Xbrane Biopharma AB (“Xbrane”) and STADA Arzneimittel AG (“STADA”) have entered into a co-development agreement for Xlucane, a Lucentis® (ranibizumab) biosimilar.
About the agreement
The collaboration between Xbrane and STADA is based on a co-development agreement, meaning that the companies will equally contribute to development expenses and share profits from commercialization in a 50/50 split. To enter into this agreement, STADA will make an upfront payment to Xbrane of EUR 7.5 million. In close consultation and agreement with STADA, Xbrane will be responsible for the development of the product until completion of the marketing authorization applications to EMA (European Medicines Agency) and FDA (US Food and Drug Administration), as well as 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 and APAC markets.
The road ahead
The next step in the development of Xlucane is the initiation of the pivotal phase I/III clinical trial. Xbrane has agreed on the study design with EMA and FDA and has selected a leading Contract Research Organization to conduct the study, which is aimed to demonstrate similarity vs. Lucentis®. The study will involve a large number of wet AMD (age-related macular degeneration) patients across 16 countries.
Martin Åmark, CEO of Xbrane says: “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. We could not have found a better partner to help develop and commercialize Xlucane.”
Anders Tullgren, Chairman of the Board of Directors at Xbrane comments: “The co-development deal with STADA is a significant achievement and opportunity for Xbrane which confirms Xbrane’s unique capabilities and competencies in biosimilar development. The deal will contribute significant funding and expertise for the development and commercialization of Xlucane and will help to accelerate the development of our pipeline of biosimilars as well as the transformation of Xbrane into a major player in the fast-growing global biosimilars market.”
STADA CEO Dr. Claudio Albrecht, says: “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.”