Medicação para Diabetes Tipo II

De: PR Newswire Brasil

Para: THERESA CATHARINA DE GÓES CAMPOS

Assunto: Positive Results of First Phase II Study in New Class of Oral

07 de junho de 2004 CIÊNCIA

Positive Results of First Phase II Study in New Class of Oral Diabetes Drugs

*Long-term improved glycemic control seen in patients with type II diabetes

*LAF237 shows promise as mono-and combination therapy

BASEL, Switzerland, June 7 /PRNewswire/ -- Research presented today showed that the investigational drug, LAF237, the first in a new class, improved glycemic control in patients with type 2 diabetes. In this study LAF237, which is administered as a tablet to be taken orally, was added to the standard diabetes treatment metformin in patients whose diabetes was not adequately controlled by metformin alone. Presented at the annual scientific meeting of the American Diabetes Association, the glucose reduction benefits attributed to the addition of LAF237 in this study were sustained for one year. "LAF237 works completely differently to all other therapies currently used to treat type 2 diabetes," said Joerg Reinhardt, Head of Development, Novartis Pharma AG. "This research confirms the potential that Novartis has seen in LAF237, and we believe it could offer a whole new strategy for controlling type 2 diabetes at a time when the disease is reaching epidemic proportions worldwide. We are pleased that phase III trials have been initiated for LAF237 to further assess the potential of this novel oral compound." Exploring new diabetes treatments like LAF237 is critically important, especially given the World Health Organization projections that the number of people with diabetes will double to 366 million by 2030.(1) Last year alone, more than 3.2 million deaths were attributed to diabetes or diabetes-related causes.(2) Novartis is leading the way in the development of the new class of oral antidiabetes agents called DPP-4 inhibitors. Researchers studying LAF237 hope to show that the therapy will help to address the underlying imbalance between insulin and glucose production that is the cause of type 2 diabetes. LAF237 works by increasing levels of a specialised incretin hormone called GLP-1 by blocking the action of DPP-4, an enzyme that normally inactivates GLP-1. GLP-1 is secreted from the intestine in response to food, and stimulates insulin production by the beta cells of the pancreas. GLP-1 also reduces the secretion of glucagon, a hormone that signals the liver to produce glucose. Based on the strength of these data and other findings from phase II studies, Novartis launched a full phase III clinical trial programme earlier this year. The completed phase II trial presented today was designed to assess the safety and dosing of LAF237 and to make initial efficacy evaluations. "In this study, HbA1c levels, the primary long-term measure of glycemic control, decreased significantly when LAF237 was added to a patient's course of therapy, and this benefit was maintained for one year," said Richard Pratley, Professor of Medicine, University of Vermont Medical School. "Bringing patients to an ideal HbA1c level early in the disease process, and maintaining those levels for as long as possible, is critical in type 2 diabetes, making these findings very encouraging." Patients who were part of the metformin plus LAF237 treatment arm sustained an HbA1c level that was an average of 1.1 percent lower than the group on metformin plus placebo. Glucose levels measured after 8-12 hours of fasting and 1-2 hours after eating a meal were also reduced in patients taking metformin plus LAF237 versus continued therapy with metformin alone. The metformin plus LAF237 group maintained lower HbA1c levels for one year. In contrast, researchers saw an increase in HbA1c in the metformin only group during the same period. LAF was found to be well tolerated with 76.2 and 89.7 percent of patients completing the 52-week investigation in the LAF237 plus metformin arm and metformin plus placebo arms respectively. The metformin plus LAF237 group reported a higher percent of patients with at least one adverse event (69%) compared to the metformin plus placebo group (58.6%) however suspected drug-related adverse events were 4.8% and 6.9% respectively. Four patients in the metformin plus LAF237 group discontinued due to an adverse event. Three patients reported hypoglycemic events in the metformin plus LAF group, none of which was considered serious. No patient discontinued study participation due to hypoglycemia. Also being presented this week at the ADA meeting are two additional studies from the LAF237 clinical development programme. A 12-week monotherapy trial and a pharmacokinetic/pharmacodynamic interaction study with glyburide. Diabetes affects about 170 million people worldwide, afflicting increasing numbers of people in both first and developing world countries.(3) According to a recent report issued by the World Health Organization, the number of people with diabetes in Europe is estimated to rise from about 33.3 million in 2000 to more than 48 million in 2030, making new therapies and novel treatment strategies an urgent need. In the year 2000 alone, there were 609,000 deaths in Europe attributable to diabetes.(4), (5) The development of LAF237 is being driven by Novartis' cardiovascular and metabolic drug franchise. A worldwide leader in cardiovascular care and in the treatment of a variety of metabolic disorders, the cardiovascular and metabolic franchise currently markets the diabetes treatment Starlix(R) (nateglinide) and the hypertensive therapies Diovan(R)(valsartan) and Co-Diovan(R) (valsartan and hydrochlorothiazide), the fastest growing hypertensive medication across the globe.

The foregoing release contains forward-looking statements that can be identified by terminology such as "potential," "could offer," "projections," "will double," "hope to show," "will address," "encouraging" or similar expressions, or by express or implied discussions regarding potential approvals to market for LAF237 or potential future sales of LAF237, or regarding the long-term impact of a patient's use of LAF237. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with LAF237 to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that LAF237 will be approved for sale in any market. Nor can there be any guarantee regarding potential future sales of LAF237. Neither can there be any guarantee regarding the long-term impact of a patient's use of LAF237. In particular, management's expectations regarding commercialization of LAF237 could be affected by, among other things, additional analysis of LAF237 clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government pricing pressures; and other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing 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 (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2003, the Group's businesses achieved sales of USD 24.9 billion and a net income of USD 5.0 billion. The Group invested approximately USD 3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 78 500 people and operate in over 140 countries around the world.

For further information please consult http://www.novartis.com.

Notes for Journalists Type 2 diabetes is a condition characterised by blood glucose levels that are too high. In people with type 2 diabetes, the body does not produce enough insulin and/or the cells do not respond properly to insulin. In the long term, high blood glucose levels increase the risk of heart disease and stroke and can damage the eyes, kidneys and nerves in particular. HbA1c (glycated haemoglobin) is a measure of blood glucose control over the previous two or three months. A lower HbA1c indicates better blood glucose control. Pharmacokinetic changes are changes in the way a drug is absorbed, distributed, metabolised, or eliminated by the body. Hypoglycaemia (a 'hypo') occurs when the level of glucose in the blood falls too low. This may cause shaking, sweating, confusion and irritability. The prevalence of diabetes in countries in the World Health Organization's European region in 2000 and the predicted prevalence in 2030 can be found on the WHO website at: http://www.who.int/diabetes/facts/world_figures/en/index4.html

(1) World Health Organization (WHO).

http://www.who.int/diabetes/en/

(2) WHO.

http://www.who.int/diabetes/actionnow/en/diabetesmessages.pdf

(3) WHO. http://www.who.int/diabetes/en/

(4) WHO.

http://www.who.int/diabetes/actionnow/en/mapdiabprev.pdf

(5) WHO.

http://www.who.int/diabetes/actionnow/en/mapdiabdeaths.pdf

SOURCE Novartis AG 06/07/2004 CONTACT: Karen Sutherland of Novartis Pharma Communications, +41-61-324-7143, or +41-79-593-1085, or karen.sutherland@pharma.novartis.com, or Satoshi Sugimoto of Novartis Global Communications, +41-61-324-6129 Web site: http://www.novartis.com BNED: NG FONTE: PR NEWSWIRE LATIN AMERICA CORAL GABLES - MIAMI-US CONTATOS: USA-MARY D'LEON BRASIL-NÉLIA GARCIA TELS: USA:1-305-507-2550/BRASIL:55-21-2132-8461 FAXES: USA:1-305-461-8670/BRASIL:55-21-2132-8469 E-MAILS: nelia_garcia@prnewswire.com.br mary_dleon@prnewswire.com PALAVRA-CHAVE: RJ PALAVRA-CHAVE/RAMO DE ATIVIDADE: INDÚSTRIA FARMACÊUTICA PALAVRA-CHAVE/EMPRESA: NOVARTIS AG

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