Sigma-tau Submits Marketing Authorization Application to EMEA for a Novel Anti-Malarial

ROME -

- An Innovative Fixed-Dose Combination Therapy, With a Very Simple Dosing Regimen, for Combating a Disease That Accounts for 250 Million Cases Worldwide Per Year and Causes 880,000 Deaths, Especially of Children Under 5 in Sub-Saharan Africa

Sigma-tau Industrie Farmaceutiche Riunite S.p.A. (sigma-tau) has announced the submission of a centralized Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for Eurartesim(R) (dihydroartemisinin/piperaquine), a novel fixed-dose Artemisinin-based Combination Therapy or ACT. Eurartesim(R) is highly effective against uncomplicated malaria in adults and children, has a simple dosing regimen (only 3 administrations over 3 days) and has been shown to offer greater protection against new infections than other ACTs, for at least 2 months after treatment.

In 2008, malaria was endemic in 109 countries, 45 of which were in Africa. It afflicts up to 250 million people worldwide every year and causes around 880,000 deaths mainly in sub-Saharan Africa, over 85% of whom are children under 5. Currently, only a handful of antimalarials remain effective as treatment. Eurartesim(R) will be a welcome addition to the arsenal of malaria drugs and, once approved and marketed, it could help to save the lives of hundreds of thousands of young African children.

This new ACT is the first product of a collaboration between sigma-tau and Medicines for Malaria Venture (MMV), an international not-for-profit organisation. Developed to high international standards, this new ACT meets WHO clinical treatment recommendations, as it combines two active antimalarial ingredients in a single tablet: the highly potent artemisinin-derivative (dihydroartemisinin) with a second antimalarial (piperaquine) which protects the first one against the emergence of resistance.

Eurartesim(R) has already received the Orphan Drug Designation by both European and US regulatory authorities. After receiving approval from the EMEA, sigma-tau also intends to consider filing for marketing authorization in the US. Stringent regulatory approval, guarantee of highest international standards respect, is a precondition for approval in Africa and, once this precondition is met the dossier will be submitted to selected African countries with the support of Pfizer, sigma-tau’s partner to commercialize the drug in Africa’s private sector in order to maximize Eurartesim’s potential to reach as many patients as possible.

The MAA is supported by data from large clinical trials that involved over 2,700 patients in Africa (Burkina Faso, Zambia, Kenya, Mozambique and Uganda) and Asia (Thailand, India and Laos). 1,600 of these were children under 5, all with uncomplicated malaria caused by Plasmodium falciparum, the most widespread and dangerous malaria parasite. The studies were designed to compare the safety and efficacy of the combination of dihydroartemisinin and piperaquine (DHA/PQP) to the ACTs artemether/lumefantrine (in Africa) and artesunate+mefloquine (in Asia).

Results from both studies show that Eurartesim(R) treats malaria as rapidly and effectively as the other ACTs. It has also been shown to offer significant protection from new infections in many cases for about 2 months. In addition, it features a simple schedule: a patient weighing 60 kg needs to take a total of 9 tablets over 3 days compared to the 14 to 24 tablets with other antimalarials. Fever and parasites disappear after only 2-3 days from start of treatment.

“sigma-tau is committed to the development of new therapies that will benefit people living with tropical diseases like malaria - said Dr. Claudio Cavazza, President of sigma-tau - We agree with the WHO’s call to pharmaceutical companies to develop new antimalarials according to the highest international quality standards. We make available our industrial know-how for allowing drug distribution, at a sustainable price, in those countries where malaria still kills unacceptable numbers of people, sharing the aim of the main industrialised countries taking part in G8 scheduled in L’Aquila. The submission for this innovative ACT brings us one step closer to providing a potent treatment to vulnerable populations in malaria-endemic countries where malaria has a tremendous health and socio-economic impact, as well as to European and American citizens travelling to those countries for business or tourism.”

“The submission of Eurartesim(R) to the EMEA is a landmark event and the culmination of several years’ productive collaboration between sigma-tau and Medicines for Malaria Venture - said Dr Chris Hentschel, President and CEO of Medicines for Malaria Venture - Head-to-head studies carried out to internationally approved standards have shown that this ACT is at least as safe and efficacious as two other well-known ACTs. Its addition to the therapeutic arsenal will give more choice to health policy makers and caregivers in malaria-endemic countries to choose the right medicine for their patients.”

Source: Publicis Consultants

For more information: Press Office, Publicis Consultants Italia, Alessandro Soldi, Email address:
combatingmalaria at publicisconsultants.it, Phone: +39-02-7632091, Fax: +39-02-76320940