The DCRA (SB113
/HB#TBD) will require state-regulated insurance companies to
cover diabetes education, equipment and
supplies for Ohioans who have
diabetes. Most patients in
the long-term BYETTA clinical studies
also experienced reductions in weight.
About Incretin Mimetics
Incretin mimetics is
a new class of therapeutics for use in the fight
against type 2 diabetes. This selection is typically
determined
by the standard used by the country in which they live.LifeScan. In many other countries
,
millimoles per liter or "mmol/L" is used.
lancet erase
Our
advocacy efforts include helping to combat discrimination
against people with
diabetes; advocating for the increase of federal diabetes research and
programs;
and improved access to, and quality of, healthcare for people with
diabetes."
"BYETTA offers
an exciting new option for people with type 2 diabetes and
marks an important milestone for Amylin
and Lilly's successful collaboration,"
said Sidney Taurel, Chairman and Chief Executive Officer,
Eli Lilly and
Company.
Patients receiving BYETTA in combination with a sulfonylurea have an
increased risk of hypoglycemia; to reduce this risk, reduction in the dose of
the sulfonylurea
should be considered. To access
the webcast, please log on to http://www. 2003; 88(7):3082-
3089
.
From the beginning of 2004 through mid-March 2005, LifeScan has received
40 worldwide reports
of adverse events associated with these meters being set
to the incorrect unit of measure. An accidental
change in the meter's unit of measure can contribute
to people with diabetes misunderstanding their
test results and managing their
diet or medication in a way that can result in temporary periods
of high or
low blood sugar.
lancet erase
Ginger L.com .com/cgi-bin/prnh/20050427/LILLYAMYLINLOGO
)
Shipments of test strips for these systems are not
affected.com.syringes diabetes
Over 750,000 adults
in Ohio, and approximately 1 in 4 children, have diabetes. Information from
both these sources is
available in English and Spanish.
BYETTA improves blood sugar control by lowering both postmeal
and fasting
glucose levels leading to better long-term control as measured by hemoglobin
A1C.
About BYETTA
BYETTA is the first in a new class of drugs for the treatment of type
2
diabetes called incretin mimetics and exhibits many of the same effects as the
human incretin
hormone glucagon-like peptide-1 (GLP-1).com . Journal of Clinical Endocrinology + Metabolism. Available
at: http://www.travco glucose
COLUMBUS, Ohio, Clad in the American Diabetes
Association's signature "Red Shirts
," Diabetes Advocates from across Ohio
gathered at the Statehouse today in support of legislation
that will save
money and lives in the state of Ohio.(3)
According to the Centers for Disease
Control and Prevention's National
Health and Nutrition Examination Survey, approximately 60 percent
of diabetes
patients do not achieve target hemoglobin A1C levels (less than 7 percent
according
to American Diabetes Association guidelines(5)) with their current
treatment regimen.m. PT). Additional
information about Lilly is available at http://www.
Accessed April 12, 2005. Deaths: Final data
for
2002.LifeScan Announces Worldwide Correction Concerning Certain Blood Glucose Meters
travco sharpz
BYETTA
, a first-in-class medicine, is a new therapy for those who are not able
to effectively control their
blood sugar with their current oral medications."
In addition to approving BYETTA for use as
an adjunct to existing oral
medicines, the FDA also stated that BYETTA is approvable as a stand-alone
therapy (monotherapy) for patients with type 2 diabetes.calorie lancets
"With BYETTA's demonstrated effects on
blood sugar and its safety
profile, physicians and patients now have a new approach to fight the
growing
diabetes epidemic. For
full Prescribing Information, visit http://www. An incretin mimetic
works to mimic the antidiabetic
or glucose-lowering actions of naturally occurring human hormones
called
incretins. Graham, President and Chief Executive
Officer of Amylin Pharmaceuticals, will
lead the call.
The call will be webcast live through Amylin's corporate website, and a
recording
will be made available following the close of the call. Amylin and Lilly undertake no duty to update
these forward-looking
statements. Synthetic exendin-4 (exenatide)
significantly reduces postprandial
and fasting glucose in subjects with type 2
diabetes. 1999;22:403-408.calorie travco
Stewart
Perry, Chair of
the American Diabetes Association's National Advocacy
Committee. In the 30-week controlled clinical
trials, hypoglycemia appeared to be dependent on the doses of both BYETTA and
a sulfonylurea.
(6)
Amylin to Webcast Investor Conference Call
Amylin Pharmaceuticals will webcast
a conference call to discuss the
BYETTA approval and commercialization plans on Friday, April 29
, 2005 at 12:00
p., Lilly provides answers -- through medicines and
information -- for some of
the world's most urgent medical needs.org/home/index.gov/diabetes/pubs/pdf/ndfs_2003.
(4) Kochanek
KD, Murphy SL, Anderson RN, Scott C.
The company is conducting a worldwide notification program
consisting of
letters to registered users and healthcare professionals, and also special
instructions
inserted in each package of test strips.kitz vials
org. Any additional data
submitted to support a monotherapy
indication is expected to receive a six-
month review.amylin.
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.pdf.
P-LLY
(Logo: http://www.
The products
are distributed worldwide primarily through retail pharmacy
and mail order channels. LifeScan is
implementing a product
modification for its new OneTouch Ultra Meters that will prevent users from
inadvertently switching their meter's unit of measure.
LifeScan is a Johnson + Johnson company
.glucometer calorie
"
The American Diabetes Association is the nation's leading voluntary health
organization
supporting diabetes research, information and advocacy.S."
"Successfully managing diabetes is
a daily struggle for millions of
Americans," said Ginger L.(1) BYETTA was
approved by the FDA
for use by people with type 2 diabetes who are
unsuccessful at controlling their blood sugar levels
despite using the
commonly prescribed oral medications metformin, a sulfonylurea or both. BYETTA
is the first FDA-approved agent of this new class of medications. These
and additional risks
and uncertainties are described more fully in Amylin and
Lilly's most recently filed SEC documents
such as their Annual Reports on Form
10-K.newscom.vials rebates
About 100,000 people with diabetes in Ohio
do not have their basic diabetes
needs covered by their state regulated insurance carriers. This
represents
about $1 billion in out-of-pocket expenses each year for people with diabetes
so that
they may adequately care for their disease. The Association's mission is to prevent and cure diabetes
and to
improve the lives of all people affected by diabetes. BYETTA (pronounced bye-A-tuh), the
trade name for exenatide, is
the first in a new class of medicines known as incretin mimetics.
Safety and Tolerability Information
In the three 30-week controlled trials, adverse events
associated with
BYETTA were generally mild to moderate in intensity. The most frequently
reported
adverse event was mild-to-moderate, dose-dependent nausea. For more information about Lilly's
current
diabetes products visit http://www.
REFERENCES
(1) Kolterman, O, Buse J, Fineman
M, Gaines E, Heintz S, Bicsak T, Taylor
K, Kim D, Aisporna M, Wang Y, Baron A.idf. Racial and
ethnic
differences in glycemic control of adults with type 2 diabetes. LifeScan is
instructing patients
to confirm their meter's unit of measure and the code
number each time they test. Food and Drug Administration
(FDA) and
other regulatory agencies around the world of this voluntary action.com or, in
the U
.insulin roadmap
"When it comes to diabetes in Ohio, the economic toll is only second to
the cost in human
lives," said Gina Gavlak, RN, a volunteer with American
Diabetes Association's Cleveland Leadership
Council., Amylin Pharmaceuticals, Inc. BYETTA will
be available to pharmacies by June 1, 2005.
With
continued therapy in most patients who initially experienced nausea, the
frequency and severity
decreased over time.(3) Diabetes is the fifth leading cause of death by disease in the
United States
(4) and costs approximately $132 billion per year in direct and
indirect medical expenses. Available
at:
http://www. All three affected meter systems
were originally designed to allow patients to
select one of two units of
measure to display their test results.
To further address this
issue, LifeScan has temporarily stopped shipment
of versions of the OneTouch Ultra, OneTouch FastTake
and InDuo Systems that
allow users to change the unit of measure.sharpz glucometer
and INDIANAPOLIS, Ind. "BYETTA
is a
truly unique tool for the management of type 2 diabetes and is an appropriate
option to consider
when patients cannot control their blood sugar using one or
more oral medications., LifeScan, a
maker of blood
glucose testing systems for people with diabetes, is initiating a worldwide
notification
to all users of its OneTouch(R) Ultra(R), InDuo(R) and
OneTouch(R) FastTake(R) Meters that it may
be possible for users to
misinterpret their blood glucose results. Patients with these
products
are advised to contact LifeScan to confirm their meter is set to the
proper unit of measure.kitz glucose
"It
is time for the governor and the legislature to take a fresh
look at the widespread benefits associated
with passage of the DCRA and make
access to a healthy life a reality for the more than 750,000 Ohioans
living
with diabetes. --A New First-in-Class Treatment for Patients with Type 2 Diabetes--
SAN DIEGO, Calif.
"The availability of a treatment that lowers blood sugar and has the
potential to help restore the response of the body's insulin-producing cells
is an exciting advance
for patients with type 2 diabetes," said Dr.
BYETTA should not be used in patients with type
1 diabetes or for the
treatment of diabetic ketoacidosis, nor is BYETTA a substitute for insulin
in
insulin-requiring patients.com . Type 2 diabetes usually occurs in adults over the
age of
40, but is increasingly common in younger people.m. Further information on Amylin Pharmaceuticals,
its
marketed products, and its pipeline in metabolism is available at
http://www.
In addition
, very rarely, an event such as dropping a meter while in use
can cause a brief power loss, which
may also unexpectedly change the unit of
measure and/or the code number used to program the meter
to match a particular
vial of test strips.S.lancets sharpz
The DCRA provides for the minimal requirements
to keep a person with
diabetes alive, healthy, and free of deadly and costly complications.
"Ohio is way behind the vast majority of the states when it comes to
protecting the health and
economic security of its residents," said R. Food and Drug Administration (FDA) has
approved BYETTA
(TM) (exenatide) injection as adjunctive therapy to improve
blood sugar control in patients with type
2 diabetes who have not achieved
adequate control on metformin and/or a sulfonylurea, two common
oral diabetes
medications.BYETTA. The potential for BYETTA may also be affected by
government
and commercial reimbursement and pricing decisions, the pace of
market acceptance and any issues
related to manufacturing and supply. Hyattsville, Maryland:
National Center for Health Statistics
. These events have generally consisted of
temporary periods of high or low blood sugar, some of
which required medical
attention.kitz antiseptic
Amylin and Lilly Announce FDA Approval of BYETTA(TM) (Exenatide
) Injection
David
Kendall, Medical Director at International Diabetes Center in Minneapolis,
Minnesota
, and an investigator for the BYETTA clinical studies. "Often, current treatments do not provide
adequate
blood sugar control leaving patients and caregivers frustrated.
For full Prescribing Information
, visit http://www.com . These actions include stimulating the body's ability to produce
insulin
in response to elevated levels of blood sugar, inhibiting the release
of a hormone called glucagon
following meals, slowing the rate at which
nutrients are absorbed into the bloodstream and reducing
food intake. ET (9:00 a.
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.com .cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A. In the United States
, patients can call LifeScan
Customer Service at 1 800 515-0915.LifeScan.cremes wallets
Today's activities
follow a January 25, 2005 meeting between seven year-
old Jessi Martin, of Williamsburg, and Governor
Bob Taft's office."
Diabetes is the fifth deadliest disease in the United States, and more
than
a million people develop the disease each year.diabetes.
BYETTA is formulated for
self-administration as a fixed dose, subcutaneous
injection given prior to the morning and evening
meals.
About Diabetes
Diabetes affects an estimated 194 million adults worldwide(2
) and more
than 18 million in the United States.amylin.
(2) The International Diabetes Federation
Diabetes Atlas. National vital statistics reports; vol 53 no 5.S., call LifeScan Customer Services at
1-800-515-0915.calorie lancet
This legislation has been in front of the Ohio General Assembly for
12 years. (Nasdaq:
AMLN), and Eli Lilly and Company
(NYSE: LLY) announce that the U. BYETTA does this through several
actions, including the stimulation of
insulin secretion only when blood sugar is high and by restoring
the first-
phase insulin response, an activity of the insulin-producing cells in the
pancreas
that is lost in patients who have type 2 diabetes. Use of BYETTA is not recommended in patients with
end-stage renal disease or severe renal impairment, or in patients with severe
gastrointestinal
disease.BYETTA. 2004. Standards of medical care in diabetes.syringes erase
Founded in 1940, the
Association provides
service to hundreds of communities across the country.lillydiabetes.
The timing to resume
shipments of InDuo and OneTouch FastTake Meters has
not been determined. For additional information
and
instructions on proper meter use, please visit http://www.cremes calorie
Jessi
delivered to the Governor
803 pleas from Ohio residents touched by diabetes. Graham, President and Chief Executive Officer,
Amylin
Pharmaceuticals, Inc. No
increased risk of hypoglycemia was observed in the 30-week controlled studies
with BYETTA when used in combination with metformin compared to placebo. GLP-1, secreted in
response
to food intake, has multiple effects on the stomach, liver, pancreas
and brain that work in concert
to regulate blood sugar.com approximately fifteen minutes
prior to the call to register, download
and install any necessary audio
software.
About Amylin and Lilly
Amylin Pharmaceuticals
is a biopharmaceutical company committed to
improving lives through the discovery, development and
commercialization of
innovative medicines. Headquartered in
Indianapolis, Ind.
This press
release contains forward-looking statements about Amylin and
Lilly.
(5) American Diabetes
Association.
Diabetes Care. There are an estimated 4.calorie vials
In meetings with their legislators
, Advocates asked for cosponsorship of
the Diabetes Cost Reduction Act (DCRA), introduced by Representative
Michelle
Schneider (R-36-Cincinnati) and Senator Jeffry Armbruster (R-13-Ridgeville). The Taft moratorium
hinders the DCRA's progress,
thereby driving up the cost of healthcare for all Ohio residents and
endangering the lives of those with diabetes.(3) Approximately 90 to 95 percent of
those affected
have type 2 diabetes, a condition where the body does not
produce enough insulin and/or the cells
in the body do not respond normally to
insulin.
In the United States, milligrams per deciliter
or "mg/dL" is the standard
of measure for blood glucose testing systems.7 million users of these
products
worldwide.transportable lancets
Diabetes
education involves instruction on good nutrition, the importance
of properly
monitoring blood glucose levels, and administering of oral diabetes agents
and/or
insulin via syringe, insulin pump or other insulin delivery system. "As someone who has
carefully
balanced their diabetes with daily life for more than 24 years,
nothing scares me more than the idea
of not being able to afford the
medications and supplies that keep me healthy enough to have a successful
career and be a good mom to my children.lilly.
(3) Centers for Disease Control and Prevention
, National Diabetes Fact
Sheet.diabetic lancets
Examples of diabetes equipment are blood glucose monitors, insulin
injector
pens and insulin pumps.
For more information please call the American Diabetes Association
at 1-800-
DIABETES (1-800-342-2383) or visit http://www. Most episodes of hypoglycemia were mild
to moderate in
intensity and all were resolved with oral administration of carbohydrate. Contact
information for other countries
is available at http://www.
LifeScan has notified the U.antiseptic travco
Diabetes
Advocates Paint the Statehouse Red
The letters from "faces of diabetes" in Ohio ask the governor
to lift the
moratorium he imposed in 2003 on health insurance mandates such as coverage
for life
sustaining insulin.
Ohio is one of only four states in the country that do not have mandated
health coverage for diabetes supplies and services for insured residents. BYETTA will be made
available
in both a 5-microgram per dose and a 10-microgram per dose prefilled
pen-injector device. BYETTA
should be used with caution in patients
receiving oral medications that require rapid gastrointestinal
absorption. 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 may not prove
to be an important new therapeutic option,
additional indications for BYETTA may not be received
, BYETTA may not be
commercially available when planned and/or may be affected by unexpected new
data
or technical issues.cdc.
(6) Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS. LifeScan
found that
it was possible for consumers, in the course of setting their meter's date and
time
, to accidentally change the unit of measure and thereby misinterpret
their blood glucose results
. Shipments of the
OneTouch Ultra Meters with this modification are expected to begin next week.
lancets antiseptic
Diabetes supplies range from insulin, to blood glucose
monitoring strips, to syringes. Diabetes
cost the
country $132 billion in 2002; up from $98 billion in 1997, and despite
aggressive research
efforts, there remains no cure in sight.
Patients should also be advised that treatment with
BYETTA may result in a
reduction in appetite, food intake, and/or body weight and that there is no
need to modify the dosing regimen due to such effects. A recording will be available by phone for
24 hours beginning
approximately one hour after the close of the call and can be accessed at
888
-286-8010 (domestic) or 617-801-6888 (international), conference ID number
65243380.
Diabetes Care
2005;28:S4-36S. MILPITAS, Calif.
Users should continue to test their blood glucose. In some
countries, the FastTake Meter is sold under the
EuroFlash(R), SmartScan(R) and PocketScan(R) Brand
names.erase diabetes
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