Date: 2011-08-30
Type of information: Licensing agreement
Compound: biosimilar rituximab - biosimilar version of Mabthera®/Rituxan® , biosimilar trastuzumab - biosimilar version of Herceptin®
Company: Gedeon Richter (Hungary) Stada (Germany)
Therapeutic area: Cancer - Oncology - Autoimmune diseases
Type agreement: licensing development commercialisation
Action mechanism: monoclonal antibody/biosimilar.
Disease:
Details: * On August 30, 2011, Gedeon Richter and Stada announced 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. 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 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 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 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.
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.
Financial terms:
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