Novartis Data at EASD From 45,000-Patient Study Demonstrate Real-World Effectiveness of Galvus in Patients With Type 2 Diabetes

• Data from global EDGE study show 1.19% reduction in HbA1c when vildagliptin was added to existing oral anti-diabetes therapies1
• A higher proportion of patients responded to vildagliptin treatment without any of the predefined tolerability issues than comparator oral anti-diabetes therapies2

• Results from one of the largest observational studies in type 2 diabetes are consistent with the efficacy and safety profile in vildagliptin’s clinical trial program1

Berlin, October 3, 2012 – Novartis announced today new data showing that a significantly higher proportion of type 2 diabetes patients responded to treatment with either Galvus® (vildagliptin), when added to existing oral anti-diabetes therapy, or Eucreas® (vildagliptin/metformin) compared to combinations of other oral anti-diabetes therapies2. Response to treatment in the global, 45,000-patient Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin (EDGE) study was defined as an HbA1c drop of greater than 0.3% without any of the predefined tolerability issues2. The results of the observational EDGE study were presented today at the 48th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Berlin2.

“The EDGE study, which was one of the largest observational studies ever conducted in type 2 diabetes, provides patients and physicians real-world evidence of the effectiveness of Galvus,” said Timothy Maloney, Global Business Franchise Head, Primary Care, Novartis. “The results of EDGE are consistent with the safety and efficacy profile established in vildagliptin’s robust clinical trial program.”

Type 2 diabetes is a progressive disease in which it becomes increasingly difficult to manage blood sugar levels with one therapy alone3,4. However, adding additional therapies can increase the risk of adverse events, including hypoglycemia, weight gain and gastro-intestinal side effects4. The EDGE study demonstrates the real-world effectiveness of vildagliptin in combination with other oral anti-diabetes therapies when treating patients with type 2 diabetes2.

Overall 55.4 percent of patients in the vildagliptin group and 51.3 percent of patients in the comparator group had a decrease in HbA1c of >0.3% without the predefined tolerability issues of peripheral edema, hypoglycemia, GI events and weight gain after 12 months of treatment (adjusted OR 1.49 [95% CI:1.42 – 1.55])2. In the EDGE study, vildagliptin in combination with another therapy was shown to achieve a 1.19% reduction in HbA1c from baseline compared to mean reductions in HbA1c of 0.99% in the comparator group1.

The incidence of adverse events was similar across both treatment groups, occurring in 5.28 percent in the vildagliptin arm and 5.73 percent in the comparator arm2.

“In addition to providing data on the benefit and risk profiles of specific treatments, EDGE is important because it offers information on when doctors around the world decide to step up oral glucose lowering therapy in type 2 diabetes,” said Chantal Mathieu, Professor of Medicine at the University of Leuven, Belgium. “Despite guidelines recommending combination treatment should be initiated when HbA1c levels remain above 7.0% for three months, clinical inertia appears to be widespread with physicians waiting until blood sugar levels are above 8.0% to add another therapy.”

Clinicians who took part in the EDGE study initiated combination therapy at a mean HbA1c baseline of 8.16%5. The baseline HbA1c for initiation of combination therapy varied considerably by region with a mean of 7.7% in East Asia, 7.9% in Europe, 8.5% in Latin America, 8.5% in the Middle East and 8.6% in India, suggesting the need for earlier use of combination therapy5.

About the EDGE study
The Novartis-sponsored EDGE study was a 12-month, multi-national, observational cohort study that enrolled patients in 27 countries, across five regions (East Asia, Europe, India, Latin America and the Middle East)2.

Patients became eligible for the study after an add-on treatment was chosen by their physician based on the patient’s need1. Patients were assigned to one of two groups:
• Vildagliptin in combination with another oral anti-diabetic drug (OAD)2
• Other OAD combinations, including any sulphonylurea, thiazolidinedione, glinide, α-glucosidase inhibitor or metformin, but excluding any DPP-4 inhibitor or GLP-1 mimetics or analogues2

The primary endpoint was the proportion of patients responding to treatment (HbA1c reduction of >0.3%) without any of the following predefined tolerability issues: peripheral edema, hypoglycemic events, discontinuation due to gastrointestinal events or weight gain (≥5%)2.
The study also evaluated the following secondary effectiveness endpoints:
• Decrease in HbA1c >0.3% from baseline to end of study without peripheral edema, proven hypoglycemic events, discontinuation due to gastrointestinal events or weight gain ≥ 3%2
• Decrease in HbA1c >0.3% from baseline to end of study without weight gain ≥ 3% or proven hypoglycemic events2
• HbA1c <7% at end of study without proven hypoglycemic events or weight gain ≥ 3% and baseline HbA1c >7%2

The safety endpoints were the incidence of death, serious adverse events (SAEs) and adverse events (AEs) and the estimated relative death, SAE and AE risk2.

About diabetes
Diabetes is one of the world’s greatest healthcare challenges, affecting 366 million people globally and killing one person every seven seconds6. The obesity epidemic and an aging world population are contributing to the escalating incidence of type 2 diabetes and by 2030 it is projected that more than half a billion people will be diagnosed with the disease6. Type 2 diabetes accounts for 90 percent of all cases of diabetes7.

About Galvus®
Galvus® (vildagliptin) is a dipeptidyl peptidase-4 (DPP-4) inhibitor, a class of oral diabetes medications that enhance the body’s natural ability to control blood sugar. The Galvus® (vildagliptin) safety and efficacy profile has been established in a comprehensive clinical trial program that included more than 15,000 type 2 diabetes patients8.
Galvus® (vildagliptin) is approved in more than 100 countries across Europe, Asia Pacific, Africa and Latin America1. It is indicated for the treatment of type 2 diabetes as a monotherapy and in combination with metformin, a sulphonylurea, a thiazolidinedione or insulin8. Specific indications vary by country.
About Eucreas®/Galvus® Met
Eucreas®/Galvus® Met (vildagliptin and metformin) is a single-pill fixed-dose combination of Galvus® (vildagliptin) and metformin9. Eucreas®/Galvus® Met (vildagliptin and metformin) is approved in more than 80 countries across Europe, Asia Pacific, Africa and Latin America for the treatment of patients with type 2 diabetes who are unable to control blood sugar with metformin alone1. Specific indications vary by country.
Disclaimer
The foregoing release contains forward-looking statements that can be identified by terminology such as “suggesting,” “projected,” “will,” or similar expressions, or by express or implied discussions regarding potential new indications or labeling for the Novartis vildagliptin products or regarding potential future revenues from the Novartis vildagliptin products. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of management regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that the Novartis vildagliptin products will be submitted or approved for any additional indications or labeling in any market. Nor can there be any guarantee that the Novartis vildagliptin products will achieve any particular levels of revenue in the future. In particular, management’s expectations regarding these products 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; unexpected manufacturing issues; the impact that the foregoing factors could have on the values attributed to the Novartis Group's assets and liabilities as recorded in the Group's consolidated balance sheet, 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 provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines and diagnostic tools, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2011, the Group achieved net sales of USD 58.6 billion, while approximately USD 9.6 billion (USD 9.2 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Novartis Group companies employ approximately 126,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.

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References
1. Novartis Pharma AG data on file.
2. Mathieu C et al. Effectiveness and safety of vildagliptin compared with other oral anti-diabetic drugs in patients with type 2 diabetes: results from a large worldwide cohort study (EDGE). Poster 863 presented at EASD 2012.
3. World Health Organization. Diabetes Fact Sheet Noº312. http://www.who.int/mediacentre/factsheets/fs312/en/index.html. Accessed September 7, 2012.
4. Inzucchi SE et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach. Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia 2012;55:1577-1596.
5. Bader G et al. Effectiveness of diabetes control with vildagliptin vs. other OADs: baseline characteristics of patients enrolled in the EDGE study. ADA abstracts 2449-PO. 72nd Scientific Sessions: 2012;June: 61 (suppl 1).
6. International Diabetes Federation. Global diabetes plan. http://www.idf.org/sites/default/files/Global_Diabetes_Plan_Final.pdf. Accessed September 7, 2012.
7. International Diabetes Federation. Types of diabetes. http://www.idf.org/types-diabetes. Accessed September 7, 2012.
8. Galvus Summary of Product Characteristics (SmPC).
9. Eucreas Summary of Product Characteristics (SmPC).

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Posted: October 2012

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