SAN DIEGO, Dec. 19 /PRNewswire/ -- Amylin Pharmaceuticals, Inc.
(Nasdaq: AMLN) today announced that it has initiated on schedule four,
pivotal, Phase III clinical studies of its diabetes drug candidate,
pramlintide, to complement two other Phase III studies started in 1995. The
six Phase III studies are part of the Company's PARADIGM development program.
This program is aimed at demonstrating pramlintide's ability to improve
glucose control when used as an adjunct to insulin therapy in people with
diabetes, thereby lowering their risk of degenerative complications.
Assuming patient enrollment in the new PARADIGM (Pramlintide for Amylin
Replacement: Adjunct for Diabetes in Glycemic Management) studies proceeds as
planned, Amylin Pharmaceuticals expects to file for regulatory approval of
pramlintide in North America and Europe by the end of 1998. The six PARADIGM
studies, three each in people with Type I and Type II diabetes who use
insulin, are scheduled to involve more than 2,600 patients at more than 200
centers in the U.S., Canada, and Europe. The Company is also conducting long-
term, open-label safety studies of pramlintide along with mechanism-of-action,
insulin-mixing, and drug-interaction studies.
"Timely initiation of these new pivotal PARADIGM studies is a key
milestone on the critical path to regulatory filings for pramlintide, a first-
in-class drug candidate for people with diabetes who use insulin," said Robert
G. Thompson, M.D., Amylin Pharmaceuticals' Vice President of Clinical
Development. "With respect to these final pivotal studies, we have begun
enrollment in two U.S. studies involving 1,000 patients with Type I and
insulin-using Type II diabetes, and a total of 800 such patients are being
enrolled in two studies in Canada and Europe. Upon completion of all three
phases of the pramlintide clinical program, we expect to have enrolled almost
5,000 patients, thus making it one of the most extensive clinical programs of
a new diabetes medicine to date."
"In previous one-month Phase II clinical studies, people with Type I and
Type II diabetes who used pramlintide in addition to their existing insulin
regimen experienced a clinically important and statistically significant
improvement in glucose control over insulin therapy alone," explained Dr.
Thompson. "Now, with help from our collaboration partner, Johnson & Johnson,
the Phase III PARADIGM program is investigating pramlintide's ability to
safely improve long-term glucose control, the primary factor in reducing the
risks of diabetic complications such as blindness, kidney failure and nerve
damage."
Amylin Pharmaceuticals, Inc. is focused on developing novel medicines for
treating diabetes and related metabolic disorders. The Company has pioneered
research of the hormone amylin, which is believed to play an important role in
glucose control and is missing or deficient in millions of people with
diabetes. The Company is collaborating with Johnson & Johnson to develop
pramlintide, a chemical analog of human amylin, with the aim of improving
glucose control for people with diabetes who use insulin. The Company also is
conducting validation studies of exendin and GLP-1 in animal models of
diabetes and evaluating technology in-licensing opportunities with the aim of
developing other medicines that could be effective in treating metabolic
disorders, including diabetes, obesity, and dyslipidemia. Founded in 1987,
Amylin is headquartered in San Diego, California.
This press release contains forward-looking statements that involve risk
and uncertainties. Actual results may differ materially from those discussed
herein, due to the research, development, and market risks which could
adversely affect the Company's timeline for regulatory approval, if such
approval is received, and time to market thereafter. Additional risks and
uncertainties are described in the Company's most recently filed SEC
documents, such as the Registration Statement for the recent public offering,
as well as its most recent Forms 10-K and 10-Q.
SOURCE Amylin Pharmaceuticals
-0- 12/19/96
/CONTACT: Richard W. Krawiec, Ph.D., Director of Corporate
Communications, or Marjorie T. Sennett, Vice President and CFO, 619-552-2200,
both of Amylin Pharmaceuticals, amylin.com |
