Co Cork, Ireland (April 4th, 2007) – Tibotec Pharmaceuticals Ltd. has signed a royalty-free, non-exclusive license agreement with Aspen of South Africa. Aspen will register, package and distribute the protease inhibitor PREZISTA™ (darunavir, DRV) in sub-Saharan Africa. Tibotec has selected Aspen because of the company’s extensive African distribution network and pioneering endeavors in enhancing access to AIDS treatment in resource constrained settings. Aspen and Tibotec will share the responsibility for ensuring prompt and affordable access to patients in the Sub-Saharan region.
As a result of the agreement there will be a single co-branded product, under the brand name PREZISTA, distributed by Aspen and sold at a an ex-factory price that should not exceed US$3 a day. (The product will be offered on a FOB basis – incoterm 2000. Additional costs may include the logistics fee in South Africa, or the freight, insurance, customs handling, taxes and duties, and other costs levied at the discretion of national authorities and other respective entities in the other sub Saharan countries, which are beyond the control of Aspen and Tibotec. Local retail prices may therefore be higher.)
PREZISTA, co-administered with ritonavir and with other antiretroviral agents (ARVs), is expected to be indicated for treatment-experienced patients, especially those failing an earlier regimen that includes a protease-inhibitor. The World Health Organization estimates that approximately 4% of people receiving antiretroviral treatment in low- and middle-income countries today need advanced treatment options because of HIV drug resistance.
Aspen will seek timely regulatory approval for PREZISTA and manage the mechanism for pre-approval access for patients in sub Saharan Africa in urgent need of PREZISTA where this is permitted by local health authorities. Tibotec is responsible for seeking pre-qualification from the World Health Organization and sNDA approval in order to facilitate the funding of PREZISTA by international organizations. Tibotec, prior to the signing of this agreement, has filed the PREZISTA dossier for regulatory approval in South Africa, Botswana and Namibia.
The agreement covers all of sub-Saharan Africa. Twenty countries, with an estimated 80% of total patient need for PREZISTA in sub-Saharan Africa, will be targeted for the first wave of regulatory submissions. These countries are Botswana, Cameroon, Democratic Rep. Congo, Ethiopia, Ghana, Ivory Coast, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, Rwanda, Senegal, South Africa, Swaziland, Tanzania, Uganda, Zambia and Zimbabwe.
The agreement also creates a framework for the manufacture of PREZISTA by Aspen for sub-Saharan Africa at a later date if sustained demand for PREZISTA increases sufficiently to make it economically viable for Aspen.
The U.S. Food and Drug Administration (FDA) granted accelerated approval to PREZISTA, a protease inhibitor formerly known as TMC114, in June 2006. The European Commission granted conditional approval in February 2007.
“More and more patients in Sub-Saharan Africa are in need of access to new therapies when their existing regimens fail. Tibotec is pleased to be working with a local partner in sub-Saharan Africa to expedite pre-approval access, registration and the development of sustainable supply-chains to meet patient need,” said Julie McHugh, Company Group Chairman, Virology, Tibotec.
“One of the single biggest challenges facing the future sustainability of ARV programs in the developing world, is the development of more accessible and affordable second- and third-line antiretrovirals. This Tibotec initiative provides further evidence of the confidence placed in the capabilities of Aspen and is yet another important step, in securing certainty in the supply of critical ARVs to patients living with AIDS in the developing world,” said Stephen Saad, Aspen Group Chief Executive.