Xbrane’s subsidiary Primm Pharma has recently submitted an application to AIFA, the Italian Medicines Agency, for good manufacturing practices (GMP) approval for its production facility for Spherotide, a generic drug candidate with the potential to be used in endometriosis, prostate cancer, and uterine fibroids.

In the next six months AIFA will evaluate the GMP submission, which includes a visit to the facility located outside Naples, Italy, and if no concerns are reported, an approval of the production facility can be expected early year.

Spherotide is a biogeneric version of Decapeptyl, with the active ingredient triptorelin. Its formulation is based on the encapsulation within microspheres of a biodegradable polymer. Triptorelin, a gonadotropin-releasing hormone agonist (GnRH agonist), causes constant stimulation of the pituitary gland, decreasing pituitary secretion of two gonadotropin hormones: luteinizing hormone (LH) and follicle stimulating hormone (FSH).

Like other GnRH agonists, triptorelin may be used in the treatment of hormone-responsive cancers such as prostate or breast cancer, precocious puberty, estrogen-dependent conditions such as endometriosis or uterine fibroids, and in assisted reproduction.

Spherotide will first be launched as a one-month formulation, while a three-month formulation is under development. The drug is administered through either subcutaneous or intra-muscular injection.

AIFA’s GMP submission is the first milestone in the Spherotide development process. The GMP approval is mandatory to allow Xbrane to manufacture Spherotide for human use.

“We are very happy to submit the application for GMP approval to AIFA in line with our time plan. The GMP approval is a critical step for us in the development process towards market approval and initiated sales of Spherotide in Iran and other markets,” Xbrane Biopharma CEO Martin Åmark said in a press release.