New Data for Galvus Provide Further Evidence of Robust Efficacy and Tolerability in Treating Patients with Type 2 Diabetes
* Patients uncontrolled on metformin four times more likely to
achieve blood sugar control by adding Galvus to treatment regimen
compared to placebo
* Other new data show Galvus well tolerated in patients with mild
renal impairment - occurs in about one-third of all type 2 diabetes
patients
* Galvus demonstrates robust efficacy and well tolerated in the
elderly - the fastest growing group of type 2 diabetes patients
BASEL, Switzerland, September 17, 2007 - Uncontrolled patients with type 2 diabetes treated with metformin, one of the most prescribed oral medicines for this disease, were four times more likely to achieve recommended blood sugar control levels by adding Galvus® (vildagliptin) to their treatment compared to those who added a placebo, according to new clinical data[1].
The study of 544 patients with type 2 diabetes who were inadequately controlled on metformin showed that 35.5% achieved glycemic control (HbA1c < 7.0%) when Galvus was added to the treatment regimen with metformin compared to 9.4% of those receiving metformin along with placebo (or sugar pill)[1].
The results further showed that 54.1% of patients in a
subset group with a baseline HbA1c of less than
8.0% achieved glycemic control
after taking both Galvus and metformin compared to 13.3%
among those who received metformin and a placebo[1].
HbA1c is a test done to measure the average amount
of sugar in the blood over the last two
to three months. The American
Diabetes
Association recommends an HbA1c level of less than 7.0%
to minimize the risk of severe complications,
which can include heart disease,
blindness, amputations, nerve damage and kidney failure[2].
These findings, presented at the 43rd European
Association for the Study of Diabetes
(EASD), add to the growing evidence
of data
demonstrating the efficacy and tolerability of Galvus in
treating a wide range of patients with type
2 diabetes, a progressive disease
estimated to affect more than 28 million
people in the European Union[3].
Galvus is a member of a new
class of medicines called DPP-4 inhibitors.
European Union approval is expected
soon after the
Committee for Medicinal Products for Human Use (CHMP), which
reviews medicines scientifically in Europe, issued a positive
opinion in July 2007. Galvus is expected to be approved as an
add-on therapy to the
most common oral anti-diabetes medicines
- metformin, thiazolidinediones, and
sulfonylureas.
"Clinical trials have consistently demonstrated the
robust efficacy and good tolerability of
Galvus in combination with many
oral
diabetes therapies," said
James Shannon, MD, Global Head of
Development at Novartis Pharma AG.
"Galvus has further proven its benefits in a wide range of
patients, helping to bring blood sugar levels under
control without the side
effects, including weight gain and
hypoglycemia, associated with
other type 2 diabetes medicines such
sulfonylureas or
thiazolidinediones," Dr. Shannon said.
Other data presented at the meeting confirmed that Galvus is well tolerated in patients with mild renal impairment[4], a condition seen n about one-third of all type 2 diabetes patients[5]. Galvus also elivers strong efficacy and tolerability in the elderly[6], the astest growing group of type 2 diabetes patients[7].
Separately, a new analysis of pooled data from 1,864
patients showed the safety and tolerability of Galvus in
patients with predominantly
mild renal (kidney) impairment was similar to both placebo as well
as to patients who did not have renal impairment[4]. Type 2
diabetes is seen in some countries as the most frequent
condition in people with renal impairment[5]. Almost half of
all patients treated with Galvus
during the clinical trial program had renal impairment.
Other data presented at the meeting included a
pooled analysis of five monotherapy studies
demonstrating the efficacy and safety of
Galvus in the elderly. This group of 238 patients were all
over age 65 and had a mean age of 70. Galvus provided
significant blood sugar
reductions of 1.2% as measured by HbA1c,
was well tolerated and associated with a low risk of
hypoglycemia[6]. Elderly patients can
be difficult to treat with existing oral therapies[7].
"It is important to have new
treatment options that are both effective
and well tolerated to address the growing number of elderly
patients who have type 2 diabetes,"
said Richard Pratley, MD, Director of
Diabetes & Metabolism
Translational Medicine at the
University of Vermont. "Clinical data have
continually demonstrated that
vildagliptin, when added to metformin, sulfonylureas,
thiazolidinediones or when used alone,
effectively reduces blood sugar levels and is well
tolerated in a range of patients."
Galvus is currently available in Brazil and Mexico. In February
2007, Novartis received an "approvable letter" from
the US Food and Drug
Administration (FDA). Novartis has submitted a proposal
to the FDA for additional clinical studies in patients with
renal impairment to
confirm good tolerability in this patient group. The
submission of additional data to the FDA is expected in
2009.
Galvus works through a novel mechanism of
action by targeting the dysfunction in
the pancreatic islets that causes high
blood sugar
levels in people with type 2 diabetes. Islet dysfunction,
along with insulin resistance, is a contributory factor in
type 2 diabetes. The
most frequent side effects seen in the Galvus clinical
program were stuffy nose, headaches,
dizziness and upper
respiratory tract
infection.
In most developed nations, diabetes is the fourth
leading cause of death[7]. Controlling blood
sugar levels is difficult, even among
patients receiving treatment, and more than half
of patients with type 2 diabetes currently taking
medicines are still not reaching
their blood sugar goals[8]. When left untreated
or not kept under control, type 2 diabetes
can lead to heart and kidney
disease,
blindness and vascular or neurological problems[7].
Disclaimer
The foregoing release contains forward-looking statements that can
be identified by terminology such as "more likely",
"can", "expected",
or similar expressions, or by
express or implied discussions regarding
potential regulatory approvals for Galvus
or regarding
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
guarantee
that Galvus will be approved for sale in the US, in the EU, or in
any other market. Nor can there be any guarantee that Galvus will
achieve
any particular levels of revenue in
the future. 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 more than 100,000 associates and operate in over 140
countries around the
world. For
more information,
please visit
http://www.novartis.com.
References
[1] Dejager S, et al. Achievement of Glycemic Targets with
Vildagliptin. Presented at EASD 17-21 September 2007
(Abstract
A-07-899).
[2] American Diabetes Association. "Diabetes and
Cardiovascular
(Heart) Disease."
http://www.diabetes.org/diabetes-statistics/heart-disease.jsp
[3] International Diabetes Federation (IDF) Diabetes Atlas
estimates there are 31 million people with diabetes in the European
Union. The
IDF estimates that in developed nations, 85-95% of all cases of
diabetes are type 2 diabetes. 90% of those with diabetes equates to
28 million with type 2 diabetes in the European Union.
[4] Thuren T, et al. Vildagliptin is Safe and Well Tolerated in
Patients with Mild or Moderate Renal Impairment. Presented at EASD
17-21 September 2007 (Abstract A-07-1190).
[5] International Diabetes Federation. Fact sheet Diabetes and
kidney disease. 2007
[6] Pratley R, et al. Efficacy and Safety of Vildagliptin in the
Elderly: Pooled Analysis of 5 Monotherapy Studies. Presented at
EASD 17-21 September 2007 (Abstract A-07-917).
[7] International Diabetes Federation. Diabetes Atlas Third
Edition. 2006.
[8] Saydah S, et al. Poor Control of Risk Factors for Vascular
Disease Among Adults with Previously Diagnosed Diabetes. JAMA
2004;
291(3):335-342.
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Posted: September 2007
