Magazin
2009-06-25
Paris and London (ots/PRNewswire) - Bristol-Myers SquibbCompany (NYSE: BMY) and AstraZeneca (LSE: AZN) today announced thattheir marketing authorisation application for ONGLYZA(TM)(saxagliptin) received a positive opinion from the Committee forMedicinal Products for Human Use (CHMP) for the treatment of type 2diabetes in adults as add-on therapy with metformin, athiazolidinedione or a sulphonylurea.
The positive opinion was reached after the CHMP reviewed datafrom a comprehensive clinical development programme that included sixcore Phase III trials assessing the safety and efficacy ofsaxagliptin as a once-daily therapy. These involved 4,148 patientswith type 2 diabetes, including 3,021 patients treated withsaxagliptin.(1-5)
Saxagliptin belongs to the class of dipeptidyl peptidase-4(DPP-4) inhibitors. These are designed to enhance the body's abilityto decrease blood sugar (glucose) when it is elevated by acting onthe natural hormones, incretins, thereby increasing insulinproduction, and by reducing the liver's production of glucose.
This application to the CHMP is for use as a once-daily 5mg dosein adult patients with type 2 diabetes mellitus to improve glycaemiccontrol:
- in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; - in combination with a sulphonylurea, when the 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 appropriate.(1-5)
The CHMP's positive opinion on ONGLYZA will now be reviewed bythe European Commission which has the authority to approve medicinesfor the European Union. Bristol-Myers Squibb and AstraZeneca expectthe European Commission to issue its decision on a MarketingAuthorisation for this type 2 diabetes investigational drug in theEuropean Union in the coming months.
About DPP-4 Inhibitors
DPP-4 inhibitors are a class of compounds that work by affectingthe action of natural hormones in the body called incretins.Incretins decrease elevated blood sugar levels (glucose) byincreasing the body's utilisation of sugar, mainly through increasinginsulin production in the pancreas and decreasing glucagon secretion.
About Type 2 Diabetes
Diabetes (diabetes mellitus) is a chronic disease in which thebody does not produce or properly use insulin. Insulin is a hormonethat is needed to convert sugar, starches (carbohydrates) and othernutrients into energy needed for daily life. The cause of diabetescontinues to be investigated, and both genetic and environmentalfactors such as obesity and lack of exercise appear to play a role.Diabetes is associated with long-term complications that affectalmost every part of the body. The disease may lead to blindness,heart and blood vessel disease, stroke, kidney failure, amputationsand nerve damage.
There are two primary underlying causes associated with type 2diabetes: the body does not produce enough insulin (insulindeficiency), or the cells ignore the insulin (insulin resistance).Symptoms of type 2 diabetes develop gradually, and their onset is notas sudden as in type 1 diabetes. Symptoms may include fatigue,frequent urination, increased thirst and hunger, weight loss, blurredvision, 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 2diabetes often are characterised with: insulin resistance, abdominalobesity, a sedentary lifestyle, having low HDL-C ("good") cholesterollevels and high triglyceride levels and hypertension. According tothe International Diabetes Federation (IDF), type 2 diabetes accountsfor approximately 85 to 95 percent of all diabetes. The IDF says thatacross the world there are 246 million people with both types ofdiabetes. Taking a 90 percent figure for type 2 this equates toroughly 221 million people with type 2 diabetes globally. It isestimated there are more than 47 million people in Europe with type 2diabetes.(6)
The International Diabetes Federation (IDF) recommends ahaemoglobin A1C measurement of less than 6.5 percent for most peoplewith type 2 diabetes.(7)
Haemoglobin A1C is a measurement of a person's average bloodglucose level over a two-to-three month period and is considered animportant marker of long-term glucose control. Other importantmarkers for type 2 diabetes include fasting plasma glucose, a measureof a person's blood glucose after at least eight hours of fasting,and postprandial glucose, a measure of a person's blood glucose aftera meal.
Bristol-Myers Squibb and AstraZeneca Collaboration
Bristol-Myers Squibb and AstraZeneca entered into a collaborationin January 2007 to enable the companies to research, develop andcommercialise two investigational drugs for type 2 diabetes -saxagliptin and dapagliflozin. The Bristol-Myers Squibb/AstraZenecadiabetes collaboration is dedicated to global patient care, improvingpatient outcomes and creating a new vision for the treatment of type2 diabetes.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whosemission is to extend and enhance human life.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as thatterm is defined in the Private Securities Litigation Reform Act of1995, regarding the research, development and commercialization ofpharmaceutical products. Such forward-looking statements are based oncurrent expectations and involve inherent risks and uncertainties,including factors that could delay, divert or change any of them, andcould cause actual outcomes and results to differ materially fromcurrent expectations. No forward-looking statement can be guaranteed.Among other risks, there can be no guarantee that a MarketAuthorisation will be granted by the European Commission or, ifgranted, that it will be granted in the time period indicated in thisrelease. Forward-looking statements in the press release should beevaluated together with the many uncertainties that affectBristol-Myers Squibb's business, particularly those identified in thecautionary factors discussion in Bristol-Myers Squibb's Annual Reporton Form 10-K for the year ended December 31, 2008, its QuarterlyReports on Form 10-Q, and Current Reports on Form 8-K. Bristol-MyersSquibb undertakes no obligation to publicly update anyforward-looking statement, whether as a result of new information,future events, or otherwise.
About AstraZeneca
AstraZeneca is a major international healthcare business engagedin the research, development, manufacturing and marketing ofmeaningful prescription medicines and supplier for healthcareservices. AstraZeneca is one of the world's leading pharmaceuticalcompanies with healthcare sales of US$ 31.6 billion and is a leaderin gastrointestinal, cardiovascular, neuroscience, respiratory,oncology and infectious disease medicines. For more information aboutAstraZeneca, please visit: http://www.astrazeneca.com.
AstraZeneca Forward-Looking Statement
The statements contained herein include forward-lookingstatements. Although we believe our expectations are based onreasonable assumptions, any forward-looking statements, by their verynature, involve risks and uncertainties and may be influenced byfactors that could cause actual outcomes and results to be materiallydifferent from those predicted.
The forward-looking statements reflect knowledge and informationavailable at the date of the preparation of this press release andthe Company undertakes no obligation to update these forward-lookingstatements.
Important factors that could cause actual results to differmaterially 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/Form20-F for 2007. Nothing contained herein should be construed as aprofit forecast.
ONGLYZA is a trademark of the Bristol-Myers Squibb Company.
References
1. Rosenstock J, et al. Glucose-lowering activity of thedipeptidyl peptidase-4 inhibitor saxagliptin in drug-naïve patientswith type 2 diabetes. Diabetes, Obesity and Metabolism 2008; 10:376-386
2. De Fronzo, et al. The efficacy and safety of saxagliptin whenadded to metformin therapy in patients with inadequately controlledtype 2 diabetes on metformin alone. Diabetes Care 2009: publishedahead of print May 28, 2009, doi:10.2337/dc08-1984
3. Ravichandran S, et al. Saxagliptin Added to a Sulfonylurea isSafe and More Efficacious Than Up-titrating a Sulfonylurea inPatients with Type 2 Diabetes. Abstract presented at EASD, 2008
4. Allen E, et al. Saxagliptin Added To A ThiazolidinedioneImproves Glycemic Control In Patients With Inadequately ControlledType 2 Diabetes. Abstract presented at EASD, 2008
5. Jadzinsky M, et al. Saxagliptin given in combination withmetformin as initial therapy improves glycaemic control in patientswith type 2 diabetes compared with either monotherapy: a randomizedcontrolled trial. Diabetes, Obesity and Metabolism 2009; 11: 611-622
6. International Diabetes Federation factsheet "diabetesprevalence" accessed 19 May, 2009http://www.idf.org/diabetes-prevalence
7. IDF Global Guideline for type 2 diabetes 2005: Chapter 6:glucose control levels accessed 19 May, 2009http://www.idf.org/webdata/docs/IDF%20GGT2D.pdf
ots Originaltext: Bristol-Myers Squibb Company and AstraZenecaIm Internet recherchierbar: http://www.presseportal.de
Contact:Contacts: Media: Bristol-Myers Squibb, Carmel Hogan, +33-674-107-658,Carmel.hogan@bms.com OR AstraZeneca, Neil McCrae, +44-207-304-5045, Neil.mccrae@astrazeneca.com; Investors: Bristol-Myers Squibb, John Elicker, +1-609-252-4611, John.elicker@bms.com OR AstraZeneca, EdwardSeage, +1-302-886-4065, Edward.seage@astrazeneca.com; Jonathan Hunt, +44-777-570-4032, Jonathan.hunt@astrazeneca.com
ONGLYZA(TM) (saxagliptin) Receives Positive Opinion in Europe for the Treatment of Type 2 Diabetes
The positive opinion was reached after the CHMP reviewed datafrom a comprehensive clinical development programme that included sixcore Phase III trials assessing the safety and efficacy ofsaxagliptin as a once-daily therapy. These involved 4,148 patientswith type 2 diabetes, including 3,021 patients treated withsaxagliptin.(1-5)
Saxagliptin belongs to the class of dipeptidyl peptidase-4(DPP-4) inhibitors. These are designed to enhance the body's abilityto decrease blood sugar (glucose) when it is elevated by acting onthe natural hormones, incretins, thereby increasing insulinproduction, and by reducing the liver's production of glucose.
This application to the CHMP is for use as a once-daily 5mg dosein adult patients with type 2 diabetes mellitus to improve glycaemiccontrol:
- in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control; - in combination with a sulphonylurea, when the 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 appropriate.(1-5)
The CHMP's positive opinion on ONGLYZA will now be reviewed bythe European Commission which has the authority to approve medicinesfor the European Union. Bristol-Myers Squibb and AstraZeneca expectthe European Commission to issue its decision on a MarketingAuthorisation for this type 2 diabetes investigational drug in theEuropean Union in the coming months.
About DPP-4 Inhibitors
DPP-4 inhibitors are a class of compounds that work by affectingthe action of natural hormones in the body called incretins.Incretins decrease elevated blood sugar levels (glucose) byincreasing the body's utilisation of sugar, mainly through increasinginsulin production in the pancreas and decreasing glucagon secretion.
About Type 2 Diabetes
Diabetes (diabetes mellitus) is a chronic disease in which thebody does not produce or properly use insulin. Insulin is a hormonethat is needed to convert sugar, starches (carbohydrates) and othernutrients into energy needed for daily life. The cause of diabetescontinues to be investigated, and both genetic and environmentalfactors such as obesity and lack of exercise appear to play a role.Diabetes is associated with long-term complications that affectalmost every part of the body. The disease may lead to blindness,heart and blood vessel disease, stroke, kidney failure, amputationsand nerve damage.
There are two primary underlying causes associated with type 2diabetes: the body does not produce enough insulin (insulindeficiency), or the cells ignore the insulin (insulin resistance).Symptoms of type 2 diabetes develop gradually, and their onset is notas sudden as in type 1 diabetes. Symptoms may include fatigue,frequent urination, increased thirst and hunger, weight loss, blurredvision, 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 2diabetes often are characterised with: insulin resistance, abdominalobesity, a sedentary lifestyle, having low HDL-C ("good") cholesterollevels and high triglyceride levels and hypertension. According tothe International Diabetes Federation (IDF), type 2 diabetes accountsfor approximately 85 to 95 percent of all diabetes. The IDF says thatacross the world there are 246 million people with both types ofdiabetes. Taking a 90 percent figure for type 2 this equates toroughly 221 million people with type 2 diabetes globally. It isestimated there are more than 47 million people in Europe with type 2diabetes.(6)
The International Diabetes Federation (IDF) recommends ahaemoglobin A1C measurement of less than 6.5 percent for most peoplewith type 2 diabetes.(7)
Haemoglobin A1C is a measurement of a person's average bloodglucose level over a two-to-three month period and is considered animportant marker of long-term glucose control. Other importantmarkers for type 2 diabetes include fasting plasma glucose, a measureof a person's blood glucose after at least eight hours of fasting,and postprandial glucose, a measure of a person's blood glucose aftera meal.
Bristol-Myers Squibb and AstraZeneca Collaboration
Bristol-Myers Squibb and AstraZeneca entered into a collaborationin January 2007 to enable the companies to research, develop andcommercialise two investigational drugs for type 2 diabetes -saxagliptin and dapagliflozin. The Bristol-Myers Squibb/AstraZenecadiabetes collaboration is dedicated to global patient care, improvingpatient outcomes and creating a new vision for the treatment of type2 diabetes.
About Bristol-Myers Squibb
Bristol-Myers Squibb is a global biopharmaceutical company whosemission is to extend and enhance human life.
Bristol-Myers Squibb Forward-Looking Statement
This press release contains "forward-looking statements" as thatterm is defined in the Private Securities Litigation Reform Act of1995, regarding the research, development and commercialization ofpharmaceutical products. Such forward-looking statements are based oncurrent expectations and involve inherent risks and uncertainties,including factors that could delay, divert or change any of them, andcould cause actual outcomes and results to differ materially fromcurrent expectations. No forward-looking statement can be guaranteed.Among other risks, there can be no guarantee that a MarketAuthorisation will be granted by the European Commission or, ifgranted, that it will be granted in the time period indicated in thisrelease. Forward-looking statements in the press release should beevaluated together with the many uncertainties that affectBristol-Myers Squibb's business, particularly those identified in thecautionary factors discussion in Bristol-Myers Squibb's Annual Reporton Form 10-K for the year ended December 31, 2008, its QuarterlyReports on Form 10-Q, and Current Reports on Form 8-K. Bristol-MyersSquibb undertakes no obligation to publicly update anyforward-looking statement, whether as a result of new information,future events, or otherwise.
About AstraZeneca
AstraZeneca is a major international healthcare business engagedin the research, development, manufacturing and marketing ofmeaningful prescription medicines and supplier for healthcareservices. AstraZeneca is one of the world's leading pharmaceuticalcompanies with healthcare sales of US$ 31.6 billion and is a leaderin gastrointestinal, cardiovascular, neuroscience, respiratory,oncology and infectious disease medicines. For more information aboutAstraZeneca, please visit: http://www.astrazeneca.com.
AstraZeneca Forward-Looking Statement
The statements contained herein include forward-lookingstatements. Although we believe our expectations are based onreasonable assumptions, any forward-looking statements, by their verynature, involve risks and uncertainties and may be influenced byfactors that could cause actual outcomes and results to be materiallydifferent from those predicted.
The forward-looking statements reflect knowledge and informationavailable at the date of the preparation of this press release andthe Company undertakes no obligation to update these forward-lookingstatements.
Important factors that could cause actual results to differmaterially 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/Form20-F for 2007. Nothing contained herein should be construed as aprofit forecast.
ONGLYZA is a trademark of the Bristol-Myers Squibb Company.
References
1. Rosenstock J, et al. Glucose-lowering activity of thedipeptidyl peptidase-4 inhibitor saxagliptin in drug-naïve patientswith type 2 diabetes. Diabetes, Obesity and Metabolism 2008; 10:376-386
2. De Fronzo, et al. The efficacy and safety of saxagliptin whenadded to metformin therapy in patients with inadequately controlledtype 2 diabetes on metformin alone. Diabetes Care 2009: publishedahead of print May 28, 2009, doi:10.2337/dc08-1984
3. Ravichandran S, et al. Saxagliptin Added to a Sulfonylurea isSafe and More Efficacious Than Up-titrating a Sulfonylurea inPatients with Type 2 Diabetes. Abstract presented at EASD, 2008
4. Allen E, et al. Saxagliptin Added To A ThiazolidinedioneImproves Glycemic Control In Patients With Inadequately ControlledType 2 Diabetes. Abstract presented at EASD, 2008
5. Jadzinsky M, et al. Saxagliptin given in combination withmetformin as initial therapy improves glycaemic control in patientswith type 2 diabetes compared with either monotherapy: a randomizedcontrolled trial. Diabetes, Obesity and Metabolism 2009; 11: 611-622
6. International Diabetes Federation factsheet "diabetesprevalence" accessed 19 May, 2009http://www.idf.org/diabetes-prevalence
7. IDF Global Guideline for type 2 diabetes 2005: Chapter 6:glucose control levels accessed 19 May, 2009http://www.idf.org/webdata/docs/IDF%20GGT2D.pdf
ots Originaltext: Bristol-Myers Squibb Company and AstraZenecaIm Internet recherchierbar: http://www.presseportal.de
Contact:Contacts: Media: Bristol-Myers Squibb, Carmel Hogan, +33-674-107-658,Carmel.hogan@bms.com OR AstraZeneca, Neil McCrae, +44-207-304-5045, Neil.mccrae@astrazeneca.com; Investors: Bristol-Myers Squibb, John Elicker, +1-609-252-4611, John.elicker@bms.com OR AstraZeneca, EdwardSeage, +1-302-886-4065, Edward.seage@astrazeneca.com; Jonathan Hunt, +44-777-570-4032, Jonathan.hunt@astrazeneca.com
Bristol-Myers Squibb Company and AstraZeneca
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