INTRODUCTION:

Cholesterol is critical to the normal function of every cell in the body. However, it also
contributes to the development of atherosclerosis, a condition in which cholesterol-
containing plaques form within arteries. These plaques block the arteries and reduce the
flow of blood to the tissues that arteries supply. When plaques rupture, a blood clot forms
on the plaque, thereby further blocking the artery and reducing the flow of blood. When
blood flow is reduced sufficiently in the arteries that supply blood to the heart, the result
is angina or a heart attack. If the clot occurs on plaques in the brain, the result is a stroke.
If the clots occur on plaques in the leg, they cause intermittent claudication (pain in the
legs while walking). By reducing the production of cholesterol, statins are able to slow
the formation of new plaques and occasionally can reduce the size of plaques that already
exist. In addition, through mechanisms that are not well understood, statins may also
stabilize plaques and make them less prone to rupturing and promoting the development
of clots.
Statins" are a class of drugs that lower the level of cholesterol in the blood by reducing
the production of cholesterol by the liver. Statins block the enzyme in the liver that is
responsible for making cholesterol. This enzyme is called hydroxy-methylglutaryl-co-
enzyme A reductase (HMG-CoA reductase). Scientifically, statins are referred to as
HMG-CoA reductase inhibitors.
Atherosclerosis is a complex process that involves more than just cholesterol. For
example, scientists have discovered that inflammation in the walls of the arteries may be
an important factor in atherosclerosis. In addition to lowering cholesterol levels, statins
also reduce inflammation, which could be another mechanism by which statins
beneficially affect atherosclerosis. This reduction of inflammation does not depend on
statins' ability to reduce cholesterol. Furthermore, these anti-inflammatory effects can be
seen as early as two weeks after starting statins.
Because it is not clear which effect of statins is responsible for their benefits, the goal of
treatment with statins should not be only the reduction of cholesterol to normal levels, but
rather the prevention of the complications of atherosclerosis (angina, heart attacks, stroke,
intermittent claudication, and death). This concept is important because it allows for
individuals who have or are at risk for atherosclerosis, but do not have high levels of
cholesterol, to be considered for treatment with statins. Statins are an important class of
drugs because they have been shown to reduce the incidence of heart attacks, strokes, and
death.
Statins are among the most commonly prescribed drugs in medicine.

The Statin Drugs

• Atorvastatin
• fluvastatin
• Lovastatin
• Pravastatin
• Simvastatin
• Rosuvastatin

Statins differ in several ways. The most obvious difference is in their ability to reduce
cholesterol. Currently, atorvastatin and rosuvastatin are the most potent, and fluvastatin
is the least potent.
The statins also differ in how strongly they interact with other drugs.
Specifically,pravastatin and rosuvastatin levels in the body are less likely to be elevated
by other drugs that may be taken at the same time as the statins. This is so because the
enzymes in the liver that eliminate pravastatin and rosuvastatin are not blocked by many
of the drugs that block the enzymes that eliminate other statins
Statins differ in the frequency with which they cause a severe type of myopathy called
rhabdomyolysis, in which muscles are severely damaged. Cerivastatin was withdrawn
from pharmacies worldwide because it caused rhabdomyolysis 10 to 100 times more
often than other statins
Statins were initially approved by the Food and Drug Administration for the prevention
of repeat heart attacks and strokes in patients with high cholesterol who had already had a
heart attack. And used for that purpose — called "secondary prevention" — the drugs are
powerful and effective medications, driving down patients' risk of another heart attack or
stroke by lowering their levels of LDL (or "bad") cholesterol.
Then physicians came to believe statins could also reduce the risk of a first heart attack in
patient who have high LDL cholesterol but are nonetheless healthy. This use of statins —
called "primary prevention" — has driven the growth in the market for statins over the
last decade
Today, a majority of people who use statins are doing so for primary prevention of heart
attacks and strokes. It is this use of statins that has come under recent attack.
Major Statins include in Pakistani market are

• Atorvastatin

• Rosuvastatin

• Simvastatin
Competition Assessment

Competitive Analysis:

Rosuvastatin fighting bulls are among all statins. There are many statins are already in
market but there are two statins, prior to rosuvastatin, which enjoys a fair bit of market
share for significant period of time. These include Simvastatin and Atorvastatin.
Simvastation was first launched by MSD with the name of ZOCOR and later many players
enter and had their share in market same as Atorvastatin which was first launched by
Pfizer in 2000 with the name of Lipitor. Rosuvastatin enter in market with concept of
better therapeutic efficacy among all statins and the companies like Getz, PharmEvo,
Ferozsons has launched Rosuvastatatin with the name of Rovista Xplended and Aurora
respectively. All three major brands come up at least common Unique Selling Proposition
i-e Rosuvastatin is most effective statin among all and soon after KOL endorse its better
efficacy. This allows many companies to enter in Rosuvastatin. If we compare entire
segment of Lipid-Reg/Anti theroma we can analyze the acceptance of Rosuvastatin as
better among other available statin. Below is the MAT at 2010/6 status of entire segment
of Lipid-Reg/Anti theroma.
Although Lipiget is still the leading brand but Rosuvastatins has taken two
places in top 5 statins in short period of time.
Competitive Analysis within Rosuvastatin

The market of rosuvastatin is growing with 69.51%, with

Getz being market leader having 26.83% of market share. As
the awareness about the therapeutic advantage is increasing
among late adopters of new molecule, rosuvastatin market
pie will also increase. Below is the IMS data, 2010/8, of
Rosuvastatin market players
Market
Brand Generic Value in Rs Share Growth

706519 ROSUVASTATIN 403,750,223 4.48 69.51

ROVIS ROVISTA GTZ 108,324,506 26.83 70.05

X-PLE X-PLENDED PV- 86,663,966 21.46 75.59

ROLIP ROLIP HL. 73,488,950 18.20 9.55

VAPTO VAPTOR SEA 33,076,851 8.19 165.54

ROSUL ROSULIN HIG 20,381,125 5.05 93.71

RAST RAST T9P 15,219,360 3.77 91.46

ROVAT ROVATOR AT3 13,008,174 3.22 57.76

AUROR AURORA FZS 12,945,494 3.21 98.12

OMNIT OMNITOR MCT 10,770,001 2.67 22.81

ROVA ROVA B6H 10,005,132 2.48 999.00

ROVIR ROVIROS NQM 3,605,525 0.89 130.62

ROSUB ROSUBAR BGO 2,803,319 0.69 999.00

ROSTA ROSTATIN MPP 1,030,769 0.26 999.00

PASAG PASAGE WRP 864,292 0.21 999.00

AMSOS AMSOS AMV 295,393 0.07 -69.93

ROSWI ROSWIN MDW 263,843 0.07 -68.56

SWOT ANALYSIS
Strength:

• Lochol represents the third generation of statins and is perhaps the most
efficacious in the management of dyslipidemia

• Lochol has clearly demonstrated its superior efficacy over Atorvastatin and
Simvastatin across dose range.

• By research interviews with key opinion-leaders we observe greater number

of patients achieved their lipid goals with Lochol in comparison to the other
available statins. Since, a large number of patients on statin therapy fail to
achieve their lipid goals; this is a significant advantage to Lochol.

• Pricing strategy has played a significant role in the market penetration

Weaknesses:

• Faces the uphill task of convincing the physicians of its safety, which is not
the case with other competing and well-established statins.

• The delay in approval.

Opportunities:

• The growing use of statins combined with increase in the number of eligible
patients after the release of adult treatment panel (ATP) III guidelines creates
a significant opportunity.

Threatening

• Entry of newer classes of products also does present a long-term threat.

• Regulated Price mechanism for local sale and price war among rosuvastatin
brand

• Increase import duty on raw materials