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. 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 $3.5 billion US and sales of Decapeptyl®/ Trelstar®/Pamorelin® is estimated to approximately $700 million US annually. Spherotide is expected to become the worlds first generic version to Decapeptyl®/ Trelstar®/Pamorelin®.