Date: 2011-08-30

Type of information: Licensing agreement

Compound: biosimilar products for monoclonal antibody rituximab

Company: Stada (Germany) Richter (Hungary)

Therapeutic area: Cancer - Oncology - Autoimmune diseases

Type agreement:


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Stada and Gedeon Richter Plc. have signed two separate license and collaboration agreements in respect of the development and marketing of two biosimilar products for the 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 as a biosimilar 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 at the signing of 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 have already been agreed on.
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.

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Is general: Yes