Navigation Links
New Data from Multiple Studies Show Galvus Delivers Consistent and,Robust Blood Sugar Control in Patients with Type 2 Diabetes

* Significant blood sugar reductions seen across range of patient populations, including varied ethnic groups, the elderly, and those at high risk of developing diabetes

* Galvus lowers blood sugar when added to a sulfonylurea, reinforcing efficacy in combination with commonly used diabetes medicines

* Data confirm good tolerability in humans with studies showing incidence of side effects similar to placebo in monotherapy trials

* European regulatory decision anticipated by end 2007; discussions continue on steps to gain US approval

BASEL, Switzerland, June 25, 2007 - Galvus® (vildagliptin), a new once-daily oral treatment for type 2 diabetes submitted for approval in the US and Europe, has been shown in new clinical data to deliver consistent and robust blood sugar reductions in patients with this progressive disease estimated to affect about 246 million people worldwide[1].

The findings, presented at the 67th Annual Scientific Sessions of the American Diabetes Association (ADA), are consistent with earlier results demonstrating the efficacy and tolerability of Galvus both as a monotherapy and when added to many commonly used diabetes medicines in a range of patients across the type 2 diabetes disease spectrum[2],[3],[4]. These include varied ethnic groups[3] and the elderly[4] as well as patients with impaired glucose tolerance at high risk of developing diabetes[5] and those with uncontrolled blood sugar levels[6].

"These results further reinforce the clinical benefits of Galvus as an important new treatment option for patients with type 2 diabetes," said James Shannon, MD, Global Head of Development at Novartis Pharma AG. "We remain convinced that Galvus is safe and effective and will continue to work with health authorities to ensure this medicine can be made available to patients worldwide as soon as possible."

A member of a new class of diabetes medici nes called DPP-4 inhibitors, Galvus is currently approved in Brazil and Mexico. A European regulatory decision is anticipated by the end of 2007. In the US, Novartis received an approvable letter in February 2007, and discussions are ongoing with the US Food and Drug Administration on steps needed to move forward to approval.

New data presented at the ADA showed that Galvus, when added to the sulfonylurea glimepiride, produced an additional significant blood sugar reduction of 0.6% in HbA1c compared to glimepiride alone[2]. HbA1c is a measure of plasma glucose levels over the preceding three months, and indicates how well diabetes is being controlled over time.

These data supplement existing findings with Galvus when used in combination with widely prescribed diabetes medicines such as metformin, an oral thiazolidinedione (TZD) and insulin.

In the Galvus clinical program no evidence has been seen of overall weight gain[7] or hypoglycemia (dangerously low blood sugar levels)[8], side effects commonly associated with some type 2 diabetes medications. The overall incidence of side effects, including edema (fluid retention), was similar to placebo in monotherapy trials[8].

"Taken together, these data provide evidence that vildagliptin could provide a safe, effective and well-tolerated therapy when used alone or in combination with other anti-diabetic therapies," said Alan J. Garber, MD, Ph.D, Professor of Medicine, Biochemistry and Molecular Biology, and Molecular and Cellular Biology at the Baylor College of Medicine in Houston, Texas. "The majority of patients with type 2 diabetes have not achieved their A1c goals and it may therefore be helpful to have additional therapeutic options such as vildagliptin."

In most developed nations, diabetes is the fourth leading cause of death[9]. 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[10]. When left untreated or not kept under control, type 2 diabetes can lead to heart and kidney disease, blindness, and vascular or neurological problems[1].

Galvus works through a novel mechanism of action, targeting a dysfunction in the pancreatic islets that causes high blood sugar levels in people with type 2 diabetes. In clinical studies, Galvus has demonstrated significant reductions in blood sugar sustained at two years[8].

At a special ceremony during the congress, Novartis presented its 9th annual Novartis Prize in Diabetes to recognize five recipients for innovative patient-oriented diabetes research. For more information about the Novartis Prize in Diabetes, please visit

Disclaimer The foregoing press release contains forward-looking statements that can be identified by the use of forward-looking terminology such as "anticipated,", "continue," "could," "may," "will" or by express or implied discussions regarding potential future regulatory filings, approvals or future sales of Galvus. 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 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 Galvus, that Galvus will be approved by regulatory authorities for any indication, that Galvus will be brought to market in the EU, the US or any additional market or that Galvus will reach any particular level of sales. In particular, management's expectations regarding the approval and commercialization of Galvus could be affected by, among other things, additional analysis of clin ical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays in government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; government, industry, and general public pricing pressures, as well as the additional risks and factors discussed in Novartis AG's Form 20-F filed 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 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

References [1] International Diabetes Federation. Diabetes Atlas. Third Edition 2006. [2] Garber, A J et al. Efficacy and Tolerability of Vildagliptin Added to a Sulfonylurea (SU) in Patients with Type 2 Diabetes (T2DM). Presented at ADA 22-26 June 2007 (501-P). [3] Rosenstock, J et al. Consistent Efficacy and Safety of Vildagliptin Monotherapy Across Ethnicities. Presented at ADA 22-26 June 2007 (2141-PO). [4] Pratley, R E et al. Benefit/Risk Assessment of Vildagliptin in the Elderly: Pooled Analysis of 5 Monotherapy Studies. Presented at ADA 22-26 June 2007 (507-P). [5] Rosenstock, J et al. Effects of Vildagliptin in Subjects with IGT. Presented at ADA 22-26 June 2007 (505-P). [6] Scherbaum, W A et al. Efficacy and Tolerability of Vildagliptin in Drug-Naïve Patients with Type 2 Diabetes (T2DM) and Mild Hyperglycemia. Presented at ADA 22-26 June 2007 (503-P). [7] Foley, JE et al. Effect of Vildagliptin Monotherapy on Body Weight in Drug-Naive Patients With Type 2 Diabetes (T2DM). Presented at IDF, December 2006 (Abstract 826). [8] Novartis. Data on file. [9] International Diabetes Federation. "Did You Know?" 2007: [10] Saydah, S H et al. Poor Control of Risk Factors for Vascular Disease Among Adults with Previously Diagnosed Diabetes. JAMA 2004; 291(3):335-342.

# # #

Novartis Media Relations

Corinne Hoff Richard Booton Novartis Global Media Relations Novartis Pharma Communications +41 61 324 9577 (direct) +41 61 324 4356 (direct) +41 79 248 5717 (mobile) +41 79 753 2593 (mobile)


Novartis Investor Relations

International North America Ruth Metzler-Arnold +41 61 324 Ronen Tamir +1 212 830 7944 2433 Katharina Ambühl +41 61 324 5316 Jill Pozarek +1 212 830 2445 Nafida Bendali +41 61 324 3514 Edwin Valeriano +1 212 830 2456 Jason Hannon +41 61 324 2152 Thomas Hungerbuehler +41 61 324 8425 Richard Jarvis +41 61 324 4353


Related medicine technology :

1. Keryx Biopharmaceuticals, Inc. Announces Positive Phase I and Phase II Data on KRX-0401 in Patients with Relapsed/Refractory Multiple Myeloma and Waldenstroms Macroglobulinemia
2. Velcade (Bortezomib) for Injection Based Therapies Produced Complete Remission Rates as High as 54 Percent in Patients With Previously Treated Multiple Myeloma
3. Velcade (bortezomib) for Injection Based Therapies Achieved Survival Rates as High as 100 Percent in Newly Diagnosed Multiple Myeloma Patients
4. Gentiums Defibrotide Seen as Active in Multiple Myeloma
5. ACE-011 Improves Multiple Myeloma Bone Disease in a Preclinical Model
6. CytRx Announces Clinical Results from Its Rising Multiple Dose Trial with Arimoclomol for ALS
7. Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Extension Trial with Tovaxin for Multiple Sclerosis
8. Velcade (bortezomib) for Injection Survival Data in Front-Line Multiple Myeloma Patients to be Featured at 11th International Myeloma Workshop
9. New Research Demonstrates Broad Efficacy of Azixa (MPC-6827) Against Multiple Tumor Types and in Drug Resistant Cell Lines
10. Orchestra Therapeutics Announces New Phase II Clinical Data on NeuroVax Demonstrating Marked Expansion of Regulatory T Cell Populations in Patients With Multiple Sclerosis
11. Trexima (Sumatriptan/Naproxen Sodium) Demonstrated Migraine-Free Response Across Multiple Attacks
Post Your Comments:
(Date:10/10/2017)... Oct. 10, 2017   West Pharmaceutical Services, Inc. ... for injectable drug administration, today shared the results of ... for improving the intradermal administration of polio vaccines. The ... Summit in May 2017 by Dr. Ondrej Mach ... World Health Organization (WHO), and recently published in the ...
(Date:10/4/2017)...  South Korean-based healthcare product Development Company I.M. Lab ... Kickstarter. The device will educate the user about ,proper, ... efficiency compared to the dated and pricey CPR training ... of the compression for a more informed CPR training. ... raise $5,000. cprCUBE ...
(Date:10/2/2017)... FLINT, Mich. , Oct. 2, 2017 ... acquired 8th Day Software and Consulting, LLC , ... 8th Day Software, based in Tennessee ... Management LLC. 8th Day expands EnvoyHealth,s service offerings for ... product development. "In ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... ... Apple Rehab Shelton Lakes , which specializes in the delivery of sub-acute ... of a disaster drill on October 3rd. , Apple Rehab participated with the Shelton ... well as the Connecticut Long Term Care Mutual Aid Plan (LTC-MAP). The LTC-MAP ...
(Date:10/13/2017)... Abilene, Texas (PRWEB) , ... October 13, 2017 , ... ... publication this week that explains one of the most popular and least understood books ... seems like cryptic and puzzling descriptions that have baffled scholars for centuries. Many have ...
(Date:10/12/2017)... ... October 12, 2017 , ... First Healthcare ... program management, will showcase a range of technology and learning solutions at the ... Convention and Expo to be held October 14–18, 2017 at the Mandalay Bay ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics (ACMI) ... FACMI, during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s ... Morris F. Collen, a pioneer in the field of medical informatics, this prestigious award ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... Leading pediatric ... peers in Washington, D.C., for the 49th Congress of the International Society of ... Vice President of the Center for Cancer and Blood Disorders at Children’s ...
Breaking Medicine News(10 mins):