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Aspen - Aspen To Supply US Government With Generic ARVs

Release Date: 08/09/2004 17:51
Code(s): APN
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Aspen - Aspen To Supply US Government With Generic ARVs Aspen Pharmacare Holdings Limited (Incorporated in the Republic of South Africa) (Registration Number 1985/002935/06) Share code APN ISIN: ZAE000023586 ("Aspen") ASPEN TO SUPPLY US GOVERNMENT WITH GENERIC ARVs Aspen Pharmacare, Africa"s largest pharmaceutical manufacturer and JSE Securities Exchange listed company, is capable of manufacturing generic anti retroviral (ARV) medicines to meet the needs of the US President"s Emergency Plan for AIDS Relief (PEPFAR). PEPFAR has pledged $15bn to assist developing countries as they address the crisis of HIV/Aids over the next 5 years. Over half of this program will support effective AIDS treatment to save lives through the provision of ARV drugs. It is the view of the U.S. Government that Africans with HIV/AIDS should have medicines available to them that are as safe and effective as those available to Americans with AIDS. PEPFAR working in partnership with the public and private sectors is dedicated to achieving this goal. The US Government recently announced a special PEPFAR initiative through which ARV manufacturers can obtain an expedited Federal Drug Administration (FDA) review and certification that their products are safe, effective and meet the highest standards of quality. Comparable to the South African Medicines Control Council, FDA is the drug regulatory authority of the United States and an agency of the US Department of Health and Human Services. Stephen Saad, Aspen Group CEO said "HIV/Aids is proving to be a major humanitarian challenge. Aspen"s response has been to formulate and develop generic ARVs under voluntary licences from the originators. We have six registered generic ARVs and we are already producing this much needed medication." "As the pioneers of generic ARVs on the African continent, we are working closely with the US FDA in order to ensure that Aspen ARVs receive FDA registration promptly. Using the expedited review system, the FDA could grant Aspen registration for co-packaged ARVs, ARV fixed dose combinations and single ingredient ARVs. Further, FDA inspections of Aspen"s multi-million rand oral solid dosage (OSD) facility in Port Elizabeth are expected within the next few months. Saad said "this would enhance patient compliance and enable Aspen to be the first African manufacturer to supply generic ARVs under the PEPFAR program. Given the commissioning of our new state-of-the-art OSD facility we believe that we have both the capability and capacity to manufacture these key ARV formulations in Africa." Johannesburg 8 September 2004 Sponsor: Investec Bank Limited Date: 08/09/2004 05:51:02 PM Supplied by www.sharenet.co.za Produced by the JSE SENS Department

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