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New ddI Peds Factory Planned in USA - UN urges BMS to protect Manufacturing of DDI HIV-drug for babies
  Ransdell Pierson Mon Jun 7, 2010 5:53pm EDT
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.

Open letter to Lamberto Andreotti, Chief Executive Officer, Bristol-Myers Squibb
The Lancet, Early Online Publication, 8 June 2010
Mohga Kamal-Yanni aEmail Address, Kim Nichols b, Esther Tallah c, Nelson Otwoma d
We, the UNITAID board members representing non-governmental organisations (NGOs) and communities affected by HIV/AIDS, tuberculosis, and malaria, are writing to you to express our deep concern that Bristol-Myers Squibb (BMS) is to close a factory in France that manufactures a second-line antiretroviral medicine for children with HIV/AIDS who weigh less than 10 kg: buffered didanosine in the 25 mg formulation.
Closing this factory means that 4000Ń7000 babies currently enrolled in treatment plans in developing countries through UNITAID could be left without the medicines they need. Didanosine is the last therapeutic option for these babies and without it they could die. We understand that closure of the plant will take place in June of this year, with no plans for resumption of production before April, 2011, at the earliest, when a new plant is due to open. Therefore there is likely to be a shortage of about 15 000 packs of didanosine 25 mg across all UNITAID beneficiary countries between now and when production is expected to resume in April, 2011.
Currently, there is no alternative generic product that has been assessed by WHO and prequalified for use by UN agencies. We urge you, as the Chief Executive Officer of BMS, a company that prides itself on its high standards of corporate responsibility, to respond urgently to our concerns, outlining the steps you will take to avoid any treatment interruption. We would also like your confirmation that a BMS plant will resume production of this vital medicine in 2011.
Supporting the NGOs and communities delegations: Action for Southern Africa; Act Up, Lusaka, Zambia; Africare; Agency for Community Care and Development; Asian Harm Reduction Network; Centre for Health Policy and Innovation; Coalition of Zambian Women Living with HIV/AIDS (COZWHA+); Coalition PLUS; Community Initiative for Tuberculosis, HIV/AIDS & Malaria (CITAM+), Zambia; Consumer Information Network (CIN), Kenya; Ecumenical Pharmaceutical Network; Global AIDS Alliance; Health Action International (HAI) Africa; Health Access Network (HAN), Ghana; Health GAP (Global Access Project); IHA's Medical and Social Foundation, India; Love Life Society; MŽdecins Sans FrontiŹres; National Community of Women Living with HIV/AIDS in Uganda (NACWOLA); Network of Maharashtra People with HIV (NMP+); Positive Generation, Cameroon; Stop AIDS Campaign, UK; TB ACTION Group, Kenya; The Touch of Hope Foundation; and Universities Allied for Essential Medicines.
a Oxfam GB, Oxford OX4 2JY, UK
b African Services Committee, New York, NY, USA
c Cameroon Coalition Against Malaria, Yaounde, Cameroon
d National Empowerment Network of People Living with HIV/AIDS in Kenya, Nairobi, Kenya
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