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Amylin Pharmaceuticals to Present at the 18th Annual Credit Suisse Healthcare Conference.
San Diego, CA – November 1, 2009 and Osaka, Japan – November 2, 2009 – Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Takeda Pharmaceutical Company Limited (TSE: 4502) announced today that they have entered into a worldwide exclusive license, development and commercialization agreement to
The agreement includes products to be developed from Amylin's pipeline, including pramlintide/metreleptin and davalintide, which are compounds currently in phase 2 development for treatment of obesity. The agreement also includes additional compounds from both companies' obesity research programs.
http://www.biospace.com/news_story.aspx?StoryID=161253&full=1
SAN DIEGO and INDIANAPOLIS, Nov. 2, 2009 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN - News) and Eli Lilly and Company (NYSE: LLY - News) today
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SAN DIEGO, Nov 05, 2009 /PRNewswire-FirstCall via COMTEX/ --
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) will be presenting at the 18th Annual Credit Suisse Healthcare Conference in Phoenix, Arizona on Wednesday, November 11, 2009 at 10:00 a.m. PT / 1:00 p.m. ET. Mark Foletta, senior vice president of finance and chief financial officer at Amylin Pharmaceuticals, will be providing a corporate overview.
The audio portion of the presentation will be webcast and a recording will be made available following the event. The webcast and recording will be accessible through Amylin's corporate Web site, located at www.amylin.com. To access the live webcast, please log on to Amylin's site approximately fifteen minutes prior to the presentation to register and download any necessary audio software.
About Amylin Pharmaceuticals
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin's research and development activities leverage the Company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California. Further information about Amylin Pharmaceuticals is available at www.amylin.com.
SOURCE Amylin Pharmaceuticals, Inc.
http://www.amylin.com
Tags: conference corporate diabetes finance healthcare nasdaq obesity pharmaceuticals president research and development software web
Companies: Amylin Pharmaceuticals, Inc. (AMLN)
Nov 02, 2009 (Fresh Brewed Media via COMTEX) --
Amylin Pharmaceuticals (AMLN) leads the list of top gainers so far today and is now at $12.14, up $1.10 (9.96%) on volume of 12,236,203 shares traded. Over the last 52 weeks the stock has ranged from a low of $5.50 to a high of $15.69. The stock is seeing momentum today on news that it signed a deal with Japan's Takeda Pharmaceutical Co. on potential weight-loss treatments that could bring AMLN up to $1 billion. Amylin Pharmaceuticals stock has been showing support around $10.69 and resistance in the $11.67 range. Technical indicators for the stock are neutral and S&P gives AMLN a neutral 3 STARS (out of 5) hold ranking. If you are looking for a hedged play on AMLN the stock seems like it could be a candidate for a January out-of-the-money bull-put credit spread below the 10 range.
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Companies: Amylin Pharmaceuticals, Inc. (AMLN)
SAN DIEGO and INDIANAPOLIS, Nov 02, 2009 /PRNewswire-FirstCall via COMTEX/ --
Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN) and Eli Lilly and Company (NYSE: LLY) today issued the following statement in response to the U.S. Food and Drug Administration (FDA) update on BYETTA(R) (exenatide) injection.
"The FDA update issued today aligns with the BYETTA label approved last week. The current label reflects our understanding of post-marketing reports of renal events and provides physicians with updated guidance about appropriate use in patients with renal conditions. There is no evidence from preclinical and clinical studies that BYETTA has any direct toxic effect on the kidney," said Orville G. Kolterman, M.D., senior vice president of research and development, Amylin Pharmaceuticals. "Post-marketing reports of serious changes in renal function have been rare and usually complicated by other factors that could have contributed to the kidney problems. It is also important to note that diabetes is the leading cause of kidney failure. Information about use of BYETTA in patients with impaired renal function was included in the initial product label in 2005 and was updated in 2007. We remain committed to working closely with the FDA to ensure that physicians and patients are provided with accurate information about any potential risks associated with the use of our products."
On October 30, the FDA approved an expanded indication for BYETTA as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes. In addition to the monotherapy indication, the FDA approved changes to the BYETTA Prescribing Information to incorporate updated safety information. The new label expands upon existing language regarding use of BYETTA in patients with renal impairment, which Amylin and Lilly updated in September 2007 to include additional language regarding renal adverse events. It specifies that BYETTA should not be used in patients with severe renal impairment or end-stage renal disease and should be used with caution in patients with renal transplantation. It also specifies that because BYETTA may induce nausea and vomiting with transient hypovolemia (low blood volume), treatment may worsen renal function. This update was communicated to physicians via a "Dear Healthcare Professional" letter, which is available at www.BYETTA.com.
BYETTA has extensive post-marketing experience and a well-documented safety profile. BYETTA has been used by more than one million patients since market introduction in 2005. It has a proven history with more than 10 million prescriptions written and 6.5 years of clinical experience.
About Diabetes
Diabetes affects more than 24 million people in the United States and an estimated 246 million adults worldwide.(i, ii) Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $174 billion per year in direct and indirect medical expenses.(iii)
According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.(iv)( )In addition, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.(v) Data indicate that weight loss (even a modest amount) supports patients in their efforts to achieve and sustain glycemic control.(vi, vii)
About BYETTA(R) (exenatide) injection
BYETTA is the first and only FDA-approved GLP-1 receptor agonist for the treatment of type 2 diabetes. BYETTA exhibits many of the same effects as the human incretin hormone glucagon-like peptide-1 (GLP-1). GLP-1 improves blood sugar after food intake through multiple effects that work in concert on the stomach, liver, pancreas and brain.
BYETTA is an injectable prescription medicine that may improve blood sugar (glucose) control in adults with type 2 diabetes mellitus, when used with a diet and exercise program. BYETTA is not insulin and should not be taken instead of insulin. BYETTA is not recommended to be taken with insulin. BYETTA is not for people with type 1 diabetes or people with diabetic ketoacidosis.
BYETTA provides sustained A1C control and low incidence of hypoglycemia when used 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 used by more than one million patients since its introduction. For full prescribing information, visit www.BYETTA.com.
Important Safety Information for BYETTA(R) (exenatide) injection
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 higher if BYETTA is taken with another medicine that can cause low blood sugar, such as a sulfonylurea. BYETTA should not be used in people who have severe kidney problems, and should be used with caution in people who have had a kidney transplant. Patients 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 commonly happens when first starting BYETTA, but may become less over time.
These are not all the side effects from use of BYETTA. A healthcare provider should be consulted about any side effect that is bothersome or does not go away.
For Prescribing Information and Medication Guide, visit www.BYETTA.com.
About Amylin and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin's research and development activities leverage the Company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California. Further information on Amylin Pharmaceuticals is available at www.amylin.com.
Through a long-standing commitment to diabetes care, Lilly seeks to provide patients with breakthrough treatments that enable them to live longer, healthier, and fuller lives. Since 1923, Lilly has been an industry leader in pioneering therapies to help healthcare professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. For more information about Lilly's current diabetes products, visit www.lillydiabetes.com.
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.
This press release contains forward-looking statements about Amylin and Lilly. Actual results could differ materially from those discussed or implied in this press release due to a number of risks and uncertainties, including the risk that BYETTA and the revenues generated from BYETTA may be affected by competition; unexpected new data; safety and technical issues; clinical trials not confirming previous results; pre-clinical trials not predicting future results; label expansion requests not being submitted in a timely manner or receiving regulatory approval; approved label expansions not producing the results we expect, or manufacturing and supply issues. The potential for BYETTA may also be affected by government and commercial reimbursement and pricing decisions, the pace of market acceptance, or scientific, regulatory and other issues and risks inherent in the commercialization of pharmaceutical products. These and additional risks and uncertainties are described more fully in Amylin's and Lilly's most recent SEC filings including their Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty to update these forward-looking statements.
P-LLY
(i) The International Diabetes Federation Diabetes Atlas. Available at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. Accessed Oct. 2, 2009.
(ii) "All About Diabetes." American Diabetes Association. Available at: http://www.diabetes.org/about-diabetes.jsp. Accessed Oct. 2, 2009.
(iii) "Direct and Indirect Costs of Diabetes in the United States." American Diabetes Association. Available at: http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp. Accessed Oct. 2, 2009.
(iv) Saydah SH, Fradkin J and Cowie CC. Poor control of risk factors for vascular disease among adults with previously diagnosed diabetes. JAMA. 2004;291:335-42.
(v) Bays HE, Chapman RH, Grandy S. The relationship of body mass index to diabetes mellitus, hypertension and dyslipidaemia: comparison of data from two national surveys. Int J Clin Pract. 2007;61:737-47.
(vi) Nutrition Recommendations and Interventions for Diabetes: a position statement of the American Diabetes Association. Diabetes Care. 2007;30 Suppl 1:S48-65.
(vii) Anderson JW, Kendall CW, Jenkins DJ. Importance of weight management in type 2 diabetes: review with meta-analysis of clinical studies. J Am Coll Nutr. 2003;22:331-9.
SOURCE Amylin Pharmaceuticals, Inc.
http://www.amylin.com
Tags: clinical commercial diabetes disease exercise expansion fda food government healthcare index manufacturing market medical medicine nasdaq note nutrition nyse obesity pharmaceuticals physicians president products research research and development science sec sugar
Companies: Amylin Pharmaceuticals, Inc. (AMLN), Eli Lilly & Co. (LLY)
SAN DIEGO and OSAKA, Japan, Nov 01, 2009 /PRNewswire-FirstCall via COMTEX/ --
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Takeda Pharmaceutical Company Limited (TSE: 4502) announced today that they have entered into a worldwide exclusive license, development and commercialization agreement to co-develop and commercialize pharmaceutical products for the treatment of obesity and related indications.
The agreement includes products to be developed from Amylin's pipeline, including pramlintide/metreleptin and davalintide, which are compounds currently in phase 2 development for treatment of obesity. The agreement also includes additional compounds from both companies' obesity research programs. Amylin will receive a one-time up-front payment of $75 million from Takeda and, over the term of the agreement and in relation to the compounds under the agreement, is eligible to receive additional payments upon achieving certain development, commercialization and sales-based milestones that could exceed $1 billion. The agreement also provides for future tiered, double-digit royalty payments to Amylin based on global product sales.
Under the terms of the agreement, Amylin will be responsible for executing development activities for potential products through phase 2 with the aim of regulatory approval in the U.S. Takeda will lead development activities beyond phase 2 in the U.S., and all development activities outside the U.S. In most instances, Amylin will be responsible for 20% of development costs associated with obtaining approval for products in the U.S. and Takeda will be responsible for 80% of such U.S. development costs. Takeda will be responsible for 100% of development costs associated with obtaining approval for products outside the U.S.
Takeda will lead product commercialization, both in the U.S. and outside the U.S., and will be responsible for 100% of commercialization costs. Amylin will have the option to co-commercialize the first two approved products in the U.S. and any follow-on products containing the identical active ingredients.
"Takeda is excited to realize this partnership with Amylin focused on the treatment of obesity and related indications. By leveraging Takeda's global development and commercial infrastructure we look forward to maximizing the significant potential of the products under this agreement," said Yasuchika Hasegawa, president & chief executive officer, Takeda Pharmaceutical Company Limited. "Both Amylin and Takeda have extensive experience in the diabetes and metabolic disease area, and this collaboration should allow us to more quickly bring promising new treatments to patients in need."
"This collaboration will leverage Amylin's experience and expertise with peptide and protein science and Takeda's worldwide development and commercial expertise," said Daniel M. Bradbury, president and chief executive officer, Amylin Pharmaceuticals. "Amylin recognizes the enormous potential of this collaboration to advance more options in obesity treatment more quickly than either company could do alone. Amylin and Takeda are excited about working together to address the significant unmet need for the millions of patients who need better solutions to manage obesity."
About Obesity
Obesity is rapidly becoming a major health problem in all industrialized nations and many developing countries. It has reached epidemic proportions globally, with more than 1 billion adults overweight, and at least 300 million of them obese. Obesity is a chronic disorder that is linked to increased health risk of several medical conditions including type 2 diabetes, non-alcoholic fatty liver disease, high blood pressure, heart disease, stroke, osteoarthritis, sleep disorders and several types of cancers. According to The Obesity Society, obesity is the second leading cause of preventable death in the United States. The total direct and indirect cost burden attributed to treating overweight and obesity and related conditions has grown to nearly $150 billion in the United States each year.
About Amylin Pharmaceuticals
Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin's research and development activities leverage the Company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California. Further information on Amylin Pharmaceuticals is available at www.amylin.com.
About Takeda
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine by developing superior pharmaceutical products. Additional information about Takeda is available through its corporate website, www.takeda.com.
Forward-Looking Statements
This press release contains forward-looking statements about Takeda and Amylin, which involve risks and uncertainties. The actual results for each Company could differ materially from those discussed due to a number of risks and uncertainties, including that the obesity co-development and commercialization agreement mentioned in this press release will not achieve the results we expect; our clinical trials may not start when planned, be completed in a timely manner and/or confirm previous results; our preclinical studies may not be predictive; our product candidates, including those covered by the co-development and commercialization agreement mentioned in this press release, may not receive regulatory approval; and inherent scientific, regulatory and other risks in the drug development and commercialization process.
With respect to Amylin, these and additional risks and uncertainties are described more fully in Amylin's most recently filed SEC documents, including its Form 10-Q. Amylin undertakes no duty to update these forward-looking statements.
SOURCE Amylin Pharmaceuticals, Inc.; Takeda Pharmaceutical Company Limited
http://www.amylin.com
Tags: cancer ceo clinical commercial corporate diabetes disease epidemic health heart disease high blood pressure japan medical medicine nasdaq obesity partnership pharmaceuticals pipeline president products research research and development sales science sec
Companies: Amylin Pharmaceuticals, Inc. (AMLN)
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...SAN DIEGO Calif. Oct. 19 2009 /- Amylin Phar...Amylin will also present new scientific findings from preclinical stud... The discovery of leptin and its role along with other endocrine sign... Key Amylin Activities at Obesity 2009:
Amylin Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving lives through the discovery, development, and commercialization of innovative medicines.
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...SAN DIEGO Nov. 5 2009 /- Amylin Pharmaceutica...The audio portion of the presentation will be webcast and a recording ... About Amylin Pharmaceuticals ...Amylin Pharmaceuticals is a biopharmaceutical company dedicated to