Royalty Pharma plc (Nasdaq: RPRX) and Ionis Pharmaceuticals, Inc.
(Nasdaq: IONS) today announced that Royalty Pharma has acquired an
interest in Ionis’ royalty in Biogen’s SPINRAZA® (nusinersen) and
Novartis’ pelacarsen for up to $1.125 billion, including an upfront
payment of $500 million and up to $625 million in additional
pelacarsen milestone payments.
SPINRAZA is the global foundation of care for the treatment of
people living with spinal muscular atrophy (SMA). Biogen licensed
SPINRAZA from Ionis in 2016. Pelacarsen is a potentially
first-in-class treatment specifically targeting elevated
lipoprotein(a), or Lp(a), an independent, inherited, and causal
risk factor for cardiovascular disease. Novartis licensed
pelacarsen from Ionis in 2019.
“This transaction provides us with significant capital to reach
our strategic objectives, the first of which is to achieve
commercial readiness for our late-stage programs eplontersen,
olezarsen and donidalorsen. It also enables us to further advance
our deep and innovative pipeline so that we can continue to deliver
a steady cadence of new genetic medicines to the market,” said
Brett P. Monia, Ph.D., Chief Executive Officer of Ionis. “Royalty
Pharma’s investment underscores their confidence in SPINRAZA’s
resilience as an important therapy for the treatment of SMA. It
also demonstrates their belief in pelacarsen’s potential to be a
first-in-class treatment for Lp(a)-driven cardiovascular disease,
representing a multibillion-dollar commercial opportunity.
Furthermore, because Ionis retains a majority interest in SPINRAZA
and pelacarsen royalties, we maintain our ability to benefit
significantly from the potential commercial upside of both
products.”
“We are thrilled to partner with Ionis, an innovator in genetic
medicine. This investment is consistent with our strategy of
acquiring royalties on innovative therapies in areas of high unmet
patient need,” said Pablo Legorreta, founder and Chief Executive
Officer of Royalty Pharma. “SPINRAZA has transformed the lives of
thousands of SMA patients. We are also excited to acquire a royalty
on pelacarsen which, if approved, has the potential to be a
practice-changing, first-in-class therapy benefiting millions of
cardiovascular disease patients by lowering Lp(a).”
Under the terms of the monetization transaction, Royalty Pharma
will receive:
- 25% of Ionis’
SPINRAZA royalty payments through 2027, increasing to 45% of
royalty payments in 2028, on up to $1.5 billion in annual sales.
Royalty Pharma’s royalty interest in SPINRAZA will revert to Ionis
after total SPINRAZA royalty payments reach either $475 million or
$550 million, depending on the timing and occurrence of certain
events; and
- 25% of Ionis’
pelacarsen royalty payments.
Under the terms of Ionis’ exclusive licensing agreement with
Biogen, Ionis is entitled to tiered royalties up to the mid-teens
on annual worldwide net sales of SPINRAZA. Ionis’ exclusive license
agreement with Novartis entitles Ionis to receive tiered royalties
in the mid-teens to low 20% range on net sales of pelacarsen. Ionis
also retains all rights to $650 million in pelacarsen development,
regulatory and commercial milestones from Novartis.
Additional information regarding the monetization agreement is
available in a Current Report on Form 8-K Ionis filed today with
the U.S. Securities and Exchange Commission.
Advisors
Goodwin Procter, Fenwick & West and Maiwald acted as legal
advisors to Royalty Pharma. Cowen acted as financial advisor to
Ionis and Cooley acted as its legal advisor.
About SPINRAZA® (nusinersen)
SPINRAZA is the first approved therapy for the treatment of
spinal muscular atrophy (SMA) and remains the global market leader
and foundation of care for patients of all ages living with the
disease. To date, more than 13,000 SMA patients have been treated
with SPINRAZA worldwide. The SPINRAZA clinical development program
encompasses 10 clinical studies, which have included more than 300
individuals across a broad spectrum of patient populations
including two randomized controlled studies (ENDEAR and CHERISH).
The ongoing SHINE and NURTURE open-label extension studies are
evaluating the long-term impact of SPINRAZA. The most common
adverse events observed in clinical studies were respiratory
infection, fever, constipation, headache, vomiting and back pain.
Laboratory tests can monitor for renal toxicity and coagulation
abnormalities, including acute severe low platelet counts, which
have been observed after administration of some ASOs.
Biogen licensed the global rights to develop, manufacture and
commercialize SPINRAZA from Ionis Pharmaceuticals, Inc. (Nasdaq:
IONS), the leader in RNA-targeted therapeutics. Please click here
for Important Safety Information and full Prescribing Information
for SPINRAZA in the U.S., or visit your respective country's
product website.
About Pelacarsen
Pelacarsen, licensed by Novartis for exclusive worldwide
development, manufacturing and commercialization, is an
investigational antisense medicine designed to reduce
apolipoprotein(a) production in the liver to offer a direct
approach for reducing circulating lipoprotein(a), or Lp(a), an
atherogenic, pro-inflammatory and thrombogenic lipoprotein that
induces additional cardiovascular risk independent of other
cardiovascular risk factors.
About Royalty Pharma plc
Founded in 1996, Royalty Pharma is the largest buyer of
biopharmaceutical royalties and a leading funder of innovation
across the biopharmaceutical industry, collaborating with
innovators from academic institutions, research hospitals and
non-profits through small and mid-cap biotechnology companies to
leading global pharmaceutical companies. Royalty Pharma has
assembled a portfolio of royalties which entitles it to payments
based directly on the top-line sales of many of the industry’s
leading therapies. Royalty Pharma funds innovation in the
biopharmaceutical industry both directly and indirectly - directly
when it partners with companies to co-fund late-stage clinical
trials and new product launches in exchange for future royalties,
and indirectly when it acquires existing royalties from the
original innovators. Royalty Pharma’s current portfolio includes
royalties on more than 35 commercial products, including Vertex’s
Trikafta, Kalydeco, Orkambi and Symdeko, Biogen’s Tysabri, AbbVie
and Johnson & Johnson’s Imbruvica, Astellas and Pfizer’s
Xtandi, GSK’s Trelegy, Novartis’ Promacta, Pfizer’s Nurtec ODT,
Johnson & Johnson’s Tremfya, Roche’s Evrysdi, Gilead’s
Trodelvy, and 12 development-stage product candidates.
About Ionis Pharmaceuticals, Inc.
For more than 30 years, Ionis has been the leader in
RNA-targeted therapy, pioneering new markets and changing standards
of care with its novel antisense technology. Ionis currently has
three marketed medicines and a premier late-stage pipeline
highlighted by industry-leading 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.
Royalty Pharma Forward-Looking Statements
The information set forth herein does not purport to be complete
or to contain all of the information you may desire. Statements
contained herein are made as of the date of this document unless
stated otherwise, and neither the delivery of this document at any
time, nor any sale of securities, shall under any circumstances
create an implication that the information contained herein is
correct as of any time after such date or that information will be
updated or revised to reflect information that subsequently becomes
available or changes occurring after the date hereof.
This document contains statements that constitute
“forward-looking statements” as that term is defined in the United
States Private Securities Litigation Reform Act of 1995, including
statements that express the company’s opinions, expectations,
beliefs, plans, objectives, assumptions or projections regarding
future events or future results, in contrast with statements that
reflect historical facts. Examples include discussion of Royalty
Pharma’s strategies, financing plans, growth opportunities and
market growth. In some cases, you can identify such forward-looking
statements by terminology such as “anticipate,” “intend,”
“believe,” “estimate,” “plan,” “seek,” “project,” “expect,” “may,”
“will,” “would,” “could” or “should,” the negative of these terms
or similar expressions. Forward-looking statements are based on
management’s current beliefs and assumptions and on information
currently available to the company. However, these forward-looking
statements are not a guarantee of Royalty Pharma’s performance, and
you should not place undue reliance on such statements.
Forward-looking statements are subject to many risks, uncertainties
and other variable circumstances, and other factors. Such risks and
uncertainties may cause the statements to be inaccurate and readers
are cautioned not to place undue reliance on such statements. Many
of these risks are outside of the company’s control and could cause
its actual results to differ materially from those it thought would
occur. The forward-looking statements included in this document are
made only as of the date hereof. The company does not undertake,
and specifically declines, any obligation to update any such
statements or to publicly announce the results of any revisions to
any such statements to reflect future events or developments,
except as required by law.
Certain information contained in this document relates to or is
based on studies, publications, surveys and other data obtained
from third-party sources and the company's own internal estimates
and research. While the company believes these third-party sources
to be reliable as of the date of this document, it has not
independently verified, and makes no representation as to the
adequacy, fairness, accuracy or completeness of, any information
obtained from third-party sources. In addition, all of the market
data included in this document involves a number of assumptions and
limitations, and there can be no guarantee as to the accuracy or
reliability of such assumptions. Finally, while the company
believes its own internal research is reliable, such research has
not been verified by any independent source.
For further information, please reference Royalty Pharma’s
reports and documents filed with the U.S. Securities and Exchange
Commission (SEC). You may get these documents by visiting EDGAR on
the SEC website at www.sec.gov.
Ionis Forward-Looking Statements
This press release includes forward-looking statements regarding
Ionis’ transaction with Royalty Pharma, Ionis' business and the
therapeutic and commercial potential of Ionis' technologies,
SPINRAZA, pelacarsen 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 the impact COVID-19 could have on our business, and including
but not limited to, 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, 2021, 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.
Royalty Pharma Investor Relations and
Communications
+1 (212) 883-6772ir@royaltypharma.com
Ionis Investor Contact
+1 (760) 603-2331
Ionis Media Contact
+1 (760) 603-4679
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