As part of the agreement, Labopharm could receive payments of up to $170 million, including an up-front licensing fee of $20 million, a payment of up to $40 million upon regulatory approval of the product by the FDA, and payments upon the product meeting specified sales targets. Labopharm will also receive royalty rates of up to 25% on product sales in the US.
“With our anticipated NDA submission later this year, our number one priority was signing a partner to allow us to commercialize our tramadol product in the world’s largest pharmaceutical market,” said James Howard-Tripp, president and CEO, Labopharm.
Tramadol is a centrally acting analgesic that is indicated for the treatment of moderate to moderately severe pain in adults. The worldwide market for tramadol is estimated to be valued at $1.3 billion and IMS Health estimates that the worldwide sales volume of tramadol has grown at a compounded annual rate of 14% over the past five years.
It is currently available only in immediate-release formulations typically requiring four to six doses per day, so the companies hope that the once daily formulation currently in development would become a popular form of the drug.