Newswise — The Walter Reed Army Institute of Research (WRAIR) and the U.S. Army Medical Materiel Development Activity (USAMMDA), announced today a new partnership with Sigma-Tau Pharmaceuticals, Inc. to help finalize the research and development of a new and promising treatment for severe malaria. A collaborative research and development agreement between WRAIR, USAMMDA, and Sigma-Tau was signed today for the medicine Intravenous (IV) Artesunate. Sigma-Tau will complete the research studies and prepare for submission to the U.S. Food and Drug Administration (FDA) for marketing clearance.
In the United States, there are 1,000 to 1,500 reported cases of malaria annually occurring mostly in persons traveling to areas of the world with ongoing malaria transmission. At least 10 to 15 percent of malaria is classified as severe rather than uncomplicated, and is associated with impaired consciousness, extreme weakness and jaundice, and typically requires immediate diagnosis and treatment. Four to eight deaths occur annually in the United States as a result of misdiagnosis or delayed treatment.
"We saw a need for improved severe malaria treatment not only to protect our troops abroad, but as a potential treatment for those around the world affected by this devastating illness," explained Colonel Peter J. Weina, MD, PhD, WRAIR. "WRAIR's vast research network played an important role in helping us research this new treatment for severe malaria, and with Sigma-Tau's help we are hopeful that IV Artesunate will one day become available to people around the globe."
"USAMMDA is excited to be a part of this partnership in the development of Intravenous (IV) Artesunate. The partners are all committed to making available safe and effective treatment options for severe malaria," said Colonel Jerome F. Pierson.
Under the agreement, Sigma-Tau will be responsible for the commercial development and manufacturing of IV Artesunate should the FDA approve it. Sigma-Tau plans to submit an application for FDA review of IV Artesunate in 2008.
"Sigma-Tau is excited to partner with WRAIR and USAMMDA on this important initiative which we hope will provide a safer and more effective therapy for severe malaria," said Gregg Lapointe, Sigma-Tau Chief Operating Officer. "As an organization, we are dedicated to providing new therapies and hope for patients with rare diseases, and we believe IV Artesunate offers a potentially new way to treat this life threatening disease."
New Treatment for Malaria Fills Current VoidWRAIR and USAMMDA initially developed IV Artesunate in response to concerns over the risks of malaria exposure to deployed forces. Additionally, IV Quinidine, the current standard therapy for severe malaria in the United States, has potentially harmful side effects.
About IV ArtesunateIV 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 reduction of mortality. In March 2006, an Orphan-Drug designation was granted for IV Artesunate for the immediate treatment of malaria.
About Walter Reed Army Institute of ResearchWRAIR 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.
About U.S. Army Medical Materiel Development ActivityThe USAMMDA mission is to develop and manage medical materiel to protect and sustain the Warfighter on point for the Nation. Their vision is to integrate with USAMRMC, Federal agencies, and the DoD, as part of the joint biomedical research and materiel community, to focus on delivering the best medical solutions for today and tomorrow. USAMMDA products will be an integral part of the DoD Force Health Protection Program, to include vaccines, drugs, and medical devices, to prevent, diagnose, and treat infectious diseases, combat-related casualties, and CBRNE threats. These products will enhance far-forward medical care across the full spectrum of health care missions worldwide.
About Sigma-Tau Pharmaceuticals, Inc.Sigma-Tau Pharmaceuticals, Inc. is a U.S. based, wholly owned subsidiary of the Sigma-Tau Group, and is dedicated solely to the global development and commercialization of medicines for patients with rare diseases. Sigma-Tau Pharmaceuticals, Inc. is based in Gaithersburg, Maryland.
Since 1989, the company's products have been focused on rare diseases, kidney disease, and cancer. With more than 6,000 identified rare diseases that affect approximately 25 million patients in the United States, Sigma-Tau places its considerable scientific resources behind the discovery of compounds that benefit the few. The company has a substantial development program focused on transplant, cancer, inherited genetic disorders, malaria, as well as other areas of unmet medical need. For more information about the company, visit http://www.sigmatau.com.
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