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In-licence the Worlds First Generic to Leading GnRH Analogue with Controlled Release Formulation
Xbrane Biopharma Sweden flag Sweden
Abstract ID:
Spherotide is a generic version of a leading GnRH analogue with controlled release based on encapsulation of the active substance in microspheres of a biodegradable polymer.
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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®.

Type of Business Relationship Sought
Sales and distribution partnerships for main countries/regions, either for bulk product from GMP approved facility (available 2017) or for EU approved final product (filled vials) (available 2018).
Last Updated Jun 2016
Technology Type THERAPEUTIC
Phase of Development CLINICAL TRIALS

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