Case Study in Antilipaemia

1. Drug Overview

Antilipaemic agents, are a diverse group of pharmaceuticals used in patients to reduce the level of cholesterol in the blood. They are often used in combination with lifestyle changes (diet, weight loss and exercise) to reduce the risk of Coronary Artery Disease (CAD) [1].

Statins (HMG-CoA reductase inhibitors), a class of cholesterol lowering drug has been directly associated with a reduction of risk in heart attacks or stroke. Their mechanism of action is to block the HMG CoA reductase enzyme in the liver and reduce the production of cholesterol [2].

Rosuvastatin O, launched in 2004, was initially only indicated for the treatment of high LDL cholesterol (dyslipidaemia), total cholesterol (hypercholesterolaemia) and/or triglycerides (hypertriglyceridemia). As a result of the association with reduction of cardiac risk, rosuvastatin was approved for the primary prevention of cardiovascular events [3].

2. Market Overview

Rosuvastatin O competes in the statin (C1OA1) market, with five other molecules. At the time of its launch, the C1OA1 market was highly competitive with five molecules, driven by a number of generic products [Figure 1].

Atorvastatin O (launched in 1997), dominated the market until 2005 where it achieved market leadership with a market share of 57%, despite the number of generics in the market. The first generic atorvastatin, was launched in 2007.

Rosuvastatin O, launched in 2004, quickly gained market share and with the first atorvastatin generic, appear to have impacted significantly on the sales of Atorvastatin O. In 2013, four rosuvastatin generics were launched.

3. Health Status

Dyslipidaemia is considered the “silent killer”, as patients have no symptoms, until they have suffered some sort of cardiovascular event. It was known that the Afrikaner, Indian and Jewish populations have a very high prevalence of familial hypercholesterolemia, but it was also perceived that the non-white population’ had favourable lipid profiles [4].

In South Africa, after the 1994 elections, there has been a significant increase in urbanisation of black and coloured South Africans from the rural areas, who have adopted an unhealthy lifestyle with a diet of increased fats and sugars. This significant increase in kilocalories has contributed to the already rising obesity problem. In 2003, about 59% of women and 30% of men over age 15 were overweight or obese, with up to 80% of the population being ‘insufficiently active’ [5] [6].

The potential for a rapidly escalating burden of disease had been highlighted in the 2000s, where CVD was the second major cause of death in Africa, after HIV/AIDs. This was supported by the ‘Heart of Soweto’ study, which indicated a very high prevalence of CVD risk factors, including dyslipidaemia [7].

4. Market Access Objectives

5. Market Players (Internal/External)

6. Results

7. References