Date: 2017-03-27
Type of information: Validation of a production plant
Compound: Spherotide production facility in Italy
Company: Xbrane Biopharma (Sweden)
Therapeutic area: Technology -Services
Type agreement: validation of a production plant
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Details: * On March 27, 2017, Xbrane Biopharma has delivered its first batch of Spherotide® (triptorelin) to its partner in the Middle East to a value of 7 MSEK. Xbrane expects shipment of at least two additional batches of similar size to its partner in the Middle East during 2017. Spherotide® is a depot formulation drug 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. * On February 17, 2017, Xbrane Biopharma announced that it has been granted GMP (Good Manufacturing Practice) certification for its Spherotide production facility by AIFA, the Italian Medicines Agency. Spherotide is the generic version of the drug marketed under the names Decapeptyl®/ Trelstar®/Pamorelin®. The compound is a depot formulation drug with GnRH analogue 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. 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. * On October 24, 2016, XBrane announced the positive outcome of the inspection of the production facility. Only minor deviations were identified which will be adjusted and reported back to AIFA within 30 days. Hence, GMP approval is expected in Q1 2017. The facility currently has capacity to produce approximately 50% of global annual volume of the originator drug that Spherotide addresses and can be expanded if need be. Upon approval Xbrane will ship its first commercial batch of Spherotide to its distribution partner in the Middle East. Distribution deals for other regions are expected during Q1-Q2 2017. * On August 1, 2016, Xbrane subsidiary Primm Pharma has submitted the application to AIFA, the Italian Medicines Agency, for GMP approval of its production facility for Spherotide situated outside Naples, Italy. AIFA will during the coming 6 months make an evaluation, including a visit of the facility and if no concerns are reported an approval can be expected by early 2017.
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