Bio Products Laboratory (BPL), a leading manufacturer of plasma-derived protein therapies, based in Elstree, UK, announced today the issuance of a marketing authorization for Coagadex® in the Dominican Republic.
Coagadex® is the first and only specific treatment for Hereditary Factor X Deficiency, an ultra-rare inherited clotting disorder, affecting up to 1 in a million people worldwide. The disease causes problems with blood clotting due to not having enough Factor X in the blood, and people with Factor X Deficiency can have serious and life-threatening bleeding episodes.
The treatment is critical to meet the increasing needs of patients in the region, with a population of 10.8 million, the Dominican Republic is the tenth largest economy in Latin America. The approval is also timely, as only two months ago, the protocol was updated in the country for the treatment of paediatric and adult Haemophilia, including Hereditary Factor X Deficiency.
This is the first marketing authorization for BPL in Central America and the Caribbean, and with a robust strategic expansion plan in motion, the company expects this to be the first of many countries in the region to receive marketing authorization.
It also follows some key milestones for BPL this past year who received two marketing authorizations for Coagadex®, firstly in India last September, followed by Mexico in May.
Bob Rossilli, Chief Commercial Officer, Global Business, said, “We are delighted by this approval, which means we can soon provide patient communities in the Dominican Republic with Coagadex® – the only treatment specifically for Hereditary Factor X Deficiency.
This authorization and our recent approvals in India and Mexico for Coagadex®, reflects our plans for expansion in Central America and across the world. It also highlights our corporate mission of providing a continuous supply of plasma-derived products worldwide to support healthcare professionals and patients every day.”
Thank you to our distributor, Bioplus Care, and all those involved, for the great collaborative work during a long journey to make another success happen for patients in the Dominican Republic and around the world.”
Stephanie Waserstein, Head of BioPlus Care, said, “It is extremely satisfying for BioPlus Care to have partnered with BPL, a truly patient centred company, committed to making its therapies available in all parts of the world where patients need them.”
Donna Mitchell, BPL Communications Manager
About Bio Products Laboratory (BPL)
Recognising the importance of plasma and with many years of experience in the industry, BPL supplies high-quality plasma derived medicines to meet the needs of clinicians, patients, and customers globally. Headquartered in the United Kingdom, with US offices in Durham, NC, and plasma collection centres across the United States, we are dedicated to producing medicines for the treatment of immune deficiencies, bleeding disorders and infectious diseases as well for critical care. BPL invests in the latest R&D, technology and manufacturing methods, and continuously adapts to ensure that we continue to serve all our stakeholders effectively. For more information visit http://www.bplgroup.com or https://www.bpl-us.com.
BPL consists of two operating divisions — BPL Plasma and BPL Therapeutics. BPL Plasma, headquartered in Austin, Texas and operating in the USA, collects plasma from donors in around 29 centers across the U.S. BPL Plasma employs over 900 staff to support the needs of donors and to ensure high-quality plasma collection in all their centers. Plasma collection is regulated by both FDA and MHRA, and BPL Plasma follows industry guidelines. BPL Plasma operates plasma facilities, staffed with trained personnel, dedicated to supporting donors through the process that leads to the donation of plasma. Plasma is shipped to the headquarters of BPL Therapeutics in Elstree, United Kingdom. The plasma is fractionated, purified, and filled through the efforts of our over 1,000 employees involved in production, quality, R&D, commercial, customer services, and administrative activities. BPL’s plasma-derived medicines are commercially available in the U.K., USA, and 30 plus other countries around the world through our network of local affiliates and distribution partners.