Biovail Corporation said its subsidiary, Biovail Laboratories International SRL, has entered into an exclusive supply agreement with Janssen Pharmaceutica NV, a division of Johnson & Johnson, for the marketing and distribution of Biovail's once-daily, extended-release formulation of tramadol hydrochloride in 86 countries in two regions - Central and Eastern Europe/Middle East and Latin America.

Under the terms of this agreement, which has a 10-year term, Biovail will manufacture and supply once-daily extended-release tramadol hydrochloride tablets in dosage strengths of 100mg, 200mg and 300mg to Janssen at contractually determined prices. Janssen affiliates will be responsible for all related promotional costs, as well as all regulatory filings and the management of the regulatory approvals process.

"The culmination of this commercialisation agreement between Biovail and Janssen is the latest endorsement of Biovail's proven formulation of once-daily tramadol, and further validates the Company's strategy to engage strategic partners to commercialise its products outside Canada," said Dr. Douglas Squires, interim chairman and chief executive officer, Biovail. "This agreement furthers our existing relationship with Ortho-McNeil, Inc., an affiliate of Janssen which markets our once-daily tramadol in the United States."

In February 2006, Ortho-McNeil, Inc. launched Biovail's extended-release version of tramadol for the treatment of moderate to moderately severe chronic pain under the brand name Ultram ER in the United States and Puerto Rico. Ultram ER extended-release tablets, which are available in 100mg, 200mg and 300mg dosage strengths, is the only once-daily tramadol formulation that has been approved by the US Food and Drug Administration (FDA). Since its launch, approximately 1.8 million prescriptions have been written for Ultram ER.

On November 1, 2007, Biovail Pharmaceuticals Canada, Biovail's sales and marketing division, launched the product in Canada under the brand name Ralivia. Ralivia is indicated for the management of pain of moderate severity in patients who require continuous treatment for several days or more.