On August 30, 2011 Gedeon Richter and STADA Arzneimittel reported that the two companies have signed two separate license and collaboration agreements in respect of the development and marketing of two biosimilar products, two monoclonal antibodies Rituximab and Trastuzumab (Press release Gedeon Richter, AUG 30, 2011, View Source [SID:1234501390]).

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​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 from today’s perspective 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, as is known, has 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 today for a low single-digit million Euro 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 CEOs both of STADA and Richter expressed their commitment to the established cooperation.

For Hartmut Retzlaff, Chairman of the Executive Board of STADA Arzneimittel AG, the cooperation agreed on today shows that the STADA strategy of refraining from its own cost-intensive biosimilar development and to instead rely on cooperations and licenses for these biosimilar projects was correct. "With today’s cooperation we have secured marketing access to two biosimilars with particularly high sales potential for our core markets in Europe at substantially more favorable conditions than with a development of our own – and that with such an outstanding partner like Richter which is known in the industry for its high degree of expertise and reliability", said Retzlaff.

Erik Bogsch, CEO of Gedeon Richter Plc., added following comments on today’s contracts:
„We always considered the development of biosimilar products as an important strategic initiative for Richter and we made significant efforts to establish our future presence in the field of biotechnology, thereby enhancing the proportion of high added value products. This agreement is considered to be a significant move in line with Richter’s aim to find strategic partners for the development, marketing and distribution of our biosimilar product portfolio. With STADA we gained an excellent, high class cooperation partner whose traditionally strong presence and expertise in the field of developing and marketing both generic and biosimilar product groups, will contribute to fulfil our long term strategy."

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 upon today. STADA will also support if necessary the relevant approval processes with its own expertise in the area of EU approvals of biosimilars.