MOUNTAIN VIEW, Calif., March 9 /PRNewswire-FirstCall/ -- Biota Holdings Limited and Aerogen, Inc. today announced that they 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(R) 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(R) 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 program.
About the NIH Grant
LANI (long-acting neuraminidase inhibitors) are being co-developed by Biota and Sankyo as second generation antivirals for the treatment and prevention of influenza. If successful, the new drugs are expected to have significant advantages over current flu antivirals, including an extended duration of action that could see the drug administered as a single dose for treatment or a weekly dose for prevention. CS-8958 is the lead compound in the LANI series and was originally developed by Sankyo. In October 2003, Biota and Sankyo agreed to pool their LANI programs under a joint development agreement. Amidst the concern about avian flu and the growing risk of a global pandemic, in September 2004 the US National Institutes of Health (NIH) granted Biota a three-year, US$5.6 million grant designed to accelerate the development of its LANI drug in a bulk dry powder form suitable for stockpiling and administration via a nebulizer. This would allow the drug to be rapidly administered to a large number of people and become the first line of defence against a flu pandemic. The grant covers formulation and all Phase 1 human safety and dosage studies over the next three years. Further clinical studies beyond those covered by the current grant would be required prior to gaining registration with regulatory authorities.
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. In partnership with Sankyo, Biota is developing second generation flu antivirals (LANI or Long Acting Neuraminidase Inhibitors), and has discovery and development programs aimed at therapies for diseases caused by Human Rhinovirus (common cold), RSV (Respiratory Syncytial Virus) and hepatitis C. In partnership with Thermo Electron, Biota also markets the FLU OIA(R) diagnostics range for the rapid detection of influenza.
Aerogen, a specialty pharmaceutical company, develops products based on its OnQ Aerosol Generator technology to improve the treatment of respiratory disorders in the acute care setting. Aerogen has presented the results of its first Phase 2 clinical study evaluating delivery of aerosolized amikacin for the treatment of ventilator-associated pneumonia; an additional Phase 2 study is currently underway. Following amikacin, additional drug products targeting improved respiratory therapy in the acute care setting are in the feasibility and pre-clinical stages of development. Aerogen's Aeroneb(R) Professional Nebulizer System is marketed world-wide for use in hospitals. Aerogen's Aeroneb Go Nebulizer for home use is currently marketed in the U.S., Japan and certain European countries. Aerogen also has development collaborations with pharmaceutical and biotechnology companies for use of its technology in the delivery of novel compounds that treat respiratory and other disorders. Aerogen is headquartered in Mountain View, California, with a campus in Galway, Ireland. For more information, visit http://www.aerogen.com/.
To the extent any statements made in this release relate to information that is not historical, these statements are necessarily forward-looking. As such, they are subject to the occurrence of many events outside of Aerogen's control and other uncertainties, and are subject to various risk factors that could cause Aerogen's actual results to differ materially from those expressed in any forward-looking statement. The risk factors include, without limitation, the need for additional funding, the inherent risks of product development, clinical outcomes, regulatory risks and risks related to proprietary rights, market acceptance and competition, and are described in Aerogen's reports and other filings with the U.S. Securities and Exchange Commission, including Aerogen's Annual Report on Form 10-K for the year ended December 31, 2003, filed with the Securities and Exchange Commission ("SEC") on April 14, 2004 and Aerogen's Quarterly Report filed on Form 10-Q for the quarter ended September 30, 2004 filed with the SEC on November 15, 2004. Aerogen does not undertake any obligation to update forward-looking statements.