Ranbaxys new chemical entity gets license

By Praveen Chandran | 27 Jun 2002

Mumbai: The domestic drug major Ranbaxy Laboratories (India) Ltd and Schwarz Pharma AG, Germany, have announced the licensing deal of Ranbaxys new chemical entity RBx-2258 for the treatment of benign prostate hyperplasia to Schwarz Pharma.

A company official says that given the successful development, Schwarz Pharma will pay to Ranbaxy a total of $42.0 million over the next five to six years, including an upfront payment of $6.3 million, followed by royalties on commercialisation.

Schwarz Pharma obtains the exclusive rights to develop, market and distribute the product in the US, Japan and Europe, while Ranbaxy retains rights to all other markets. The agreement also provides for Ranbaxy to manufacture and supply finished formulations of the product to Schwarz Pharma.

The deal has to be approved by the Reserve Bank of India.  In India the compound RBx-2258 is currently in clinical phase-II trials. Schwarz Pharma is taking over the clinical development in the US, Europe and Japan.

This includes further clinical phase-I studies. The compound (Schwarz Pharma code: SPM969) is a uro-selective alpha-blocker, which has patent protection until 2018. This alpha-1-adrenoceptor antagonist belongs to the latest generation of alpha-blockers for the treatment of BPH.

"With the new compound we are strengthening our urology pipeline," says Prof Iris Lw-Friedrich, MD, a member of Schwarz Pharma AGs executive board. "It seems to be a highly uro-selective alpha-1-adrenoceptor antagonist with a well-known and established mechanism of action."