Thousands of babies may die in the developing world when a factory making the only cheap drug that keeps them alive closes.
As many as 7,000 babies in the world’s poorest countries owe their lives to a vital Aids drug called ddl or didanosine.
And the giant drug company Bristol Myers Smith that owns the French factory making ddl is set to close this month.
It means the drug, could be out of production until April 2011 at the earliest when a new factory is due to open.
There is likely to be a shortage of about 15,000 packs of ddI 25 mg, the last line of anti-retroviral medicine for children with HIV and Aids who weigh under 10 kg, between now and when production is expected to restart in April 2011, Aids campaigners forecast. At the moment there is no alternative generic medicine that has been approved for use by the World Health Organisation.
"Closing this factory means that 4,000–7,000 babies currently enrolled in treatment plans in developing countries could be left without the medicines they need," said united which tries to improve access to Aids drugs in poor countries.
“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," UNITAID wrote in a protest letter to Bristol Myers Smith chief executive officer Lamberto Andreotti, published in The Lancet medical journal.
UNITAID, the main buyer of ddl for developing countries, is urging the drug company to take all possible measures to make sure that the supply of didanosine 25mg and 50mg continues while it moves its manufacturing site, to avoid interrupting treatment of the children whose lives depend on it.
The company said unexpected demand had threatened supplies of ddl, but they had taken steps to make sure its supply doesn’t stop until its US factory opens. The medicine would be available as soon as the US site gets the go-ahead from regulators.
But, UNITAID that the Clinton Health Access Initiative, through that hands out UNITAID bought ddl, reported that existing stocks will only last until December this year, and that regulatory approval of the new factory site isn’t likely to be granted before April 2011, leaving four months of shortages.
"At the moment we are still in talks but we are also looking at other solutions,” spokeswoman Daniela Bagozzi told the United Nations news service, IRIN. “We are asking manufacturers of generic versions of didanosine to seek World Health Organization pre-qualification."