AMRI entered an agreement to help Biota develop and manufacture the influenza antiviral CS-8958 (laninamivir). Biota is working to establish the U.S. manufacturing for the drug, optimize its manufacturing processes, and conduct clinical trials for safety and efficacy in adult and pediatric populations.
CS-8958 is a second-generation, long-acting neuraminidase inhibitor (LANI). AMRI’s role will initially involve the development and manufacture of the API for use in clinical trials. In the future there is the potential for AMRI to be selected as the commercial manufacturer of the product.
Last March the Office of Biomedical Advanced Research and Development Authority 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.
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.
Biota developed the first-in-class neuraminidase inhibitor, zanamivir, subsequently marketed by GlaxoSmithKline as Relenza. Biota’s research breakthroughs include a series of candidate drugs aimed at treatment of respiratory syncytial virus disease and HCV. Biota has clinical trials under way with its lead compound for human rhinovirus infection in patients with compromised respiration or immune systems.