Xbrane Biopharma's (ST:XBRANE) first product offering will be Spherotide: the first generic formulation of the prostate cancer GnRH agonist triptorelin (sales $446m) made by Xbrane’s Italian subsidiary. First sales are likely to be in Iran from 2017. Bigger sales could be generated by a biosimilar of Lucentis, Xlucane, produced at a low cost using a proprietary process. Xlucane might be marketed in the US from 2021, a year after patent expiry, and from patent expiry in Europe in 2022. Lucentis sales worldwide are about $3.6bn.
Prostate cancer – a $500m generic opportunity
Triptorelin, branded as Decapeptyl (total sales 2015: $446m – Ipsen sales €334m plus Allergan (NYSE:AGN) and Ferring) is indicated for advanced, non-metastatic prostate cancer. It also treats Endometriosis. Triptorelin is one of a well-established class that down-regulate GnRH receptors; all brands are off patent. Most sales are of three-month depot formations; continuity of dosing is crucial. The leaders are goserelin (Zoladex, AstraZeneca sales 2015: $816m) and leuprolide (Lupron Abbive: $826m). Generic depot formulations been very difficult to make. Spherotide is produced in Xbrane’s Italian subsidiary, acquired in September 2015. Initial sales are planned to Iran in 2017; Xbrane estimates this market as worth $30m. It is awaiting GMP approval to ship a SEK7m order. A recent Chinese SEK70m deal should yield SEK17m cash in Q117. Clinical trials will be required for approval elsewhere. EU and US applications are planned in 2018. There is no clinical data.
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