ALBANY, New York, 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).
(Logo: http://photos.prnewswire.com/prnh/20120229/NY61160LOGO
)
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."
In 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.
About AMRI
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, Europe, and 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.
About Laninamivir
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.
About Biota
Biota is a leading anti-infective drug development company based
in Melbourne Australia, with key
expertise in respiratory diseases, particularly influenza. Biota
developed the first-in-class neuraminidase inhibitor, zanamivir,
subsequently marketed by GlaxoSmithKline as Relenza. Biota research
breakthroughs include a series of candidate drugs aimed at
treatment of respiratory syncytial virus (RSV) disease and
Hepatitis C (HCV) virus infections. Biota has clinical trials
underway with its lead compound for human rhinovirus (HRV)
infection in patients with compromised respiration or immune
systems.
In addition, Biota and Daiichi Sankyo co-own a range of second
generation influenza antivirals, of which the lead product Inavir®,
is marketed in Japan. Biota holds
a contract from the US Office of Biomedical Advanced Research and
Development Authority (BARDA) for the advanced development of
laninamivir in the USA.
Relenza™ is a registered trademark of the GlaxoSmithKline group
of companies.
*Further information available at www.biota.com.au
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve risks and uncertainties. Readers should not place
undue reliance on our forward-looking statements. The company's
actual results may differ materially from such forward-looking
statements as a result of numerous factors, some of which the
company may not be able to predict and may not be within the
company's control. Factors that could cause such differences
include, but are not limited to: (a) results of Biota's clinical
trials involving laninamivir; (b) problems or delays which may
arise during clinical trials or in the course of developing,
testing or manufacturing laninamivir; (c) continued funding of
Biota's laninamivir program by BARDA or other entities; (d) the
planned timing of initiation and completion of clinical trials for
laninamivir are subject to the ability of Biota to enroll patients,
enter into agreements with clinical trial sites and investigators,
and other technical hurdles and issues that may not be resolved;
(e) efficacy of laninamivir as a treatment and/or a preventative
and appropriate dosing levels; (f) delay or denial of regulatory
approvals from the FDA resulting from, among other things, adverse
FDA decisions or interpretations of data that differ from Biota's
interpretations and that may require additional clinical trials or
potential changes in the cost, scope and duration of clinical
trials; and (g) those factors discussed in the company's Annual
Report on Form 10-K for the year ended December 31, 2011 as filed
with the Securities and Exchange Commission, and the company's
other SEC filings. The company does not undertake any obligation to
and does not intend to update any forward-looking statements
contained in this press release.