Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate
of Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) and Pfizer Inc.
(NYSE:PFE), today announced that the companies have entered into a
worldwide exclusive licensing agreement for AKCEA-ANGPTL3-LRx, an
investigational antisense therapy being developed to treat patients
with certain cardiovascular and metabolic diseases.
AKCEA-ANGPTL3-LRx is designed to reduce the production of
angiopoietin-like 3 (ANGPTL3) protein in the liver, a key regulator
of triglycerides, cholesterol, glucose and energy metabolism.
AKCEA-ANGPTL3-LRx is currently being evaluated in a Phase 2 study
in patients with Type 2 diabetes, hypertriglyceridemia and
non-alcoholic fatty liver disease (NAFLD).
“AKCEA-ANGPTL3-LRx has the potential to treat people suffering
from certain cardiovascular and metabolic diseases. Given the unmet
medical need for this patient population and the broad market
potential, we believe Pfizer’s expertise and breadth of experience
in cardiovascular and metabolic diseases makes it well suited to
accelerate clinical development of AKCEA-ANGPTL3-LRx, and to
deliver it to patients in need of additional therapies for these
life threatening diseases,” said Damien McDevitt, Ph.D., interim
chief executive officer at Akcea.
“Pfizer is committed to delivering breakthrough medicines to
patients with unmet medical needs,” said Mikael Dolsten, Chief
Scientific Officer and President, Worldwide Research &
Development and Medical, Pfizer. “AKCEA-ANGPTL3-LRx is a novel
therapy that will complement our clinical mid-stage internal
medicine pipeline, and we believe that our deep expertise in
cardiovascular and metabolic diseases will help allow this program
to reach its maximum potential for patients.”
Under terms of the agreement, Akcea and Ionis will receive a
$250 million upfront license fee, which will be split equally
between the two companies. Akcea will settle its $125 million
obligation to Ionis in Akcea common stock. The companies are also
eligible to receive development, regulatory and sales milestone
payments of up to $1.3 billion and tiered, double-digit royalties
on annual worldwide net sales following marketing approval of
AKCEA-ANGPTL3-LRx. Future milestone payments and royalties will be
split equally between Akcea and Ionis. Pfizer is responsible for
all development and regulatory activities and costs beyond those
associated with the ongoing Phase 2 study. Prior to regulatory
filing for marketing approval, Akcea has the right, at its option
to participate in certain commercialization activities with Pfizer
in the U.S. and certain additional markets on pre-defined terms and
based on meeting pre-defined criteria.
This transaction is subject to clearance under the Hart-Scott
Rodino Antitrust Improvements Act and other customary closing
conditions.
ABOUT AKCEA-ANGPTL3-LRxAKCEA-ANGPTL3-LRx is an
investigational antisense therapy being developed to treat patients
with certain cardiovascular and metabolic diseases. This antisense
medicine is designed to reduce the production of angiopoietin-like
3 (ANGPTL3) protein in the liver, a key regulator of triglycerides,
cholesterol, glucose and energy metabolism. AKCEA-ANGPTL3-LRx was
developed using Ionis’ advanced LIgand
Conjugated Antisense (LICA)
technology platform. The potential therapeutic benefits of ANGPTL3
reduction are supported by the discovery that people with a genetic
deficiency in ANGPTL3 have reduced levels of low-density
lipoprotein cholesterol (LDL-C) and triglycerides, and a decreased
risk of diabetes and cardiovascular disease1. In a Phase 1/2 study,
patients treated with AKCEA-ANGPTL3-LRx achieved robust,
dose-dependent reductions of ANGPTL3, triglycerides,
LDL-cholesterol and total cholesterol with a positive safety and
tolerability profile2. AKCEA-ANGPTL3-LRx is currently being
evaluated in a Phase 2 study in patients with Type 2 diabetes,
hypertriglyceridemia and non-alcoholic fatty liver disease (NAFLD).
AKCEA-ANGPTL3-LRx was discovered by Ionis and has been co-developed
by Akcea and Ionis.
ABOUT AKCEA THERAPEUTICS, INC.Akcea
Therapeutics, Inc., an affiliate of Ionis Pharmaceuticals, Inc., is
a biopharmaceutical company focused on developing and
commercializing drugs to treat patients with serious and rare
diseases. Akcea is commercializing TEGSEDI® (inotersen) and
WAYLIVRA® (volanesorsen) as well as advancing a mature pipeline of
novel drugs, including AKCEA-APO(a)-LRx, AKCEA-ANGPTL3-LRx,
AKCEA-APOCIII-LRx, and AKCEA-TTR-LRx, with the potential to treat
multiple diseases. All six drugs were discovered by Ionis, a leader
in antisense therapeutics, and are based on Ionis’ proprietary
antisense technology. TEGSEDI is approved in the U.S., E.U. and
Canada. WAYLIVRA is approved in the E.U. and is currently in Phase
3 clinical development for the treatment of people with familial
partial lipodystrophy, or FPL. Akcea is building the infrastructure
to commercialize its drugs globally. Akcea is a global company
headquartered in Boston, Massachusetts. Additional information
about Akcea is available at www.akceatx.com and you can follow us
on twitter at @akceatx.
Pfizer Inc.: Breakthroughs that Change Patients’
LivesAt Pfizer, we apply science and our global resources
to bring therapies to people that extend and significantly improve
their lives. We strive to set the standard for quality, safety and
value in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 150 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.pfizer.com. In addition, to
learn more, please visit us on www.pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
AKCEA FORWARD-LOOKING STATEMENTThis press
release includes forward-looking statements regarding the business
of Akcea Therapeutics, Inc. and the therapeutic and commercial
potential of AKCEA-ANGPTL3-LRx and other products in development.
Any statement describing Akcea’s goals, expectations, financial or
other projections, intentions or beliefs, including the commercial
potential of AKCEA-ANGPTL3-LRx or other of Akcea’s drugs in
development 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. Akcea’s 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 Akcea’s forward-looking statements reflect the good faith
judgment of its management, these statements are based only on
facts and factors currently known by Akcea. As a result, you are
cautioned not to rely on these forward-looking statements. These
and other risks concerning Akcea’s programs are described in
additional detail in Akcea’s quarterly report on Form 10-Q and
annual report on Form 10-K, 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,
“Pfizer”, “Akcea,” “Company,” “Companies,” “we,” “our,” and “us”
refers to Pfizer and/or Akcea Therapeutics.
Ionis Pharmaceuticals™ is a trademark of Ionis Pharmaceuticals,
Inc. Akcea Therapeutics®, TEGSEDI® and WAYLIVRA® are trademarks of
Akcea Therapeutics, Inc.
PFIZER DISCLOSURE NOTICE: The information
contained in this release is as of October 7, 2019. Pfizer assumes
no obligation to update forward-looking statements contained in
this release as the result of new information or future events or
developments.
This release contains forward-looking information about a
worldwide exclusive licensing agreement among Pfizer, Akcea
Therapeutics, Inc. and Ionis Pharmaceuticals, Inc., and
AKCEA-ANGPTL3-LRx, an investigational antisense therapy being
developed to treat patients with certain cardiovascular and
metabolic diseases, including its potential benefits, that involves
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
the uncertainties inherent in research and development, including
the ability to meet anticipated clinical endpoints, commencement
and/or completion dates for our clinical trials, regulatory
submission dates, regulatory approval dates and/or launch dates, as
well as the possibility of unfavorable new clinical data and
further analyses of existing clinical data; the risk that clinical
trial data are subject to differing interpretations and assessments
by regulatory authorities; whether regulatory authorities will be
satisfied with the design of and results from our clinical studies;
whether and when drug applications may be filed in any
jurisdictions for AKCEA-ANGPTL3-LRx; whether and when any such
applications may be approved by regulatory authorities, which will
depend on myriad factors, including making a determination as to
whether the product's benefits outweigh its known risks and
determination of the product's efficacy and, if approved, whether
AKCEA-ANGPTL3-LRx will be commercially successful; decisions by
regulatory authorities impacting labeling, manufacturing processes,
safety and/or other matters that could affect the availability or
commercial potential of AKCEA-ANGPTL3-LRx; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2018 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
Akcea Investor Contact:Kathleen GallagherVice
President, Corporate Communications and Investor
Relations(617)-207-8509kgallagher@akceatx.com
Bill BerryBerry & CompanyT: 212
253-8881bberry@berrypr.com
Lynn GranitoBerry & CompanyT: 212
253-8881lgranito@berrypr.com
Pfizer Media Relations:Patricia
Kelly212-733-3810patricia.kelly@pfizer.com
Pfizer Investor Relations:Chuck
Triano212-733-3901charles.e.triano@pfizer.com
References
- JAMA Cardiol. 2018 Oct 1;3(10):957-966.
- N Engl J Med. 2017 Jul 20;377(3):222-232.
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