Onglyza(R) (saxagliptin) Receives Marketing Authorisation in Europe for the Treatment of Type 2 Diabetes
Paris and London (ots/PRNewswire) - Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) (LSE: AZN) announced today that the European Commission has granted marketing authorisation for Onglyza in the 27 countries of the European Union.
Onglyza is indicated as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycaemic control:
@@start.t1@@ - in combination with metformin, when metformin alone, with diet and
exercise, does not provide adequate glycaemic control;
- in combination with a sulphonylurea, when sulphonylurea alone, with
diet and exercise, does not provide adequate glycaemic control in
patients for whom use of metformin is considered inappropriate; or
- in combination with a thiazolidinedione, when the thiazolidinedione
alone, with diet and exercise, does not provide adequate glycaemic
control in patients for whom use of a thiazolidinedione is considered
The marketing authorisation is based on data submitted from a comprehensive clinical development programme that included six core Phase III registrational trials and a Phase IIIB study comparing saxagliptin plus metformin with sitagliptin plus metformin. The registrational trials assessed the safety and efficacy of Onglyza and involved 4,148 patients with type 2 diabetes, including 3,021 patients treated with Onglyza.(1-5)
Onglyza is the first medicine to be launched in Europe through the worldwide collaboration of Bristol-Myers Squibb and AstraZeneca to enable the companies to research, develop and commercialise select investigational medicines for the treatment of type 2 diabetes.
Béatrice Cazala, Bristol-Myers Squibb's President Europe, and President, Global Commercialization, said: "The European Commission decision marks an important milestone in the alliance between Bristol-Myers Squibb and AstraZeneca. Our legacy in treating type 2 diabetes and cardiovascular disease, together with our knowledge and expertise, enables us to deliver to patients a medicine that will offer further choice for the treatment of this serious condition."
Ulf Sather, AstraZeneca's Regional Vice President for Europe, said: "Diabetes is a growing epidemic currently affecting some 53 million people in Europe with the number of cases expected to increase. Today's announcement is good news for those affected by type 2 diabetes and further demonstrates the commitment of AstraZeneca and Bristol-Myers Squibb to bring much needed options for the treatment of type 2 diabetes."
Onglyza belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. These are designed to enhance the body's ability to decrease blood sugar (glucose) when it is elevated by acting on the natural hormones, incretins, thereby increasing insulin production, and by reducing the liver's production of glucose.
The launch of Onglyza is expected to begin in the fourth quarter of 2009.
About Type 2 Diabetes
Diabetes (diabetes mellitus) is a chronic disease in which the body does not produce or properly use insulin (a hormone that is needed for the cells of the body to properly take up glucose). This leads to elevated blood glucose levels (hyperglycemia) that are sustained over time. Sustained hyperglycemia, the hallmark of diabetes, is associated with long-term complications that can affect almost every part of the body.
The genesis of diabetes continues to be investigated, and both genetic and environmental factors such as obesity and lack of exercise appear to play a role. There are two primary underlying causes associated with type 2 diabetes: the body does not produce enough insulin (insulin deficiency), and the cells are resistant to the effect of insulin (insulin resistance).
Symptoms of type 2 diabetes develop gradually, and their onset is not as sudden as in type 1 diabetes. Symptoms may include fatigue, frequent urination, increased thirst and hunger, weight loss, blurred vision, and slow healing of wounds or sores. Some people, however, have no symptoms.
Type 2 diabetes is most often associated with older age, obesity, family history of diabetes, previous history of gestational diabetes, physical inactivity and certain ethnicities. People with type 2 diabetes often are characterised with: insulin resistance, abdominal obesity, a sedentary lifestyle, having low HDL-C ("good") cholesterol levels and high triglyceride levels and hypertension. According to the International Diabetes Federation (IDF), type 2 diabetes accounts for approximately 85 to 95 percent of all diabetes. The IDF says that across the world there are 246 million people with both types of diabetes.(7) Taking a 90 percent figure for type 2, this equates to roughly 221 million people with type 2 diabetes globally. It is estimated there are more than 53 million people in Europe with type 2 diabetes.(8) The International Diabetes Federation (IDF) recommends a haemoglobin A1C measurement of less than 6.5 percent for most people with type 2 diabetes.(9)
Haemoglobin A1C is a measurement of a person's average blood glucose level over a two-to-three month period and is considered an important marker of long-term glucose control. Other important markers for type 2 diabetes include fasting plasma glucose, a measure of a person's blood glucose after at least eight hours of fasting, and postprandial glucose, a measure of a person's blood glucose after a meal.
Bristol-Myers Squibb and AstraZeneca Collaboration
Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to develop and commercialize select investigational drugs for type 2 diabetes. These therapies address two key pathways in managing type 2 diabetes and seek to expand the range of current and future therapeutic options. Our collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of patients living with type 2 diabetes.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company committed to discovering, developing and delivering innovative medicines that help patients prevail over serious diseases.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed.
Forward-looking statements in the press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2008, its Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines.
AstraZeneca Forward-Looking Statement
The statements contained herein include forward-looking statements. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted.
The forward-looking statements reflect knowledge and information available at the date of the preparation of this press release and the Company undertakes no obligation to update these forward-looking statements.
Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things, those risk factors identified in the Company's Annual Report/Form 20-F for 2008. Nothing contained herein should be construed as a profit forecast.
ONGLYZA is a registered trademark of Bristol-Myers Squibb Company.
(1). Rosenstock J, et al. Glucose-lowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naïve patients with type 2 diabetes. Diabetes, Obesity and Metabolism 2008; 10: 376-386.
(2). De Fronzo, et al. The efficacy and safety of saxagliptin when added to metformin therapy in patients with inadequately controlled type 2 diabetes on metformin alone. Diabetes Care. 2009 Sep;32(9):1649-55. Epub 2009 May 28
(3). Ravichandran S, et al. Saxagliptin added to a sulfonylurea is safe and more efficacious than up-titrating a sulfonylurea in patients with type 2 diabetes. Diabetologia. 2008; 51 (Suppl 1): S342, Abstract 858 (Poster presented at EASD. September 7-11,2008, Rome, Italy).
(4). Allen E, et al. Saxagliptin added to a thiazolidinedione improves glycemic control in patients with inadequately controlled type 2 diabetes. Diabetologia. 2008; 51 (Suppl 1):S342-S343, Abstract 859 (Poster presented at EASD. September 7-11, 2008, Rome, Italy).
(5). Jadzinsky M, et al. Saxagliptin given in combination with metformin as initial therapy improves glycaemic control in patients with type 2 diabetes compared with either monotherapy: a randomized controlled trial. Diabetes, Obesity and Metabolism 2009; 11: 611-622
(6). Data on file
(7). International Diabetes Federation factsheet "diabetes prevalence" accessed 19 May, 2009 http://www.idf.org/diabetes-prevalence
(8). http://www.eatlas.idf.org/upload/files/Tables%20Chapter%201.1.xls (accessed 1601 hours September 15th 2009)
(9). IDF Global Guideline for type 2 diabetes 2005: Chapter 6: glucose control levels accessed 19 May, 2009 http://www.idf.org/webdata/docs/IDF%20GGT2D.pdf
Karl J. Hard,
ots Originaltext: Bristol-Myers Squibb Company and AstraZeneca
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