Novartis invests in next generation therapies to reduce cardiovascular risk in patients with underlying lipid disorders

NovartisNovartis 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)-LRx and AKCEA-APOCIII-LRx-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)-LRx and AKCEA-APOCIII-LRx 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.

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.

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.

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

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