Scandinavian Biopharma expand their portfolio with Coagadex® - the first and only tailormade treatment for the rare bleeding disorder ‘factor X deficiency’

Scandinavian Biopharma has entered into a distribution agreement with Bio Products Laboratory Limited (BPL), a leading manufacturer of plasma-derived protein therapies, for their unique factor X deficiency product Coagadex®.

Coagadex® is the first and only tailormade treatment for factor X deficiency bleeding disorder in Europe. Coagadex® is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency.

Factor X deficiency is a rare and serious condition caused by not having enough of the Factor X protein in the blood; this protein plays a crucial role in coagulation (blood clotting) which helps patients stop bleeding. People with Factor X deficiency are at increased risk of bleeding or experience excessive or prolonged bleeding. Severely affected individuals, usually children, have an increased risk of bleeding inside the brain, in the lungs or in the gastrointestinal tract, which can be life-threatening.Hereditary Factor X deficiency is very rare and affects approximately 700 patients in Europe.

“We are very proud to be able to make this unique product available in the Nordic countries and the Baltic states. Until recently, the treatments available were designed for other diseases and contain larger amounts of other proteins, such as factors II and IX, in addition to factor X. With Coagadex® you replace exactly what’s missing for the patients who suffer from this rare disease and this gives the product a favourable safety profile“, says Lisa Sandberg, VP Marketing at Scandinavian Biopharma.

About Coagadex®

Coagadex® is derived from human plasma and used as a replacement for the naturally existing coagulation Factor X in patients with hereditary Factor X deficiency. In the EU, Coagadex® is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in adult and children with hereditary factor X deficiency. It was first approved by the Food and Drug Administration (FDA) in October 2015. In 2016 the product was granted European marketing authorisation and orphan designation from European Medicines Agency.