Insulet to Develop New Version of the OmniPod Insulin Pump for Use With Humulin
R U-500 Concentrated Insulin for People With Type 2
BEDFORD, MA -- (Marketwired) -- 05/02/13 -- Insulet Corporation
(NASDAQ: PODD), the leader in tubeless insulin pump technology with
its OmniPod(R) Insulin Management System, today announced it has
entered into an agreement with Eli Lilly and Company in which Insulet
will develop a new version of the OmniPod insulin pump specifically
designed to deliver Humulin(R) R U-500 insulin, (regular U-500
[Concentrated] insulin human injection, USP [rDNA origin]), a
concentrated form of insulin used by people with highly insulin
resistant type 2 diabetes. Insulet is partnering with Eli Lilly and
Company on the clinical development program to evaluate the safety
and efficacy of the combined delivery system.
As the incidence of severe insulin resistance continues to rise, more
and more people with type 2 diabetes are requiring significantly
higher doses of insulin in order to control their blood glucose. This
new version of the OmniPod System would be the first insulin pump
designed with specific feature modifications to deliver Humulin(R) R
U-500 insulin. Given the rapid increases in rates of obesity and
corresponding increases in daily insulin requirements, the new
delivery system, if approved, would represents a significant and
growing opportunity for people with highly insulin resistant type 2
diabetes to potentially better manage their disease with such a
"We are pleased to develop the first insulin pump specifically for
Humulin(R) R U-500 insulin to bring the advantages of the OmniPod
System to people with highly insulin resistant type 2 diabetes," said
Duane DeSisto, President and Chief Executive Officer of Insulet. "The
tubeless design of the OmniPod insulin pump provides freedom and ease
of use for tens of thousands of people living with diabetes today."
About the OmniPod Insulin Management System
The OmniPod Insulin
Management System is the world's first tubeless insulin pump. The
OmniPod offers people living with insulin-requiring diabetes all the
benefits of insulin pump therapy, with freedom and ease. The
tubing-free OmniPod insulin pump has just two easy-to-use parts: the
discreet, waterproof Pod,
which automatically inserts and can be worn
on many parts of the body to hold and deliver insulin; and the
Personal Diabetes Manager (PDM), a hand-held device that wirelessly
programs the Pod, calculates suggested doses and has a built-in blood
glucose meter. To read inspiring stories of people with diabetes
living their lives to the fullest with OmniPod, visit our customer
blog, Suite D: http://suited.myomnipod.com. For more information on
the OmniPod insulin pump, please visit: http://www.myomnipod.com.
About Insulet Corporation
Insulet Corporation (NASDAQ: PODD) is an
innovative medical device company dedicated to making the lives of
people with diabetes easier. Through its OmniPod Insulin Management
System, Insulet seeks to expand the use of insulin pump therapy among
people with insulin-dependent diabetes. The OmniPod is a
revolutionary and easy-to-use tubeless insulin pump that features
just two parts and fully-automated cannula insertion. Insulet's
subsidiary, Neighborhood Diabetes, is a leading distributor for
diabetes products and supplies, delivered through a high touch
customer service model. Founded in 2000, Insulet Corporation is based
in Bedford, Mass.
About Humulin R U-500
Humulin R U-500 is indicated as an adjunct to diet and exercise to
improve glycemic control in adults and children with type 1 and type
2 diabetes mellitus.
Humulin R U-500 is useful for the treatment of insulin-resistant
patients with diabetes requiring daily doses of more than 200 units,
since a large dose may be administered subcutaneously in a reasonable
Important Safety Information for Humulin R U-500
-- Humulin R U-500 is contraindicated during episodes of hypoglycemia and
in patients hypersensitive to Humulin R U-500 or any of its
-- Starting or changing insulin therapy should be done cautiously and
only under medical supervision.
-- Humulin R U-500 contains 500 units of insulin in each milliliter
(5-times more concentrated than Humulin R U-100). For Humulin R U-500,
extreme caution must be observed in the measurement of dosage because
inadvertent overdose may result in serious adverse reaction or
-- Fluid Retention and Heart Failure with Concomitant Use of PPAR-gamma
Agonists: Thiazolidinediones (TZDs), which are PPAR-gamma agonists,
can cause dose-related fluid retention, particularly when used in
combination with insulin, including Humulin R U-500. Fluid retention
may lead to or exacerbate heart failure. Observe patients for signs
and symptoms of heart failure and consider discontinuation or dose
reduction of the PPAR-gamma agonist.
-- Dosing Confusion/Dosing Errors: Medication errors associated with
Humulin R U-500 have occurred and resulted in hyperglycemia,
hypoglycemia, or death. The majority of errors occurred due to errors
in dispensing, prescribing, or administration.
-- The Humulin R U-500 vial, which contains 20 mL, versus the Humulin
R U-100 vial, which contains 10 mL, is marked with a band of
diagonal brown stripes to distinguish it from the U-100 vial,
which has no stripes. "U-500" is also highlighted in red on the
-- The prescribed dose of Humulin R U-500 should always be expressed
in actual units of Humulin R U-500 along with corresponding
markings on the syringe the patient is using (ie, a U-100 insulin
syringe or volumetric [tuberculin or allergy] syringe).
-- A majority of administration errors occurred due to dosing
confusion when the Humulin R U-500 dose was prescribed in units or
volume corresponding to a U-100 insulin syringe or volumetric
syringe markings, respectively, or the prescribed dose was
administered without recognizing that the markings on the syringe
used do not directly correspond to U-500 dose. Instructions for
use should always be read and followed before use.
-- Instruct the patient to inform hospital or emergency department
staff of the dose of Humulin R U-500 prescribed.
-- A conversion chart should always be used when administering
Humulin R U-500 doses with U-100 insulin syringes or volumetric
-- Hypoglycemia: Hypoglycemia is the most common adverse reaction of all
insulin therapies, including Humulin R U-500. Hypoglycemia may occur
suddenly. Severe hypoglycemia may lead to unconsciousness,
convulsions, temporary or permanent impairment of brain function, or
death. As with all insulin preparations, the time course of Humulin R
U-500 action may vary in different individuals or at different times
in the same individual and is dependent on dose, site of injection,
blood supply, temperature, and physical activity.
-- Adjustment of dosage of any insulin may be necessary in patients
with renal or hepatic impairment or if patients change their
physical activity or their usual meal plan, or during times of
illness, emotional disturbances, or other stresses. Concomitant
oral antidiabetic treatment may need to be adju
concomitant use is not recommended.
-- Any patient who requires Humulin R U-500 for control of diabetes
should be under close observation until appropriate dosage is
established. Insulin resistance may be transitory, and dosage
requirements may change over time. Use caution in patients with
hypoglycemia unawareness and in patients who may be predisposed to
hypoglycemia. The patient's ability to concentrate and react may
be impaired as a result of hypoglycemia. These abilities are
especially important in driving or operating other machinery.
-- Severe hypoglycemia may develop 18 to 24 hours after the original
injection of Humulin R U-500.
-- Hyperglycemia, Diabetic Ketoacidosis, and Hyperosmolar Non-Ketotic
Syndrome: Hyperglycemia, diabetic ketoacidosis, or hyperosmolar coma
may develop if the patient takes less Humulin R U-500 than needed to
control blood glucose levels. Severe sustained hyperglycemia may
result in hyperosmolar coma or death.
-- Hypokalemia: Insulin use can lead to hypokalemia, that left untreated
may cause respiratory paralysis, ventricular arrhythmia, and death.
Use caution in patients who may be at risk for hypokalemia (eg,
patients using potassium-lowering medications, patients taking
medications sensitive to serum potassium concentrations).
-- Hypersensitivity and Allergic Reactions: Severe, life-threatening,
generalized allergy, including anaphylaxis, can occur with insulin
products, including Humulin R U-500. Localized reactions and
generalized myalgias have been reported.
-- Renal or Hepatic Impairment: Frequent glucose monitoring and insulin
dose reduction may be required.
-- Drug Interactions: Some medications may alter insulin requirements and
the risk for hypoglycemia and hyperglycemia. Some medications may mask
the signs of hypoglycemia in some patients. Therefore, insulin dose
adjustment and particularly close monitoring may be required.
-- Pregnancy Category B: There are no adequate and well-controlled
clinical studies of the use of Humulin R U-500 in pregnant or nursing
women or during labor and delivery.
-- Pediatric Use: There are no well-controlled studies of use of Humulin
R U-500 in children.
-- Hypoglycemia: Hypoglycemia is one of the most frequent adverse events
experienced by insulin users.
-- Early warning symptoms of hypoglycemia may be different or less
pronounced under certain conditions, such as long duration of
diabetes, autonomic diabetic neuropathy, use of medications such
as beta-adrenergic blockers, changing insulin preparations, or
intensified control (3 or more insulin injections per day) of
-- Hypoglycemia when using Humulin R U-500 can be prolonged and
-- Additional adverse reactions include hypokalemia, lipodystrophy, local
and systemic allergy, weight gain, and peripheral edema.
Dosage and Administration
-- The injection of Humulin R U-500 should be followed by a meal within
approximately 30 minutes of administration.
-- Humulin R U-500 should only be administered subcutaneously. Do not
administer Humulin R U-500 intravenously or intramuscularly.
-- Do not mix Humulin R U-500 with other insulins in the same syringe.
For more safety information, please click to access Patient Information
and Full Prescribing Information.
This press release contains
forward-looking statements within the meaning of the federal
securities laws, including those related to the development of a new
version of the OmniPod System and partnering with Eli Lilly and
Company on a clinical development program. These forward-looking
statements are based on Insulet's current expectations and beliefs
concerning future developments and their potential effects on it.
There can be no assurance that future developments affecting it will
be those that it has anticipated. These forward-looking statements
involve a number of risks, uncertainties (some of which are beyond
its control) or other assumptions that may cause actual results or
performance to be materially different from those expressed or
implied by these forward-looking statements. These risks and
uncertainties include, but are not limited to: Insulet's ability to
increase customer orders and manufacturing volumes; adverse changes
in general economic conditions; impact of healthcare reform
legislation; Insulet's inability to raise additional funds in the
future on acceptable terms or at all; potential supply problems or
price fluctuations with sole source or other third-party suppliers on
which Insulet is dependent; failure by Insulet to retain key supplier
and payor partners; international business risks; Insulet's inability
to obtain adequate coverage or reimbursement from third-party payors
for the OmniPod System and potential adverse changes in reimbursement
rates or policies relating to the OmniPod System; failure to retain
key partner payors and their members; potential adverse effects
resulting from competition with competitors; technological
innovations adversely affecting the Company's business; potential
termination of Insulet's license to incorporate a blood glucose meter
into the OmniPod System; Insulet's ability to protect its
intellectual property and other proprietary rights; conflicts with
the intellectual property of third parties, including claims that
Insulet's current or future products infringe the proprietary rights
of others; adverse regulatory or legal actions relating to the
OmniPod System; failure of Insulet's contract manufacturers or
component suppliers to comply with FDA's quality system regulations,
the potential violation of federal or state laws prohibiting
"kickbacks" or protecting patient health information, or any
challenges to or investigations into Insulet's practices under these
laws; product liability lawsuits that may be brought against Insulet;
unfavorable results of clinical studies relating to the OmniPod
System or the products of Insulet's competitors; potential future
publication of articles or announcement of positions by physician
associations or other organizations that are unfavorable to Insulet's
products; the expansion, or attempted expansion, into foreign
markets; the concentration of substantially all of Insulet's
manufacturing capacity at a single location in China and
substantially all of Insulet's inventory at a single location in
Massachusetts; Insulet's ability to attract and retain key personnel;
and other risks and uncertainties described in its Annual Report on
Form 10-K for the year ended December 31, 2012, and in its other
filings from time to time filed with the Securities and Exchange
Commission. Should one or more of these risks or uncertainties
materialize, or should any of its assumptions prove incorrect, actual
results may vary in material respects from those projected in these
forward-looking statements. Insulet undertakes no obligation to
publicly update or revise any forward-looking statements.
Erich Sandoval for Insulet Corporation
Stephanie Marks for Insulet Corporation
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