GLOBAL: Factory closure could leave 7,000 babies without ARVs

NAIROBI, 9 June 2010 (PlusNews) - Civil society activists are protesting the closure of a factory that produces the only UN World Health Organization-pre-qualified version of a life-prolonging antiretroviral (ARV) drug for infants.

Pharmaceutical giant Bristol-Myers Squibb (BMS), which owns the French factory that produces didanosine, a second-line ARV for babies weighing less than 10kg, will shut down the plant in June 2010, stopping production of the drug until at least February 2011, when regulatory approval of a new United States-based manufacturing site is expected.

"Closing this factory means that 4,000–7,000 babies currently enrolled in treatment plans in developing countries through UNITAID [a funding mechanism for HIV treatment] could be left without the medicines they need," said the authors of a letter to BMS chief executive officer Lamberto Andreotti.

Didanosine is the last therapeutic option for these babies, and without it they could die ... 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 April 2011," the letter, published in The Lancet, read.

UNITAID, the main buyer of didanosine for distribution to developing nations, issued a statement urging BMS to take all measures to ensure the continued supply of didanosine 25mg and 50mg during the transition of its manufacturing site, so as to avoid interrupting treatment of the children whose lives depend on it.

BMS said unforeseen demand had put a strain on the supply of didanosine, but they had taken steps to ensure uninterrupted supply of the drug until the US factory opened. The product would become available immediately upon regulatory approval of the US site.

"We preventively built up inventory to twice the level of 2009 demand," BMS spokeswoman Sonia Choi told IRIN/PlusNews. "We are actively working with procurement agencies to provide didanosine to patients in need, and to ensure minimal disruption."

Didanosine is the last therapeutic option for these babies, and without it they could die

However, UNITAID spokeswoman Daniela Bagozzi told IRIN/PlusNews that the Clinton Health Access Initiative, through which UNITAID distributes the medication, reported that existing stocks would last only until December 2010, and that regulatory approval of the new BMS site was unlikely to be received before April 2011, extending the period of likely shortages.

"At the moment we are still in talks with BMS but we are also looking at other solutions. We are asking manufacturers of generic versions of didanosine to seek WHO [World Health Organization] pre-qualification, and are in talks with WHO to expedite the pre-qualification of alternatives," Bagozzi said.

"By having alternatives we bridge the current gap, but we also ensure that should the same thing happen in the future, the lives of young children are not jeopardized."

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Theme (s): Care/Treatment - PlusNews, Children, Early Warning, HIV/AIDS (PlusNews), PWAs/ASOs - PlusNews,

[This report does not necessarily reflect the views of the United Nations]