Animas Makes Progress in Development of a First-Generation Closed-Loop Insulin Delivery System With Study Participants

Animas Makes Progress in Development of a First-Generation Closed-Loop Insulin
 Delivery System With Study Participants Maintaining Safe Glucose Levels for
                   Over 90 Percent of the Overnight Period

Development Continues With Data Presented at the American Diabetes Association
(ADA) Scientific Sessions

PR Newswire

WEST CHESTER, Pa., June 21, 2013

WEST CHESTER, Pa., June 21, 2013 /PRNewswire/ --Animas Corporation announced
today further promising results from the second phase of human clinical trials
of a first-generation closed-loop insulin delivery system in development. Data
investigating the predictive Hypoglycemia-Hyperglycemia Minimizer (HHM)
System* demonstrated that the system is capable of maintaining safe glucose
levels overnight. The data was presented at the 73^rd Scientific Sessions of
the American Diabetes Association (ADA) in Chicago, Illinois.

The feasibility study of the predictive glucose control system in development
was conducted in 20 adults with type 1 diabetes and designed to investigate
the System's automatic control algorithm, with emphasis on the overnight
period from 9 PM to 7 AM. The System showed encouraging performance with the
participants, on average, spending over 90 percent of the overnight period
with blood glucose values in the range between 70-180 mg/dl. Additionally,
fewer than half of the study participants had blood glucose values less than
70 mg/dL during the overnight period. 

These results build on the data Animas presented from the same feasibility
study earlier this year at the annual Advanced Technologies and Treatments for
Diabetes (ATTD) conference, which demonstrated that the System shows promising
ability to minimize the number, duration and severity of hypoglycemic events
with no safety concerns. The study was conducted in partnership with leading
academic research institutions, including the University of California, Santa
Barbara; Sansum Diabetes Research Institute; and the Center for Diabetes
Technology at the University of Virginia.

"Avoiding hypoglycemia during the overnight period is a primary concern for
people with diabetes, so maintaining safe glucose levels during this time
frame is crucial in helping to not only achieve better control, but also helps
ease worry throughout the night," said Ramakrishna Venugopalan, Director,
Research & Development at Animas Corporation. "We are encouraged by the
results of this overnight study, and we are excited to be one step closer to
bringing this technology to patients."

Animas began collaborating with industry, academia and advocacy organizations,
including the JDRF (formerly the Juvenile Diabetes Research Foundation), in
2010. After receiving Investigational Device Exemption (IDE) approval from the
U.S. Food and Drug Administration (FDA) in 2011, researchers began the first
human clinical feasibility studies for the development of a closed-loop
insulin delivery system. Together with these key partners, Animas continues to
work toward developing such an automated system to help people living with
type 1 diabetes better control their disease.

"We are encouraged by Animas' latest findings that indicate the System is able
to control overnight blood glucose levels safely," said Aaron Kowalski, Ph.D.,
Vice President of Treatment Therapies Research at JDRF. "For children and
their families living with diabetes, the fear of hypoglycemia during the night
is very real, so any peace of mind we can provide, particularly in the
overnight period, would be a tremendous benefit.

* The HHM System includes a continuous subcutaneous insulin infusion pump, a
continuous glucose monitor (CGM) and a control algorithm used to predict
changes in blood glucose.

About the Clinical Study
The study investigated an automatic control algorithm of a predictive glucose
control system in development during the overnight period of 9 PM – 7 AM.
Glucose-related metrics calculated specifically for this overnight period were
based on both continuous glucose monitor (CGM) readings and readings obtained
from the YSI 2300 STAT Plus. The results demonstrated that the System was
capable of maintaining safe glucose levels overnight, and indicate feasibility
for continuing development.

During the study, the System dosed insulin automatically based on CGM values.
The mean overnight glucose value based on CGM was 135 mg/dl (129 mg/dl by YSI)
for the entire cohort. The median percentage of overnight time spent at
glucose values between 70-180 mg/dl was 93.8% (90.9% by YSI). The median
percentage of overnight time spent at glucose values less than 70 mg/dl was 0%
by both CGM and YSI.

About Animas Corporation
With a shared vision of "creating a world without limits" for people with
diabetes, Animas is a part of Johnson & Johnson Diabetes Solutions Companies,
a cross-company collaboration that reflects an ongoing commitment to better
serve the diabetes community with integrated solutions that meet the needs of
people with diabetes across the continuum of care. Animas provides a wide
range of insulin delivery products for people living with diabetes, including
the OneTouch® Ping® Glucose Management System, Animas® Vibe™ insulin pump and
CGM system and the Animas® 2020 insulin pump. Animas, from the Latin word
meaning "true inner self or soul," has been committed since 1996 to meeting
individual patient needs through the development of life-performance
technology and customer service 24 hours a day, 7 days a week, 365 days a
year. To learn more about Animas, visit http://www.animas.com/. 

SOURCE Animas Corporation

Website: http://www.animas.com
Contact: Caroline Pavis, Animas Corporation, Mobile: 610.357.3121,
CPavis@its.jnj.com, or Kaitlin Meiser, Animas Corporation, Mobile:
908.938.3209, KMeiser3@its.jnj.com
 
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