Group urges Bristol to protect HIV-drug for babies

NEW YORK (Reuters) - Board members of an international group that helps ensure patient get access to HIV drugs has warned that Bristol-Myers Squibb Co’s plans to close a factory in France could leave thousands of babies without a life-saving treatment for the virus that causes AIDS.

The United Nations-affiliated group UNITAID, in an open letter published in the online edition of the medical journal the Lancet, urged Bristol-Myers chief executive Lamberto Andreotti to ensure that babies continue to have access to its drug, didanosine, which is made at a company plant in France slated to close this month.

The plant makes the drug in a small 25 milligram dosage form given to babies to control their infections. The medicine, sold under the brand name Videx, is a member of the class of HIV treatments known as nucleoside reverse transcriptase inhibitors, or NRTIs, and was approved by U.S. regulators in 1991.

“Closing this factory means that 4,000 to 7,000 babies currently enrolled in treatment plans in developing countries through UNITAID could be left without the medicines they need,” said the open letter.

The letter said the drug is the last therapeutic option for the babies and there will likely be a shortage of the 25-milligram dosage between June -- when the Bristol factory is closed -- and when a new Bristol-Myers factory in the United States begins making the drug next year.

Bristol-Myers spokeswoman Sonia Choi said production is expected to resume immediately upon anticipated regulatory approval of the new U.S. plant in February 2011.

Choi said Bristol-Myers is closing its plant in Meymac, France this month as part of an effort to streamline manufacturing operations.

Before closing, she said the company ramped up production of the medicine to create an inventory of the drug equal to twice the demand for the medicine in 2009.

But she said there will likely still be a “supply strain” because of an unexpected recent surge in demand for the product, although the company is now still able to fulfill current demand.

“We’re doing everything we can to ensure minimal disruption,” she said.

Choi said generic forms of the medicine are made at the same 25 milligram dose by other drugmakers, but have not been included in a list of drugs pre-qualified by the World Health Organization for use by U.N. agencies.

Reporting by Ransdell Pierson; editing by Andre Grenon