FORT DETRICK -- In the continuing effort to find an efficacious and safe treatment for the severest form of the tropical disease malaria, the U.S. Army Medical Materiel Development Activity and the Walter Reed Army Institute of Research jointly signed a Cooperative Research and Development Agreement.
They teamed up with Sigma-Tau Industrie Farmaceutiche Riunte S.p.A., Rome, Italy, to develop a New Drug Application for the investigational new drug Intravenous Artesunate Oct. 5.
"The goal of this collaboration is to develop a U.S. Food and Drug Administration-approved, affordable Intravenous Artesunate that will reduce mortality from severe malaria with minimal risk for toxicity," Said Judy Holian, Office of Research and Technology Applications officer for USAMMDA.
A new formulation of Intravenous Artesunate was developed by scientists at WRAIR to treat severe and complicated malaria.
The NDA for Intravenous Artesunate will be prepared jointly between the U.S. Army Medical Research and Materiel Command and Sigma-Tau S.p.A.
"In this collaboration the partners have agreed to regulatory and manufacturing milestones," said Holian. "Key staff members from both parties will meet regularly to review status and progress of the collaborative effort."
At the final phase, the IND will be transferred to Sigma-Tau S.p.A who will assume the designation of the Sponsor's representative and file the NDA with the U.S. FDA. Sigma-Tau S.p.A will also be responsible for the manufacturing and commercialization of the Intravenous Artesunate.
An amendment to the Food, Drug, and Cosmetic Act entitles a company, such as Sigma-Tau S.p.A, to receive a Priority Review Voucher from the U.S. FDA in the event that the company submits and obtains approval for an NDA pertaining to a drug intended for the treatment of certain tropical diseases, including malaria. If received, the PRV will entitle Sigma-Tau S.p.A to an expedited review of an NDA submission for the new formulation of Intravenous Artesunate, regardless of the indication.
"The PRV is awarded to companies who have received approval for first of a kind drugs or vaccines against disease in underdeveloped countries," said Dr. Robert Miller, Director of USAMMDA's Division of Regulated Activities and Compliance. "These products may not make much money for the company, but the PRV will allow them to seek rapid reviews of a potential 'block buster' drug in the future."
This is the first time that the USAMRMC has negotiated a CRADA with a potential PRV involved.
The new Intravenous Artesunate formulation is available in the United States and Canada under a treatment IND, sponsored by the Centers for Disease Control and Prevention. In the past two years, 70 persons with severe malaria have been successfully treated with the WRAIR product.