New Galvus® clinical data reinforces efficacy profile; safety update
provided to regulatory agencies
* New data accepted for publication show Galvus 50 mg twice-daily
dose as effective as a thiazolidinedione (TZD), well tolerated
and not causing weight gain
* Novartis proposes improving Galvus risk/benefit profile through
use of approved 50 mg once-daily and twice-daily doses instead of
approved 100 mg once-daily
Basel, November 6, 2007 - New clinical data involving Galvus®
(vildagliptin) has been accepted for publication in the journal
Diabetes, Obesity and Metabolism showing this new oral medicine was
as effective as one of the leading oral type 2 diabetes treatments
and well tolerated.
Separately, Novartis provided on November 6 a safety update to
European regulators of pooled data showing numerically less frequent
liver enzyme elevations in patients who took either 50 mg per day or
50 mg twice daily of Galvus compared to 100 mg once-daily. As a
result, Novartis has proposed changes to European prescribing
information recommending use of the already-approved 50 mg once-daily
and twice-daily doses instead of the 100 mg once-daily dose. Novartis
will discuss the data and recommendations with other regulators.
New clinical data reaffirms effectiveness against a TZD
The results of a new clinical study further confirmed the efficacy of
Galvus in combination with metformin, a long-standing oral type 2
diabetes treatment. This trial showed Galvus was as effective as
pioglitazone, a member of the thiazolidinedione (TZD) class of
diabetes medicines, when each was combined with metformin. Galvus was
well tolerated and did not cause the weight gain that often occurs in
patients taking a TZD.
In the 24-week study of 576 patients with type 2 diabetes, all of
whom had inadequately controlled diabetes despite taking the oral
medicine metformin, the addition of a 50 mg twice-daily dose of
Galvus to metformin treatment reduced blood sugar levels as
effectively as adding a 30 mg once-daily dose of pioglitazone to
metformin.
Galvus was shown to be weight neutral, while the addition of the TZD
was associated with weight gain (up to 1.9 kg after 24 weeks of
treatment).
Novartis provides safety update to regulatory agencies
An updated analysis of pooled clinical trial data involving more than
8,000 patients treated with Galvus was finalized following the
European Union approval on September 26 and included recently
completed studies.
Novartis will discuss these data with the Committee for Medicinal
Products for Human Use (CHMP), which is responsible for the review of
medicines in Europe, and will seek a revision of prescribing
information before Galvus is launched for sale in European markets.
The recent analysis further characterized a known imbalance in liver
enzyme levels, which now appears more visibly in the higher Galvus
once-daily dosing regimen. The results showed 0.86% of Galvus
patients taking the 100 mg once-daily dose, 0.34% of those taking the
50 mg twice-daily dose and 0.21% of those taking the 50 mg once-daily
dose had elevations of the liver enzymes aspartate aminotransferase
(AST) and alanine aminotransferase (ALT) of greater than three times
the upper limit of normal (3xULN).
At a 50 mg daily dosage, the incidence rate was comparable to the
0.20% in the pooled comparator group of about 4,400 patients taking
metformin, a TZD, a sulfonylurea or a placebo. The placebo rate was
0.40%, and this was numerically higher than the Galvus 50 mg
twice-daily dose. Elevated levels of these enzymes can indicate liver
cell damage.
Novartis will continue working with the CHMP and other agencies to
review these results and to revise prescribing information for
Galvus, which is a member of a new drug class known as DPP-4
inhibitors. The currently approved European information recommends a
50 mg once-daily dose for use in combination with a sulfonylurea as
well as a 50 mg twice-daily or 100 mg once-daily dose for combination
use with either metformin or a TZD.
Galvus is currently available in Brazil and Mexico as both a 50 mg
and 100 mg daily dose. In February 2007, Novartis received an
"approvable letter" from the US Food and Drug Administration (FDA)
and is in discussions with the agency.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "proposes", "will", "approvable",
or similar expressions, or by express or implied discussions
regarding the potential launch of Galvus for sale in European
markets, potential future approvals of Galvus in other countries,
including the US, and potential future revenues from Galvus. Such
forward-looking statements reflect the current views of the Company
regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with
Galvus to be materially different from any future results,
performance or achievements expressed or implied by such statements.
There can be no guarantees that Galvus will be launched for sale in
any European market, or that Galvus will be approved in the US or in
any other markets. Nor can there be any guarantee that Galvus will
achieve any particular levels of revenue. In particular, management's
expectations regarding Galvus could be affected by, among other
things, unexpected regulatory actions or delays or government
regulation generally; unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of
existing clinical data; competition in general; government, industry
and general public pricing pressures; the company's ability to obtain
or maintain patent or other proprietary intellectual property
protection; and other risks and factors referred to in Novartis AG's
current Form 20-F on file with the US 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 anticipated, believed,
estimated or expected. Novartis is providing the information in this
press release as of this date and does not undertake any obligation
to update any forward-looking statements contained in this press
release 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.
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Novartis International AG
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