ROME, January 16 /PRNewswire/ -- The results of two new large scale
trials show that the combination of dihydroartemisinin and piperaquine
(DHA+PQP) not only is effective against uncomplicated malaria in a way which
is comparable to other artemisinin-based combination therapies (ACTs), but it
also protects patients against new infections for at least two months after
treatment. The DHA/PQP combination is very well tolerated with no significant
These notable results were presented at the 57th Annual Meeting of the
American Society of Tropical Medicine & Hygiene (ASTMH) held in New Orleans,
Louisiana, USA, (December 7-11, 2008). The results demonstrate the benefits
of a treatment which is effective against a neglected disease contracted by
400-500 million people worldwide every year and the cause of death of over 1
million people, sadly largely children under 5 in Sub-Saharan Africa.
"If not promptly and effectively treated, malaria can kill in just a few
days after the onset of symptoms," said Prof. Umberto D'Alessandro, Prince
Leopold Institute of Tropical Medicine, Antwerp, Belgium, coordinator of one
of the trials. "This novel medication expands the treatment arsenal available
to us, delivers immediate benefits because it acts rapidly, and
unquestionably provides help to the populations of Africa and Asia, who are
the hardest hit by the disease, but also to Westerners who visit those
countries for business or pleasure."
Developed by sigma-tau, the new ACT meets WHO clinical evidence-based
treatment strategy recommendation as it is a medication combining in a single
tablet the highly potent artemisinin-based active ingredient which does not
stay long in the body with a second antimalarial which stays longer in the
body. This combination treatment is to be taken only for three days and
facilitates the mutual protection of the two active ingredients against drug
The results presented in New Orleans come from a development program for
worldwide drug approval. The most important trials in the program were two
large phase III comparative clinical trials conducted in Africa (Burkina
Faso, Zambia, Kenya, Mozambique and Uganda) and Asia (Thailand, India and
Laos) respectively, which involved a total of about 2,700 patients, of whom
1,600 children under 5, all with uncomplicated malaria caused by Plasmodium
falciparum, the most widespread and dangerous parasite and the cause of the
highest mortality in infected individuals.
"The new data," said Claudio Cavazza, sigma-tau Chairman. "Confirm the
huge potential of this new combination which may become the gold standard in
malaria treatment in all those countries where fatal drug-resistance has been
observed with conventional antimalarials. Our hope is that the joint efforts
made to develop this new drug and make it available to the greatest possible
number of patients will substantially contribute to the achievement of the
ambitious goal of the Gates Foundation to eliminate and ultimately fully
eradicate malaria. The extremely positive results of the clinical trials make
us hope the drug will rapidly receive marketing approval. The NDA is expected
to be filed with the EMEA and the FDA around mid-2009, so that the drug can
be made available as soon as possible not only in Europe and the United
States, but also in all those countries where malaria is endemic."
sigma-tau's commitment began to become tangible in 2004 when the company
entered into a partnership with Medicines for Malaria Venture, the
Geneva-based non-profit organization created to discover, develop and deliver
effective and affordable antimalarial drugs through public-private
partnerships, supported primarily by the Bill & Melinda Gates Foundation and
the University of Oxford.
sigma-tau is a leading, all Italian capital, international pharmaceutical
group that invests in the research, development and marketing of innovative
and effective treatments to improve patient well-being and quality of life.
sigma-tau Group has headquarters in Pomezia (Rome, Italy), and
subsidiaries in France, Switzerland, the Netherlands, Portugal, Germany, the
UK and the USA, as well as in Spain and Sudan where the Group operates two
production facilities. It has over 2500 employees and an extensive network of
sigma-tau was founded in Italy in 1957 and achieved a global turnover of
EUR 665 million ($ 920 million) in 2007.
sigma-tau SpA consistently invests 16% of its annual turnover in R&D.
sigma-tau's 400 R&D staff are currently running 43 R&D projects. A total of
14 NCEs and 12 known molecular entities in 30 different indications are at
various stages of development.
Therapeutic areas in which the company's research and development are
focused include metabolism, neurology, cardiovascular, oncology and
sigma-tau website: http://www.sigma-tau.it
For further information:
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