- Builds on existing collaboration with Novartis for
pelacarsen, which is currently being evaluated in a Phase 3
cardiovascular outcome study with data expected in 2025
- Ionis' new and advanced technologies will be used to create
next generation compound targeting Lp(a)
- Ionis will receive a $60
million upfront payment
CARLSBAD, Calif., Aug. 3, 2023
/PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS)
today announced that it has entered a collaboration and license
agreement with Novartis for the discovery, development and
commercialization of a novel medicine for patients with
lipoprotein(a), or Lp(a)-driven cardiovascular disease (CVD). This
builds on the companies' existing collaboration focused on the
development and commercialization of pelacarsen, which Novartis is
currently evaluating in a Phase 3 cardiovascular outcome study. The
next generation compound will be a potential follow-on to
pelacarsen.
![(PRNewsfoto/Ionis Pharmaceuticals, Inc.) (PRNewsfoto/Ionis Pharmaceuticals, Inc.)](https://mma.prnewswire.com/media/882077/Ionis_Logo.jpg)
"We are pleased to expand our productive collaboration with
Novartis aimed at delivering transformative therapies to patients
with elevated Lp(a) who are at high risk of cardiovascular events,"
said Brett P. Monia, Ph.D., Ionis'
chief executive officer. "This collaboration is designed to
leverage Ionis' advancing RNA-targeting platform technologies to
deliver a novel Lp(a)-targeting therapy that we expect will provide
industry-leading efficacy and dosing frequency."
Ionis will receive a $60 million
upfront payment from Novartis and is eligible to earn development,
regulatory and commercial milestone payments and tiered royalties.
Novartis will be solely responsible for the development,
manufacturing and potential commercialization of the next
generation Lp(a) therapy.
The agreement is subject to the satisfaction of requirements of
the Hart-Scott-Rodino Antitrust Improvements Act of 1976.
About Lp(a)
Lp(a) is a lipoprotein particle assembled in the liver that
consists of a low-density lipoprotein cholesterol (LDL-C)-like
particle and apolipoprotein(a). Lp(a) levels in the blood can vary
greatly between individuals primarily due to genetic variations and
do not correlate with LDL-C levels. Even patients with LDL-C
lowered to target levels (<70 mg/dL) remain at high-risk of
cardiovascular events if they have high levels of Lp(a). Elevated
Lp(a) is a genetically determined condition that is not responsive
to lifestyle changes, therefore patients are unable to adequately
control their Lp(a) levels through improved diet or increased
physical activity. Elevated Lp(a) is recognized as an independent,
genetic cause of coronary artery disease, heart attack, stroke,
peripheral arterial disease and aortic stenosis. Currently, there
is no effective drug therapy to specifically and robustly lower
elevated levels of Lp(a).
About Pelacarsen
Pelacarsen was discovered by Ionis and licensed to Novartis in
2019 for exclusive worldwide development, manufacturing and
commercialization. It is an investigational antisense medicine
designed to reduce apolipoprotein(a) production in the liver to
offer a direct approach for reducing circulating Lp(a). It is
estimated that more than eight million people worldwide have
elevated Lp(a) and CVD.
Pelacarsen is currently being evaluated in Lp(a) HORIZON
(NCT04023552), a global, multicenter, double-blind,
placebo-controlled pivotal Phase 3 study conducted by Novartis. The
study completed enrollment with 8,323 participants. Data are
expected in 2025.
About Ionis Pharmaceuticals, Inc.
For more than 30 years, Ionis has been a leader in RNA-targeted
therapy, pioneering new markets and changing standards of care.
Ionis currently has four marketed medicines and a promising
late-stage pipeline highlighted by cardiovascular and neurological
franchises. Our scientific innovation began and continues with the
knowledge that sick people depend on us, which fuels our vision to
become the leader in genetic medicine, utilizing a multi-platform
approach to discover, develop and deliver life-transforming
therapies.
To learn more about Ionis visit www.ionispharma.com and follow
us on Twitter @ionispharma.
Ionis' Forward-looking Statements
This press release includes forward-looking statements regarding
Ionis' business and the therapeutic and commercial potential of
pelacarsen, Ionis' next generation program targeting Lp(a), Ionis'
technologies and other products in development. Any statement
describing Ionis' goals, expectations, financial or other
projections, intentions or beliefs is a forward-looking statement
and should be considered an at-risk statement. Such statements are
subject to certain risks and uncertainties including those related
to our commercial products and the medicines in our pipeline, and
particularly those inherent in the process of discovering,
developing and commercializing medicines that are safe and
effective for use as human therapeutics, and in the endeavor of
building a business around such medicines. Ionis' forward-looking
statements also involve assumptions that, if they never materialize
or prove correct, could cause its results to differ materially from
those expressed or implied by such forward-looking statements.
Although Ionis' forward-looking statements reflect the good faith
judgment of its management, these statements are based only on
facts and factors currently known by Ionis. As a result, you are
cautioned not to rely on these forward-looking statements. These
and other risks concerning Ionis' programs are described in
additional detail in Ionis' annual report on Form 10-K for the year
ended Dec. 31, 2022, and the most
recent Form 10-Q quarterly filing, which are on file with the
Securities and Exchange Commission. Copies of these and other
documents are available from the Company.
In this press release, unless the context requires otherwise,
"Ionis," "Company," "we," "our," and "us" refers to Ionis
Pharmaceuticals and its subsidiaries.
Ionis Pharmaceuticals® is a trademark of Ionis
Pharmaceuticals, Inc.
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SOURCE Ionis Pharmaceuticals, Inc.