Our leading biosimilar, Xlucane (ranibizumab biosimilar) will save elderly suffering from Age related Macular Degeneration from severe vision impairment, providing a more cost-efficient treatment than currently available.
Portfolio of niche biosimilars with limited competition
Xbrane select which biosimilar opportunities to pursue on the basis of the attractiveness of the market, competitive situation and the competitive advantage Xbrane can have on the basis of its technological platform and capabilities.
Xlucane is a ranibizumab (Lucentis®) biosimilar which will provide a more cost efficient treatment for a potential patient population over +18 million suffering from vision impairment.
Xlucane is used in the treatment of wet form of age-related macular degeneration (AMD), diabetes-related macular edema (DME), diabetic retinopathy (DME) and retinal vein occlusion (RVO). Overall it is estimated that all indications combined has a prevalence of over 18 million potential patients globally. Xlucane will provide a more cost-efficient treatment compared to the established VEGFa inhibitors Lucentis® and Eylea® and thereby make the treatment accessible to large population groups globally and realize significant savings to the healthcare community. In 2018 the VEGFa inhibitor market for ophthalmic use generated sales of €9.1 billion out of which Lucentis® sold for €3.2 billion.
Xbrane has completed the development of the production process for Xlucane at commercial scale and has demonstrated a high level of similarity compared with the originator product on the basis of a panel analysis methods in accordance with guidelines from EMA and FDA.
The confirmatory clinical equivalence phase III trial was initiated Q1 2019 with primary aim to evaluate comparative efficacy in terms of change in visual acuity 8 weeks after initiation of treatment. Xbrane has acceptance for the study design from both EMA and FDA. The target is to launch the product upon patent expiration in Europe beginning of 2022.
Xbrane has entered into a co-development agreement for Xlucane with the German generic/biosimilar company STADA. Under the agreement Xbrane is responsible for development of the product and STADA for sales and marketing. Development expenses and profits generated from sales of the product are shared 50/50.
Spherotide is the worlds first generic to long acting triptorelin, providing a more cost efficient treatment to over 10 million patients suffering from prostate cancer and breast cancer as well as millons of patients suffering from endometriosis and myoma.
Spherotide is a long-acting injectable with the active substance triptorelin. It is used principally in the treatment of prostate cancer, breast cancer, endometriosis and myoma. The drug is based on encapsulation of the active substance in biological degradable microspheres which are broken down in the body after injection, creating a long-acting effect. Spherotide is the world’s first generic of long-acting triptorelin (originator drug Decapeptyl®/Pamorelin®/Trelstar®), which has an annual sales of about € 0.4 billion.
Xbrane intends to conduct confirmatory phase III clinical trials, in prostate cancer patients and in endometriosis patients, with the aim is to demonstrate non-inferior efficacy of Spherotide, in terms of hormone suppression levels in the patients after treatment, in comparison with the originator drug.
Xbrane currently has commercial partners for Spherotide in China (CR Pharma), South Korea (BL&H), Israel (Bioavenir) and Iran (Pooyesh Darou). Spherotide received market approval in Iran in July 2017 through its local partner under the Microrelin® brand.