Arbutus’ LNP Licensee Alnylam Announces Positive Phase 3 Results for LNP-Enabled Patisiran Program
21 September 2017 - 2:23AM
Arbutus’ LNP Technology Further Validated with
New Results
Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading
hepatitis B virus (HBV) therapeutic solutions company, announced
today that the Company's lipid nanoparticle (LNP) licensee Alnylam
Pharmaceuticals, Inc. (Nasdaq:ALNY), announced that the APOLLO
Phase 3 study of patisiran, an investigational RNAi therapeutic
being developed for patients with hereditary ATTR amyloidosis with
polyneuropathy, met its primary efficacy endpoint and all secondary
endpoints. Patisiran is enabled by Arbutus’ lipid nanoparticle
(LNP) technology. The program represents the most clinically
advanced application of Arbutus proprietary LNP delivery
technology. Per the terms of the LNP license agreement for
patisiran, Arbutus will be owed single digit royalties on sales of
patisiran. Alnylam stated that it intends to file a New Drug
Application (NDA) in late 2017 and a Marketing Authorisation
Application (MAA) in early 2018.
Dr. Mark J. Murray, Arbutus’ President and CEO,
said, "We are very pleased by the successful outcome of Alnylam’s
APOLLO Phase 3 study of patisiran. This is an important achievement
for patients and for the field of RNAi therapeutics. These data
provide further validation of the utility of our leading LNP
technology. Our LNP technology represents the most proven delivery
technology for the systemic delivery of nucleic acid-based
therapeutics."
About Arbutus’ Lipid Nanoparticle
Delivery (LNP) Technology
Arbutus’ LNP technology represents the most
clinically validated nucleic acid delivery technology. Arbutus’ LNP
formulations are manufactured by a proprietary method, which is
robust, scalable, and highly reproducible and LNP-based products
have been reviewed by multiple FDA divisions for use in clinical
trials. LNP formulations comprise several lipid components that can
be adjusted to suit the specific application. Arbutus has built a
strong intellectual property portfolio directed to various aspects
of LNPs and LNP formulations, including 46 patents issued in the
United States alone and patent applications throughout the United
States and Europe. Arbutus continues to explore opportunities to
generate value from its LNP platform technology, which is well
suited to deliver therapies based on RNAi, mRNA, and gene editing
constructs. The broad applicability of this platform to nucleic
acid therapeutic development has established Arbutus as a leader in
this new area of innovative medicine.
About Arbutus
Arbutus Biopharma Corporation is a
biopharmaceutical company dedicated to discovering, developing and
commercializing a cure for patients suffering from chronic HBV
infection. Arbutus is headquartered in Vancouver, BC, and has
facilities in Warminster, PA. 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 receiving single digit royalties on sales of patisiran;
Alnylam filing a New Drug Application (NDA) in late 2017 and a
Marketing Authorisation Application (MAA) in early 2018; exploring
opportunities to generate value from Arbutus’ LNP platform
technology; and discovering, developing and commercializing a cure
for chronic hepatitis B virus (HBV) infection.
With respect to the forward-looking statements
contained in this press release, Arbutus has made numerous
assumptions regarding, among other things: the continued demand for
Arbutus’ assets, including its LNP technology; continued positive
preclinical and clinical efficacy data; 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: patisiran may not generate significant
royalties for Arbutus, or at all; Alnylam may not file the
applications on a timely basis, or at all; demand for Arbutus’
assets may lower; Arbutus’ LNP technology may not continue to
produce positive preclinical and clinical efficacy data; 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
InvestorsAdam CutlerSenior Vice President,
Corporate AffairsPhone: 604-419-3200 Email:
acutler@arbutusbio.com
Tiffany TolmieManager, Investor RelationsPhone: 604-419-3200
Email: ttolmie@arbutusbio.com
MediaDavid SchullRusso PartnersPhone:
858-717-2310Email: david.schull@russopartnersllc.com
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