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Blockbuster Brands
Generate Generic Goals
London
,
Wednesday February 2, 2005-
Despite being the
current gold standard and sales heavyweight of the antipsychotic market,
with $4billion in
global* sales, Eli Lilly’s Zyprexa
(olanzapine) is facing legal action in the US over alleged side effects
and along with other blockbuster drugs in
the market, may also run into
intense competition from generics earlier than expected, according to a
new report by independent market analyst
Datamonitor**.
Large market
Today, the antipsychotic market is one of the largest and most
commercially attractive central nervous system (CNS) markets, with
annual revenues of
$10.4 billion in 2003 and a growth
rate of 24.1%, says Datamonitor CNS analyst Alistair Sinclair. “There
are two main classes of antipsychotics: the
older conventional dopamine
antipsychotics, first launched in 1950’s; and the new
second-generation antipsychotics (SGAs), which currently drive the
antipsychotic market, yielding
revenues of over $9.5 billion in 2003, with a 93.3% market share.”
Zyprexa (an SGA) leads the market with 2003 revenues of $4.1 billion
across the seven major markets, a CAGR of 24.3% and market share of
39.3%. The
success of Zyprexa comes from a
combination of its second-to-market status, impressive efficacy, range
of formulations and aggressive marketing
tactics by Lilly. It was also
Zyprexa that spearheaded the penetration of SGAs into the bipolar
disorder market, being one of the first drugs to be
recognized as suitable for
maintenance therapy since the approval of lithium over 30 years ago,
Sinclair says. “However, 2004 has been a bad year for
Zyprexa, with fourth quarter
revenues down by 5% from the year-ago quarter to $1.1 billion, while US
sales of the drug fell by 19% over the previous
quarter”
The future outlook for Zyprexa is also being hampered by the ongoing
patent challenges from numerous generic drug manufacturers. Although the
trial
proceedings ended in February 2004,
a final verdict has still yet to be given.
“Datamonitor expects a judge’s decision during the current financial
quarter, although a delay of this
length has to have a reason, and must continue to worry Lilly,”
Sinclair says.
“Whatever the outcome of patent litigation, revenues from Zyprexa are
forecast to continue to decline as Lilly also faces numerous lawsuits in
the
US
stemming from diabetes and other
alleged side effects from Zyprexa.”
Generics want piece
of the action
With Johnson and Johnson’s Risperdal (risperidone) and AstraZeneca’s
Seroquel (quetiapine) also blockbusters in the SGA class, and Bristol
Myers
Squibb’s Abilify (aripiprazole)
forecast to attain blockbuster status in 2005, the extreme interest in
this market from generics manufacturers is
unsurprising, Sinclair says.
“Risperdal is approved for schizophrenia and bipolar mania and because
it is available in numerous formulations, there
is significant off-label usage of
the drug. However looming patent expires from 2006 onward present a
significant threat.”
“Likewise, Seroquel faces patent expiries in the EU and
Japan
in 2007, although it is protected in the
US
until 2011.”
Although the antipsychotic market has up until now had relatively low
exposure to generics, the future entrance of generic risperidone and
quetiapine
from 2007 onwards, plus the
increasing drive towards generic prescribing as a cost-saving measure
means that brand companies will find it
increasingly difficult to avoid the
effects of generic erosion on their revenues, Sinclair says.
“SGAs are generally acknowledged by payers as a cost concern, and with
rising general and mental healthcare costs, governments are now
increasingly
looking towards cost-containment
measures, including reducing the amount spent on medications and thereby
encouraging physicians to prescribe cheaper
generics.”
Notes
*In this case, global
is defined as the seven major pharmaceutical markets, which are:
France
,
Germany
,
Italy
,
Japan
,
Spain
, the
UK
, the
USA
** Commercial Insight: Antipsychotics - From Blockbuster Brands to
Billion Dollar Generics
(7/2/05)
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