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Agreements

Date: 2011-08-30

Type of information: Licensing agreement

Compound: biosimilar products for monoclonal antibody trastuzumab

Company: Stada (Germany) Richter (Hungary)

Therapeutic area: Cancer - Oncology

Type agreement:

licensing
collaboration
development

Action mechanism:

Disease:

Details:

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. Stada, as is known, 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 upon today. Stada will also support if necessary the relevant approval processes with its own expertise in the area of EU approvals of biosimilars.

Financial terms:

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Is general: Yes