CARLSBAD, Calif., Dec. 21, 2017 /PRNewswire/ -- Ionis
Pharmaceuticals, Inc. (NASDAQ: IONS) today announced that it has
earned a $5 million milestone payment
associated with initiation and enrollment in a newly initiated
Phase 1 clinical study of IONIS-JBI1-2.5Rx, an orally
delivered antisense drug designed to treat patients with a
gastrointestinal (GI) immune disorder by reducing the production of
an undisclosed target locally in the GI tract. Janssen Biotech,
Inc. (Janssen), which is responsible for global development,
regulatory and commercialization activities, is conducting the
Phase 1 study.
"This study represents an important milestone for us and our
antisense technology because IONIS-JBI1-2.5Rx is our
first orally delivered antisense drug for the treatment of GI
disorders to advance into the clinic. We are pleased with the
success of our collaboration with Janssen. In under two years, we
have advanced a drug into clinical trials and identified and
initiated IND-enabling studies for a second drug development
candidate, IONIS-JBI2-2.5Rx. Our collaboration with
Janssen combines Ionis' broad applicability of our antisense
technology with their expertise in GI autoimmune disorders and
therapeutic formulation," said C. Frank
Bennett, senior vice president of research at Ionis
Pharmaceuticals.
Under its global collaboration agreement with Janssen, Ionis is
eligible to receive nearly $585
million in development, regulatory and sales milestone
payments and license fees. In addition, Ionis will receive tiered
royalties that on average are double-digits on sales from any
product that is successfully commercialized.
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 three
dozen drugs in development. SPINRAZA® (nusinersen)
has been approved in global markets for the treatment of
spinal muscular atrophy (SMA). Biogen is responsible for
commercializing SPINRAZA. Drugs that have successfully completed
Phase 3 studies include inotersen, an antisense drug Ionis is
developing to treat patients with hereditary TTR amyloidosis
(hATTR), and volanesorsen, an antisense drug discovered by Ionis
and co-developed by Ionis and Akcea Therapeutics to treat
patients with either familial chylomicronemia syndrome or familial
partial lipodystrophy. Akcea, an affiliate of Ionis, is a
biopharmaceutical company focused on developing and commercializing
drugs to treat patients with serious cardiometabolic diseases
caused by lipid disorders. If approved, volanesorsen will be
commercialized through Ionis' affiliate, Akcea. Inotersen filings
for marketing approval have been submitted in the U.S. and
EU. Volanesorsen filings for marketing approval have been
submitted in the U.S., EU, and Canada. Ionis' patents provide strong and
extensive protection for its drugs and technology. Additional
information about Ionis is available
at www.ionispharma.com.
IONIS' FORWARD-LOOKING STATEMENT
This press release
includes forward-looking statements regarding the therapeutic and
commercial potential regarding Ionis' alliance with Janssen, Ionis
research, development and commercial opportunities in developing
antisense drugs to treat autoimmune disease in the gastrointestinal
tract. 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, 2016, 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 registered trademark of Biogen.
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SOURCE Ionis Pharmaceuticals, Inc.