Science And Health Editor
26 January 2005
Cape Town — Medicines regulator gives SA company approval to supply generic drugs through Bush's five-year emergency programme
JSE Securities Exchange SA-listed Aspen Pharmacare, Africa's biggest generic drug maker, has won US regulatory approval for some of its AIDS drugs.
This opens the way for it to supply the medicines to developing countries through the Bush administration's $15bn programme to fight the disease.
By the end of last year, about 39,4-million people were infected with HIV and as many as 6- million needed treatment with anti- retroviral (ARV) AIDS medicines, according to the United Nations.
Aspen is the first generic supplier to have won access to the President's Emergency Plan for AIDS Relief (Pepfar) in the US through its registration with the US Food and Drug Administration (FDA). "It's a hell of a milestone for us. I don't think many people would have bet on a company from SA being the first to get (FDA) accreditation," said Aspen CEO Stephen Saad.
The company won FDA approval for its drug manufacturing plant in Port Elizabeth last month, which is a prerequisite for FDA registration of its drugs.
No other generic drug makers with voluntary licences to make copies of patented AIDS drugs had obtained FDA approval for their manufacturing facilities, he said.
The FDA has given "tentative approval" for Aspen's co-packaged versions of nevirapine tablets and a pill combining lamivudine and zidovudine. Tentative approval is granted when the drugs are still under patent in the US.
GlaxoSmithKline, the world's biggest maker of AIDS drugs, holds the patents on the combined lamivudine and zidovudine pill , which is branded Combivir, while Boehringer Ingelheim holds the patent on nevirapine, which is branded Viramune.
This combination is the world's most widely used triple cocktail regimen, but is not the most widely used in SA.
Saad said Aspen was seeking FDA approval for other generic AIDS drugs, but declined to provide details. FDA approval means Pepfar funds can be used to purchase Aspen's approved drugs for treatment programmes in countries where the local regulatory authorities have approved their use.
The five-year Pepfar programme, announced in 2003, targets 15 of the countries hardest hit by HIV/AIDS Botswana, Côte d'Ivoire, Ethiopia, Guyana, Haiti, Kenya, Mozambique, Namibia, Nigeria, Rwanda, SA, Tanzania, Uganda, Vietnam and Zambia.
Pepfar had so far spent $78m in SA, said US embassy spokeswoman Judy Moon.
Saad said Aspen had applied to the South African Medicines Control Council (MCC) for registration of the combined pack.
He said Aspen was also seeking regulatory approval for its generic AIDS drugs in the UK and with the World Health Organisation (WHO).
Aspen is one of three companies, along with Cipla and Ranbaxy, that won contracts to provide generic AIDS drugs to the programmes supported by the Clinton Foundation, which requires manufacturers to register their drugs with a regulatory body such as the MCC, or obtain approval from the WHO.
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