Co-development deal for ranibizumab biosimilar Xlucane

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Co-development deal for ranibizumab biosimilar Xlucane

INICIO/Noticias Farmacéuticas | Posted 07/09/2018 0 Post your comment

German generics giant Stada and Swedish biotech company Xbrane announced on 12 July 2018 that they had entered into a co-development agreement for Xlucane, a proposed biosimilar to Lucentis (ranibizumab).

Stada and Xbrane will equally contribute to development expenses and share profits from commercialization in a 50/50 split. As part of the agreement, Stada will make an upfront payment to Xbrane of Euros 7.5 million, while Xbrane will be responsible for the development of the product until completion of the marketing authorization applications to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA). Xbrane will also be responsible for supply of the finished pharmaceutical product. Stada will hold the marketing authorizations and will be responsible for sales and marketing of the product across all territories included in the agreement. The co-development agreement covers Europe, the US and a variety of MENA (Middle East and North Africa) and Asia-Pacific markets.

Ranibizumab is a monoclonal antibody fragment created from the same parent mouse antibody as bevacizumab. Ranibizumab inhibits angiogenesis (the formation of new blood vessels) by inhibiting vascular endothelial growth factor A (VEGF-A), a mechanism similar to bevacizumab [1]. Ranibizumab can be used to treat macular degeneration by inhibiting VEGF, which is responsible for the excessive formation of blood vessels in the retina leading to progressive loss of vision. The monoclonal antibody drug is indicated for the treatment of wet age-related macular degeneration (AMD), macular oedema, degenerative myopia and diabetes complications; all conditions of the eye causing vision loss.

Xbrane reported positive in-vitro biosimilarity data for Xlucane in February 2017 [2] and is planning to initiate a pivotal phase I/III clinical trial for the ranibizumab biosimilar. The company has already agreed on the study design with both EMA and FDA, which aims to demonstrate similarity compared to Lucentis. The study will involve a large number of wet AMD patients across 16 countries.

References
1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of bevacizumab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 7]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab
2. GaBI Online - Generics and Biosimilars Initiative. Advances in ranibizumab and teriparatide biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Sep 7]. Available from: www.gabionline.net/Biosimilars/News/Advances-in-ranibizumab-and-teriparatide-biosimilars

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Source: Stada,Xbrane