E-DRUG: eflornithine for trypanosomiasis
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[WHO press release; see http://www.who.int/inf-pr-1999/en/pr99-74.html
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 M�decins sans Fronti�res (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 Andr� 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 M�decins
sans Fronti�res 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".
For more info, contact Valery Abramov, WHO, Gen�ve.
Tel: (41 22) 791 2543, Fax (41 22) 791 4858. Email: abramovv@who.int
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