Introducing The World’s First generic to leading GnRH analogue with controlled release
Pioneering complex generics
Spherotide is a generic version of the drug marketed under the names Decapeptyl®/ Trelstar®/Pamorelin® with formulation for controlled release. The active substance in the drug is Triptorelin and the controlled release formulation is based on encapsulation in microspheres of a biodegradable polymer.
Triptorelin is a GnRH analogue that after an initial stimulation suppresses sex-hormone production and is used in the treatment of hormone-responsive cancers such as prostate cancer or breast cancer, precocious puberty, estrogen dependent conditions such as endometriosis and uterine fibroids.
Spherotide will first be launched as 1-month formulation, while a 3-month formulation is under development. Spherotide is administered through either subcutaneous or intra-muscular injection. After injection of the 1-month formulation leads to an initial increase of sex hormone levels followed by a fall below the castration levels for at least 4 weeks. Extensive in-vivo trials have demonstrated similar effects on testosterone plasma concentration in male rats between Spherotide and Decapeptyl®/ Trelstar®/Pamorelin®. Comparative clinical trials will be conducted during 2017 with target for market registration in EU.
Xbrane has a production facility in Italy for Spherotide which currently undergoes the process for GMP approval. The production is done through a very cost efficient process with speciality equipment designed for the specific process.
The global GnRH analogue market is estimated to 22 BSEK and sales of Decapeptyl®/ Trelstar®/Pamorelin® is estimated to 3,7 BSEK annually. Spherotide is expected to become the worlds first generic version to Decapeptyl®/ Trelstar®/Pamorelin®. Xbrane is currently seeking partners for sales and marketing of Spherotide.