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EXHIBIT 99.1
FOR IMMEDIATE RELEASE
For further information, contact:
Sophia H. Twaddell
Fleishman-Hillard, Inc.
(312) 751-3738
[email protected]
INSMED INCORPORATED ANNOUNCES
POSITIVE RESULTS OF INS-1 IN PATIENTS WITH TYPE 2 DIABETES
RICHMOND, VA -- (January 4, 2001) - Insmed Incorporated (Nasdaq: INSM) today
announced positive results following a full analysis of its recently completed
clinical trial of Type 2 diabetes patients treated with INS-1 in combination
with sulfonylureas. The results of a preliminary intent-to-treat analysis were
reported in November 2000.
This full analysis demonstrated that in those patients who received both INS-1
and a sulfonylurea, there was a statistically significant improvement in
glycohemoglobin (HbA1c) of 0.36% compared to patients receiving a sulfonylurea
alone (p (less than) 0.05). This finding is consistent with those reported in
previous clinical trials of INS-1. In addition, the improvement in HbA1c was
more pronounced (0.80%, p (less than) 0.01) in those patients who were either
better controlled by their sulfonylurea therapy or had a less severe form of
their disease as judged by their baseline fasting plasma glucose.
The results of this study also demonstrated that the improvement in glycemic
control achieved in patients with Type 2 diabetes receiving INS-1 was
accompanied by a more favorable lipid profile, thus confirming results from
earlier trials.
"This is a very significant observation," said Geoffrey Allan, Ph.D, president
and chief executive officer of Insmed. "It suggests that INS-1 may be a more
effective therapy in patients with less severe Type 2 diabetes or that higher
doses may be required to treat patients who are more refractory, or resistant,
to their standard therapy. We are very pleased with the outcome of this clinical
study. These results reaffirm the efficacy and excellent safety profile of our
product and provide substantial guidance for the future clinical development of
INS-1."
This double-blind, placebo-controlled study was conducted at 49 clinical centers
in the United States and evaluated the effects of INS-1 administered once daily
for three months (1200 mg/day) to a population of patients with Type 2 diabetes
who were sub-optimally managed on a standard sulfonylurea drug regimen. The
analysis of the data focused on the evaluable patients in the study (n=165),
those patients who met entry criteria and completed the study according to the
requirements of the protocol. Of these evaluable patients, a total of 83 were
given placebo in addition to their existing sulfonylurea therapy and 82 had
INS-1 added to their existing sulfonylurea therapy.
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Insmed intends to submit the results of this trial for presentation at the
upcoming American Diabetes Association Annual Meeting to be held in Philadelphia
in June 2001.
Insmed's management team will host a conference call tomorrow Friday, January 5
at 8:00 a.m. EST to discuss these results. The dial-in number is 800-289-0437
(domestic) or 913-981-5508 (international). The reference code is 509579. A
replay of the call will be available from 11:00 a.m. EST, Friday, January 5
through 11:00 a.m. EST, Friday, January 12, 2001. The replay dial-in number is
888-203-1112 (domestic) or 719-457-0820 (international). Please use the above
reference code to access the replay.
The company also reported that a trial of INS-1 in patients with Polycystic
Ovary Syndrome (PCOS) and a trial in patients with dyslipidemia were completed
on schedule. "We expect to be releasing data from these two trials as soon as
our analyses are complete," stated Dr. Allan.
About Insmed Incorporated
Insmed Incorporated is a biopharmaceutical company focused on the discovery and
development of pharmaceutical products for the treatment of metabolic diseases
and endocrine disorders associated with insulin resistance. Further information
is available at www.insmed.com.
# # #
Statements included within this press release, which are not historical in
nature, may constitute forward-looking statements for purposes of the safe
harbor provided by the Private Securities Litigation Reform Act of 1995.
Forward-looking statements include all statements regarding expected financial
position, results of operations, cash flows, dividends, financing plans,
business strategies, operating efficiencies or synergies, budgets, capital and
other expenditures, competitive positions, growth opportunities for existing or
proposed products or services, plans and objectives of management, demand for
new pharmaceutical products, market trends in the pharmaceutical business,
inflation and various economic and business trends. Such forward-looking
statements are subject to numerous risks and uncertainties, including risks that
product candidates may fail in the clinic or may not be successfully marketed,
the company may lack financial resources to complete development of product
candidates, competing products may be more successful, demand for new
pharmaceutical products may decrease, the biopharmaceutical industry may
experience negative market trends and other risks detailed from time to time in
the company's filings with the Securities and Exchange Commission. As a result
of these and other risks and uncertainties, actual results may differ materially
from those described in this press release.
