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Eli Lilly and Company

Phase 2 Study Shows Lilly/Alkermes Inhaled Insulin System Achieved Blood Sugar Levels Similar to Injected Insulin

Athens, Greece (ots/PRNewswire)

- 80 percent of diabetes patients in study preferred inhaled
insulin system to mealtime injections
Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq:
ALKS) today presented detailed results from a Phase 2 clinical study
of inhaled insulin in people with type 1 diabetes, showing that
patients using the Lilly/Alkermes inhaled insulin system achieved
blood sugar levels similar to patients treated with injected insulin.
In addition, 80 percent of patients in this study expressed a
preference for the Lilly/Alkermes inhaled insulin system at mealtime
over injected insulin.
Using the standard measure of blood sugar, A1C, patients achieved
an average level of 7.9 using the Lilly/Alkermes inhaled insulin
system, compared to 8.0 in the injected insulin group. A1C is an
average measure of blood sugar (glucose) over a three-month period.
The study was designed to evaluate whether inhaled insulin delivered
through the Lilly/Alkermes system and injected insulin showed similar
safety and effectiveness at controlling blood sugar based on dosing
regimens commonly used in the everyday management of diabetes. These
findings are the first disclosure of these results in Europe and were
presented today at the 41st annual meeting of the European
Association for the Study of Diabetes in Athens, Greece.
Researchers also presented results from a Phase 1 dose response
and equivalence study, which showed that the Lilly/Alkermes inhaled
insulin system and injected insulin lispro were generally
well-tolerated and the overall effect on blood sugar was similar,
illustrating that doses could be reliably correlated. This is the
first comparative study of dose equivalence between inhaled insulin
and insulin lispro, a rapid-acting insulin analog and a commonly-used
mealtime insulin.
"Our goal is to provide patients with an innovative product that
offers a more acceptable treatment option for patients and may enable
them to achieve better blood sugar control, a key aspect in managing
diabetes," said Dr. Douglas B. Muchmore, Medical Fellow, Eli Lilly
and Company. "These studies, taken together, show that inhaled
insulin delivered by the Lilly/Alkermes system is equivalent in
various clinical measures to injected insulin. The Lilly/Alkermes
Alliance is committed to conducting additional studies needed to
confirm the safety and efficacy of inhaled insulin."
Lilly and Alkermes established an alliance in 2001 to develop an
inhaled insulin system that delivers human insulin inhalation powder
(known as HIIP), based on Alkermes' AIR(R) pulmonary drug delivery
technology. The Lilly/Alkermes program is focused on developing an
innovative treatment option that can address the challenges
associated with managing type 1 and type 2 diabetes. The HIIP
delivery system uses a small, simple inhaler that fits in the palm of
a hand.
"Despite the health benefits of tight blood glucose control, some
physicians and patients are reluctant to initiate insulin therapy.
Delaying insulin treatment can contribute to higher blood sugar
levels, which can lead to complications such as nerve damage, vision
loss and kidney disease," said Dr. Satish Garg, Chief of Young Adult
Clinics at the Barbara Davis Center for Childhood Diabetes and
Professor of Pediatrics and Medicine at the University of Colorado
School of Medicine Health Sciences Center, USA. "These studies
suggest that inhaled insulin, such as the Lilly/Alkermes system, may
encourage patients to move more quickly to a therapy that best
improves glucose control."
Phase 3 trials initiated
Lilly and Alkermes initiated a comprehensive Phase 3 clinical
program, including pivotal efficacy studies and additional long-term
safety studies in both type 1 and type 2 patients, in July 2005 with
the start of Phase 3 safety trials required for registration. Those
safety studies will be conducted with approximately 1,000 patients at
multiple sites in 15 countries, including four countries in Europe:
Belgium, Bulgaria, Croatia and Hungary.
Other sites will enroll patients in North America (United States,
Canada and Mexico), South America (Argentina, Chile and Colombia) and
Asia-Pacific (India, the Philippines, Singapore, Taiwan and
Thailand). The studies will be up to 24 months duration and will
include patients with type 1 and type 2 diabetes who also have
chronic obstructive pulmonary disease or asthma, as well as patients
with type 1 diabetes without lung disease.
Study results at EASD
Phase 2 Study Results in Type 1 Patients: Safety and Efficacy of
Inhaled Insulin Compared to Injected Insulin
The Phase 2 randomized, open-label, noninferiority crossover study
compared the safety and efficacy of the Lilly/Alkermes system using
human insulin inhalation powder (HIIP) and subcutaneous injected
insulin in patients with type 1 diabetes.
Patients with type 1 diabetes and normal lung function were
randomized to pre-meal HIIP (N = 133) or insulin injections (N =
126), both with long-acting insulin glargine once-daily, for 12
weeks. The primary endpoint was based on noninferiority of A1C values
(margin of 0.3%) between inhaled insulin and injected insulin. A1C is
an average measure of blood glucose over a three-month period. Safety
measures included hypoglycemia (low blood sugar) rates, fasting blood
glucose (FBG) and carbon monoxide lung diffusing capacity (DLCO), a
measure of gas exchange capacity of the lung. Key results included:
-- Based on A1C, the HIIP and injected insulin treatments were
equivalent in controlling blood glucose. The A1C levels were an
average of 7.9 in the HIIP group, compared to an average of 8.0 in
the injected insulin group.
-- HIIP and injected insulin were generally well tolerated. There
were no clinically meaningful differences with respect to FBG, DLCO
and severe hypoglycemia.
-- 80 percent of patients preferred the Lilly/Alkermes inhaled
insulin system over mealtime injections.
Phase 1 Study of Dose Response and Equivalency of Inhaled Insulin
Compared to Injected Insulin Lispro
The Phase 1 open-label, randomized, seven-period crossover trial
compared the absorption and action of insulin following a dose of
HIIP using the Lilly/Alkermes inhaled insulin system to a similar
dose of subcutaneous injected, rapid-acting insulin lispro. Twenty
healthy, nonsmoking male (N = 10) and female subjects received up to
four single doses of HIIP and three doses of insulin lispro. The
primary endpoint was based on pharmacokinetic and glucodynamic
assessments. Pulmonary lung function was also evaluated. Key findings
included:
-- Based on tmax (time to maximum serum insulin concentration) the
Lilly/Alkermes HIIP showed an initial rapid absorption similar to
insulin lispro.
-- Pharmacokinetic and glucodynamic measures showed that doses of
HIIP could be reliably correlated with doses of insulin lispro.
-- Intra-patient dosing variability, assessed by administering
replicate doses of HIIP and insulin lispro, demonstrated that HIIP
had a comparable degree of dosing variability as compared to insulin
lispro (coefficient of variability 31 and 29 percent, respectively).
-- HIIP and insulin lispro were equally well tolerated. There were
no statistically significant differences between patients' pre-dose
and post-dose pulmonary function and there were no serious adverse
events.
About Diabetes
Diabetes affects an estimated 194 million adults worldwide(1) and
around 48.4 million in Europe.(1) Of those affected approximately 85
to 95 percent 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.(2) Type 2 diabetes usually occurs in
adults over the age of 40, but is increasingly common in younger
people.(2) 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)(3). The calculated estimates of the costs of diabetes care
in Europe amount to 42.8 million International Dollars per year.(4)
About Alkermes, Inc.
Alkermes, Inc. is a pharmaceutical company that develops products
based on sophisticated drug delivery technologies to enhance
therapeutic outcomes in major diseases. The Company's lead commercial
product is the first and only long-acting atypical antipsychotic
medication approved for use in schizophrenia, and is marketed
worldwide by Janssen-Cilag ("Janssen"), a wholly owned subsidiary of
Johnson & Johnson. The Company's lead proprietary product candidate,
Vivitrex(R) (naltrexone long-acting injection), is being developed as
a once-monthly injection for the treatment of alcohol dependence. The
Company has a pipeline of extended-release injectable products and
pulmonary drug products based on its proprietary technology and
expertise. Alkermes' product development strategy is twofold: the
Company partners its proprietary technology systems and drug delivery
expertise with several of the world's finest pharmaceutical companies
and it also develops novel, proprietary drug candidates for its own
account. The Company's headquarters are in Cambridge, Massachusetts,
and it operates research and manufacturing facilities in
Massachusetts and Ohio.
Lilly's Leadership in Diabetes
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.
About Lilly
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, Ind., Lilly provides
answers -- through medicines and information -- for some of the
world's most urgent medical needs.
P-LLY
This press release contains forward-looking statements about the
investigational compound inhaled insulin, and its efficacy and rate
of adoption by patients, and reflects Lilly's and Alkermes' current
beliefs. However, as with any pharmaceutical product under
development, there are substantial risks and uncertainties in the
process of development and regulatory review. There is no guarantee
that the product will receive regulatory approvals, or that the
regulatory approval will be for the indication(s) anticipated by the
company. There is also no guarantee that the product will enhance
current levels of glucose control or prove to be commercially
successful. For further discussion of these and other risks and
uncertainties, see Lilly's and Alkermes' filings with the United
States Securities and Exchange Commission. Lilly and Alkermes
undertake no duty to update forward-looking statements.
REFERENCES
(1) The International Diabetes Federation, Prevalence / All
diabetes. Available at
http://www.eatlas.idf.org/Prevalence/All_diabetes/.
(2) The International Diabetes Federation, Types of Diabetes.
Available at
http://www.eatlas.idf.org/Types_of_diabetes/#Type2diabetes
(3) The International Diabetes Federation, Complications.
Available at http://www.eatlas.idf.org/Complications/
(4) The International Diabetes Federation, Diabetes Atlas, Second
edition. The Economic Impact of Diabetes. 2003: 186.
Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
          http://www.newscom.com/cgi-bin/prnh/20050912/ALKERMESLOGO

Contact:

Rebecca Peterson of Alkermes, +1-617-583-6378 (office); or Scott
MacGregor of Lilly, +1-317-651-1494 (office), +1-317-332-5557
(mobile) / Photo: NewsCom:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO ,
http://www.newscom.com/cgi-bin/prnh/20050912/ALKERMESLOGO

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