INDIANAPOLIS and SAN DIEGO, July 10 /PRNewswire/ --
- This appraisal decision, as well as the recent reimbursement
approval in Sweden, opens access for more European patients who have not
achieved adequate glycaemic control on metformin and/or sulphonylureas -
Eli Lilly and Company (NYSE: LLY) and Amylin Pharmaceuticals, Inc.
(Nasdaq: AMLN) welcomed today the recent decision by the Scottish Medicines
Consortium (SMC) on the use of BYETTA(R) (exenatide) in Scotland. The
decision states that exenatide is restricted for use in National Health
Service (NHS) Scotland for the treatment of type 2 diabetes mellitus in
combination with metformin and/or sulphonylureas in patients who have not
achieved adequate glycaemic control on maximally tolerated doses of these
oral therapies.(1)
Exenatide has shown non-inferiority to two insulin regimens with which it
has been compared and has a beneficial effect on weight. It is restricted to
use as an alternative to insulin in patients who have failed treatment on
metformin and/or sulphonylureas and in whom insulin would be the next
treatment option.(1)
"Exenatide is the first incretin mimetic to be appraised by the SMC,"
said Andrew Hotchkiss, General Manager at Lilly UK. "Diabetes affects 170,000
people in Scotland(2) and we are delighted that the innovative nature of this
new medicine and its potential benefit to patients has been recognised by the
SMC."
BYETTA is the first in a new class of medicines for the treatment of
type 2 diabetes known as incretin mimetics.
As well as the positive guidance from the SMC on the use of BYETTA, there
has recently been a reimbursement approval for BYETTA in Sweden where the
Pharmaceutical Benefits Board (LFN) concluded that BYETTA should be
reimbursed in the pharmaceutical benefits system for use in people with type
2 diabetes.(3)
About BYETTA(R) (exenatide) injection
BYETTA is the first in a class of medicines for the treatment of type 2
diabetes called incretin mimetics. 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 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 common oral diabetes
medications.(4) BYETTA provides sustained HbA1c control, low incidence of
hypoglycaemia when used with metformin and progressive weight loss. In three
separate insulin comparator studies, patients initiating exenatide generally
lost weight while patients initiating insulin therapy generally gained
weight.(5,6,7) In addition, when compared to insulin glargine, exenatide was
associated with a lower incidence of hypoglycaemia when used with
metformin.(8)
Important Safety Information for BYETTA(R) (exenatide) injection
In clinical studies, the most common side effects were hypoglycaemia (low
blood sugar) when taken with a sulphonylurea, nausea (feeling sick), vomiting
and diarrhoea. For the full list of all side effects reported with BYETTA,
see the Package Leaflet. BYETTA should not be used in people who may be
hypersensitive (allergic) to exenatide or any of the other ingredients.
About Diabetes
Diabetes affects an estimated 246 million adults worldwide and more than
48 million in Europe.(9,10) Approximately 90 to 95 percent of those are
affected by type 2 diabetes, a condition characterized by failure of the
pancreatic beta cells to adequately respond to the increased demands for
insulin that occur as a result of obesity-related insulin resistance.(11)
Type 2 diabetes usually occurs in adults over the age of 40, but is
increasingly common in younger people.(10) In virtually every developed
society, diabetes is ranked among the leading causes of blindness, renal
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).(12) The calculated estimates of the costs of
diabetes care in Europe amount to 42.8 billion International Dollars per
year.(13)
About Lilly and Amylin
Through a long-standing commitment to diabetes care, Lilly provides
patients with breakthrough treatments that enable them to live longer,
healthier and fuller lives. Since 1923, Lilly has been the industry leader in
pioneering therapies to help health care professionals improve the lives of
people with diabetes, and research continues on innovative medicines to
address the unmet needs of patients.
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Indiana, Lilly provides answers - through medicines and
information - for some of the world's most urgent medical needs.
Amylin Pharmaceuticals is a biopharmaceutical company committed to
improving lives through the discovery, development and commercialization of
innovative medicines. Amylin has developed and gained approval for two
first-in-class medicines for diabetes. Amylin's research and development
activities leverage the company's expertise in metabolism to develop
potential therapies to treat diabetes and obesity. Amylin is located in San
Diego, California with over 1,700 employees nationwide.
This press release contains forward-looking statements about Lilly and
Amylin. 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, technical issues, clinical
trials not confirming previous results or predicting future results, label
expansion requests not being submitted in a timely manner or receiving
regulatory approval, 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 Lilly and Amylin's most recently filed United States
Securities Exchange Commission documents such as their Quarterly Reports on
Form 10-Q. Lilly and Amylin undertake no duty to update these forward-looking
statements.
REFERENCES
(1) www.scottishmedicines.org.uk
(2) Diabetes UK: State of the Nations 2006. January 2007
(3) Swedish Pharmaceutical Benefits Board (LFN) www.lfn.se
(4) The European Public Assessment Report for Byetta. Available at
http://www.emea.europa.eu/humandocs/Humans/EPAR/byetta/byetta.htm. Accessed
July 5, 2007.
(5) Barnett AH, Trautmann M, Burger J, Johns D, Kim D, Brodows R, Festa
A, Roberts A. A comparison of exenatide and insulin glargine in patients
using a single oral antidiabetic agent. Data disclosure at the 42nd annual
meeting of the European Association of the Study of Diabetes. September 16,
2006.
(6) Heine RJ, Van Gaal LF, Johns D, Mihm MJ, Widel MH, Brodows RG.
Exenatide versus insulin glargine in patients with suboptimally controlled
type 2 diabetes: A randomized trial. Annals of Internal Medicine 2005;
143(8):559-69.
(7) Nauck MA, Duran S, Kim D, Johns D, Northrup J, Festa A, Brodows B,
Trautmann M. A comparison of twice-daily exenatide and biphasic insulin
aspart in patients with type 2 diabetes who were suboptimally controlled with
sulfonylurea and metformin: A noninferiority study. Diabetologia 2007;
50:259-267
(8) Trautmann ME., Burger J., Johns D., Brodows R., Okerson T., Roberts
A., and Barnett A. Less hypoglycemia with exenatide versus insulin glargine,
despite similar HbA1c improvement, in patients with T2DM adjunctively treated
with metformin. Data disclosure at the 67th Scientific Sessions of the
American Diabetes Association, June 24, 2007, Abstract # 0172-OR.
(9) The International Diabetes Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed June 14, 2007.
(10) The International Diabetes Federation, Prevalence / All diabetes.
Available at http://www.eatlas.idf.org/Prevalence/All_diabetes/.
(11) Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with diet,
sulfonylurea, metformin, or insulin in patients with type 2 diabetes
mellitus: progressive requirement for multiple therapies (UKPDS 49). JAMA
1999; 281(21):2005-2012.
(12) The International Diabetes Federation, Complications. Available at
http://www.eatlas.idf.org/Complications/
(13) The International Diabetes Federation, Diabetes Atlas, Second
edition. The Economic Impact of Diabetes. 2003:186.
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