Gilead Sciences (Foster City, CA) (GILD) And Aspen Pharmacare Ltd. Sign Letter Of Intent To Establish Non-Exclusive Licensing And Distribution Agreement For Antiretrovirals Truvada And Viread In Developing World Countries
10/19/2005 5:10:58 PM
FOSTER CITY, Calif. & JOHANNESBURG, South Africa--(BUSINESS WIRE)--April 25, 2005--Gilead Sciences, Inc. (Nasdaq:GILD) and JSE Securities Exchange listed Aspen Pharmacare (APN) today announced that the companies have signed a letter of intent under which they have committed to enter into a non-exclusive licensing and distribution agreement for Gilead's antiretroviral (ARV) products Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Viread(R) (tenofovir disoproxil fumarate). Aspen will manufacture finished product for the 95 resource-limited countries included in Gilead's global Access Program and will distribute the products in every country in Africa.
Under the terms of the collaborative agreement, Aspen will manufacture Truvada and Viread, according to U.S. standards for Good Manufacturing Practices (GMP), and distribute the products under their global tradenames in specified countries. Gilead will provide active pharmaceutical ingredient (API) for its products to Aspen and will transfer the necessary technology for tableting of the products in Aspen's U.S. Food and Drug Administration (FDA) approved facilities in South Africa. In addition, Aspen will pursue regulatory approval for the products in the countries in Africa where one or both products are not already registered. By leveraging Aspen's capabilities to rapidly expand the numbers of countries in which registrations for Gilead's antiretrovirals are sought, the companies hope to increase access to therapy in those countries most in need.