Arrowhead Pharmaceuticals Presents Promising ARC-520 Hepatitis B Data at The International Liver Congress™ 2016

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Arrowhead Pharmaceuticals Presents...

PASADENA, Calif.–(BUSINESS WIRE)–

Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) today announced that

three presentations are being made on ARC-520, its investigational

medicine for the treatment of chronic hepatitis B infection, at The

International Liver Congress™ 2016 (ILC 2016), in Barcelona, Spain,

April 13-17, 2016.

Collectively, these presentations demonstrate several important findings

from Arrowhead’s clinical and nonclinical studies of ARC-520, including

the following:

  • ARC-520 and entecavir produced rapid HBV DNA suppression with all

    hepatitis B e-antigen (HBeAg) positive, treatment naïve patients

    achieving serum HBV DNA reductions of up to 5.5 log (99.9997%), and

    all HBeAg negative, treatment naïve patients achieving reductions that

    put them below the limit of quantitation

  • ARC-520 effectively inhibited HBV cccDNA-derived mRNA with observed

    viral protein reduction in HBV patients of up to 2.0 log (99%) after a

    single dose

  • Based on HBsAg epitope profile analysis, poster authors and Arrowhead

    collaborators had previously identified a predictive hepatitis B

    surface-antigen (HBsAg) Clearance Profile associated with HBsAg

    clearance in antiviral therapy cohorts

  • There was a significant association between the development of an

    HBsAg Clearance Profile and ARC-520 therapy in HBV patients

  • Complexed HBsAg antibodies (anti-HBs) were developed and detected in

    HBV patients treated with ARC-520, which may represent a recovery of

    the immune system response

  • After monthly administration of 6-11 doses of ARC-520 in chimpanzees

    chronically infected with HBV, the ARC-520 target site sequences

    remained virtually unchanged, indicating that no drug resistance

    developed during the treatment period

Chris Anzalone, Ph.D., president and CEO of Arrowhead Pharmaceuticals,

said: “These are exciting results that continue to show that ARC-520 can

reduce the production of HBV viral proteins. We have ongoing

multiple-dose and combination studies designed to assess if this will

allow the body’s natural immune defenses to control the virus and lead

to a functional cure.”

Copies of the poster presentations are currently available as ePosters

to ILC 2016 attendees, and we have also made them available on the

Arrowhead website on the Events and Presentations page.

About ARC-520

Arrowhead’s RNAi-based candidate ARC-520 is being investigated in the

treatment of chronic HBV infection. The small interfering RNAs (siRNAs)

in ARC-520 intervene at the mRNA level, upstream of the reverse

transcription process where current standard of care nucleotide and

nucleoside analogues act. Arrowhead is investigating ARC-520

specifically to determine if it can be used to achieve a functional

cure, which is an immune clearant state characterized by hepatitis B

s-antigen negative serum with or without seroconversion. Approximately

350-400 million people worldwide are chronically infected with the

hepatitis B virus, which can lead to cirrhosis of the liver and is

responsible for 80% of primary liver cancers globally. Arrowhead is

currently conducting Phase 2b multiple dose and combination studies in

chronic HBV patients. In clinical studies to date, the most common

reported adverse events in all subjects completing treatment were upper

respiratory infection and headache.

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. The company’s pipeline includes ARC-520 and ARC-521 for

chronic hepatitis B virus, ARC-AAT for liver disease associated with

alpha-1 antitrypsin deficiency, ARC-F12 for hereditary angioedema and

thromboembolic disorders, ARC-LPA for cardiovascular disease, and

ARC-HIF2 for renal cell carcinoma.

For more information please visit www.arrowheadpharma.com,

or follow us on Twitter @ArrowheadPharma.

To be added to the Company’s email list and receive news directly,

please visit

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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 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. 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.

DYNAMIC POLYCONJUGATES is a trademark of Arrowhead

Pharmaceuticals, Inc.

Source: Arrowhead Pharmaceuticals, Inc.

Arrowhead Pharmaceuticals, Inc.
Vince Anzalone, 626-304-3400
CFA
ir@arrowheadpharma.com
or
Investor

Relations:
The Trout Group
Chad Rubin, 646-378-2947
ir@arrowheadpharma.com
or
Media:
Russo

Partners
Matt Middleman, 212-845-4272
M.D.
matt.middleman@russopartnersllc.com

Source: Arrowhead Pharmaceuticals, Inc.

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