AMRI was selected by Biota Holdings Limited to further develop and manufacture the influenza antiviral CS8958 (laninamivir), a second-generation, long-acting neuraminidase inhibitor.
AMRI will provide these services to support a New Drug Application for laninamivir to the United States Food and Drug Administration (FDA).
Biota is working to establish the U.S. manufacturing of laninamivir, optimize its manufacturing processes, and conduct clinical trials for safety and efficacy in adult and pediatric populations. These studies are needed to apply for FDA approval of the drug.
AMRI’s role will initially involve the development and manufacture of the active pharmaceutical ingredient for use in clinical trials.
In the future there is the potential for AMRI to be selected as the commercial manufacturer of the product.
“The agreement with Biota demonstrates AMRI’s global reputation as a preferred partner for delivering best-in-class drug discovery, development and manufacturing services,” said AMRI's Chairman, President and CEO, Thomas E. D'Ambra, Ph.D.
D'Ambra continued, “We look forward to working with Biota to accelerate the advanced development of laninamivir.”
In March 2011, the Office of Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health and Human Services awarded Biota Scientific Management, a wholly owned subsidiary of Biota Holdings Limited, a five-year contract estimated to be worth $231 million for the advanced development of laninamivir.
The drug is already approved for sale in Japan and was launched as Inavir by Daiichi Sankyo in October 2010. It is not currently approved for sale in other markets.