CARLSBAD, Calif., Dec. 16, 2016 /PRNewswire/ -- Ionis
Pharmaceuticals, Inc. (NASDAQ: IONS) announced today that it has
earned $28 million from AstraZeneca
(NYSE:AZN) following AstraZeneca's completion of IND-supporting
studies and license of IONIS-KRAS-2.5Rx, or
AZD4785. IONIS-KRAS-2.5Rx is a Generation 2.5
antisense drug discovered by Ionis designed to directly target
KRAS, one of the most frequently mutated genes in cancer.
KRAS mutations are thought to underlie the
pathogenesis of up to 30% of human tumors. The KRAS protein
is involved in regulating cell division and tumor cell survival.
However, developing therapeutics using traditional drug
modalities to block KRAS activity has proven difficult.
IONIS-KRAS-2.5Rx will be the first drug to enter
clinical development that directly targets KRAS, regardless
of mutation type. AstraZeneca will be responsible for further
developing and commercializing IONIS-KRAS-2.5Rx.
Brett Monia, Ph.D., senior vice
president of drug discovery at Ionis, said: "We and AstraZeneca are
uniquely positioned to advance the first antisense drug in
development to target KRAS as this is a very challenging
target to engage with other therapeutic modalities. Our
partner AstraZeneca has extensive experience in successfully
developing and commercializing drugs to treat cancer and we look
forward to working with them to advance this innovative cancer
treatment through clinical development."
As IONIS-KRAS-2.5Rx advances in development, Ionis is
eligible to receive up to $137
million for additional development and regulatory milestone
payments. In addition, Ionis is eligible to receive up to
low double-digit royalties
from sales of the drug.
ABOUT IONIS AND ASTRAZENECA
Ionis and AstraZeneca are
collaborating to discover and develop antisense drugs to treat
cancer under a Collaboration, License and Development Agreement
entered into in December 2012. The collaboration combines
AstraZeneca's experience and expertise in developing anti-cancer
agents with Ionis' antisense technology platform to broaden Ionis'
cancer franchise. With the completion of the IND-supporting
studies for IONIS-KRAS-2.5Rx, Ionis has received more
than $85 million in upfront and
milestone payments from its oncology collaboration with AstraZeneca
and is eligible to earn additional milestone payments as the drug
progresses in development as well as royalties on sales of
IONIS-KRAS-2.5Rx if it is commercialized.
AstraZeneca is also evaluating, as part of the oncology
collaboration, another drug to treat cancer, AZD9150
(IONIS-STAT3-2.5Rx), in combination with durvalumab,
AstraZeneca's investigational anti-PD-L1 antibody, in patients with
head and neck cancer and in patients with diffuse large B-cell
lymphoma. The two companies have also formed a strategic
collaboration to discover and develop antisense therapies for
treating cardiovascular, metabolic and renal diseases.
ABOUT IONIS PHARMACEUTICALS, INC.
Ionis is the leading
company in RNA-targeted drug discovery and development focused on
developing drugs for patients who have the highest unmet medical
needs, such as those patients with severe and rare diseases.
Using its proprietary antisense technology, Ionis has created a
large pipeline of first-in-class or best-in-class drugs, with over
a dozen drugs in mid- to late-stage development. Drugs
currently in Phase 3 development include volanesorsen, a drug Ionis
is developing and plans to commercialize through its wholly owned
subsidiary, Akcea Therapeutics, to treat patients with either
familial chylomicronemia syndrome or familial partial
lipodystrophy; IONIS-TTRRx, a drug Ionis is developing
with GSK to treat patients with TTR amyloidosis; and SPINRAZA™
(nusinersen), a drug licensed by Biogen to treat infantile and
later-onset spinal muscular atrophy. Ionis' patents provide
strong and extensive protection for its drugs and technology.
Additional information about Ionis is available at
www.ionispharma.com.
ABOUT ASTRAZENECA
AstraZeneca is a global, science-led
biopharmaceutical company that focuses on the discovery,
development and commercialisation of prescription medicines,
primarily for the treatment of diseases in three main therapy areas
- Oncology, Cardiovascular & Metabolic Diseases and
Respiratory. The Company also is selectively active in the
areas of autoimmunity, neuroscience and infection.
AstraZeneca operates in over 100 countries and its innovative
medicines are used by millions of patients worldwide. For more
information, please visit www.astrazeneca.com.
IONIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT
This
press release includes forward-looking statements regarding Ionis'
alliance with AstraZeneca. 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, particularly those inherent in the process
of discovering, developing and commercializing drugs that are safe
and effective for use as human therapeutics, and in the endeavor of
building a business around such drugs. 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 December 31,
2015, and its most recent quarterly report on Form 10-Q,
which are on file with the SEC. 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. Akcea Therapeutics™ is a trademark of Ionis
Pharmaceuticals, Inc. SPINRAZA™ is a trademark of Biogen.
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SOURCE Ionis Pharmaceuticals, Inc.