�Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company
(NYSE: LLY) in a conference call today provided context and additional
information regarding the August 18, 2008 U.S. Food and Drug Administration
(FDA) update to a prior qui vive for BYETTA(R) (exenatide) injection referencing
pancreatitis. The companies were aware of the pancreatitis cases referenced
in the alarm, as good as others, and antecedently reported these cases to the
FDA. The complete conference call replay will be usable through Amylin's
and Lilly's corporate websites after the call.
Since 2006, the U.S. prescribing information for exenatide has included
information about pancreatitis. A recent study has also shown that patients
with type 2 diabetes were at nearly trey times the risk of developing
pancreatitis than those without diabetes.(1) While a definite causal
relationship between exenatide and pancreatitis has non been proven, to
better understand the suspected human relationship, Amylin and Lilly proceed to
engage a comprehensive drug safe program that includes extended internal
and external review of single cases, and clinical and epidemiologic
studies.
"At Amylin and Lilly, patient safety is our foremost care. We are
committed to continuing to work closely with the FDA to ensure that
physicians and patients ar provided with accurate entropy about any
potential risks associated with the use of our products," said Orville G.
Kolterman, Senior Vice President, Research and Development at Amylin. "It is
crucial to read that pancreatitis, an rabble-rousing condition of the
pancreas, is a rare event. Further, the characteristics and complications of
the pancreatitis cases in patients on exenatide ar consistent with
pancreatitis in the general population. We believe exenatide continues to
have a positive benefit-risk profile for patients with type 2 diabetes."
About BYETTA(R) (exenatide) Injection
Exenatide is the first base and only approved incretin mimetic, a class of
drugs for the discourse of type 2 diabetes. Exenatide exhibits many of the
same effects as the human incretin endocrine glucagon-like peptide-1 (GLP-1).
GLP-1, secreted in response to food intake, has multiple effects on the
bowel, liver, pancreas and head that work in concert to regularize blood
refined sugar.(2) Exenatide is approved in the European Union as adjunctive therapy
to improve blood sugar control in patients with type 2 diabetes who have not
achieved adequate glycaemic control on maximally tolerated doses of metformin
and/or a sulphonylurea, two unwashed oral diabetes medications. Since the U.S.
market instauration in June 2005, close to one billion patients
worldwide have been treated with exenatide.
About Diabetes
Diabetes affects an estimated 246 zillion adults general and more than
48 million in Europe.(3,4) Approximately 90 to 95 percentage of those are
affected by type 2 diabetes, a condition characterized by failure of the
pancreatic beta-cell to adequately respond to the increased demands for
insulin that occur as a result of obesity-related insulin resistance.(5) In
westerly countries, around 90 per centum of type 2 diabetes cases are
attributable to weight attain.(6)
Type 2 diabetes usually occurs in adults over the age of 40, just is
increasingly common in younger people.(7) In virtually every developed
society, diabetes is ranked among the preeminent causes of blindness, nephritic
failure and lower limb amputation, as well as death through its effects on
cardiovascular disease (70-80 percent of people with diabetes die of
cardiovascular disease).(8) The total cost of caring for people with diabetes
in Europe is estimated 'tween 28 1000000000 and 53 billion Euros per year. The
deliberate estimates of the costs of diabetes care in Europe measure to 42.8
zillion International Dollars per year.(9)
Important Safety Information for exenatide
In clinical studies, the most common side personal effects were hypoglycaemia (low
blood sugar) when taken with a sulphonylurea, nausea (feeling sick), vomit
and looseness of the bowels. For the full list of all side personal effects reported with exenatide,
see the Package Leaflet. Exenatide should non be used in people who may be
hypersensitized (allergic) to exenatide or any of the other ingredients.
About Incretin Mimetics
Incretin mimetics are a distinct grade of agents used to treat type 2
diabetes. An incretin mimetic workings to mimic the antidiabetic drug or glucose
lowering actions of the naturally occurring human incretin hormone GLP-1.
These actions include stimulating the body's ability to produce insulin in
response to elevated levels of blood refined sugar, inhibiting the release of a
internal secretion called glucagon following meals, slowing the rate at which nutrients
are engrossed into the bloodstream and reducing food intake.
About Amylin and Lilly
Amylin Pharmaceuticals is a biopharmaceutical company committed to
improving lives through the discovery, development and commercialization of
innovative medicines. Amylin's research and development activities leverage
the company's expertness in metabolic process to educate potential therapies to treat
diabetes and obesity. Amylin is headquartered in San Diego, California with
over 2,000 employees in the United States.
Through a longstanding commitment to diabetes caution, Lilly provides
patients with breakthrough treatments that enable them to live yearner,
healthier and fuller lives. Since 1923, Lilly has been the industry drawing card in
pioneering therapies to help health care professionals ameliorate the lives of
citizenry with diabetes, and research continues on innovative medicines to
speak the unmet needs of patients.
Lilly, a leading innovation-driven corporation, is development a maturation
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own general laboratories and from
collaborations with high scientific organizations. Headquartered in
Indianapolis, Indiana, Lilly provides answers - through medicines and
data - for some of the world's most urgent medical inevitably.
This campaign release contains forward-looking statements about Amylin and
Lilly. Actual results could disagree materially from those discussed or implied
in this press discharge due to a number of risks and uncertainties, including
the risk that exenatide and the revenues generated from exenatide may be
affected by contender; unexpected new data; guard and technical issues;
clinical trials not confirming premature results; presymptomatic trials not
predicting future results; new drug applications and label expansion requests
not being submitted in a timely manner or receiving regulative approval; or
manufacturing and supply issues. The potential for exenatide may besides be
unnatural 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 latterly filed SEC 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.
(1) Noel R, Braun D, Patterson R, Bloomgren G. Increased risk of e
pancreatitis observed in patients with type 2 diabetes. twenty-fourth International
Conference on Pharmacoepidemiology and Therapeutic Risk Management.
Copenhagen, Denmark. International Society for Pharmacoepidemiology.
(2) Kolterman, O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T, Taylor
K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic exendin-4 (exenatide)
significantly reduces postprandial and fasting glucose in subjects with type
2 diabetes. Journal of Clinical Endocrinology & Metabolism. 2003;
88(7):3082-3089.
(3) The International Diabetes Federation Diabetes Atlas. Available here.Accessed on May 22, 2008.
(4) The International Diabetes Federation, Prevalence / All diabetes.
Available http://www.eatlas.idf.org/Prevalence/All_diabetes/. Accessed on
May 22, 2008.
(5) Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with dieting,
sulfonylurea, metformin, or insulin in patients with type 2 diabetes
mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA.
1999; 281 (21):2005-2012.
(6) The International Diabetes Federation Diabetes Atlas. Available
here. Accessed on May 22,
2008.
(7) The International Diabetes Federation, Prevalence / All diabetes.
Available here. Accessed on
May 22, 2008.
(8) The International Diabetes Federation, Complications. Available here. Accessed on May 22, 2008.
(9) The International Diabetes Federation, Diabetes Atlas, Second
edition. Available here.
Accessed August 26, 2008
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