Healthcare Prof:
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) announced that the newest investigation findings on BYETTA? (exenatide) injection as well as the investigational product BYDUREON? (exenatide extended-release for injectable suspension) will probably be presented in the 46th Annual Meeting of the European Association for the Study of Diabetes (EASD). The EASD annual meeting, taking place from Sept. 20-24 in Stockholm, Sweden, brings together more than 16,000 attendees and is an important platform in Europe for expert exchange inside the diabetes field.
“At this year’s EASD, we are pleased to share data that deepen our understanding of the safety and efficacy of BYETTA, together with the possible benefits of BYDUREON,” stated Orville G. Kolterman, M.D., senior vice president, chief medical officer, Amylin Pharmaceuticals. “These studies underscore our commitment to advancing diabetes therapy.”
Key BYETTA and BYDUREON abstracts for EASD 2010 contain:
— Oral: Presentation #73, Sept. 22, 10:45 a.m.-12:15 p.m. CEST
“Exenatide Added to Insulin Glargine-Treated Patients with Kind 2 Diabetes Supplied Exceptional Fasting and Postprandial Manage with Weight Loss and no Elevated Threat of Hypoglycaemia” will probably be presented by Richard Bergenstal, M.D., International Diabetes Center, Minneapolis
— Poster: Presentation #833, Sept. 21, 1:30-2:30 p.m. CEST
“Exenatide Added to a Thiazolidinedione with or with out Metformin Resulted in Superior Glycaemic Manage Versus Placebo after 26 Weeks of Treatment” will be presented by Joanne Liutkus, M.D., Medicine Professional Corporation, Cambridge, Ontario, Canada
— Poster: Presentation #836, Sept. 21, 1:30-2:30 p.m. CEST
“Meta-Analysis of the Efficacy of GLP-1R Agonists and DPP-4 Inhibitors for Remedy of Type two Diabetes Mellitus” will probably be presented by Vanita Aroda, M.D., MedStar Analysis, Hyattsville, Md.
— Poster: Presentation #837, Sept. 21, 1:30-2:30 p.m. CEST
“Risk of Cardiovascular Events in Patients with Kind 2 Diabetes Treated with Exenatide or Other Glucose-Lowering Therapies: A Retrospective Analysis of the LifeLink? Database” is going to be presented by Jennie Best, Ph.D., Amylin
— Poster: Presentation #842, Sept. 22, 12:30-1:30 p.m. CEST
“DURATION-2: Effect of Switching to Once-Weekly Exenatide from Maximum Daily Doses of Sitagliptin or Pioglitazone” is going to be presented by Carol H. Wysham, M.D., Rockwood Clinic, Spokane, Wash.
— Poster: Presentation #858, Sept. 23, 12:30-1:30 p.m. CEST
“Antibodies to Exenatide did not Cross-React with Human GLP-1 or Glucagon or Alter the Efficacy or Safety of Exenatide” is going to be presented by Mark Fineman, Amylin
— Poster: Presentation #863, Sept. 23, 1:30-2:30 p.m. CEST
“Impact of Exenatide Once Weekly and Insulin Glargine on Glucose Manage and Cardiovascular Danger Aspects in Subjects with Type two Diabetes” is going to be presented by Michaela Diamant, M.D., Diabetes Centre, VU University Medical Centre, Amsterdam
BYDUREON (pronounced by-DUR-ee-on) could be the proposed brand name for exenatide once weekly. It truly is an investigational, extended-release medication for sort 2 diabetes designed to deliver continuous therapeutic levels of exenatide in a single weekly dose. BYDUREON is actually a once-weekly formulation of exenatide, the active ingredient in BYETTA. BYETTA has been available within the U.S. since June 2005 and is utilized in far more than 60 countries worldwide to enhance glycemic control in adults with sort two diabetes. BYDUREON and BYETTA belong towards the glucagon-like peptide-1 (GLP-1) receptor agonist class of medications.
About Diabetes
Diabetes affects an estimated 285 million adults worldwide and a lot more than 24 million folks in the U.S.(1,two) Roughly 90-95 percent of those affected have type 2 diabetes. Diabetes costs roughly $174 billion per year in direct and indirect medical expenses in the U.S.(3)
According towards the Centers for Illness Manage and Prevention’s National Health and Nutrition Examination Survey, roughly 60 percent of individuals with diabetes do not achieve their target blood sugar levels with their existing treatment regimen.(four) In addition, 85 percent of type two diabetes patients are overweight and 55 percent are considered obese.(five) Information indicate that weight loss (even a modest quantity) supports patients in their efforts to achieve and sustain glycemic manage.(6,7)
About BYETTA? (exenatide) injection
BYETTA will be the very first FDA-approved GLP-1 receptor agonist for the remedy of kind 2 diabetes. BYETTA exhibits numerous of exactly the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake by way of multiple effects that perform in concert on the stomach, liver, pancreas and brain.
BYETTA is an injectable prescription medicine that may possibly enhance blood sugar (glucose) manage in adults with type 2 diabetes mellitus, when utilized with a diet regime and exercise program. BYETTA is not insulin and must not be taken instead of insulin. BYETTA is not suggested to be taken with insulin. BYETTA is not for individuals with type 1 diabetes or men and women with diabetic ketoacidosis.
BYETTA supplies sustained A1C manage and low incidence of hypoglycemia when utilised alone or in combination with metformin or perhaps a thiazolidinedione, with prospective weight loss. BYETTA is not a weight-loss product. BYETTA was approved in April 2005 and has been utilized by more than 1.three million patients since its introduction. See essential safety details below.
About Diabetes
Diabetes affects an estimated 285 million adults worldwide and much more than 24 million folks within the U.S.(1,two) Approximately 90-95 percent of those affected have form 2 diabetes. Diabetes costs approximately $174 billion per year in direct and indirect medical expenses inside the U.S.(three)
According to the Centers for Illness Manage and Prevention’s National Health and Nutrition Examination Survey, roughly 60 percent of men and women with diabetes don’t achieve their target blood sugar levels with their existing therapy regimen.(four) Additionally, 85 percent of kind 2 diabetes patients are overweight and 55 percent are considered obese.(five) Information indicate that weight loss (even a modest quantity) supports patients in their efforts to achieve and sustain glycemic control.(6,7)
About BYETTA? (exenatide) injection
BYETTA may be the 1st FDA-approved GLP-1 receptor agonist for the remedy of form 2 diabetes. BYETTA exhibits several of exactly the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar right after food intake via multiple effects that perform in concert on the stomach, liver, pancreas and brain.
BYETTA is an injectable prescription medicine that may possibly increase blood sugar (glucose) control in adults with kind two diabetes mellitus, when utilized with a diet and physical exercise program. BYETTA is not insulin and ought to not be taken instead of insulin. BYETTA is not advised to be taken with insulin. BYETTA is not for folks with form 1 diabetes or men and women with diabetic ketoacidosis.
BYETTA gives sustained A1C control and low incidence of hypoglycemia when utilized alone or in combination with metformin or a thiazolidinedione, with potential weight loss. BYETTA is not a weight-loss product. BYETTA was approved in April 2005 and has been utilised by much more than 1.three million patients since its introduction. See critical safety info below.
Important Safety Details for BYETTA? (exenatide) injection
Based on post-marketing information, BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. The danger for obtaining low blood sugar is higher if BYETTA is taken with another medicine that can trigger low blood sugar, including a sulfonylurea. BYETTA ought to not be used in people who have severe kidney troubles, and ought to be utilised with caution in people who have had a kidney transplant. Patients must talk with their healthcare provider if they have severe troubles with their stomach, including delayed emptying of the stomach (gastroparesis) or difficulties with digesting food. Severe allergic reactions can happen with BYETTA.
The most frequent side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea most frequently happens when 1st starting BYETTA, but may become less more than time.vThese are not all the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect which is bothersome or does not go away.
For further crucial safety details about BYETTA, please see the full Prescribing Details and Medication Guide
Based on post-marketing data, BYETTA has been associated with acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. The risk for getting low blood sugar is greater if BYETTA is taken with another medicine that can trigger low blood sugar, like a sulfonylurea. BYETTA must not be employed in people who have severe kidney troubles, and ought to be employed with caution in people who’ve had a kidney transplant. Patients really should talk with their healthcare provider if they have severe problems with their stomach, such as delayed emptying of the stomach (gastroparesis) or problems with digesting food. Severe allergic reactions can happen with BYETTA.
The most common side effects with BYETTA include nausea, vomiting, diarrhea, dizziness, headache, feeling jittery, and acid stomach. Nausea most generally happens when 1st starting BYETTA, but could become less over time.
These are not all the side effects from use of BYETTA. A healthcare provider ought to be consulted about any side effect that is bothersome or does not go away.
This press release contains forward-looking statements about Amylin, Lilly and Alkermes. Actual outcomes could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the danger that BYDUREON might not be approved by the FDA in a timely manner or at all; the companies’ response towards the complete response letter may possibly not satisfy the FDA; the FDA may request further details prior to approval; BYETTA and/or the approval of BYDUREON and the revenues generated from these products may be affected by competition; unexpected new data; safety and technical troubles; clinical trials not becoming completed in a timely manner, not confirming previous results, not getting predictive of real globe use or not achieving the intended clinical endpoints; label expansion requests or NDA filings not receiving regulatory approval; the commercial launch of BYDUREON being delayed; or manufacturing and supply issues. The possible for BYETTA and/or BYDUREON, if approved, may also be affected by government and commercial reimbursement and pricing decisions; the pace of marketplace acceptance; or scientific, regulatory along with other problems and risks inherent inside the development and commercialization of pharmaceutical products, including those inherent inside the collaboration with and dependence upon Amylin, Lilly and/or Alkermes. These and extra risks and uncertainties are described much more completely in Amylin’s, Lilly’s and Alkermes’ most recent SEC filings, including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin, Lilly and Alkermes undertake no duty to update these forward-looking statements
BYDUREON? and BYETTA? are trademarks of Amylin Pharmaceuticals, Inc., and Medisorb? is really a registered trademark of Alkermes, Inc. All other marks are the marks of their respective owners.
P-LLY
References
(1) The International Diabetes Federation Diabetes Atlas.
(2) Diabetes Statistics. American Diabetes Association.
(three) Direct and Indirect Costs of Diabetes in the United States. American Diabetes Association.
(4) Saydah SH, Fradkin J and Cowie CC. Poor manage of danger factors for vascular disease among adults with previously diagnosed diabetes. JAMA. 2004;291:335-42.
(5) Bays HE, Chapman RH and Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of information from two national surveys. Int J Clin Pract. 2007;61:737-47.
(6) Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007;30 Suppl 1:S48-65.
(7) Anderson JW, Kendall CW and Jenkins DJ. Importance of weight management in form two diabetes: assessment with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9.
Source: Amylin Pharmaceuticals, Inc
View drug info on Byetta; Glucagon.
