BPL receives orphan drug marketing authorization for Coagadex® in Mexico

ELSTREE, England, May 4, 2022 /PRNewswire/ -- Bio Products Laboratory (BPL), a leading manufacturer of plasma-derived protein therapies, based in Elstree, UK, announced today it has received orphan drug marketing authorization for Coagadex^® in Mexico.

Coagadex^® is the first and only treatment specifically for Hereditary Factor X Deficiency, a very rare inherited clotting disorder that causes problems with blood clotting due to not having enough Factor X in the blood. People with Factor X Deficiency can have serious and life-threatening bleeding episodes.

This approval is critical to meet the needs of Mexican patients, where currently there is little epidemiological information on ultra-rare bleeding disorders and there is limited knowledge of the disease among health professionals¹.

This is the second milestone in Mexico for BPL, who announced in December its first ever direct sale in Mexico of Zenalb^® 20%, another important supply that is critical to meet the needs of Mexican patients who will benefit from albumin.

Bob Rossilli, Chief Commercial Officer, Global Business, said, "BPL continues its focus on delivering high-quality and clinically differentiated medicines like Coagadex^® to new markets around the world and we are honoured that this designation means we can soon bring to market another of our life-enhancing products to patients in Mexico, in addition to Zenalb^® 20%.

BPL continues to strengthen its global commercial presence by launching products into new markets – as demonstrated by the recent news that BPL was granted its first ever approval for a BPL product, Albuminex^® 25% in China - the largest albumin market globally.

Thank you to all those involved for the great collaborative work during a long journey to make another success happen to benefit patients in Mexico and around the world."

Leonardo Torres, General Manager for BPL Mexico, said, "We are delighted with this key success for BPL. In addition to our first product delivery of Zenalb^® 20% this year in Mexico, we will soon be able to provide Coagadex^®, which is of major importance for patients suffering from Hereditary Factor X Deficiency in the country and is another example of BPL's commitment to enhance patients' lives and serve more people who depend on our products."

1. Registro Mexicano de Coagulopatías. Federación de hemofilia de la República Mexicana. [Internet] Citado el 14 de diciembre de 2021. 6 p. Disponible en: https://hemofilia.org.mx/la-importancia-de-estar-registrado/

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.

SOURCE Bio Products Laboratory USA