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In-licence Leading Ranibizumab Biosimilar
Xbrane Biopharma Sweden flag Sweden
Abstract ID:
Xlucane is a Biosimilar candidate to Lucentis® which is mainly used for treatment of the wet form of age related macula degeneration, an eye disease that leads to impaired vision and in worst case blindness....
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Xlucane is a Biosimilar candidate to Lucentis® which is mainly used for treatment of the wet form of age related macula degeneration, an eye disease that leads to impaired vision and in worst case blindness, but has also in latter time received approvals for treatment of macular oedema (swelling of the macula) caused by diabetes, macular oedema caused by occlusion (blockage) of the veins behind the retina and choroidal neovascularisation caused by pathologic myopia.

The active substance of Lucentis® is Ranibizumab, a monoclonal antibody fragment. The mode of action of Ranibizumab is to bind to the vascular endothelial growth factor A (VEGF‑A) present in the eyes of the patients. VEGF‑A stimulates growth of blood vessels which leak fluid and blood that damage the macula and cause the impaired vision. By binding to VEGF-A Ranibizumab can inhibit the growth of these blood vessels and thereby slow down the progression of the disease and improve the vision of the patients. Lucentis® currently generates annual sales of $4.2 billion US globally.

Xlucane has been developed with Xbranes patented technology and deep know-how in protein production resulting in a very high production yield – currently 7x what a standard system in E.coli (BL21) would result in. In-vitro characterization of Xlucane compared to Lucentis® has been conducted with very good results. After optimization of the production process is finalized Xlucane will be taken to GMP production and phase I clinical trials will be initiated. Xbrane is open for partnering discussions regarding Xlucane globally or for specific markets.

Type of Business Relationship Sought
In-licensing (available from now and onwards) or sales and distribution of main countries/regions, either for bulk product from GMP approved facility (available 2018) or filled vials (available 2018). EU approval expected in 2022, US approval expected in 2020.
FEATURED
Last Updated Jun 2016
Technology Type THERAPEUTIC
Phase of Development PRECLINICAL
CORPORATION