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.

Spherotide Box

Commercial Map

Partnering?

Don’t hesitate to contact us. Please fill in the contact form and an Xbrane Executive Partner Representative will contact you.

Or contact directly:

For our Controlled Release Generics
Martin Åmark
+46 76-309 37 77
martin.amark@xbrane.com

For our Biosimilars
Siavash Bashiri
+46 73-434 36 19
siavash.bashiri@xbrane.com