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Title: FDA Approves Once-Daily Avinza (Extended Release Morphine) For Chronic, Moderate-To-Severe Pain

"FDA Approves Once-Daily Avinza (Extended Release Morphine) For Chronic, Moderate-To-Severe Pain"

DUBLIN, IRELAND -- March 21, 2001 -- The U.S. Food and Drug Administration has granted marketing approval of Elan Corporation, plc's new drug application for Avinza (morphine sulfate extended-release) capsules for the once-daily treatment of chronic, moderate-to-severe pain in patients who require continuous, around-the-clock therapy for an extended period of time, Elan announced today. Avinza (formerly Morphelan™) was developed by Elan Corporation, ("Elan"), which licensed the U.S. and Canadian marketing rights to Ligand Pharmaceuticals Inc. (Nasdaq: LGND) in 1998. Elan retains marketing rights for the rest of the world and regulatory filings are pending in major territories. The product will be manufactured by Elan in the United States and is expected to be launched in the second quarter of 2002. "Avinza represents a major technical achievement for Elan and a medical advance in the management of chronic pain," said Donal J. Geaney, Chairman and Chief Executive Officer of Elan. "Using our proprietary controlled release technology (SODASŽ), we have engineered a morphine capsule product, which gives patients protection from moderate to severe pain over a 24-hour period. In safety and effectiveness trials conducted by Elan, Avinza, given once daily, provided effective 24-hour pain relief. Avinza will provide an important therapeutic option for many patients who live with the pain associated with cancer and other medical conditions." Avinza's novel dual release formulation contains immediate- and sustained-release morphine beads. Once steady-state plasma levels of morphine are achieved, the immediate-release beads enable Avinza to provide rapid exposure to morphine. The sustained-release beads enable morphine to be absorbed by the body gradually, thus maintaining plasma morphine levels over a 24-hour dosing period. SOURCE: Elan Corporation, plc

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