Launches RECOMBINATE a genetically engineered, non-plasma-derived FVIII bringing advanced care to people with Hemophilia in India

Chennai, 21 November 09- Baxter India Private Limited, a wholly owned subsidiary of Baxter International Inc., the global leader in Hemophilia care today announced the launch of RECOMBINATE in India. RECOMBINATE, a genetically engineered non plasma-derived recombinant factor (rFVIII) through increased viral safety and uninterrupted supply, represents a significant step forward in raising the standards of care for people with Hemophilia in India. RECOMBINATE is indicated for the prevention and control of hemorrhagic episodes and for the preoperative management of people with Hemophilia A.

Announcing the launch Dr Wing-Yen Wong, MD, Therapeutic Area Head for Hemophilia/Hematology Clinical Research and Development and Global Senior Medical Director, Bioscience, Baxter said “The introduction of innovative factor replacement therapies have helped to advance hemophilia treatment and raise the standard of care around the world for hemophiliacs. The launch of RECOMBINATE is yet another step in the advancement of hemophilia care in India. At Baxter, we will continue to support advocacy for hemophilia in India through community participation, investing in the areas of patient and clinical education, medical outcomes and expanding patient access to therapies, all to help drive increased treatment and improved quality of life for hemophilia patients in India”.

Sharing his thoughts, Dr. Alok Srivastava, Head-Department of Hematology, Christian Medical College, Vellore said, “Introduction of newer therapies in hemophilia treatment are welcomed both by the industry and the medical fraternity which would help in bringing relief to the patients suffering from this condition.”

RECOMBINATE [Antihemophilic Factor (Recombinant),] is the first genetically engineered, non-plasma-derived, recombinant factor VIII (rFVIII) therapy in the world1. Available since 1992, used in over 41 different countries, and with in excess of 12 billion IU dispensed, RECOMBINATE is a known choice for hemophilia management. (Baxter Sales Data for RECOMBINATE 1992 – 2007).


As a genetically engineered product, RECOMBINATE contains only a minimal amount of human blood components2. It thus minimizes the risk of transmission of blood-borne pathogens as well as offering a much more dependable supply than plasma-derived FVIII products, which are reliant upon donations and prone to shortages.

Current India Hemophilia Incidence

Owing to the prevailing disease condition in the world where there is an estimated prevalence rate of 1 in every 10,0003 and the population of India being over 1000 million, it could be estimated that there are almost up to 100,000 people in India affected with hemophilia. Most of them, as per worldwide estimations, would be with severe hemophilia. Access to factor concentrates is not uniform throughout the country and depends not only on the socio-economical factors but also on local availability. The production and availability of plasma derived factor concentrates is dependent on the healthy human donors. Pathogen safety has been an issue around the world and so also in India. About 10-14% of People with Hemophilia in India have hepatitis B infection and 24-30% of them are positive for hepatitis C.4

Baxter’s Commitment

Baxter works closely with the hemophilia community to raise the standard of care and provide access to care for the community through several areas. Baxter makes available a number of resources, including education, advocacy programs and support, clinician support and factor replacement therapies, an integral component of the comprehensive care approach.


In particular, the company has donated $1.5 million and nearly 3 million IUs of its hemophilia products to the World Federation of Hemophilia’s Global Alliance for Progress (GAP) program, of which the company is founding member and leading sponsor. The program was launched by the World Federation of Hemophilia and its members to improve the diagnosis and treatment of people with hemophilia in up to 30 developing countries.

In 2008, Baxter also donated more than $1.4 million in hemophilia products through its valued partnership with AmeriCares, an international disaster relief and humanitarian aid organization that airlifts critical medicines, medical supplies and other aid to areas suffering humanitarian crises resulting from natural disasters or political strife.

Thanks, in part, to therapies from Baxter, the life expectancy for people with hemophilia has increased from 11 years prior to the 1960s to more than 60 years today5.