BMS factory closure could interrupt HIV drug supply
pharmafile | June 11, 2010 | News story | Manufacturing and Production |Â Â BMS, HIV, manufacturing, supply chainÂ
Closure of a manufacturing facility in France operated by Bristol-Myers Squibb could lead to shortages of an important treatment for HIV in young children, according to aid groups.
In an open letter to BMS chief executive Lamberto Andreotti, members of the board at UNITAID said the decision by the company to close down its facility in Meymac threatened access to a formulation of the antiretroviral Videx (didanosine) which is currently used by the aid agency treat to 4,000-7,000 infants in developing countries.
“Didanosine is the last therapeutic option for these babies and without it they may die,” says the letter, which is published in the British Medical Journal.
The formulation in question is a 25mg suspension used to treat infants under 10kg of weight who have failed to respond to other treatments.
BMS is the only company in the world for which this low-dose formulation has been approved for use in developing countries via the World Health Organization’s Pre-Qualification programme.
The company said last year it decided to shut down Meymac because many of the products made there had lost patent protection, and it made commercial sense to transfer their manufacture to other plants in the BMS group.
Since then what BMS described as “unexpectedly high demand” for the didanosine formulation has depleted stocks, raising the possibility of a shortfall in supply emerging towards the end of 2010 or early in 2011.
The company said it was working with procurement agencies to try to mobilise all available supplies of the drug.
Didanosine production is due to transfer from Meymac to a facility in the US that is unlikely to be approved by the FDA until April 2011. With the French plant closing its doors this month, there are concerns that available stocks of didanosine will not be sufficient to meet demand until the new production comes online.
“There is likely to be a shortage of about 15,000 packs of didanosine 25mg across all UNITAID beneficiary countries between now and when production is expected to resume in 2011,” says the UNITAID letter.
A spokesperson for the aid group said that it had asked generic drugmakers to step forward to fill the gap, but these would still need to meet WHO Pre-Qualification, which requires an evaluation by the agency and inspection of facilities.
At the moment, Indian company Aurobindo Pharma is the only other company that has been WHO-Prequalified to supply didanosine, but does not offer a low-dose version and only makes it in strengths of 125mg, 200mg, 250mg and 400mg.
Other generic manufacturers make the low-dose formulation but have not been Pre-Qualified.
Phil Taylor
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