Richter, STADA to co-develop biopharmaceuticals


Hungarian drugmaker Richter Gedeon Nyrt and STADA Arzneimittel AG announced Tuesday they had signed two separate license and collaboration agreements on the development and marketing of two biosimilar products, two monoclonal antibodies Rituximab and Trastuzumab.

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 and whose approval can be expected at the end of 2017.

In addition to STADA and eventual own marketing, Richter may grant a maximum of one additional partner a relevant distribution license in the contract area. If such a partially exclusive license marketing in Russia become regulatory possible, STADA would also receive such a distribution license there from Richter.

Under the terms of the agreement in addition to a payment on the event of signing the contract, STADA is obliged to make further payments, each depending on the progress of the project, which amount in total to a low double-digit million euro figure.

STADA will exclusively purchase the Rituximab biosimilar from Richter for marketing and distribution of the product for which the major commercial terms are already agreed on.

STADA is known to have done preparatory work 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 now for a low single-digit million euro figure, in order to thus accelerate the ongoing own development for a Trastuzumab biosimilar.


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