Biota Holdings Limited and Aerogen, Inc. have signed an agreement for the development of CS-8958, one of the new LANI (long-acting neuraminidase inhibitor) compounds being developed by Biota and Sankyo, suitable for use with Aerogen's proprietary Aeroneb Go Micropump Nebulizer. The development work will be funded under a US$5.6 million grant to Biota from the US National Institutes of Health (NIH).
Aerogen is a leader in the development of novel aerosolization devices that incorporate its proprietary OnQ Aerosol Generator technology for the treatment of respiratory disorders. Under the agreement, Aerogen will undertake development of an aerosol formulation of CS-8958, and supply drug formulation and devices for the clinical studies to be conducted by Biota.
Costs for the development project and clinical trial supplies will be covered by the NIH grant.
"The Aeroneb Go Nebulizer is particularly suited for delivery of LANI; it is efficient and easy to use by patients of all ages. We are looking forward to working closely with Biota on this important development activity," said Dr. Jane E Shaw, Aerogen's chairman and CEO.
"The formulation project is an important first step in the development plan, and once completed, the clinical studies can commence," added Biota CEO, Peter Molloy. The Phase 1 clinical studies, which will be conducted by Biota, will assess safety and tolerability of the aerosolized formulation of the drug as well as establish the dosage for use in any subsequent efficacy trials.
"Stockpiling of flu antivirals is a critical issue for many governments, especially with the current outbreaks of the highly pathogenic avian influenza in Asia; LANI could become the first line of defense against pandemic influenza," said Dr. Jane Ryan, Director of Business Development at Biota and the Principal Investigator of the overall programme.
Biota is a world-leading antiviral drug discovery company with its headquarters in Melbourne, Australia. Biota was responsible for zanamivir, a neuraminidase inhibitor, subsequently launched by GSK as Relenza for the treatment of influenza.