June 2002
Drugs in R&D;2002, Vol. 3 Issue 3, p208
Academic Journal
Adis Comments Elan Corporation is developing an oral, once daily, controlled-release formulation of morphine sulphate (formerly called Morphelanâ„¢) for use in pain management therapy. Elan Corporation has been granted marketing approval by the FDA for Avinzaâ„¢ (morphine sulphate extended-release) capsules for chronic pain in oncology and HIV-positive patients. Avinzaâ„¢ was approved for once daily treatment of chronic, moderate to severe pain in patients who require continuous pain management for an extended period of time. Avinzaâ„¢ was investigated in clinical trials in 560 patients with chronic moderate to severe pain resulting from both malignant and non-malignant causes. The proprietary formulation of morphine consists of two components: an immediate-release component that provides fast onset and rapid achievement of the plateau of plasma morphine concentrations, and an extended-release component that maintains plasma concentrations of morphine throughout the 24-h interval. The rationale behind the once-daily formulation of Avinzaâ„¢ is to create and maintain the plateau concentration of morphine after reaching steady-state plasma morphine level. Avinzaâ„¢ will be available as a prescription medicine in 30, 60, 90 and 120mg capsules. It can be taken with or without food. Labeling of Avinzaâ„¢ warns against chewing, crushing or dissolving the capsule due to the risk of absorption of potentially fatal dose of morphine. Elan Corporation has licensed the morphine oral formulation to Ligand Pharmaceuticals with exclusive rights in the USA and Canada for the treatment of chronic pain in cancer and HIV patients. Both companies have also granted each other co-promotional rights to the USA, Canada and Europe. Under the agreement, Ligand Pharmaceuticals pays Elan Corporation upfront license fees on closing and milestone payments upon the occurrence of certain events. Payments of the milestones may be either in cash or in shares of Ligand common stock. In connection with the NDA submission, Ligand Pharmaceuticals paid Elan Corporation 367 183 shares of Ligand common stock, with a total value of US$4 million. The approval of Avinzaâ„¢ triggers a US$5 million milestone payment from Ligand to Elan in the form of 302 554 shares of common stock. Ligand Pharmaceuticals is planning to launch Avinzaâ„¢ early in Q2 of 2002. Morphine oral formulation was licensed exclusively worldwide to Targon, a joint venture between Cytogen and Elan Corporation. However, the joint venture was dissolved, and the rights to the drug were retained by Elan Corporation.


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