Key ARV Products Viread® and Truvada® Registered by MCC

24/04/07:

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JSE listed Aspen, a leading global manufacturer and distributor of anti-retroviral (ARV) medicines, today announced that it has been granted certification from the Medicines Control Council of South Africa (MCC) to manufacture and distribute the two key ARV products Viread® (tenofovir disoproxil fumarate) and Truvada® (emtricitabine and tenofovir disoproxil fumarate) in the South African market. This certification enables immediate availability of these two products to South African patients, particularly the many hundreds that have been receiving treatment with these medicines under the special named patient exemption permitted by MCC.

Both Viread® and Truvada® have extensive usage in North America, Europe and some African countries. Last week both products were included in the World Health Organisation’s revised Essential Medicines List.

The registration of Viread® and Truvada® follows the non-exclusive manufacturing, licensing, technology transfer and distribution agreement which Aspen entered into in 2005 with leading research-based biopharmaceutical company Gilead Sciences, Inc. (Nasdaq: GILD). Under this agreement, Aspen will manufacture and distribute these products for all 53 African countries.

On receipt of the certification, Aspen Group CE, Stephen Saad said, “Both Viread® and Truvada® represent significant advantages for patients to existing first line ARV treatments, for example patient compliance is enhanced through simpler and more convenient dosing, and Viread® and Truvada® do not seem to exhibit some of the unwanted side effects that place patients at increased risk of other morbidities with some of the other ARVs.”

Saad went on to comment that, “Tenofovir is now the most prescribed molecule for the treatment of HIV/AIDS patients in the United States, and the MCC’s certification means that South African patients can now begin to enjoy the same benefits as patients have in the developed world, but at significantly reduced prices. The market availability of Viread® and Truvada® has been long anticipated by South African patients, particularly given the scale up of AIDS treatment in South Africa and many existing and new South African patients now stand to benefit from this certification, in a country when the total number of infected HIV patients is the second highest in the world.”