EXHIBIT 99.1
For further information, contact:
Media
Sophia Twaddell
Fleishman-Hillard, Inc.
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Investors
Maija Jacobson
Fleishman-Hillard, Inc.
(312) 751-4193
jacobsom@fleishman.com
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FOR IMMEDIATE RELEASE
INSMED ANNOUNCES POSITIVE SOMATOKINE(R) DATA IN
PATIENTS WITH TYPE 2 DIABETES
RICHMOND, VA -- (March 20, 2001) -- Insmed Incorporated (Nasdaq: INSM) today
announced positive results following a full analysis of its previously reported
Phase II trial of SomatoKine(R) in patients with Type 2 diabetes. SomatoKine is
a recombinant protein being developed as an injectable insulin sensitizer
targeted towards the treatment of patients with either Type 1 or Type 2 diabetes
who are unable to maintain adequate blood glucose control.
"Not only are we very pleased with the improvement in patients with Type 2
diabetes, the findings support previously reported results in patients with Type
1 diabetes," said Geoffrey Allan, Ph.D., president and chief executive officer
of Insmed. "We also found that SomatoKine was well tolerated and patients
responded quickly and positively. In sum, these results suggest that SomatoKine
may have a unique role in the treatment of patients with diabetes who are unable
to maintain adequate blood glucose control with currently available therapies."
This trial was a randomized, open-label, parallel design dose-ranging study of
14-day duration to determine the efficacy of SomatoKine in subjects with Type 2
diabetes. Data from the study revealed statistically and clinically significant
results in several key measures. At all dosages and via all routes of
administration, average daily insulin requirements in SomatoKine-treated
patients decreased, as did the corresponding average daily fasting glucose
levels.
In twelve patients treated with 2 mg/kg/day via subcutaneous six-hour infusion
overnight, daily insulin required decreased 82.6 percent and blood glucose
levels decreased 36.9 percent. In ten patients treated with 2mg/kg/day via
continuous subcutaneous infusion, daily insulin required
decreased by 67.7 percent and blood glucose levels decreased 32.5 percent. In 14
patients treated with 2 mg/kg twice daily via subcutaneous injection, average
daily insulin requirements decreased 56.4 percent, with a corresponding drop in
blood glucose levels of 31.7 percent. In 15 patients treated with 1 mg/kg/day
via a single, subcutaneous injection at bedtime, SomatoKine produced a 51.2
percent decrease in insulin use and 33.7 percent decrease in blood glucose
levels.
"These results demonstrate that SomatoKine can be an effective adjunct to
insulin in patients with Type 2 diabetes whose diabetes is poorly controlled,"
added Dr. Alan Moses, Chief Medical Officer of the Joslin Diabetes Center at
Harvard Medical School, and one of the principal investigators of the study.
"SomatoKine may have a significant place in the pharmacotherapy of Diabetes
Mellitus."
The company anticipates that the detailed study results will be presented at
both the American Diabetes Association annual meeting and at the annual
Endocrine Society meeting in June 2001. The American Diabetes Association
abstract will be presented by Alan Moses, M.D., Chief Medical Officer of the
Joslin Diabetes Center and Professor of Medicine, Harvard Medical School, and
David Clemmons, M.D., Chief, Division of Endocrinology, University of North
Carolina, will present the Endocrine Society abstract.
SomatoKine is the human recombinant equivalent of the natural complex formed by
the hormone insulin-like growth-factor-I (IGF-I) and its major regulatory
binding protein (BP-3). IGF-I, in concert with insulin and other hormones,
plays an important role in the natural regulation of glucose control. The BP-3
component contains biological information important for the regulation of IGF-I
bioavialability, biodistribution, and bioactivity. Insmed is developing
SomatoKine for the treatment of Type 1 and 2 diabetes.
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.
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# # #
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the company may lack financial resources to complete development of product
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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.