Roche said on Tuesday that it had reached an agreement for Aspen Pharmacare, the South African generics drug company, to produce a generic version of Tamiflu for Africa.
The deal is the Swiss company’s first agreement with an African firm to produce a generic version of the antiviral drug to boost supply in preparation for a bird flu pandemic.
Under the terms of the non-exclusive agreement with Aspen, Roche will provide its technical know-how to Aspen to help it speed its production of a generic version of the drug. It could also sell the company the active pharmaceutical ingredient to make the treatment.
Roche does not have any patents on Tamiflu in Africa but it could earn royalties on sales of a generic version manufactured by Aspen. While the financial terms of the agreement have not been disclosed, David Reddy, head of Roche’s pandemic taskforce, said that they were “not onerous.”
While Roche says it will be able to meet all orders from African governments by early 2007, the collaboration with Aspen will further enhance the supply of the antiviral drug for Africa.
Governments in some other countries, such as Thailand, where Roche does not hold a patent, have begun producing the drug themselves.
In some countries where it does have patents, Roche has come under pressure from governments and generic manufacturers who have raised the possibility of a challenge to its patent on Tamiflu. By working with16 third parties around the world who can manufacture part of the drug, Roche has ramped up production capacity to 400m treatments annually by the end of this year - double the current order demand of 200m from governments.
In its sub-licencing deal with an Indian company, Hetero, announced at the end of last year, Roche authorised the production and sale of Tamiflu in the company’s home market as well as other developing countries at a price of its choice. Its sublicencing deals with Hetero and Shanghai Pharmaceutical Group of China, and its deal with Aspen, will boost global production beyond 400m treatments.
Roche has maintained only a modest discount on Tamiflu to low-income nations, but says it already offers a deep discount on pandemic orders compared with the price for seasonal flu and therefore its price is comparable to what generic makers are producing.
It has so far received orders and letters of intent for Tamiflu from over 75 governments around the world for pandemic stockpiling, with some European countries aiming to order sufficient to cover 20-40 per cent of their populations. However, researchers have found that government stockpiling of antiviral drugs varies greatly between countries.
Unlike the vaccines in development by various companies to guard against a bird flu pandemic, Tamiflu does not prevent infection but reduces the risk of fatality if taken within a couple days of onset of symptoms. Some studies have shown that bird flu is developing resistance to Tamiflu.
While bird flu has caused the deaths of about 200m birds, it has only killed 110 people who have been in direct contact with the animals, as the virus has so far failed to mutate into a form that is effectively transmitted between humans.
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