Eucreas, a single-tablet combination of Galvus and metformin, set for launch in first EU countries as new treatment for type 2 diabetes
• First single-tablet combination of a DPP-4 inhibitor and metformin approved for European countries
• Eucreas results in no overall weight gain and low incidence of hypoglycemia • Both Eucreas and Galvus to be available to patients in the first EU countries in the next few weeks
BASEL, Switzerland, February 25, 2008 – European health authorities have approved Eucreas®, an oral
tablet combining Galvus® (vildagliptin) and metformin, as a new treatment for patients
with type 2 diabetes. Eucreas is the first single-tablet combination of a member of the new
DPP-4 inhibitor class with metformin to be approved in the European Union.
The approval comes after Novartis proposed changes to the EU label recommending that
liver monitoring should be conducted at the start of treatment, every three months for the
first year, and periodically thereafter. The Eucreas approval closely follows European
approval of the updated label for Galvus announced earlier this month.
The decision applies in all 27 countries of the EU as well as in Norway and Iceland, and
both medicines will be available in the first European countries within the next few weeks.
Studies show that more than half of patients currently taking medication to manage their
type 2 diabetes are still not reaching blood glucose goals1. Combination therapy usually
becomes necessary due to progressive worsening of blood sugar control during the natural
course of the disease2.
In clinical studies, patients inadequately controlled on metformin, one of the most
prescribed oral therapies for type 2 diabetes, were four times more likely to achieve blood
sugar control by adding Galvus to their treatment compared to those who added a placebo
(or sugar pill)3. Furthermore, Galvus when administered with metformin resulted in
additional blood sugar reductions of 1.1% as measured by HbA1c4, the gold standard
measure of blood sugar control5.
“The approval of Eucreas marks an important step forward in the management of type 2
diabetes, as it is the first single-tablet combination of a DPP-4 inhibitor with metformin for
patients in Europe,” said James Shannon, MD, Chief Medical Officer at Novartis Pharma
AG. “The complementary actions of Galvus and metformin, which are the medicines
combined in Eucreas, help to bring blood sugar levels under control without the side
effects commonly associated with many widely-used type 2 diabetes medicines.”
In clinical trials, the addition of Galvus to metformin provided robust blood sugar control
without weight gain and with fewer cases of hypoglycemia (i.e. dangerously low blood
sugar)4, side effects associated with other therapies for type 2 diabetes such as
sulfonylureas or thiazolidinediones.
Eucreas has been approved for use in type 2 diabetes patients who are inadequately
controlled with metformin alone, or are being treated with Galvus and metformin as
separate tablets. Eucreas is recommended for use twice-daily at a dose of either 50 mg
vildagliptin/850 mg metformin or 50 mg vildagliptin/1000 mg metformin.
Eucreas combines two agents that work together to target both a dysfunction in the
pancreatic islets and insulin resistance, two of the main factors contributing to type 2
diabetes. Galvus works through a novel mechanism of action that targets islet dysfunction
and restores the body’s natural ability to increase insulin and decrease glucagon – the two
main hormones controlling blood sugar levels. Metformin works mainly by decreasing the
production of sugar by the liver and increasing insulin sensitivity.
Type 2 diabetes is a progressive disease in which control of blood sugar deteriorates over
time. If left untreated or not kept under control, it can lead to heart and kidney disease,
blindness, and vascular or neurological problems6.
The foregoing release contains forward-looking statements that can be identified by
terminology such as “likely,” “to be,” “will,” “usually,” “can” or similar expressions, or
by express or implied discussions regarding the launch of Galvus and Eucreas in Europe,
potential future approvals of Galvus and Eucreas in other countries, potential new
indications or labelling for Galvus and Eucreas or regarding potential future revenues from
Galvus and Eucreas. 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 Galvus and Eucreas to be materially different
from any future results, performance or achievements expressed or implied by such
statements. There can be no guarantee that Galvus and Eucreas will be approved for sale,
or for any additional indications or labelling in any market. Nor can there be any
guarantee that Galvus and Eucreas will be launched in any particular market, or will
achieve any particular levels of revenue in the future. In particular, management’s
expectations regarding Galvus and Eucreas 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; the company’s ability to obtain or
maintain patent or other proprietary intellectual property protection; production delays or
business interruption generally; government, industry and general public pricing pressures,
and other risks and factors referred to in Novartis AG’s current Form 20-F on file 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 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.
Novartis AG provides healthcare solutions that address the evolving needs of patients and
societies. Focused solely on growth areas in healthcare, Novartis offers a diversified
portfolio to best meet these needs: innovative medicines, cost-saving generic
pharmaceuticals, preventive vaccines and diagnostic tools, and consumer health products.
Novartis is the only company with leading positions in these areas. In 2007, the Group’s
continuing operations (excluding divestments in 2007) achieved net sales of USD 38.1
billion and net income of USD 6.5 billion. Approximately USD 6.4 billion was invested in
R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 98,200 full-time associates and operate in over
140 countries around the world. For more information, please visit
1 Saydah S, et al. Poor Control of Risk Factors for Vascular Disease Among Adults With Previously
Diagnosed Diabetes. JAMA 2004: 291(3): 335-342.
2 Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet, sulfonylurea, metformin, or
insulin in patients with type 2 diabetes mellitus: progressive requirement for multiple therapies (UKPDS
49). JAMA 281:2005-2012, 1999.
3 Dejager S, et al. Achievement of Glycemic Targets with Vildagliptin. Presented at EASD 17-21 September
2007. (Abstract A-07-899).
4 Bosi E, et al. Effects of Vildagliptin on Glucose Control Over 24 Weeks in Patients With Type 2 Diabetes
Inadequately Controlled With Metformin. Diabetes Care. 2007; 30:890-895.
5 American Diabetes Association. Standards of Medical Care in Diabetes – 2006.
6 International Diabetes Federation Diabetes Atlas. Third edition 2006: http://www.eatlas.idf.org/
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Posted: February 2008