`Treatment of ATTR Amyloidosis
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`August 13, 2018
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`ONPATTRO Approval Triggers Royalty to Arbutus
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`Clinically Validated LNP Technology Now in the Hands of Genevant to Develop RNA-based Products
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`WARMINSTER, Pa., Aug. 13, 2018 (GLOBE NEWSWIRE) -- Arbutus Biopharma Corporation (Nasdaq: ABUS), an industry-leading Hepatitis B Virus
`(HBV) therapeutic solutions company, today announced that the Company's lipid nanoparticle (LNP) licensee, Alnylam Pharmaceuticals, Inc.
`(Nasdaq:ALNY), announced that their new drug application (NDA) for ONPATTRO, an RNAi therapeutic, has been approved by the U.S. Food and
`Drug Administration (FDA) for the treatment of hereditary ATTR amyloidosis with polyneuropathy.
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`“ONPATTRO is the first RNA interference therapeutic product to be approved by the FDA and represents a milestone for the technology as well as a
`revolutionary new treatment with the potential to transform the care of patients with hereditary transthyretin amyloidosis. Because ONPATTRO is
`enabled by our proprietary LNP technology, this approval triggers a royalty to Arbutus and provides us with important non-dilutive revenue to support
`our HBV cure mission, through several important clinical milestones next year,” said Dr. Mark Murray, Arbutus’ President and CEO. Dr. Murray added,
`“This approval also represents unprecedented clinical validation of our LNP technology which we have improved upon significantly since licensing it to
`Alnylam, and have recently granted broad rights to Genevant, a company we formed in the second quarter of 2018 that is jointly owned by Arbutus and
`Roivant Sciences. Genevant aims to advance multiple product candidates into the clinic across RNAi, mRNA, and gene editing modalities using the
`Arbutus LNP and ligand conjugate delivery platforms.”
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`About Arbutus
`Arbutus Biopharma Corporation is a publicly traded (Nasdaq: ABUS) biopharmaceutical company dedicated to discovering, developing and
`commercializing a cure for patients suffering from chronic Hepatitis B infection. Arbutus is developing multiple drug candidates, each of which have the
`potential to improve upon the standard of care and contribute to a curative combination regimen. For more information, visit www.arbutusbio.com.
`
`Forward-Looking Statements and Information
`This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the
`Securities Exchange Act of 1934, and forward looking information within the meaning of Canadian securities laws (collectively, “forward-looking
`statements”). Forward-looking statements in this press release include statements about the potential for ONPATTRO ™ (patisiran) to transform the
`care of patients with genetic and other diseases; receiving a royalty from Alnylam; Genevant advancing multiple product candidates into the clinic
`across RNAi, mRNA, and gene editing modalities using the Arbutus LNP and ligand conjugate platforms; and discovering, developing and
`commercializing a cure for patients suffering from chronic HBV infection.
`
`With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other
`things: the timely receipt of expected payments; the effectiveness and timeliness of preclinical and clinical trials, and the usefulness of the data; the
`continued demand for Arbutus’ assets; the timing of regulatory approvals; the continued availability of key management personnel; and the stability of
`economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to
`significant business, economic, competitive, market and social uncertainties and contingencies.
`
`Additionally, there are known and unknown risk factors which could cause Arbutus' actual results, performance or achievements to be materially
`different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk
`factors include, among others: anticipated pre-clinical and clinical trials may be more costly or take longer to complete than anticipated, and may never
`be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus and Genevant may not
`receive the necessary regulatory approvals for the clinical development of their products on a timely basis, if at all; expected payments, financings, and
`royalties may not be as large or as timely as expected, if at all; key management personnel may become unavailable; economic and market conditions
`may worsen; and market shifts may require a change in strategic focus.
`
`A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus' Annual Report on Form 10-K and Arbutus' continuous
`disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by
`this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the
`result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required
`by law.
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`Contact Information
`
`Investors
`Mark J. Murray
`President and CEO
`Phone: 604-419-3200
`Email: ir@arbutusbio.com
`
`Pam Murphy
`Investor Relations Consultant
`Phone: 604-419-3200
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`PROTIVA - EXHIBIT 2026
`Moderna Therapeutics, Inc. v. Protiva Biotherapeautics, Inc.
`IPR2018-00739
`
`
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`Email: ir@arbutusbio.com
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`Primary Logo
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`Source: Arbutus Biopharma Corporation
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