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[e-drug] Zocor patent expiry in UK and Germany

E-drug: Zocor patent expiry in UK and Germany

Dear e-druggers,

The following Reuters article was posted on the web in early May
but I only found it now. It is interesting for me as I use statins in my
practice all the time but for e-druggers who are not clinicians, or
whose clinical load doesn't include ischaemic cardiovascular
disease, it may be interesting for other reasons. "Crestor", the
Astro Zeneca drug mentioned at the end is rosuvastatin and results
from a large but short open label study show that it is significantly
more effective than simvastatin, atorvastatin and pravastatin in
cholesterol lowering but no long term clinical outcome or safety
data are yet available. It has been licensed in UK in March this year
but as in this country we keep a watchful eye on cost benefit ratio, I
don't think it will be widely used until both safety and a real benefit
in clinical events (ie reduction in heart attacks and strokes) is
demonstrated to accompany the greater cholesterol reduction.


Dr Valeria Frighi
Diabetes Trials Unit
Oxford Centre for Diabetes Endocrinology and Metabolism
Churchill Hospital
Old Road, Oxford, OX3 7LJ
tel +44-1865-857248
fax +44-1865-856286
e-mail valeria.frighi@dtu.ox.ac.uk

Generics spark cholesterol drug war in UK, Germany

By Richard Woodman, Reuters, 2 May 2003

A fierce battle for sales of cholesterol-lowering statin drugs is
looming in Britain and Germany as generic companies line up to
launch cheap copycat versions of Merck & Co Inc's (nyse: MRK -
news -people) Zocor. Zocor, or simvastatin, which had global sales
of $1.25 billion in the first quarter, loses patent protection in both
countries this week and numerous generic companies are ready to
enter the market. In Britain, where Zocor sells more than any other
medicine, a Department of Health spokesman said nine generic
firms had been granted marketing authorisation. An analyst at
Lehman Brothers said that with so much competition the price of
simvastatin could fall by up to 90 percent. She said this would
make life very difficult for AstraZeneca Plc's new so-called
"superstatin", Crestor, which has just been launched in Britain at
the same price as Zocor and the other branded statins.

Statin drugs, which help reduce levels of harmful cholesterol in the
blood, are among the most widely used medicines in the Western
world. The global statin market is worth around $19 billion and is
growing at around 15 percent annually. The generic companies
declined to disclose the price of their versions of simvastatin in the
UK but in Germany the AOK health insurance group said recently
prices could be 43 percent cheaper as a result of a deal it had
concluded with the German generic company Hexal.

Astrazeneca Sanguine

An AstraZeneca spokesman said: "We do not believe generics will
inhibit market penetration for Crestor (which) gets eight out of 10
patients to their (cholesterol) goal compared with five out of 10 for

"Experience has shown that the negative impact of a generic
alternative is to the brand it is replacing, rather than other brands in
the same class." Merck declined to respond saying it would be
inappropriate to comment on the activities of other companies.

The lion's share of Zocor sales are in the United States, where the
drug has patent protection until 2005. In Europe, analysts believe
part of Merck's defence strategy is to promote the newly launched
cholesterol-lowering agent Ezetrol/Zetia in collaboration with
Schering-Plough Corp. Industry sources also suggested Merck
could be the first company to respond to UK government
encouragement to apply for the right to sell Zocor over-the-counter
(OTC), without prescription. Switching medicines to OTC following
patent expiry is a strategy frequently employed by drug companies
to defend sales of well-known branded products.
The German statin market is worth around 1.4 billion euros ($1.57
billion) a year, half of which has been captured by Pfizer Inc's
(nyse: PFE - news - people) Lipitor and nearly a third by Zocor. In
Britain, Zocor sales totalled around 185 million pounds ($298
million) in 2002. The UK department of health said the generic
companies with simvastatin marketing authorisation were
Alpharma Ltd, Approved Prescription Services Ltd, Arrow Generics
Ltd, A/S Gea Farmaceutisk Fabrik, Generics (UK) Ltd, Genthon
BV, Lagap Pharmaceuticals Ltd, Ratiopharm Gmbh and Sterwin
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