CHOLESTEROL-LOWERING AGENTS -
PRODUCTS IN MARKET &
DEVELOPMENT


by Zhion, May 11, 2004

The current market for cholesterol-lowering agent is about $25 billion
worldwide.

DRUGS UNDER DEVELOPMENT

DRF-10945 [Dr. Reddy's Laboratories]

The Phase 1 clinical trials for DRF-10945 has been commenced in
Canada in February, 2004. This chemical is a PPAR alpha agonist,
which is targeted for the treatment of dyslipidemia.  Source: Phase I
Trials of Dr. Reddy's Dyslipidemia Drug Commence in Canada, Press
Release, Dr. Reddy's Laboratories, March 3, 2004.

VYTORIN(ezetimibe/simvastatin) [Schering-Plough]

Schering-Plough and Merck are co-developing this product. This
product contains two active ingredients: Schering-Plough's Zetia
(eztimibe; a cholesterol absorption inhibitor) and Merck's Zocor
(simvastatin; a cholesterol production inibitor). Because of this
dual-inhibition property, Vytorin should match for the strongest existing
cholesterol treatment available. Presently, this product is under
regulatory review and is expected to be launched this year. Source:
Schering-Plough Chairman/CEO Fred Hassan Reviews Progress, Vision
for Future at Annual Shareholders Meeting, PR Newswire, May 14,
2004.

DRUGS IN MARKET

CRESTOR (rosuvastatin) [AstraZeneca]

OBSERVATION Millions of people with type 2 diabetes are three times
more likely to die from a cardiovascular event than non-diabetics with
the same cholesterol level and up to 80 per cent die of cardiovascular
disease.

TREATMENT Reducing high levels of LDL-C is considered as one of
the primary treatments for type 2 diabetics.

RECENT FINDINGS According to a recent study, CRESTOR; reduces
LDL-cholesterol (LDL-C or bad cholesterol) significantly in patients with
type 2 diabetes and dyslipidaemia (high cholesterol) more than
atorvastatin [1]. For each dose of CRESTOR, LDL-C was reduced
significantly more than with double the dose of atorvastatin; LDL-C was
reduced by 46%, 51% and 54% with CRESTOR 10 mg, 20 mg and 40
mg respectively compared to 41%, 46% and 48% with atorvastatin
20mg, 40mg and 80mg, respectively (all p<0.05).

According to the report [1], CRESTOR can also reduce the level of
C-reactive protein (CRP). High levels of CRP are associated with
cardiovascular events. CRESTOR 10mg and 20mg reduced CRP by
34% and 40% respectively while atorvastatin 10 mg and 20 mg reduced
CRP by 21% and 34%, respectively.

In patients with type 2 diabetes and dyslipidaemia, CRESTOR also
improved other lipid parameters such as triglyceride levels, non-HDL-C
and the ApoB/ApoA-I ratio.

Extracted from Crestor better than Atorvastatin in patients with type 2
diabetes and dyslipidaemia, Steve Brown and Edel McCaffrey [+44 207
304 5033], Medical News Today, 20 Apr 2004.

ZOCOR

In 2000, FDA rejected the initial bid to move Merck's Mevacor and
Bristol-Myers Squibb's Pravachol to nonprescription status because of
safety concerns. However, a more potent statin, Zocor is likely to be
recommended for over-the-counter (OTC) sale in Britain as early as
Wednesday, making that the first market selling the drugs on retail
shelves.

Merck will back over the counter use for Zocor, as its US patent expires
in 2006. Merck is eager to make up profits in the nonprescription
market. Moving statins over-the-counter will also be welcomed by
HMOs, who typically don't pay for OTC drugs. Zocor at low dose is a
good candidate. Merck is targeting a population with slightly elevated
cholesterol. It won't give sales estimates, but says up to 20 million
people fit into the group and 70 percent are not treated.  Extracted from
U.S. could be next market for OTC cholesterol drugs, by Kim Dixon,
Reuters, May 11, 2004

                                         
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updated on April 26, 2005                    email zhion@zhion.com