Novartis invests in next generation therapies to reduce cardiovascular risk in patients with underlying lipid disorders
(Thomson Reuters ONE) -
Novartis International AG /
Novartis invests in next generation therapies to reduce cardiovascular risk in
patients with underlying lipid disorders
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The issuer is solely responsible for the content of this announcement.
* Novartis enters into an exclusive option agreement with Ionis and Akcea to
license two investigational treatments expected to significantly reduce
cardiovascular risk in patients living with elevated levels of lipoprotein
Lp(a) or ApoCIII, which is a potent regulator of triglycerides
* Investment in biomarker-based therapies bolsters Novartis' cardiovascular
specialty pipeline and commitment to address unmet medical need of high-risk
atherosclerosis/dyslipidemia patients
* Atherosclerosis, commonly called the "silent killer", is a major cause of
death globally and no options exist today to effectively treat patients
whose disease is driven by Lp(a) and ApoCIII
Basel, January 06, 2017 - Novartis announced today a collaboration and option
agreement with Ionis Pharmaceuticals, Inc. and its affiliate Akcea Therapeutics,
Inc., to license two novel treatments with the potential to significantly reduce
cardiovascular risk in patients suffering from high levels of lipoproteins known
as Lp(a) and ApoCIII. The two investigational antisense therapies developed by
Ionis-called AKCEA-APO(a)-L(Rx) and AKCEA-APOCIII-L(Rx)-have the potential to
lower both lipoproteins up to 90% and significantly reduce cardiovascular risk
in high-risk patient populations. In addition Novartis entered into a stock
purchase agreement with Ionis.
"Novartis is building a robust cardiovascular portfolio of targeted therapies to
address unmet medical need of high-risk patients," said Vasant Narasimhan,
Global Head, Drug Development and Chief Medical Officer, Novartis. "Lp(a) and
ApoCIII are potent, genetically validated cardiovascular risk reduction targets.
The importance of predictive biomarkers in achieving successful cardiovascular
outcomes will also be essential in the future payer environment. We look forward
to working with Ionis and Akcea to develop both treatments."
Novartis will be able to exercise its options to license and commercialize
AKCEA-APO(a)-L(Rx) and AKCEA-APOCIII-L(Rx) following the achievement of
specified development milestones and prior to the initiation of Phase 3 studies
for each program. Upon in-licensing Novartis will be responsible for worldwide
development and commercialization of both assets.
Ionis' antisense technology is currently the most effective way to inhibit
synthesis of both lipoproteins in the liver, according to data published in the
Lancet[1]. The GalNAc3-conjugated antisense oligonucleotide technology is 30
times more potent than the parent antisense oligonucleotide, leading to a lower
dose and the potential for highly effective therapeutic targeting and much
improved tolerability.
The deal is subject to customary closing conditions and regulatory approvals.
About Atherosclerosis
Atherosclerosis is a disease in which plaque builds up inside the arteries
leading to gradual narrowing and hardening of the arteries and increased risk of
blood clots, heart attack and stroke. Atherosclerosis that affects the arteries
of the heart is commonly known as coronary heart disease.
About Dyslipidemia
Dyslipidemia is the elevation of plasma cholesterol, triglycerides, or both, or
a low high-density lipoprotein level that contributes to the development of
atherosclerosis.
About Lipoprotein(a) (Lp(a))
Lp(a) is a lipoprotein that travels through the blood. Elevated levels of Lp(a)
collect in the arteries, gradually narrowing the arteries and limiting blood
supply to the heart, brain, kidneys and legs. This leads to increased risk of
coronary heart disease, atherosclerosis, thrombosis and stroke. Additional
information is available through Lipoprotein (a) Foundation at
www.lipoproteinafoundation.org
About Apolipoprotein-CIII (ApoCIII)
ApoCIII is a protein produced in the liver that plays a central role in the
regulation of triglycerides, a type of fat found in the blood. People with
elevated levels of ApoCIII have high triglycerides which are associated with
multiple metabolic abnormalities such as insulin resistance and/or metabolic
syndrome. People who do not produce ApoCIII have lower levels of triglycerides
and lower instances of cardiovascular disease.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by words such as "invests," "next generation," "option," "investigational,"
"expected," "pipeline," "commitment," "potential," "building," "portfolio,"
"will," "look forward," "options," or similar terms, or by express or implied
discussions regarding potential marketing approvals for AKCEA-APO(a)-L(Rx,)
AKCEA-APOCIII-L(Rx) and the other products in the Novartis cardiovascular
portfolio, or regarding potential future revenues from AKCEA-APO(a)-L(Rx),
AKCEA-APOCIII-L(Rx) and the other products in the Novartis cardiovascular
portfolio, or regarding the possible exercise of the options to license and
commercialize AKCEA-APO(a)-L(Rx) and AKCEA-APOCIII-L(Rx), or regarding the
intended goals and objectives of the transaction with Ionis and Akcea and the
license to commercialize AKCEA-APO(a)-L(Rx) and AKCEA-APOCIII-L(Rx). You should
not place undue reliance on these statements. Such forward-looking statements
are based on the current beliefs and expectations of management regarding future
events, and are subject to significant known and unknown risks and
uncertainties. Should one or more of these risks or uncertainties materialize,
or should underlying assumptions prove incorrect, actual results may vary
materially from those set forth in the forward-looking statements. There can be
no guarantee that the necessary government approvals for the transaction or
option exercises will be obtained in any particular time frame, or at all.
Neither can there be any guarantee that any other closing conditions for the
transaction or option exercises will be met in any particular time frame, or at
all. Nor can there be any guarantee that the options to license and
commercialize AKCEA-APO(a)-L(Rx) and AKCEA-APOCIII-L(Rx) will be exercised
within the expected time frame, or at all. Neither can there be any guarantee
that the transaction with Ionis and Akcea and license to commercialize AKCEA-
APO(a)-L(Rx) and AKCEA-APOCIII-L(Rx) will achieve any of their intended goals
and objectives, or in any particular time frame. Nor can there be any guarantee
that AKCEA-APO(a)-L(Rx), AKCEA-APOCIII-L(Rx) or the other products in the
Novartis cardiovascular portfolio will be submitted or approved for sale in any
market, or at any particular time. Neither can there be any guarantee that
AKCEA-APO(a)-L(Rx), AKCEA-APOCIII-L(Rx) or the other products in the Novartis
cardiovascular portfolio will be commercially successful in the future. In
particular, management's expectations regarding AKCEA-APO(a)-L(Rx), AKCEA-
APOCIII-L(Rx) and the other products in the Novartis cardiovascular portfolio,
the transaction with Ionis and Akcea, and the options to license and
commercialize AKCEA-APO(a)-L(Rx) and AKCEA-APOCIII-L(Rx) could be affected by,
among other things, the potential that the intended goals and objectives of the
transaction with Ionis and Akcea and the license to commercialize AKCEA-APO(a)-
L(Rx) and AKCEA-APOCIII-L(Rx) may not be achieved or may take longer to achieve
than expected; the uncertainties inherent in research and development, including
unexpected clinical trial results and additional analysis of existing clinical
data; unexpected regulatory actions or delays or government regulation
generally, including an unexpected failure to obtain necessary government
approvals for the transaction or option exercises, or unexpected delays in
obtaining such approvals; the potential that any other closing conditions for
the transaction or option exercises may not be met; the company's ability to
obtain or maintain proprietary intellectual property protection; general
economic and industry conditions; global trends toward health care cost
containment, including ongoing pricing pressures; unexpected manufacturing
issues, and other risks and factors referred to in Novartis AG's current
Form 20-F on file with the US Securities and Exchange Commission. Novartis is
providing the information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements contained in
this press release as a result of new information, future events or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care and cost-saving generic pharmaceuticals. Novartis is the only global
company with leading positions in these areas. In 2015, the Group achieved net
sales of USD 49.4 billion, while R&D throughout the Group amounted to
approximately USD 8.9 billion (USD 8.7 billion excluding impairment and
amortization charges). Novartis Group companies employ approximately 118,000
full-time-equivalent associates. Novartis products are available in more than
180 countries around the world. For more information, please visit
http://www.novartis.com.
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References
[1] Lancet 2016; 388: 2239-53 Antisense oligonucleotides targeting
apolipoprotein(a) in people with raised lipoprotein(a): two randomised, double-
blind, placebo-controlled, dose-ranging trials
# # #
Novartis Media Relations
Central media line: +41 61 324 2200
E-mail: media.relations(at)novartis.com
Eric Althoff Agnes Estes
Novartis Global Media Relations Novartis Global Pharma Communications
+41 61 324 7999 (direct) +41 61 324 1986 (direct)
+41 79 593 4202 (mobile) +41 79 644 1062 (mobile)
eric.althoff(at)novartis.com agnes.estes(at)novartis.com
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations(at)novartis.com
Central North America
Samir Shah +41 61 324 7944 Richard Pulik +1 212 830 2448
Pierre-Michel Bringer +41 61 324 1065 Sloan Pavsner +1 212 830 2417
Thomas Hungerbuehler +41 61 324 8425
Isabella Zinck +41 61 324 7188
Media release (PDF):
http://hugin.info/134323/R/2069333/777359.pdf
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Source: Novartis International AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 06.01.2017 - 07:15 Uhr
Sprache: Deutsch
News-ID 516157
Anzahl Zeichen: 12491
contact information:
Town:
Basel
Kategorie:
Business News
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