NEW YORK and SAN DIEGO, May 10,
2011 /PRNewswire/ -- The Juvenile Diabetes Research
Foundation (JDRF) and Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN)
announced today that they have entered into a research
collaboration agreement to provide financial support for a series
of clinical studies to investigate the feasibility of mixing
pramlintide, an analog of the human hormone amylin, with insulin to
treat type 1 diabetes. Pramlintide, marketed by Amylin as SYMLIN®
(pramlintide acetate) injection, is approved for use as an adjunct
treatment in patients with diabetes who use mealtime insulin
therapy and who have failed to achieve desired glucose control
despite optimal insulin therapy. SYMLIN and insulin are currently
not approved to be mixed and must be administered as separate
injections.
"Type 1 diabetes is a chronic disease that requires blood sugar
testing and insulin administration multiple times a day in order to
keep blood glucose levels in check. The study of this combination
therapy is exciting because, if successful, it could potentially
help patients achieve tighter glucose control without increasing
treatment complexity," said Aaron
Kowalski, Ph.D., Assistant Vice President of Treatment
Therapies for JDRF. "Successfully co-formulating pramlintide and
insulin could potentially help people living with type 1 diabetes
to better, and more conveniently, control their disease."
In a healthy pancreas, both insulin and amylin are produced and
released by the same cells. The two hormones work together to help
stabilize blood glucose levels. Insulin helps the body regulate
production and storage of glucose, while amylin helps control the
rate at which glucose enters the blood after meals.
"People with type 1 diabetes produce neither insulin nor amylin,
and with insulin replacement alone, even with intensive basal/bolus
therapy, managing blood sugar becomes a daily balancing act," said
Matthew Riddle, M.D., Professor of
Medicine, Division of Endocrinology, Diabetes, & Clinical
Nutrition, Oregon Health & Science University. "Pramlintide may
provide additional benefit for these patients by stabilizing their
blood sugar levels, so they spend more time in the normal glucose
range."
Currently, patients who use pramlintide must separately
administer their daily insulin therapy, either through injections
or an insulin pump. A co-formulated therapy that harnesses the
benefit of both hormones might better mimic the natural physiology
of the pancreas and simplify dosing decisions.
"Ultimately, it might reduce the complexity of daily treatment
for patients who are working hard to manage this disease, and
improve their ability to achieve treatment goals," continued Dr.
Riddle.
About the Research Collaboration
This is the second research collaboration between JDRF and
Amylin to advance innovative treatments for people with type 1
diabetes. This collaboration, consisting of formulation and
clinical work, will investigate whether a fixed ratio of
pramlintide and insulin can effectively help treat type 1 diabetes.
The formulation research will assess the feasibility of
co-formulating pramlintide and insulin (both currently administered
using separate injections) as a single injection. An optimal ratio
of pramlintide and insulin will be identified through modeling
work. In a series of up to three clinical proof-of-concept
studies, the program will also investigate the optimal
pramlintide:insulin dose ratios, and determine whether delivering
pramlintide and insulin in this fixed ratio, can improve glucose
control and optimize treatment of type 1 diabetes compared with
insulin alone.
The collaboration between JDRF and Amylin is part of JDRF's
Industry Discovery and Development Partnership (IDDP) program to
accelerate research that will lead to better treatments and a cure
for type 1 diabetes. JDRF and Amylin are also currently
collaborating on a proof-of-concept study at the UT Southwestern
Medical Center to investigate the effects of metreleptin, an analog
of the human hormone leptin, in patients with type 1 diabetes to
determine whether it can help to decrease insulin requirements and
better control glucose levels. To date, JDRF has funded 39
partnerships with 32 companies and committed approximately
$73 million as part of its IDDP
program.
About SYMLIN
Taken at mealtime, SYMLIN is the first and only amylin mimetic
(or imitator of amylin) for use in patients with diabetes treated
with mealtime insulin. In patients with type 2 diabetes who use
insulin, and in patients with type 1 diabetes, beta cells in the
pancreas that make both insulin and amylin are either damaged or
destroyed, resulting in reduced secretion of both insulin and
amylin after meals. Amylin deficiency can make it harder to control
glucose levels after meals; therefore, using SYMLIN helps to make
glucose control more attainable.
Healthcare professionals and patients with diabetes may obtain
more information, including the complete Prescribing Information
and the Medication Guide, at https://www.symlin.com/.
Important Safety Information for SYMLIN
SYMLIN is not intended for all patients with diabetes. SYMLIN is
used with insulin and has been associated with an increased risk of
insulin-induced severe hypoglycemia, particularly in patients with
type 1 diabetes. When severe hypoglycemia associated with SYMLIN
use occurs, it is seen within three hours following a SYMLIN
injection. If severe hypoglycemia occurs while operating a motor
vehicle, heavy machinery, or while engaging in other high-risk
activities, serious injuries may occur. Appropriate patient
selection, careful patient instruction, and insulin dose
adjustments are critical elements for reducing this risk.
Other adverse events commonly observed with SYMLIN when
co-administered with insulin were mostly gastrointestinal in
nature, including nausea, which was the most frequently reported
adverse event. The incidence of nausea was higher at the beginning
of SYMLIN treatment and decreased with time in most patients. The
incidence and severity of nausea are reduced when SYMLIN is
gradually increased to the recommended doses.
About JDRF
JDRF is the worldwide leader for research to cure type 1
diabetes. It sets the global agenda for diabetes research, and is
the largest charitable funder and advocate of diabetes science
worldwide.
The mission of JDRF is to find a cure for diabetes and its
complications through the support of research. Type 1 diabetes is
an autoimmune disease that strikes children and adults suddenly,
and can be fatal. Until a cure is found, people with type 1
diabetes have to test their blood sugar and give themselves insulin
injections multiple times or use a pump - each day, every day of
their lives. And even with that intensive care, insulin is not a
cure for diabetes, nor does it prevent its potential complications,
which may include kidney failure, blindness, heart disease, stroke,
and amputation.
Since its founding in 1970 by parents of children with type 1
diabetes, JDRF has awarded more than $1.5
billion to diabetes research, including $107 million last year. More than 80 percent of
JDRF's expenditures directly support research and research-related
education. For more information, please visit www.jdrf.org.
About Amylin Pharmaceuticals
Amylin Pharmaceuticals is a biopharmaceutical company dedicated
to improving lives of patients through the discovery, development,
and commercialization of innovative medicines. Amylin has developed
and gained approval for two first-in-class medicines for diabetes,
SYMLIN® (pramlintide acetate) injection and BYETTA® (exenatide)
injection. Amylin's research and development activities leverage
the Company's expertise in metabolism to develop potential
therapies to treat diabetes and obesity. Amylin is headquartered in
San Diego, California. Further
information on Amylin Pharmaceuticals is available at
www.amylin.com.
This press release contains forward-looking statements about
Amylin, which involve risks and uncertainties. Amylin's actual
results could differ materially from those discussed herein due to
a number of risks and uncertainties, including that Amylin's
research with JDRF to explore whether co-formulation of insulin and
pramlintide can improve blood glucose control will not produce
favorable results; clinical trials or studies, including those
mentioned in this press release, may not start when planned,
confirm previous results, be predictive of real world use or
achieve intended clinical endpoints; preclinical studies may not be
predictive; our product candidates may not receive regulatory
approval; and inherent scientific, regulatory and other risks in
the drug development and commercialization process. These and
additional risks and uncertainties are described more fully in
Amylin's most recently filed SEC documents, including its Form
10-Q. Amylin undertakes no duty to update these
forward-looking statements.
SOURCE Amylin Pharmaceuticals, Inc.; Juvenile Diabetes Research
Foundation