The company has established a mammalian cell based technological platform and accelerate the development of Xdivane, a biosimilar of the PD-1 inhibitor Nivolumab (Opdivo) as the first product of this platform.

“With this announcement we continue to broaden our technology platforms to improve the quality and production of our mammalian cell based products, further confirming our goal of becoming a leading innovative biosimilar development company,” stated Martin Åmark, CEO of Xbrane.

Launch of Xdivane in 2026-2030

Opdivo is a leading immunoncology product for the treatment of cancer with annual sales of SEK 54 billion in 2018, in a total oncology pharmaceutical market that generated sales of SEK 1200 billion in 2018. Opdivo is also, as most biologics, an expensive treatment with annual per patient costs often above SEK 1 million. Developing a cost efficient biosimilar to Opdivo is therefore of great importance in order to increase accessibility globally of the treatment, states the company.

Xbrane expects to be able to launch Xdivane at patent expiration of Opdivo occurring 2026-2030 depedent on country.

Key experts and strategic partnerships

Xbrane continues to focus on innovation in development and production efficiency, it states. For its E. coli based biosimilars, this is ensured by Xbrane’s patented production technology, which provides up to a 12 times yield advantage compared to the current standard systems in the market, according to the company. Xbrane has now secured the required competence and technology for mammalian cell based biosimilars, with the ambition of providing a similar yield advantage. The company has recruited key experts with deep experience in the development of mammalian cell based biosimilars primarily within cell line development, process development and analytics. Additionally, Xbrane has entered into strategic partnerships with selected key technology providers regarding cell line development and expression vectors.

New sales target for Xlucane

Xbrane Biopharma also recently initiated their phase III trial in the US with Xlucane, a ranibizumab (Lucentis) biosimilar candidate. Xlucane’s co-development and commercialization partner is the German pharmaceuticals company Stada Arzneimittel AG and Xbrane expects the first revenues from Xlucane sales during the first quarter 2022.

The following sales target have now been adopted by the company: “Xbrane’s target is to reach €350 million in annual net sales three years after the product launch. This renders approximately €100 million in annual license income for Xbrane, after deduction of production and sales related expenses and profit sharing with STADA.”

The sales target is based on reaching a volume market share of 25% in Europe and US of the current (2018) Lucentis (ranibizumab) market at a price discount in line with recent biosimilar product launches. During 2018 Lucentis global sales amounted to €3.5 billion.

Photo of Martin Åmark, CEO, Xbrane Biopharma