Canada’s Biovail has signed up Johnson & Johnson as its marketing partner for two formulations of the analgesic tramadol in the USA and Puerto Rico.
The deal covers an extended-release version of the painkiller, tramadol ER, as well as an immediate-release version that dissolves on the tongue, called tramadol ODT, that can be taken without water.
Biovail will receive a $60 million prepayment under the terms of the 10-year deal, as well as royalties on sales of the tramadol products, which will be sold by J&J subsidiary Ortho-McNeil as Ultram ER. It will also make the product for J&J.
Ortho already sells a number of different formulations of tramadol under the Ultram and Ultracet (tramadol plus acetaminophen) brand names, but sales have been impacted recently in the USA by generic competition [[19/10/05i]]. Biovail’s once-daily and melt-in-the-mouth formulations should help Ortho defend the franchise from copycat rivals, which need to be dosed multiple times a day.
Ultram ER was approved by the US Food and Drug Administration (FDA) in 100mg, 200mg and 300mg strengths in September, and is the only once-daily formulation of the drug registered there. Ultram ODT was cleared in May and is available in a 50mg format. Both products are due for launch in early 2006, said Biovail.
Ortho-McNeil has also retained an option to license Ultram ER for other jurisdictions, excluding Canada and Europe, said Biovail.