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Malaria: New Treatment is Upcoming
Date:1/16/2009

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 side effects.

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 resistance.

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.

About sigma-tau

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 licensees worldwide.

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 immunology.

    sigma-tau website:http://www.sigma-tau.it
    For further information:

    Press Office
    Publicis Consultants Italia
    Virginie Colonna-Foschi
    Mobile. +39-349-8762101

    virginie.colonna-foschi@publicisconsultants.it
    Tel. +39-02-7632091
    Fax +39-02-76320940



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