Alnylam to Appeal Claim Construction Ruling on Two Patents Asserted Against Moderna
25 Agosto 2023 - 6:00PM
Business Wire
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi
therapeutics company, today announced an update on its ongoing
patent infringement litigation. On March 17, 2022, Alnylam
initiated litigation in the United States District Court for the
District of Delaware against Moderna for patent infringement. To
date, in two separate actions against Moderna, Alnylam has sought
to recover reasonable compensation for Moderna’s infringement of
five Alnylam patents that cover key lipid technology embedded in
Moderna’s COVID-19 Vaccine, SPIKEVAX®.
On August 21, 2023, the Delaware Court issued an order
construing certain claim terms in two of the asserted Alnylam
patents. In light of that order, Alnylam and Moderna have jointly
agreed to final judgment of non-infringement of two of Alnylam’s
patents. Alnylam respectfully disagrees with the Delaware Court’s
ruling and intends to appeal the decision. Alnylam anticipates that
its second action against Moderna for infringement will move
forward in the Delaware Court.
The Delaware Court’s claim construction ruling did not impact
Alnylam’s infringement contentions in its two separate suits
against Pfizer. Alnylam will continue to assert six patents against
Pfizer to recover reasonable compensation for Pfizer’s use of
Alnylam’s technology in its COVID-19 vaccine, COMIRNATY®.
Alnylam strongly believes in the strength of its patents and its
cases against both Moderna and Pfizer and will continue its efforts
to have its claims heard before a jury at trial.
About RNAi
RNAi (RNA interference) is a natural cellular process of gene
silencing that represents one of the most promising and rapidly
advancing frontiers in biology and drug development today. Its
discovery has been heralded as “a major scientific breakthrough
that happens once every decade or so,” and was recognized with the
award of the 2006 Nobel Prize for Physiology or Medicine. By
harnessing the natural biological process of RNAi occurring in our
cells, a new class of medicines known as RNAi therapeutics is now a
reality. Small interfering RNA (siRNA), the molecules that mediate
RNAi and comprise Alnylam’s RNAi therapeutic platform, function
upstream of today’s medicines by potently silencing messenger RNA
(mRNA) – the genetic precursors – that encode for disease-causing
or disease pathway proteins, thus preventing them from being made.
This is a revolutionary approach with the potential to transform
the care of patients with genetic and other diseases.
About Alnylam Pharmaceuticals
Alnylam Pharmaceuticals (Nasdaq: ALNY) has led the translation
of RNA interference (RNAi) into a whole new class of innovative
medicines with the potential to transform the lives of people
afflicted with rare and prevalent diseases with unmet need. Based
on Nobel Prize-winning science, RNAi therapeutics represent a
powerful, clinically validated approach yielding transformative
medicines. Since its founding in 2002, Alnylam has led the RNAi
Revolution and continues to deliver on a bold vision to turn
scientific possibility into reality. Alnylam’s commercial RNAi
therapeutic products are ONPATTRO® (patisiran), AMVUTTRA®
(vutrisiran), GIVLAARI® (givosiran), OXLUMO® (lumasiran), and
Leqvio® (inclisiran), which is being developed and commercialized
by Alnylam’s partner, Novartis. Alnylam has a deep pipeline of
investigational medicines, including multiple product candidates
that are in late-stage development. Alnylam is executing on its
“Alnylam P5x25” strategy to deliver transformative medicines in
both rare and common diseases benefiting patients around the world
through sustainable innovation and exceptional financial
performance, resulting in a leading biotech profile. Alnylam is
headquartered in Cambridge, MA. For more information about our
people, science and pipeline, please visit www.alnylam.com and
engage with us on Twitter at @Alnylam, on LinkedIn, or on
Instagram.
Alnylam Forward Looking Statements
This press release contains forward-looking statements within
the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. All statements
other than historical statements of fact regarding Alnylam’s
expectations, beliefs, goals, plans or prospects including, without
limitation, expectations regarding Alnylam’s aspiration to become a
leading biotech company and the planned achievement of its “Alnylam
P5x25” strategy, and statements about Alnylam’s patent infringement
litigation against Pfizer and Moderna, should be considered
forward-looking statements. Actual results and future plans may
differ materially from those indicated by these forward-looking
statements as a result of various important risks, uncertainties
and other factors, including, without limitation: uncertainties
associated with litigation generally and patent litigation
specifically, the direct or indirect impact of the COVID-19 global
pandemic or any future pandemic on Alnylam’s business, results of
operations and financial condition and the effectiveness or
timeliness of Alnylam’s efforts to mitigate the impact of the
pandemic; Alnylam’s ability to successfully execute on its “Alnylam
P5x25” strategy; Alnylam's ability to discover and develop novel
drug candidates and delivery approaches and successfully
demonstrate the efficacy and safety of its product candidates; the
pre-clinical and clinical results for Alnylam’s product candidates,
including patisiran and vutrisiran; actions or advice of regulatory
agencies and Alnylam’s ability to obtain and maintain regulatory
approval for its product candidates, including patisiran and
vutrisiran, as well as favorable pricing and reimbursement;
successfully launching, marketing and selling Alnylam’s approved
products globally; delays, interruptions or failures in the
manufacture and supply of Alnylam’s product candidates or its
marketed products; delays or interruptions in the supply of
resources needed to advance Alnylam’s research and development
programs, including as may arise from recent disruptions in the
supply of non-human primates; obtaining, maintaining and protecting
intellectual property; Alnylam’s ability to successfully expand the
indication for ONPATTRO or AMVUTTRA in the future; Alnylam's
ability to manage its growth and operating expenses through
disciplined investment in operations and its ability to achieve a
self-sustainable financial profile in the future without the need
for future equity financing; Alnylam’s ability to maintain
strategic business collaborations; Alnylam's dependence on third
parties for the development and commercialization of certain
products, including Roche, Novartis, Sanofi, Regeneron and Vir; and
unexpected expenditures; as well as those risks more fully
discussed in the “Risk Factors” filed with Alnylam's 2022 Annual
Report on Form 10-K filed with the Securities and Exchange
Commission (SEC), as may be updated from time to time in Alnylam’s
subsequent Quarterly Reports on Form 10-Q and in its other SEC
filings. In addition, any forward-looking statements represent
Alnylam's views only as of today and should not be relied upon as
representing its views as of any subsequent date. Alnylam
explicitly disclaims any obligation, except to the extent required
by law, to update any forward-looking statements.
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Alnylam Pharmaceuticals, Inc. Christine Regan Lindenboom
(Investors and Media) +1-617-682-4340 Josh Brodsky (Investors)
+1-617-551-8276
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