Nitec Pharma, a Switzerland-based specialty pharma company, has granted an exclusive license to Mundipharma International for the distribution of Lodotra in Europe.
Under the terms of the agreement, Mundipharma will acquire the distribution rights to Lodotra in Europe, excluding Germany and Austria which are licensed to Merck KGaA, and Nitec will receive undisclosed royalty payments. Nitec retains all commercialization rights for the rest of the world.
Lodotra, Nitec’s novel single-pulse delayed-release low-dose prednisone tablet, was recommended for European regulatory approval for the treatment of rheumatoid arthritis and associated morning stiffness in January 2009. Germany led the decentralized procedure and Lodotra is now also considered approvable by the regulatory agencies of 14 other countries (the ‘Euro15’). Lodotra is expected to be launched in Germany within the next few weeks.
Anders Harfstrand, CEO of Nitec Pharma, said: Our agreement with Mundipharma is a key milestone for Nitec as we prepare for a European launch. Mundipharma has a proven track record in successfully launching and commercializing pharmaceutical products in Europe. Their strength, as a partner, is with their strong expertise with the target prescribers in these key markets.
We are confident that this agreement with Mundipharma’s sales force will accelerate Lodotra’s market success. Personally, I strongly believe that our two companies will co-operate effectively as we share values and an entrepreneurial philosophy.