* Novartis had hoped to re-launch drug pulled in EU in 2007
* Submission to EMA withdrawn after demand for more data
* Originally sold as Prexige, medicine now renamed Joicela
* Drug belongs to same class as Merck's withdrawn Vioxx
(Adds background, Novartis comment)
By Ben Hirschler
LONDON, April 19 A bid by Novartis NOVN.VX to
revive a painkiller that was pulled from the market in Europe in
2007 has hit a roadblock after regulators demanded new data.
The European Medicines Agency said on Tuesday the Swiss
drugmaker had formally withdrawn its marketing application for
the drug -- originally known as Prexige and now renamed Joicela
-- as a treatment to relieve pain caused by osteoarthritis.
The decision follows a request for more data that the
company felt it could not supply in time for the regulatory
Novartis's pill belongs to the same class as Merck & Co's
(MRK.N) controversial treatment Vioxx, which was withdrawn from
markets worldwide in 2004 after being linked to heart attacks
The re-launch of Joicela, if successful, would have helped
Novartis compensate for the loss of patents on other drugs, such
as high blood pressure treatment Diovan. Novartis at one stage
estimated the product could sell more than $1 billion a year.
It planned to get around earlier problems by supplying a
genetic test for use alongside the medicine to detect if
patients taking it could be susceptible to liver damage.
The use of such biomarkers or companion diagnostics is
becoming more common, particularly in cancer, as doctors and
pharmaceutical companies seek to work out which patients are
most likely to benefit from a certain drug.
Joicela was resubmitted to the European watchdog with its
biomarker on Dec. 3, 2009, and at the time of the withdrawal it
was under review by the agency's Committee for Medicinal
Products for Human Use (CHMP).
Novartis said it had decided to pull its application because
it was unable to provide the additional data requested by the
CHMP within the timeframe of the current procedure.
"Novartis remains committed to personalised medicines and
biomarker testing programmes," the company said in a statement.
Novartis earlier reported stronger-than-expected
first-quarter sales, buoyed by other new drugs, which lifted its
shares more than 3 percent. [ID:nLDE73H1TJ]
(Editing by Will Waterman)