Aspen and BMS conclude strategic ARV deal

15/02/06:

JSE listed Aspen Pharmacare Holdings Limited, Africa’s largest pharmaceutical manufacturer and the largest generic manufacturer in the southern hemisphere, has signed a non-exclusive license and technology transfer collaboration agreement with New York based Bristol-Myers Squibb (BMS) for the manufacture and distribution of a generic version of Atazanavir, a new generation anti-retroviral (ARV).

BMS selected Aspen through a bidding process as one of only two pharmaceutical manufacturers globally. The royalty-free, perpetuity agreement provides for the manufacture and distribution of Aspen Atazanavir, a generic version of Atazanavir, to World Bank Tier 1 designated territories. This country classification is rated according to the human development index and it equates to some 70 countries including a number of countries outside of Africa.

Stephen Saad, Aspen Group CEO says “this initiative between a world healthcare leader and a South African based pharmaceutical company further highlights the confidence that global pharmaceutical manufacturers have in Aspen’s capabilities. It is indicative of Aspen’s ability to align itself with one of the world’s leading companies in an attempt to solve what has largely become an African based problem. The deal is evident of Aspen’s positioning at the cutting edge of treatments for the developing world as the group continues to strive to ensure that ARV treatment reaches as many people as possible.”

“A further advantage of this agreement is that Aspen has collaborated with Indian-based Asterix Laboratories, of which Aspen owns 50%, for the development of the active pharmaceutical ingredients (APIs) thereby fully integrating the deal from base level chemicals to the finished products.”

Saad said “this announcement shortly follows the State of the Union Address of the President of South Africa, in which President Mbeki confirmed that South Africa has one of the largest ARV treatment programmes in the world. This initiative with BMS will assist in broadening access to resource limited communities in the South Africa programme and beyond the boarders of South Africa.”

“This agreement builds on Bristol-Myers Squibb’s long-standing commitment to the global fight against AIDS,” said Peter R. Dolan, Chief Executive Officer, Bristol-Myers Squibb. “In Sub-Saharan Africa, where the HIV/AIDS pandemic has been especially devastating, we’ve taken a broad-based approach to addressing the AIDS crisis, including providing our AIDS medicines at no profit prices and committing to ensure our patents do not prevent inexpensive treatment in the region. With this new agreement, we’re taking our commitment to the next level, by expanding access to our newest antiretroviral in sub-Saharan Africa, where HIV/AIDS is a significant and growing public health challenge.”

“Aspen has remained committed to expanding access to HIV medicines in sub-Saharan Africa, where millions are suffering with the disease.” said Stephen Saad. “We are pleased to be part of this innovative agreement, and have already begun the steps needed to get Atazanavir to the patients in sub-Saharan Africa who so desperately need it.”

Saad says “the addition of Aspen Atazanavir further boosts Aspen’s already significant basket of ARVs. It provides broader global access to ARVs to meet the healthcare needs of some 4 million HIV/Aids positive Africans of which an estimated 10% are presently receiving treatment. Primary advantages of Atazanavir include it being a new generation ARV providing significant improvement over existing therapies, and that it is taken orally once daily. With ARV molecules continually being refined, available data confirms that Atazanavir has an enhanced efficacy and safety profile compared to other ARV molecules. Atazanavir is also a United States Food and Drug Administration dossier which further complements Aspen’s strategy to manufacture ARVs for President Bush’s US$15 billion Emergency Plan for AIDS relief (PEPFAR) programme.

The product will be produced at Aspen’s world class oral solid dosage (OSD) facility which has been accredited by the US FDA for the manufacture of co-packed generic ARVs. This deal enables Aspen to access existing data, fulfil the technology transfer, register the product through the South African Medicines Control Council and start manufacturing Aspen Atazanavir locally.

Johannesburg : February 15, 2005
Sponsoring Brokers: Investec Bank Limited