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South Africa's Aspen gets U.S. approval for AIDS drugs
  By James Macharia
JOHANNESBURG (Reuters, 01/25/05) - Africa's biggest generic drug maker, Aspen Pharmacare said on Tuesday it had won regulatory approval for some of its antiretroviral drugs (ARV) to be included in a $15 billion US anti-HIV programme.
"Aspen through its FDA registration has now become the first accredited generic supplier to have access to the US President's Emergency Plan for AIDS Relief (PEPFAR) fund," Stephen Saad, Aspen's chief executive, said in a statement to the Johannesburg Securities Exchange.
"The approval is for the co-packed and most widely used triple cocktail combination of lamivudine/zidovudine and nevirapine tablets in conventional adult dosages," he said, adding that Aspen would sell the drugs at affordable prices.
The United States must first approve generic drugs before using them under its own funding programmes.
Analysts cheered the approval, but said even though sales volumes would rise, it was uncertain how the cheap prices for the drugs would impact on profits.
"As far as sales volumes are concerned, these are likely to be significant, especially if the company cracks open the private US market," Julien Veron at Andisa Securities said.
He said the effect on margins would depend on the extent to which increased sales of cheaply priced ARVs will be compensated by improved overhead recoveries and plant efficiencies.
The US embassy said funds from the AIDS programme can now be used to buy Aspen's drugs for use in countries where local drug regulators have approved their use, but the drugs cannot be sold in the United States unless Aspen gets new approvals.
Saad later told Reuters that Aspen intends to sell its drugs under the 5-year initiative launched by President George W. Bush in 2003, and to the South African government.
Bush's plan aims to pay for treatment for two million AIDS patients and provide care for 10 million others in 15 target countries, mostly in Africa.
"We have invested in a new facility and [approval] could contribute significantly to profits if sales volumes are huge," Saad told Reuters, but could not give specific figures.
"A generic combination using three different products would cost between 100 rand ($16.88) and 200 rand per month," he said.
It is understood that upwards of 50% to 60% of the funds under the US programme will be used to purchase a combination of drugs to prolong the lives of those infected with HIV, Saab said.
A factory in Port Elizabeth built to produce the drugs and approved by the FDA in December would be launched soon, he said.
In Africa around 25.4 million are infected with HIV - but just 3% have access to ARV drugs. At least 2.3 million people died from the disease in sub-Saharan Africans last year.
Aspen's pioneering of ARVs on the African continent and the first generic ARV recognition by the FDA was achieved after getting voluntary licences from the original drug makers.
These include GlaxoSmithKline Plc, the world's leading supplier of HIV/AIDS drugs, private German drug maker Boehringer Ingelheim and Bristol-Myers Squibb.


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