United Kingdom and Germany Suspend Marketing and Sale of Prexige Pending Outcome of European Regulatory Review
Suspensions in UK and Germany come as European Union regulators
initiate so-called "Article 107 procedure" to review drug's
benefit/risk profile
Novartis to continue discussions with health authorities and
believes Prexige is a valuable treatment option for appropriate
patients with osteoarthritic pain
BASEL, Switzerland, November 19, 2007 - Health regulators in the
United Kingdom and Germany have suspended the marketing and sale of
Prexige® (lumiracoxib), a COX-2 inhibitor for patients with
osteoarthritic pain, following a review of the drug's benefit/risk
profile.
Novartis is informing regulatory agencies around the world of these
changes, which come after similar actions in other countries in
recent months. Novartis will also comply with a request from the
Austrian health authority to suspend sales pending a final decision
by the Committee for Medicinal Products for Human Use (CHMP), which
reviews medicines in the European Union.
Patients taking Prexige in the UK, Germany and Austria should
consult their healthcare provider.
Prexige is available in some European countries as a 100 mg
once-daily treatment for osteoarthritic pain following EU approval
through the Mutual Recognition Procedure (MRP) in October 2006,
with the UK as the reference member state. Prexige is also marketed
and sold in Belgium, Cyprus, Hungary, Malta, Portugal and Sweden.
In the first nine months of 2007, Prexige had net sales of USD 8
million in Europe.
The suspensions were announced today after the CHMP initiated a
so-called "Article 107" procedure on November 16. This occurs when
an EU member state withdraws, suspends or changes the status of a
nationally authorized medicine after a review of safety data. This
enables the CHMP to prepare an opinion as to whether the regulatory
action should apply throughout the EU.
Other EU countries may decide to independently suspend the
marketing authorization or sale of Prexige ahead of a decision by
the CHMP, which is expected in December.
Liver enzyme changes are a known side effect of all COX-2
inhibitors and traditional non-steroidal anti-inflammatory drugs
(NSAIDs). Available data suggest that Prexige 100 mg once-daily for
osteoarthritis is not associated with increased hepatic (or liver)
risk compared to other NSAIDs.
The latest analysis of patients taking the Prexige 100 mg dose
showed nine severe hepatic events reported worldwide. This
corresponds to a rate of 5.19 events per 100,000 patient-years,
which is within the rate expected for NSAIDs. Although a direct
comparison cannot be made between spontaneous reports and
epidemiological data, a major analysis of epidemiological studies
on NSAID-induced liver injury resulting in hospitalization showed
an incidence rate of between 3.1 and 23.4 per 100,000
patient-years[1].
The actions in Europe come after an Urgent Safety Restriction was
initiated in August 2007 for the Prexige 100 mg dose. Novartis
worked with European regulators to update prescribing information,
including additional warnings and precautions about liver
monitoring for patients. Prexige was first withdrawn in August 2007
in Australia where a number of liver side effects were reported,
including two deaths, associated with the use of Prexige at doses
higher than 100 mg. No deaths have been reported worldwide with the
100 mg dose.
Prexige is the only selective COX-2 inhibitor or NSAID to be shown
to demonstrate gastrointestinal (GI) benefit in patients with
osteoarthritis in a large outcome study versus other NSAIDs,
decreasing serious GI ulcer complications (including bleeds) by
over 70%. NSAID-related serious GI ulcer complications occur more
frequently than hospitalization for hepatic complications.
Approximately 1,000 deaths related to GI ulcerations from NSAIDs
occur in the UK each year[2].
Novartis continues to believe Prexige is an important treatment
option with a positive benefit/risk ratio when used in appropriate
patients. Novartis will continue discussions with European health
regulators, and with the US Food and Drug Administration following
its decision in September 2007 not to approve Prexige, to determine
how to make this treatment option available to appropriate
patients.
Disclaimer
The foregoing press release contains forward-looking statements
such as "will," "may," or similar expressions, or by express or
implied discussions regarding the results of the pending regulatory
review in Europe, potential future discussions with
regulators, regulatory filings, decisions or approvals or potential
future sales of Prexige (lumiracoxib). Such forward-looking
statements reflect the current views of Novartis regarding future
events, and involve known and unknown risks, uncertainties and
other factors that may cause actual results with Prexige
(lumiracoxib) to be materially different from any future results,
performance or achievements expressed or implied by such
statements. There can be no guarantee that any future regulatory
filings will satisfy regulatory requirements regarding Prexige
(lumiracoxib), that Prexige (lumiracoxib) will be approved for any
indications or labeling in any additional markets or that Prexige
(lumiracoxib) will reach any particular level of sales. In
particular, management's expectations regarding Prexige
(lumiracoxib) could be affected by, among other things, unexpected
regulatory actions or delays or government regulation generally;
the public debate and regulatory activity regarding COX-2
inhibitors like Prexige (lumiracoxib); unexpected clinical trial
results, including unexpected additional analysis of existing
clinical data and unexpected new clinical data; government,
industry, and general public pricing pressures; competition in
general; Novartis' ability to obtain or maintain patent or other
proprietary intellectual property protection; as well as other risk
factors discussed in Novartis AG's Form 20-F filed with the U.S.
Securities and Exchange Commission. Should one or more of these
risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially
from those described herein as anticipated, believed, estimated or
expected. Novartis is providing this information as of this date
and does not undertake any obligation to update any forward-looking
statements contained in this document as a result of new
information, future events or otherwise.
About Novartis
Novartis AG (NYSE: NVS) is a world leader in offering medicines to
protect health, cure disease and improve well-being. Our goal is to
discover, develop and successfully market innovative products to
treat patients, ease suffering and enhance the quality of life. We
are strengthening our medicine-based portfolio, which is focused on
strategic growth platforms in innovation-driven pharmaceuticals,
high-quality and low-cost generics, human vaccines and leading
self-medication OTC brands. Novartis is the only company with
leadership positions in these areas. In 2006, the Group's
businesses achieved net sales of USD 37.0 billion and net income of
USD 7.2 billion. Approximately USD 5.4 billion was invested in
R&D. Headquartered in Basel, Switzerland, Novartis Group
companies employ approximately 100,000 associates and operate in
over 140 countries around the world. For more information, please
visit http://www.novartis.com.
References
1 Rubenstein JH, Laine L.
Systematic review: the hepatotoxicity of non-steroidal
anti-inflammatory drugs. Aliment Pharmacol Ther 2004; 20: 373-380.
doi: 10.1111/j.1365-2036.2004.02092.x
2 Hawkey CJ, Langman MJS.
Non-steroidal anti-inflammatory drugs: overall risks and
management. Complementary roles for COX-2 inhibitors and proton
pump inhibitors. Gut 2003;52;600-608.
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Posted: November 2007
