ZURICH U.S. regulators have not approved
Novartis AG's Prexige painkiller, the Swiss drugmaker said on
Thursday, a move that had been expected after Australia
withdrew the drug on concerns over liver side-effects.
"Novartis has received a 'not approvable' letter from the
U.S. Food and Drug Administration," the company said.
"Novartis (will) continue discussions with (the) FDA and
believes Prexige a valuable treatment option for appropriate
patients with osteoarthritic pain," it added.
Shares in the group were unchanged at 64.40 Swiss francs in
Novartis has in the past touted Prexige as a potential
blockbuster, with hopes for sales of over $1 billion a year,
but Chairman and CEO Daniel Vasella said earlier this month
Prexige was unlikely to gain U.S. approval due to the liver
Many analysts had also doubted the drug, a so-called COX-2
inhibitor, would get on the market in the United States after
the Australian regulators' decision last month to withdraw it.
Vontobel analyst Karl Heinz Koch said the decision could
prompt Novartis to cut 1,000 sales representatives in the U.S.,
which would boost profitability.
"The profit margin in the United States is likely to rise
as the cost-intensive launch of Prexige is falling away," he
Australia's drugs watchdog had received eight reports of
serious liver side-effects associated with the use of the drug,
including two deaths and two liver transplants.
Prexige, which had modest sales of $52 million in the first
half of the year, is approved in more than 50 countries, and is
currently being rolled out in Europe.
Last month, Novartis informed doctors in Europe of new
restrictions on prescribing Prexige, saying it should not be
used in patients with current liver disease or those at risk
because of their histories or other medicines.
Nonetheless, Novartis argues its product is no more risky
than other older non-steroidal anti-inflammatory drugs
(NSAIDs), and the number of patients -- 0.85 percent -- with
raised liver enzymes greater than three times the upper limit
of normal is in line with other NSAIDs.
At the same time, tests have shown Prexige has
significantly less impact on blood pressure.
COX-2s have been under a cloud since the withdrawal of
Merck & Co Inc's Vioxx in 2004 after studies found it raised
heart attack risks.
Novartis has suffered a series of setbacks this year,
tarnishing what should have been a bumper year for the launch
of new blockbusters.
Another key new drug, Galvus for diabetes, was also delayed
in the U.S. because of safety concerns. The product is expected
to be launched in Europe by the fourth quarter of this year,
but will only be resubmitted in the U.S. in 2009.
Novartis was also forced to cut its 2007 guidance after
withdrawing the bowel drug Zelnorm from U.S. shelves in March.
(Additional reporting by Douwe Miedema and Sven Egenter,
with Ben Hirschler in London)