Arbutus’ LNP Licensee Alnylam Initiates Rolling Submission of New Drug Application (NDA) to U.S. Food and Drug Administrati...
November 16 2017 - 12:40PM
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), initiated submission of a
rolling New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for patisiran, an investigational RNAi
therapeutic being developed for patients with hereditary ATTR
amyloidosis with polyneuropathy. This submission allows the FDA to
review completed portions of the NDA on an ongoing basis. Alnylam
expects to submit final clinical data by year end.
“Our LNP licensing partner continues to make
great progress towards achieving final regulatory approval for
patisiran. This is a testament to the value of our proprietary LNP
platform, which is the most widely adopted RNAi delivery technology
to date,” said Dr. Mark J. Murray, Arbutus’ President and CEO.
“Arbutus is entitled to receive single digit royalties on global
sales of patisiran, pending final regulatory approvals.”
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 Alnylam submitting final clinical data by year end; achieving
final regulatory approval for patisiran; Arbutus receiving single
digit royalties on global sales of patisiran; 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 speed of regulatory
approvals; continued and timely positive preclinical and clinical
efficacy data; the continued demand for Arbutus’ assets, including
its LNP technology; 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 receive regulatory
approval on a timely basis, or at all; Arbutus may not receive
timely royalty payments, or at all; 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
InvestorsBruce CousinsExecutive Vice President
and Chief Financial OfficerPhone:
604-419-3200Email: bcousins@arbutusbio.com
Tiffany TolmieManager, Investor RelationsPhone:
604-419-3200Email: ttolmie@arbutusbio.com
MediaDavid SchullRusso PartnersPhone:
858-717-2310Email: david.schull@russopartnersllc.com
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