Combined, the 20 countries covered by the agreement represent annual pharmaceutical sales of more than $13 billion and pain product sales of more than $1.2 billion. Labopharm has now secured marketing partners for its tramadol product for 41 countries, including the US and four of the five largest markets for tramadol products in Europe.
“With over 70 years of experience in Latin America and the expertise to support the regulatory approval process in these countries, GSK is the ideal partner to capitalize on this opportunity,” said James Howard-Tripp, president and CEO, Labopharm.
Under the terms of the agreement, Labopharm will supply GSK with bulk tablets and GSK will register, package and distribute the product throughout the licensed territory.
Labopharm will receive a transfer price on tablet supply based on a percentage of the anticipated selling price, resulting in an effective royalty rate commensurate with those of the company’s US and European partnerships. GSK will use the regulatory dossier from which approval was gained in Europe as a basis for the registration of the product in each country.