[Ip-health] ACT to combat malaria receives marketing authorization from EMA

Jaya Banerji banerjij at mmv.org
Wed Nov 30 05:46:51 PST 2011

EurartesimR (dihydroartemisinin-piperaquine)

ACT to combat malaria receives marketing authorization from EMA

. A fixed-dose combination therapy to combat malaria, EurartesimR,
(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

Geneva, 30 November 2011. 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, EurartesimR
(dihydroartemisinin-piperaquine), was developed collaboratively by
Sigma-Tau s.p.a Industrie Farmaceutiche Riunite, Italy, and the
not-for-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 antimalarial
drug by the 27 EU Member States from the EMA.
Eurartesim, a fixed-dose combination of two antimalarials,
dihydroartemisinin and piperaquine (DHA-PQP), is generally well-tolerated
and is administered once a day for 3 days instead of twice a day, 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. This is good news for
children in high transmission areas who often succumb to another
life-threatening malaria episode after they have recovered from the

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. The
studies tested this ACT in more than 2,700 patients in Africa (Burkina
Faso, Zambia, Kenya, Mozambique and Uganda) and in Asia (Thailand, India
and Laos), in around 1,036 African children aged 6 months to 10 years, all
affected by uncomplicated P. falciparum malaria.

"Clinical studies carried out on patients treated with Eurartesim have
confirmed high cure rates, above 95% - says Marco Corsi, Sigma-Tau's
Medical Director.  Moreover, compared to comparator drugs, Eurartesim has
shown a secondary protective effect - an almost 50% reduction in the
number of new infections in the 2 months following treatment. In highly
endemic countries, where treated patients often become newly infected,
this secondary protective effect might have a positive outcome on public
health. The marketing authorization for Europe will allow us not only to
provide a highly effective treatment to vulnerable populations of endemic
countries, where malaria has a devastating impact on health and
socio-economic systems, but also to European citizens."

Developed to high internationally recognized standards, Eurartesim meets
the therapeutic guidelines outlined by the World Health Organization (WHO)
which, on the basis of clinical evidence, recommends the combination of
two active ingredients in the same tablet: an artemisinin derivative with
a high antimalarial efficacy (dihydroartemisinin) and a second
antimalarial drug (piperaquine),  which helps protect the artemisinin
component from the risk of resistance.
"The approval of Eurartesim by the EMA comes at a critical time in the
fight against malaria - says David Reddy, CEO, MMV. This high quality
treatment is a much-awaited addition to the malaria arsenal and will be
welcomed by health care professionals in a number of malaria-endemic
countries. Eurartesim is the product of a close collaboration between MMV
and Sigma-Tau. The partnership between Sigma-Tau and MMV will continue as
we focus on the development of a paediatric formulation of the treatment
targeted at children under 5 years of age."

Malaria burden on mankind

Malaria is one of the most devastating diseases in the world with
approximately 250 million new cases reported every year. Of the 780,000
people who die annually from malaria, over 90% are from sub-Saharan
Africa, and 85% are children under 5.

On the other hand, most cases of "imported" malaria are reported in
Western Europe. Every year there are 10,000 to 12,000 new cases within the
EU. According to data from the World Health Organization (WHO), in some
areas of Western Europe, and more precisely in France, the United Kingdom,
Germany, Italy and Spain from 2000 and 2010 there have been approximately
93,000 malaria cases, the majority of which were caused by P. falciparum
which is the most deadly species among the five that cause malaria.

In particular, over the last decade, France is the country most affected
by malaria with 56,638 cases, followed by the United Kingdom with 19,132
cases, Germany with 7,581 cases, Italy with 5,881 cases (data available
only up to 2007) and Spain with 3,755 cases2.

According to data released in recent years the malaria epidemic is
continuing to expand worldwide also as a result of climate change which is
leading to the expansion of areas where the vector mosquitoes can live and
infect people. Over 40% of the world's population is at risk of infection
and, although over 90% of cases occur in Africa, the new frontier of the
disease is South East Asia where 83% of the population (over 1.3 billion
people) is at risk. According to the World Health Organization, together
with HIV/AIDS and tuberculosis, malaria is one of the 3 most widespread
diseases in Africa and the leading cause of death in children under 5 year
old (the disease is estimated to kill a young child every 30 seconds).

In Europe, autochthonous cases are rare. These are largely cases of people
accidentally bitten by infective mosquitoes carried by air carriers. Much
larger is the number of cases of imported malaria, i.e. of travellers or
migrants infected in countries where malaria is endemic. In 2002, the
World Health Organization reported about 230,000 cases of malaria imported
into the EU in the past 30 years. In 2007 more than 8,000 cases occurred
in the EU.

Notes for editors

About the combination dihydroartemisinin-piperaquine (DHA-PQP)
Dihydroartemisinin (DHA) is obtained from artemisinin, an active
ingredient extracted from Artemisia annua (sweet wormwood) a herb used in
Chinese traditional medicine for treating "fevers", which acts very
rapidly against the malaria parasite  and is rapidly eliminated from the
body. Piperaquine (PQP), is a molecule with a much longer half-life than
other currently available antimalarials. It stays longer in the body and
ensures the complete eradication of any residual infection. As a
combination, the dosage of DHA-PQP varies by patient weight - children are
usually prescribed one tablet a day for 3 days while adults are
recommended three tablets once a day for three days.

About Sigma-Tau
Sigma-Tau Group is one of the leading players in the international
pharmaceutical industry, and is 100% Italian-owned. The company has always
been committed to the research, development and marketing of innovative
medicines, in order to improve patients' well-being and quality of life.
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 - where the Group owns two
production facilities - it has more than 2,400 employees and an expanding
network of licensees worldwide.
Sigma-Tau was founded in Italy in 1957 and in 2010 hit a turnover of 673
million euros. The company invests 16% of its annual turnover on research
and development. Sigma-Tau's R&D team of 400 people is currently working
on 45 projects, from pre-clinical studies to clinical development.
Thirty-five studies underwent clinical trials with 26 different molecules,
18 of which mostly (11) new and original, resulting from Sigma-Tau's
research or upon which Sigma-Tau has exclusive rights. The Company's
research and development projects focuses on several therapeutic areas,
including rare and neglected diseases that cause a significant social
impact, e.g., oncology, immunology and biotech; also, the company's
experience and know-how in cardiovascular diseases, nervous system and
metabolic diseases cannot be disregarded.
Sigma-Tau's website: www.sigma-tau.it

Sigma-Tau's Malaria Programs
For several years now Sigma-Tau has focused on areas that have a major
social and healthcare impact, namely the research and development of drugs
for the treatment of rare diseases and malaria. In the case of malaria,
the company's commitment has been made concrete via its partnership with
Medicines for Malaria Venture.

About Medicines for Malaria Venture (MMV)
MMV is a leading product development partnership (PDP) in the field of
anti-malarial drug research and development. It was established as a
foundation in 1999, and registered in Switzerland. MMV's mission is to
reduce the burden of malaria in disease-endemic countries by discovering,
developing and facilitating delivery of new, effective and affordable
anti-malaria drugs. Its vision is a world in which these innovative
medicines will cure and protect the vulnerable and under-served
populations at risk of malaria, and help to ultimately eradicate this
terrible disease.
MMV is currently managing the largest-ever portfolio of over 50 promising
antimalarial projects. Its strength comes from its product development
partnership (PDP) model reflected in its network of more than 140
pharmaceutical, academic and endemic-country partners in 45 countries. MMV
also works in close partnership with Roll Back Malaria (RBM) and a number
of WHO programmes that include TDR, the Global Malaria Programme (GMP) and
the Essential Medicines Programme.
For more information, please visit http://www.mmv.org

For more information:
Sigma-Tau Communications and Information Manager		
Bruno Chiavazzo

Phone +39 06 91394181						
e-mail: bruno.chiavazzo at sigma-tau.it 				
Director Communications and Advocacy, MMV
Jaya Banerji
Phone +41 79 707 71 81
e-mail: banerjij at mmv.org

Press Officer, Noesis Comunicazione
Noesis Comunicazione
Phone +39 02 83105122 - Mob. +39 348 7022510
e-mail: giovanna.vetere at noesis.net

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