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news.Xbrane Biopharma’s subsidiary Primm Pharma has submitted GMP approval application to the Italian Medicines Agency AIFA for its production facility for Spherotide located outside Naples, Italy.
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The agency is expected to take a decision by early 2017.
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.
It is used in the treatment of hormone-responsive cancers like prostate cancer or breast cancer, precocious puberty, estrogen dependent conditions such as endometriosis and uterine fibroids.
The GMP approval, which is an important step in the development process, will allow Xbrane to produce Spherotide for human use
Xbrane acquired Primm Pharma in September 2015 in form of a convertible note that can be converted into its shares depending on meeting six milestones tied to the development of Spherotide.
The GMP application submission to AIFA is the first milestone in the process.
Xbrane Biopharma CEO Martin Åmark said: "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.”
Sweden-based Xbrane is engaged in the development of generics for injectable controlled release drugs and high yield protein expression technology for the development of biosimilars.