Tuesday, February 21, 2017
Xbrane Biopharma has been granted GMP (Good Manufacturing Practice) certification for its Spherotide production facility by AIFA, the Italian Medicines Agency. The GMP certification follows an inspection by AIFA where the production facility was found to demonstrate compliance with GMP standards. The GMP certification is related to the production of Spherotide as a 1 month formulation in bulk. It allows Xbrane to sell and export Spherotide to partners seeking local market authorization for the product as well as to produce material for the clinical trials required for market authorization in Europe. Within the present year, Xbrane expects to receive extension for the GMP certification also to comprise the Spherotide 3 month formulation.
According to EU regulations a GMP certificate of a member state authority is automatically recognized by all 28 member states and, based on Mutual Recognition Agreements, also in Australia, Japan, Switzerland, Canada, Israel and New Zealand. In addition, there are multiple countries accepting an EU GMP certificate as basis for the import of pharmaceutical products.
"The importance of obtaining the GMP certification of our Spherotide production facility can not be overstated. This allows us to ship batches of GMP quality to our partner in the Middle East as well as to produce the clinical batch for the upcoming clinical trial to be initiated this year", says Martin Åmark, Xbranes CEO.
Obtaining the GMP certification of the Spherotide production facility in Italy constituted the second milestone in the outstanding convertible to the former owners of Primm Pharma. The second milestone is hence considered accomplished and gives the former owners the right to convert 20% of the convertible notes corresponding to 265 000 shares in Xbrane Biopharma AB.
Spherotide is a depot formulation drug with the active substance triptorelin and is used primarily in the treatment of prostate cancer, endometriosis and uterine fibroids. The drug is based on encapsulation of the active ingredient in biodegradable microspheres that degrade in the body after injection and create a long acting effect.
