ALBANY, N.Y.—Global contract research and manufacturingorganization AMRI was recently selected by Biota Holdings Ltd., ananti-infective drug development company based in Australia, to further developand manufacture the influenza antiviral CS8958 (laninamivir), asecond-generation, long-acting neuraminidase inhibitor. AMRI will provide theseservices to support a New Drug Application for laninamivir to the U.S. Food andDrug Administration (FDA).
Biota is working to establish the U.S. manufacturing oflaninamivir, optimize its manufacturing processes, and conduct clinical trialsfor safety and efficacy in adult and pediatric populations. These studies areneeded to apply for FDA approval of the drug.
AMRI's role will initially involve the development andmanufacture of the active pharmaceutical ingredient for use in clinical trials.In the future, there is the potential for AMRI to be selected as the commercialmanufacturer of the product, the company said.
"The agreement with Biota demonstrates AMRI's globalreputation as a preferred partner for delivering best-in-class drug discovery,development and manufacturing services," said AMRI Chairman, President and CEODr. Thomas E. D'Ambra. "We look forward to working with Biota to accelerate theadvanced development of laninamivir."
In March 2011, the Office of Biomedical Advanced Researchand Development Authority (BARDA) at the U.S. Department of Health and HumanServices awarded Biota a five-year contract estimated to be worth $231 millionfor the advanced development of laninamivir. The drug is already approved forsale in Japan and was launched as Inavir by Daiichi Sankyo in October 2010. Itis not currently approved for sale in other markets.