Lipisense^® primarily targets diseases characterized by significantly elevated blood triglycerides. One of these diseases is severe hypertriglyceridemia (SHTG), where triglyceride levels are equal to or exceed 500 milligrams per deciliter (mg/dL).

Currently, about five million patients in the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) suffer from SHTG. With rising rates of obesity, metabolic syndrome, and type 2 diabetes, this number is expected to increase. Of those treated with existing triglyceride-lowering drugs, only half reach the treatment goals. Notably, despite these limitations, two such existing drugs have seen peak sales surpassing 1 billion USD.

Lipisense^® has an estimated sales potential of roughly USD 1.5 billion. This assumes a yearly price of USD 6,000 (mirroring the price of Repatha, a lipid-lowering PCSK9 inhibitor) and Lipisense^® capturing five percent of the number of patients with very high triglyceride levels (SHTG).

Beyond the initial indications targeted by Lipisense^®, dyslipidemia stands out as the predominant lipid disorder. Dyslipidemia is a significant risk factor for cardiovascular diseases like heart attacks and strokes. Cardiovascular disease is the leading cause of death both in Sweden and globally. In 2019, cardiovascular diseases accounted for nearly one-third of all global deaths, totaling close to 18 million individuals.

For about 30 years, statins have been the standard treatment for dyslipidemia. For a long time, the statin Lipitor was the world's best-selling drug, achieving peak sales of nearly 13 billion USD in 2006. While statins have been successful in mitigating the risk of cardiovascular disease, there remains a significant residual risk due, in part, to raised triglyceride levels and lowered HDL levels. In Sweden alone, around one million individuals receive cholesterol-lowering medications annually, with statins being the predominant choice. This underscores the pressing need for newer, more potent drugs.

According to GlobalData, the dyslipidemia market is anticipated to see consistent growth through 202. Its valuation is projected to rise from about USD 6 billion in 2018 to an estimated USD 14 billion by 2027 in the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan). Some estimates even suggest higher values. The market is driven by a rising patient count, signaling potential sales expansion for newer, more innovative and more effective adjunctive treatments.

Our patent strategy

Existing Treatments on the Market

Often, these agents fall short in effectively managing extremely high triglycerides and the lingering cardiovascular risk in patients with mixed hyperlipidemia, where both LDL cholesterol and triglyceride levels are raised.

Currently, only a limited number of drug classes, like fibrates and Omega 3 fatty acids, are designed to target triglyceride levels. Often, these agents fall short in effectively managing extremely high

triglycerides and the lingering cardiovascular risk in patients with mixed hyperlipidemia, where both low-density lipoprotein (LDL) cholesterol and triglyceride levels are raised.

Relevant Structural Deals

• Akcea-Pfizer licensed a Phase II project with the indication ANG-PTL3 from Akcea; USD 250 million initial payment, USD 1,300 million in milestone payment.

• In 2019, Novo Nordisk acquired Dicerna for the development of cardiometabolic drugs, USD 175 million in initial payment and several billion USD in milestone payment.

• In 2016, Ionis/Akcea entered a strategic collaboration with Novartis, phase I/IIa USD 225 million (near-term payment) with a total transaction value of over USD 1,000 million.