Sigma-Tau Pharmaceuticals Receives Orphan-Drug Designation for Artesunate for the Immediate Treatment of Malaria from the European Commission

GAITHERSBURG, MD, April 22, 2008 – Sigma-Tau Pharmaceuticals, Inc., a US based, wholly owned subsidiary of the Sigma-Tau Group, announced that the European Commission has granted an Orphan Drug designation for Artesunate for the treatment of malaria. Sigma-Tau is developing this product as an emergency treatment for severe and complicated malaria in collaboration with the Walter Reed Army Institute of Research (WRAIR). In March 2006, an Orphan Drug Designation was also granted in the United States to Artesunate for the treatment of malaria.

“We commend the European Commission for granting Orphan Drug designation to Artesunate,” commented Gregg Lapointe, Sigma-Tau Pharmaceutical’s chief operating officer. “The designation reinforces Sigma-Tau’s commitment to the development of new medicines for neglected diseases.”
 
The European Commission’s “Orphan Medicinal Product Designation” has been designed to promote the development of drugs intended for diagnosis, prevention or treatment of life-threatening or very serious diseases or disorders that are rare and may provide significant benefit to patients suffering from rare diseases. A disease or disorder is defined as rare in Europe when it affects less than 1 in 2,000 citizens. There are an estimated 10,000-12,000 new cases of malaria diagnosed each year in Western Europe. Most cases are “imported” by travelers who have visited endemic areas.  

Sigma-Tau is also collaborating with Medicines for Malaria Venture (MMV) in the development of an oral therapy for uncomplicated malaria. Eurartesim®, a fixed-dose artemisinin combination therapy (ACT), has completed the Phase III development program, with the registration filing planned during 2008. Eurartesim® has been granted an Orphan Drug designation in both the U.S. and E.U.
 
MMV is a non-profit organization dedicated to discovering, developing and delivering new affordable antimalarials through effective public-private partnership.

About Artesunate
Artesunate is a semi-synthetic derivative of the natural product Artemisinin, from qing hao, the sweet wormwood plant. It was developed for the treatment of severe malaria with the goals of rapid parasite reduction, prevention of death and the reduction of mortality.

About Malaria
Malaria is a parasitic disease, caused by protozoa of the genus Plasmodium. The parasite is transmitted to human beings through the bite of a female mosquito belonging to the genus Anopheles.  People of all ages are susceptible to the disease, but malaria is both preventable and curable.

About Sigma-Tau Group
Sigma-Tau Group is a leading research-based Italian pharmaceutical company with a 2007 consolidated turnover equal to approximately US$ 980 million and over 2,500 employees worldwide. Therapeutic areas in which Sigma-Tau Group’s research and development are focused include cardiovascular disease, metabolism, oncology, immunology, central and peripheral nervous system with 47 projects, 30 clinical indications studied with 17 proprietary molecules, most of which are new and original. Sigma-Tau is also dedicated to creating novel therapies for the unmet needs of patients with rare diseases. Truly unique in its field, Sigma-Tau places its considerable scientific resources behind the discovery, development and distribution of compounds that benefit the few. Sigma-Tau Group has operating subsidiaries throughout Europe and the United States and maintains a presence in all of the world’s major pharmaceutical markets. For additional information about Sigma Tau Group, please visit www.sigma-tau.it .

About Walter Reed Army Institute of Research
WRAIR is the largest, most diverse, and oldest laboratory in the US Army Medical Research and Material Command. It conducts research on a range of military relevant issues, including naturally occurring infectious diseases, combat casualty care, operational health hazards, and medical defense against biological and chemical weapons. WRAIR is the Department of Defense's lead agency for infectious disease research and a crucial source of research support for medical product development.

For Further Information from Sigma-Tau Pharmaceuticals, Inc.:
Marc Tewey
Vice President of Commercial Operations
Phone: 301-670-1518
Email: This email address is being protected from spam bots, you need Javascript enabled to view it
www.sigmatau.com

IVA003  04/08

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