Nitec Pharma AG (BASEL, Switzerland), a specialist pharmaceutical company that focuses on the treatment of chronic inflammatory diseases, announced that it has granted marketing rights in Germany to Merck Pharma GmbH, a division of Merck KGaA, for Lodotraâ„¢, a modified-release tablet that has been developed to optimize the efficacy of orally administered low-dose prednisone for rheumatoid arthritis (RA). Terms of the deal were not disclosed.

Lodotra is a nighttime release formulation of prednisone, developed to address morning stiffness associated with RA. Phase III trials of Lodotra were successfully completed in 2006 and Nitec will be using the same modified-release technology to develop treatments for other indications such as polymyalgia rheumatica and inflammatory diseases.

Nitec was created in 2004 in a spin-off from Merck KGaA. Lodotra was developed by Merck in cooperation with SkyePharma PLC, using SkyePharma's Geoclockâ„¢ technology. Merck retained, and is now exercising, the option of marketing Lodotra in Germany, following the positive results of the phase III trial.

Nitec plans to launch the drug in Europe this year, pending completion of regulatory filing, and hopes to grant licenses outside of Germany to specialized players in order to exploit the full potential of Lodotra.

—A Techman

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