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April 17, 2012 /PRNewswire/ -- AMRI (NYSE: AMRI), a leading global contract research and manufacturing organization, was selected by Biota Holdings Limited (ASX: BTA), a leading anti-infective drug development company based in
Australia, 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. "We look forward to working with Biota to accelerate the advanced development of laninamivir."
March 2011, the Office of Biomedical Advanced Research and Development Authority (BARDA) at the U.S. Department of Health and Human Services awarded Biota 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.
AMRI is a global contract research and manufacturing organization with more than twenty years experience providing customers fully integrated drug discovery, development, and manufacturing services. AMRI supplies a broad range of services and technologies that support the discovery and development of pharmaceutical products and the manufacturing of API and drug product for existing and experimental new drugs. With locations in
the United States,
Asia, AMRI maintains geographic proximity and flexible cost models. AMRI has successfully partnered certain programs and is actively seeking to out-license its remaining programs to strategic partners for further development.
Laninamivir is an influenza antiviral, known as a long acting neuraminidase inhibitor (LANI) and a unique treatment for influenza. Unlike vaccines, neuraminidase inhibitors offer the ability to treat an influenza infection, but may also be used preventatively. Current or first-generation neuraminidase inhibitors require twice daily dosing. LANI compounds offer the potential of a single administration for treatment and once a week for prevention. This represents a significant advantage compared with existing influenza antiviral treatments.