MOUNTAIN VIEW, Calif., March 9 /PRNewswire-FirstCall/ -- Biota Holdings
Limited (ASX: BTA) and Aerogen, Inc. (Nasdaq: AEGN) 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.
About Biota
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.
http://www.biota.com.au
About Aerogen
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.
SOURCE Aerogen, Inc.
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Related links:
http://www.aerogen.com
CONTACT:
Jane E. Shaw, Ph.D., of Aerogen,
+1-650-864-7333; or Peter Molloy of Biota, +613-9915-3729)
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