Gilead Sciences, a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need, and World Health Organization (WHO) have established a new five-year initiative to prevent deaths from visceral leishmaniasis. Gilead will donate 445,000 vials of AmBisome (amphotericin B liposome for injection) to help the WHO to treat more than 50,000 patients with visceral leishmaniasis (VL), also known as kala-azar.
AmBisome is a liposomal formulation of amphotericin B that is administered by intravenous injection. AmBisome is indicated for empirical therapy for presumed fungal infection in febrile, neutropenic patients; for treatment of cryptococcal meningitis in HIV-infected patients; for treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory (non-responsive) to conventional amphotericin B, or in patients where renal impairment or unacceptable toxicity precludes the use of conventional amphotericin B; and for treatment of visceral leishmaniasis.
Visceral leishmaniasis is widespread in South Asia and the Horn of Africa, where it affects hundreds of thousands of people annually. Without treatment, the mortality rate is close to 100 percent. In the Indian subcontinent, where VL is endemic, the WHO Leishmaniasis Expert Committee recommends single-dose AmBisome as the safest, most effective treatment for the disease. AmBisome is approved for the treatment of VL in the United States.
"This commendable donation means that every AmBisome vial will contribute to saving a life," commented Dr. Jorge Alvar, who heads WHO's Leishmaniasis programme in the Department of Control of Neglected Tropical Diseases. "We hope that this commitment by Gilead will encourage other partners to join the fight in overcoming this neglected tropical disease."
"Gilead is proud to expand our long-standing partnership with WHO," said John C. Martin, PhD, Chairman and Chief Executive Officer of Gilead Sciences. "We continually seek to identify new ways to increase access to our anti-infective therapies, and have the highest regard for WHO's efforts to combat VL worldwide. Working in conjunction with health ministries, WHO will now be able to save more lives by expanding patient access to AmBisome."
Gilead has supported WHO's leishmaniasis control programme since 1992. Currently Gilead offers AmBisome through the company's access program at no-profit pricing - or pricing that is at or below Gilead's manufacturing cost - in a number of countries hardest hit by VL. If sold at Gilead's no-profit access price, today's donation would cost more than $8 million. The company also donates AmBisome for use in clinical studies aimed at identifying the most effective VL treatment regimens.
These initiatives are part of the Gilead Access Program, which aims to provide wider access to the company's medications to affected populations in the developing world. The Access Program is currently delivering branded or generic versions of Gilead's HIV therapies to 1.8 million patients in developing countries.
Visceral leishmaniasis is transmitted by the bite of sand flies carrying the Leishmania parasite. The parasite attacks organs and can cause complications such as fever, weight loss, enlargement of the spleen and liver, and increased vulnerability to other life-threatening infections.
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need.