Biovail Corporation's subsidiary has entered into a supply agreement with Ortho-McNeil, Inc., a Johnson & Johnson company, for the marketing and distribution of a once daily, extended-release (ER) formulation and an orally disintegrating (ODT), immediate-release formulation of tramadol hydrochloride in the United States and Puerto Rico. Ortho-McNeil has retained an option for Ultram ER for other jurisdictions, excluding Canada and Europe. The agreement is subject to Hart-Scott-Rodino regulatory clearance in the United States.
"The approval of our ER and ODT tramadol products represents the culmination of several years of perseverance, commitment and confidence in our technologies and formulation expertise. The value of Biovail's product-development efforts have now been further enhanced by aligning these products with the best possible commercial partner, an established brand name and attractive financial terms. I'd like to thank all Biovail employees who have helped bring this tremendous opportunity to fruition," said Biovail's executive chairman Eugene Melnyk
According to a company release, the products will be known by the trade names Ultram ER and Ultram ODT respectively, pending approval from the United States Food and Drug Administration's Office of Drug Safety's division of medical errors and technical support. Ultram ER, which is indicated for moderate to moderately severe chronic pain, received FDA approval in September 2005 and will be available in 100mg, 200mg and 300mg dosage strengths. Biovail is the first and only company to submit an application to the FDA for review and to receive an approval for a once-daily tramadol formulation. In addition, Ultram ER has received three years of exclusivity for the indication and doses approved.
Ultram ODT, which is indicated for moderate to moderately severe pain, received FDA approval in May 2005, and will be available in 50mg dosage strength. Ortho-McNeil anticipates an early-2006 launch for Ultram ER and Ultram ODT.
The release further states that under the agreement, which has a 10-year term, Biovail will manufacture, supply and sell Ultram ER to Ortho-McNeil for distribution at contractually determined prices, which will be based on Ortho-McNeil's net selling price. Upon closing of the transaction, Ortho-McNeil will pay to Biovail a supply prepayment of $60 million to be credited against product purchases of Ultram ER.
Ortho-McNeil will market these products to primary care physicians and other specialists who treat pain through PriCara, a unit of Ortho-McNeil that was formed recently as a new Johnson & Johnson operating company designed to leverage the heritage that the legacy companies (Ortho-McNeil Pharmaceutical, Inc. and Janssen Pharmaceutica, LP) had within the primary-care marketplace.
Tramadol is a centrally acting synthetic opioid analgesic, effective in the treatment of pain.
Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialisation of pharmaceutical products utilising advanced drug-delivery technologies.