Novartis has signed an exclusive option agreement with Ionis and affiliate Akcea to license two investigational therapies that could significantly reduce cardiovascular risk in patients living with elevated levels of lipoproteins Lp(a) and ApoCIII.
Elevated levels of Lp(a) collect in the arteries, gradually narrowing the arteries and limiting blood supply to the heart, brain, kidneys and legs, thus increasing the risk of coronary heart disease, atherosclerosis, thrombosis and stroke.
People with higher levels of ApoCIII – a protein produced in the liver – have high triglycerides which are associated with multiple metabolic abnormalities such as insulin resistance and/or metabolic syndrome.
According to Novartis, the two investigational antisense therapies being developed by Ionis – AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx – have the potential to lower both lipoproteins up to 90 percent and “significantly reduce cardiovascular risk in high-risk patient populations”.
Under the terms of the deal, which remains subject to closing conditions, Novartis will be able to exercise its options to license and commercialise these novel therapies following achievement of specified development milestones and before the start of Phase III trials. The drug giant will then take on responsibility for their worldwide development and commercialisation.
According to Ionis, it and partner Akcea could bank $225 million in “near-term payments”, including an immediate $75 million up-front option payment and a $100 million equity investment in Ionis.
The deal, it says, would be valued at “significantly over $1 billion” if both drugs are licensed and successfully commercialised.
“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, commenting on the deal.
“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.”
