Stada and Richter to co-develop rituximab and trastuzumab

September 1, 2011 1:57 PM

Stada Arzneimittel AG, the German pharmaceuticals company, has signed an agreement with Gedeon Richter Plc. of Hungary to license and develop two biosimilar products, rituximab and trastuzumab. Originator of both products are Genentech (Roche) and they are marketed under the brand names Rituxan (Mabthera) and Herceptin respectively. According to the agreement STADA receives non exclusive distribution rights for the area of geographical Europe and the CIS area, but due to regulatory reasons, excluding Russia, for the biopharmaceutical active ingredient Rituximab, which Richter is currently developing as a biosimilar and whose approval from today’s perspective can be expected at the end of 2017.

STADA, has done preparatory work for a biosimilar for the biopharmaceutical active ingredient Trastuzumab, which, however, was stopped at the end of 2010 because STADA made the strategic decision to pursue the lower-cost approach of an in-licensing. The stage of development that STADA had reached up until that point will now be acquired by Richter as part of a contract concluded today for a low single-digit million figure, in order to thus accelerate the ongoing own development for a Trastuzumab biosimilar. In addition, STADA receives, at the time of the beginning of the clinical studies in approximately two years, a unilaterally for STADA exercisable option from Richter to acquire also for such a Trastuzumab biosimilar a distribution license at commercial conditions analogous to those of the Rituximab.

The development of both biosimilars will now be continued under the leadership of Richter. A supporting function from STADA for specific patent rights questions in both projects has also already been agreed. STADA will also support if necessary the relevant approval processes with its own expertise in the area of EU approvals of biosimilars.

Source: STADA Press release


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