Arbutus Biopharma and Genevant Sciences File Patent Infringement Lawsuit Against Pfizer/BioNTech
04 Abril 2023 - 8:52AM
Arbutus Biopharma Corporation (Nasdaq: ABUS) (“Arbutus”), a
clinical-stage biopharmaceutical company leveraging its extensive
virology expertise to develop novel therapeutics that target
specific viral diseases, and Genevant Sciences (Genevant) today
filed a lawsuit in the U.S. District Court for the District of New
Jersey against Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq:
BNTX) seeking damages for infringement of U.S. Patent Nos.
9,504,651; 8,492,359; 11,141,378; 11,298,320; and 11,318,098 in the
manufacture and sale of any COVID-19 mRNA-LNP vaccines. The patents
relate to nucleic acid-lipid particles and their composition,
manufacture, delivery and methods of use. The filed complaint is
available on the Arbutus website.
With this suit, Arbutus and its licensee
Genevant seek compensation for Pfizer’s and BioNTech’s unlicensed
use of patented lipid nanoparticle (LNP) delivery technologies
without which Pfizer-BioNTech’s COVID-19 vaccines would not have
been successful.
William Collier, President and CEO of Arbutus,
stated, “During the pandemic, there was an urgent need for LNP
technologies to deliver mRNA-based COVID-19 vaccines to cells in
the human body. We believe that Pfizer and BioNTech could not have
created and manufactured effective vaccines at such an
unprecedented speed without the existing, proven and patented LNP
technologies owned by Arbutus and licensed to Genevant. Therefore,
we are pursuing legal action against both Pfizer and BioNTech for
the unlicensed use of our patented technologies in their COVID-19
vaccines.”
While scientists have been able to easily create
mRNA molecules, they struggled to develop a delivery mechanism to
ensure the mRNA molecule engages safely and effectively with human
cells. This delivery challenge persisted for decades until a team
of Arbutus scientists, many of whom are now at Genevant, developed
and refined LNP delivery technologies, for which they were awarded
many patents. Arbutus’ LNP technologies rely on microscopic
particles built from four carefully selected types of fat-like
molecules that are stable enough to shelter and protect fragile RNA
molecules as they move through the human body to a target cell, and
then through the target cell’s membrane, before finally releasing
the RNA. These particles are called lipid nanoparticles and their
invention was widely recognized as a major achievement that is
essential for mRNA vaccines. Without these crucial delivery
technologies, the RNA would quickly degrade in the body and be
ineffective.
Arbutus also developed the technologies needed
to manufacture these LNPs. Previously, methods of manufacturing
lipid encapsulants for RNAs used harsh and extreme conditions that
would damage the fragile RNA payload. Arbutus developed new,
sophisticated manufacturing methods that avoided these deleterious
effects.
Arbutus remains committed to taking all legal
actions necessary to defend and protect its intellectual
property.
About Arbutus
Arbutus Biopharma Corporation (Nasdaq: ABUS) is
a clinical-stage biopharmaceutical company leveraging its extensive
virology expertise to develop novel therapeutics that target
specific viral diseases. Our current focus areas include Hepatitis
B virus (HBV), SARS-CoV-2, and other coronaviruses. To address HBV,
we are developing a RNAi therapeutic, an oral PD-L1 inhibitor, and
an oral RNA destabilizer to potentially identify a combination
regimen with the aim of providing a functional cure for patients
with chronic HBV by suppressing viral replication, reducing surface
antigen and reawakening the immune system. We believe our lead
compound, AB-729, is the only RNAi therapeutic with evidence of
immune re-awakening. AB-729 is currently being evaluated in
multiple phase 2 clinical trials. We also have an ongoing drug
discovery and development program directed to identifying novel,
orally active agents for treating coronaviruses, (including
SARS-CoV-2), for which we have nominated a compound and have begun
IND-enabling pre-clinical studies. In addition, we are exploring
oncology applications for our internal PD-L1 portfolio. 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 patent infringement lawsuit against Pfizer and BioNTech
and our future development plans for our product candidates.
With respect to the forward-looking statements
contained in this press release, Arbutus has made numerous
assumptions regarding, among other things: the effectiveness and
timeliness of preclinical studies and clinical trials, and the
usefulness of the data; the timeliness of regulatory approvals; the
continued demand for Arbutus’ assets; 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, including uncertainties and
contingencies related to the ongoing COVID-19 pandemic and patent
litigation matters.
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: uncertainties associated with litigation
generally and patent litigation specifically; anticipated
pre-clinical studies 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 product candidate; Arbutus may elect to
change its strategy regarding its product candidates and clinical
development activities; Arbutus may not receive the necessary
regulatory approvals for the clinical development of Arbutus’
products; economic and market conditions may worsen; Arbutus and
its collaborators may never realize the expected benefits of the
collaborations; market shifts may require a change in strategic
focus; and the ongoing COVID-19 pandemic could significantly
disrupt Arbutus’ clinical development programs.
A more complete discussion of the risks and
uncertainties facing Arbutus appears in Arbutus’ Annual Report on
Form 10-K, Arbutus’ Quarterly Reports on Form 10-Q and Arbutus’
continuous and periodic 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
Investors and Media
Lisa M. CaperelliVice President, Investor RelationsPhone:
215-206-1822Email:lcaperelli@arbutusbio.com
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