PASADENA, Calif.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24arwr&src=ctag" target="_blank"gt;$arwrlt;/agt;–Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it
has begun dosing in a new triple combination cohort (cohort 12) that
includes JNJ-3989 (formerly ARO-HBV) and additional undisclosed agents
selected by Janssen Pharmaceuticals, Inc. in its ongoing Phase 1/2 study
(AROHBV1001) in patients with chronic hepatitis B virus (HBV). In
connection with the start of this new cohort, Arrowhead has earned a $25
million milestone payment from Janssen Pharmaceuticals, Inc., part of
the Janssen Pharmaceutical Companies of Johnson & Johnson.
Christopher Anzalone, Ph.D., president and chief executive officer at
Arrowhead, said: “Both Arrowhead and Janssen share the aim to advance
transformational medicines that achieve higher rates of functional cure
with a finite treatment duration for patients with chronic hepatitis B
viral infection. Beginning this new triple combination cohort in our
ongoing AROHBV1001 study has the potential to generate valuable data
rapidly.”
AROHBV1001 (NCT03365947)
is a Phase 1/2 clinical study evaluating the safety, tolerability, and
pharmacokinetic effects of single-ascending doses (SAD) of ARO-HBV in
healthy adult volunteers, as well as the safety, tolerability, and
pharmacodynamic effects of multiple-ascending doses (MAD) of ARO-HBV in
patients with chronic HBV.
Arrowhead entered into a license and collaboration agreement with
Janssen in October 2018 to develop and commercialize ARO-HBV. Under the
initial terms of the HBV license agreement, Arrowhead was eligible to
receive a $50 million milestone payment linked to a Phase 2 study.
Arrowhead and Janssen subsequently amended the HBV license agreement to
accelerate the payment of $25 million of the $50 million Phase 2
milestone with the initiation of cohort 12 of the AROHBV1001 trial.
Arrowhead is eligible to receive the remaining $25 million upon the
initiation of a Phase 2 study by Janssen.
Hepatitis B infection is a life-threatening viral infection of the
liver, which can cause cirrhosis — scarring of liver tissue — and liver
cancer if the infection becomes chronic. The World Health Organization
cites that hepatitis B is a global public health problem with 257
million people living with the disease, resulting in 887,000 deaths in
2015.1 While a preventive vaccine is available, cure rates
for those infected remain low and most patients will endure lifelong
therapy.
About Arrowhead Pharmaceuticals
Arrowhead Pharmaceuticals develops medicines that treat intractable
diseases by silencing the genes that cause them. Using a broad portfolio
of RNA chemistries and efficient modes of delivery, Arrowhead therapies
trigger the RNA interference mechanism to induce rapid, deep, and
durable knockdown of target genes. RNA interference, or RNAi, is a
mechanism present in living cells that inhibits the expression of a
specific gene, thereby affecting the production of a specific protein.
Arrowhead’s RNAi-based therapeutics leverage this natural pathway of
gene silencing.
For more information, please visit www.arrowheadpharma.com,
or follow us on Twitter @ArrowheadPharma.
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Safe Harbor Statement under the Private Securities Litigation Reform
Act:
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 the safety and efficacy of our product
candidates, the duration and impact of regulatory delays in our clinical
programs, our ability to finance our operations, the likelihood and
timing of the receipt of future milestone and licensing fees, the future
success of our scientific studies, our ability to successfully develop
and commercialize drug candidates, the timing for starting and
completing clinical trials, rapid technological change in our markets,
and the enforcement of our intellectual property rights. Our 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.
Source: Arrowhead Pharmaceuticals, Inc.
________________
1 World Health Organization (WHO). Hepatitis B. July 2017.
Available at: http://www.who.int/mediacentre/factsheets/fs204/en/
Contacts
Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, CFA
626-304-3400
ir@arrowheadpharma.com
Investors and Media:
LifeSci Advisors, LLC
Brian Ritchie
212-915-2578
britchie@lifesciadvisors.com
www.lifesciadvisors.com