Eurartesim® (dihydroartemisinin-piperaquine) ACT to Combat Malaria Receives Marketing Authorization From EMA

GENEVA, November 30, 2011 /PRNewswire/ --

• A fixed-dose combination therapy to combat malaria, Eurartesim®, (dihydroartemisinin-piperaquine) the product of Italian research conducted by Sigma-Tau and MMV, approved by the European Medicines Agency (EMA)

• Therapy with a simple dosage regimen, up to 3 tablets once a day for 3 days. Studies have demonstrated high cure rates, above 95%, and a significant reduction of re-infection rates compared to leading antimalarial treatments

• Every year almost 250 million people all over the world are affected by malaria. The disease takes the lives of over 780,000 people, mainly in sub-Saharan Africa, 85% of whom are children under 5

For the very first time, the European Medicines Agency (EMA), using a centralised procedure, has granted regulatory approval to an artemisinin combination therapy (ACT) for the treatment of uncomplicated P.falciparum malaria. This ACT, Eurartesim® (dihydroartemisinin-piperaquine), was developed collaboratively by Sigma-Tau s.p.a Industrie Farmaceutiche Riunite, Italy, and the non-profit product development partnership Medicines for Malaria Venture (MMV). The development of Eurartesim has made Sigma-Tau the first Italian company to be granted marketing authorization for an anti-malarial drug by the 27 EU Member States from the EMA.

Eurartesim, is generally well-tolerated and is administered once a day for 3 days, making the drug more patient friendly. In addition, clinical trials have shown that compared to other approved ACTs, Eurartesim provides better and longer protection from new malaria infections.

The EMA's authorization is based on the results of a series of large-scale clinical trials that assessed Eurartesim's safety and efficacy in comparison to artemether-lumefantrine or artesunate + mefloquine. "Clinical studies carried out on patients treated with Eurartesim have confirmed high cure rates, above 95%," says Marco Corsi, Sigma-Tau's Medical Director.

About Sigma-Tau

Sigma-Tau Group is one of the leading players in the international pharmaceutical industry, and is 100% Italian-owned. Sigma-Tau Group has its headquarter in Pomezia (Rome) and subsidiaries in France, Switzerland, Belgium, Holland, Portugal, Germany, United Kingdom, India, as well as United States and Spain - with more than 2,400 employees.

Sigma-Tau was founded in Italy in 1957 and in 2010 turnover was €673 million.

Sigma-Tau's website: http://www.sigma-tau.it