Novartis has negotiated rights to two cardiovascular disease therapies developed by antisense specialist Ionis in a deal valued at up to $1bn.
The agreement covers drugs designed to reduce two well-characterised factors – lipoprotein(a) and apolipoprotein CIII – that elevate the risk of serious complications such as heart attack and stroke in patients with underlying cardiovascular disease such as atherosclerosis.
Novartis has made no secret of its ambitions to bring forward new therapies for cardiovascular diseases, which have seen little innovation in the last decade. The company launched first-in-class chronic heart failure therapy Entresto (sacubitril and valsartan) in 2015 and is hoping to re-file acute heart failure candidate serelaxin (RLX030) this year.
The new agreement with Ionis subsidiary Akcea Pharma gives Novartis an option to license the two lipoprotein-targeting drugs, which are in early-stage clinical development.
Novartis is making an upfront payment of $75m and an $100m equity investment in Ionis under the terms of the deal, with another $150m due if Novartis exercises its license option for both drugs. Development and commercialisation milestones could bring Ionis another $1.13bn, assuming both drugs reach the market and meet sales targets.
Novartis is also expected to make a further equity investment of $50m in the next 18 months in either Ionis or in Akcea, with the two biotechs eligible for double-digit royalties on sales. Akcea has retained the right to co-market the drugs.
In early studies, AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx were able to lower circulating levels of the lipoproteins by up to 90%, which according to Ionis could lead to significant reductions in cardiovascular risk in high-risk patients.
Ionis and Akcea will take the treatments through phase II studies to identify the best dosing schedule – which may include monthly injections – with Novartis picking up the reins for phase III trials if all goes well.
“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,” said Novartis in a statement.
“The importance of predictive biomarkers in achieving successful cardiovascular outcomes will also be essential in the future payer environment,” said the company’s chief medical officer Vasant Narasimhan.
Aside from the new additions, Novartis late-stage pipeline is focused on expanding the indications for Entresto into two new areas – heart failure with preserved ejection fraction (HFpEF) and for patients who have just suffered an acute myocardial infarction (AMI).