|Press Release WHO/74
6 December 1999
ORPHAN DRUG FINDS HOME
Human African trypanosomiasis or sleeping sickness rarely makes the headlines in the international press but according to health authorities in the Democratic Republic of the Congo (formerly Zaire), the number of deaths due to human trypanosomiasis at least equals the number of deaths due to AIDS in two provinces of the largest central African country. It is estimated that 55 million people in 36 African countries south of Sahara are exposed to the risk of contracting the disease.
The World Health Organization (WHO) as well as its Special Programme for Research and Training in Tropical Diseases, has been collaborating for twenty years with a major pharmaceutical company Hoechst Marion Roussel Inc. in the development of a life-saving drug, eflornithine, to treat human African trypanosomiasis.
Hoechst Marion Roussel and WHO have signed a License Agreement at WHO headquarters in Geneva today which allows WHO in collaboration with other partners to arrange for the production and distribution of the drug.
With the signing of the License Agreement, WHO and its partners will actively seek the means to ensure the continued availability of eflornithine. Earlier this year, WHO established a Human African Trypanosomiasis Network which is to "monitor drug resistance and find and recommend solutions for the treatment of sleeping sickness". One of the Network's working groups Drugs Availability and Affordability is chaired by a nongovernmental organization Médecins sans Frontières (MSF). Part of the Working Group's brief is to "ensure the production, commercialisation and registration of eflornithine in Africa and Europe."
Technology transfer from Hoechst Marion Roussel will take place once WHO has found a new partner in the private sector, capable of producing eflornithine. In the meantime, MSF and WHO have been in contact with the international donor community to finance the purchase of adequate drug supplies. Since the vast majority of people with sleeping sickness will not be able to afford to pay for the drug, international financing will be needed. Securing procurement funds in advance will facilitate the search for a producer.
"The partnership between WHO, Hoechst Marion Roussel and MSF is a wonderful example of the new hands-on cooperation between the United Nations system, private sector and nongovernmental organizations in fighting diseases of the poor", commented Dr David Heymann, Executive Director of Communicable Diseases at WHO.
Mr André Rouvillois, one of the Directors of Hoechst Marion Roussel, expressed his company's "full satisfaction in handing over eflornithine patent rights and manufacturing know-how to WHO, as a logical conclusion of a long standing collaboration between Hoechst Marion Roussel and WHO's Special Programme for Research and Training in Tropical Diseases which permitted the full characterization development of the compound in the treatment of sleeping sickness". On behalf of his company, he thanked WHO "for the spirit of open collaboration as well as those interested parties and particularly Médecins sans Frontières who will now contribute to the distribution of eflornithine to the needy patients".
The drug should be administered intravenously in four equal doses every six hours for 14 days in a hospital setting. The current cost of treatment per patient is US$700. Eleven of the 16 countries that regularly report cases of sleeping sickness have per capita Gross National Product about US$ 1000. In many of the affected countries, the total annual health budget is less than US$10 per person. The worst affected countries are Angola, Democratic Republic of the Congo, Sudan and Uganda.
Credible data are extremely difficult to obtain. In 1998, there were 27 000 reported cases from the Democratic Republic of the Congo as compared to an estimated 350 000 cases. Angola reported just under 8 000 cases while independent estimates were speaking of 100 000 cases. In many villages prevalence of sleeping sickness is over 50%, thus making it usually the first cause of mortality.
Difficult-to-control epidemics occur in the absence of adequate medical surveillance affecting a large number of people and leading to high mortality rates. Epidemics have serious social and economic consequences when large areas of fertile land become totally depopulated. "The current resurgence of African trypanosomiasis in Central Africa is comparable to the situation in the 1930s when great epidemics occurred", said Mr Felix Kuzoe, WHO African trypanosomiasis expert. "This situation is of great concern to governments involved, to the WHO and to the international aid agencies".
Pour de plus amples informations, les journalistes peuvent prendre contact avec Valery Abramov, OMS, Genève. Tel: (41 22) 791 2543, Fax (41 22) 791 4858. Email: firstname.lastname@example.org
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