Arbutus’ LNP Licensee Alnylam Announces FDA Approval of ONPATTRO™ (patisiran), for the Treatment of ATTR Amyloidosis
August 13 2018 - 8:30AM
ONPATTRO Approval Triggers Royalty to Arbutus
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.
“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.”
About ArbutusArbutus 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
InformationThis 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.
Contact Information
InvestorsMark J. MurrayPresident and CEOPhone:
604-419-3200Email: ir@arbutusbio.com
Pam Murphy Investor Relations Consultant Phone: 604-419-3200
Email: ir@arbutusbio.com
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