SAN DIEGO, Jan. 8 /PRNewswire/ -- Amylin Pharmaceuticals, Inc.
(Nasdaq: AMLN) today announced Phase II clinical trial results that support
the ability to mix its diabetes drug candidate, pramlintide, with any of the
four most common forms of short and intermediate-acting insulin produced by
Eli Lilly & Co. and Novo Nordisk A/S. Being able to syringe-mix pramlintide
and insulin may lessen the need for people with diabetes to administer
separate injections of these two agents. Based on the study results, there
were no safety concerns and no loss of pramlintide's glucose lowering activity
when pramlintide was syringe-mixed with regular (short-acting) and/or NPH
(intermediate-acting) insulin. In addition, these preliminary studies suggest
that syringe-mixing pramlintide and NPH insulin may lead to improved glucose
control. The Company has submitted patent applications directed to this newly
discovered benefit of mixing pramlintide and NPH insulin.
The Company conducted two, open-label crossover pharmacokinetic studies in
people with Type I diabetes. One study evaluated 30 patients using Eli Lilly
insulins; the other evaluated 28 patients using Novo Nordisk insulins. All
patients who injected a syringe mixture of pramlintide, NPH insulin, and
regular insulin before breakfast experienced a reduction in average blood
glucose concentrations over a ten-hour period, compared to separate injections
of each given before breakfast. No clinically relevant differences were noted
between Novo Nordisk and Eli Lilly insulins.
Pramlintide is currently the subject of six, pivotal, Phase III clinical
studies aimed at demonstrating its ability to improve glucose control when
used as an adjunct to insulin therapy in people with diabetes, thereby
lowering their risk of degenerative complications. Elevated glucose
concentrations are the primary cause of diabetic complications, including
blindness, kidney failure, and amputations. Regulatory submissions for
pramlintide are planned for 1998 in North America and Europe.
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- 01/08/97
/CONTACT: Richard W. Krawiec, Ph.D, Director of Corporate Communications,
or Marjorie T. Sennett, Vice President and CFO, both of Amylin, 619-552-2200;
amylin.com |
