Xbrane Biopharma AB is a biotechnology company which develops, manufactures and produces commercial biosimilars. The collaboration with STADA - the experts in generics, non-prescription OTC products and biosimilars in particular - will initiate phase I/III clinical trials, progressing the development of Xlucane.
Under the terms of the agreement, STADA will make an upfront payment to Xbrane of EUR 7.5 million.
Xbrane will be responsible for the development of the product until completion of the marketing authorisation applications to EMA (European Medicines Agency) and FDA (US Food and Drug Administration), as well as the supply of the finished pharmaceutical product.
STADA will hold the marketing authorisations and will be responsible for sales and marketing of the product across the specified territories, including Europe, the US, and a variety of MENA and APAC markets.
"We are very excited to enter into this co-development partnership with STADA. STADA is a strong player and has long experience in distributing and marketing biosimilars" said Martin Åmark, CEO of Xbrane. "We could not have found a better partner to help develop and commercialise Xlucane."
The product, Xlucane, is a biosimilar to the VEGFa inhibitor ranibizumab (Lucentis). Lucentis is used in treatment of several eye diseases, mainly neovascular age-related macular degeneration (wet AMD), diabetic related macular oedema (DME) and retinal vein occlusion (RVO). All these conditions cause deteriorating vision and, if untreated, can lead to blindness.
The development of Xlucane presents a lucrative opportunity for the companies, especially since Lucentis global sales amounted to €2.8 billion in 2017.
As a first development step, Xbrane has enlisted a leading Contract Research Organisation to conduct a study to demonstrate similarity vs Lucentis. The study will involve a large number of wet AMD patients across 16 countries.
STADA CEO Dr Claudio Albrecht, added: "The collaboration with Xbrane, with its team of very experienced development experts, is a great opportunity for STADA to accelerate the expansion of our biosimilar portfolio and to strengthen our market position in this segment."
