Arrowhead Research Corporation (NASDAQ:ARWR), a biopharmaceutical
company developing targeted RNAi therapeutics, today reaffirmed its
belief that it has broad access to intellectual property required to
develop ARC-520, its clinical candidate against chronic hepatitis B
infection. The Company has licenses to relevant patents and patent
applications enabling the development and commercialization of ARC-520
in key pharmaceutical markets globally. Arrowhead does not believe there
are additional unlicensed patents directed to RNAi therapeutics
targeting the hepatitis B virus that affect its freedom to operate.
The company signed a license agreement with Alnylam Pharmaceuticals in
January 2012, giving it access to intellectual property that enables the
discovery, development, and commercialization of an RNAi therapeutic
targeting the hepatitis B virus. Moreover, Arrowhead holds multiple
levels of patent protection on ARC-520 including U.S. Patent Nos.
8,313,772 and 8,501,930 covering the Dynamic Polyconjugate (DPC)
delivery system, and U.S. Patent Application number 13/535,454 covering
ARC-520's siRNA component, which was recently allowed by the U.S. Patent
and Trademark Office.
Arrowhead and its legal advisors continually review the patent landscape
to ensure freedom to operate and the Company believes that development
and commercialization of ARC-520 would not infringe patents governing
RNAi therapeutics targeting the hepatitis B virus, including U.S. Patent
No. 8,618,277 in the McSwiggen patent estate.
"We are moving ARC-520 as quickly as possible to market and do not
believe anything limits our ability to do so," said Christopher
Anzalone, Ph.D., Arrowhead's President and Chief Executive Officer. "The
roughly 400 million people world-wide with chronic hepatitis B infection
currently have limited options, and we remain committed to them."
Arrowhad's RNAi-based candidate ARC-520 is designed to treat chronic
HBV infection by reducing the expression and release of new viral
particles and key viral proteins. The goal is to achieve a functional
cure, which is an immune clearant state characterized by hepatitis B
s-antigen negative serum with or without sero-conversion. The siRNAs in
ARC-520 intervene at the mRNA level, upstream of where nucleotide and
nucleoside analogues act. In transient and transgenic mouse models of
HBV infection, a single co-injection of Arrowhead's DPC delivery vehicle
with cholesterol-conjugated siRNA targeting HBV sequences resulted in
multi-log knockdown of HBV RNA, proteins and viral DNA with long
duration of effect. Arrowhead has completed enrollment in a Phase 1
single ascending dose study in normal volunteers. The company is
conducting a single dose Phase 2a study in chronic HBV patients, which
it expects to follow with a multi dose, multi national Phase 2b study.
Approximately 350 million people worldwide are chronically infected with
the hepatitis B virus. Chronic HBV infection can lead to cirrhosis of
the liver and is responsible for 80% of primary liver cancers globally.
About Arrowhead Research Corporation
Arrowhead Research Corporation is a biopharmaceutical company developing
targeted RNAi therapeutics. The company is leveraging its proprietary
drug delivery technologies to develop targeted drugs based on the RNA
interference mechanism that efficiently silences disease-causing genes.
Arrowhead technologies also enable partners to create peptide-drug
conjugates that specifically home to cell types of interest while
sparing off-target tissues. Arrowhead's pipeline includes clinical
programs in chronic hepatitis B virus and partner-based programs in
obesity and oncology.
For more information please visit http://www.arrowheadresearch.com,
or follow us on Twitter @ArrowRes.
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Safe Harbor Statement under the Private Securities Litigation Reform
This news release contains forward-looking statements within the
meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995. These statements are based upon our
current expectations and speak only as of the date hereof. Our actual
results may differ materially and adversely from those expressed in any
forward-looking statements as a result of various factors and
uncertainties, including our ability to finance our operations, the
future success of our scientific studies, our ability to successfully
develop drug candidates, the timing for starting and completing clinical
trials, rapid technological change in our markets, and the enforcement
of our intellectual property rights. Arrowhead Research Corporation's
most recent Annual Report on Form 10-K and subsequent Quarterly Reports
on Form 10-Q discuss some of the important risk factors that may affect
our business, results of operations and financial condition. We assume
no obligation to update or revise forward-looking statements to reflect
new events or circumstances.
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