INSMED TO HALT DEVELOPMENT OF INS1 – THE NEW DRUG FOR PCOS & DIABETES

Insmed Discontinues Internal Development of INS-1 for Diabetes and Polycystic Ovary Syndrome – PCOS –

RICHMOND, Va., Sep 10, 2002 (BUSINESS WIRE) — Insmed Incorporated (Nasdaq:INSM):

Decision Follows Results of Phase II Clinical Trials
Company Will Direct Resources Toward Most Promising
Clinical Drug Candidates
Insmed Continues Its Commitment to Develop Drugs
for Diabetes and PCOS

Insmed Incorporated today announced that it has discontinued its internal development of INS-1, one of its investigational drug candidates for type 2 diabetes and polycystic ovary syndrome (PCOS). The decision not to proceed was based on the results of recently completed Phase II clinical trials.
In a recently completed clinical trial in patients with type 2 diabetes, INS-1 was safe and well tolerated but did not achieve statistical significance on its primary efficacy measures. These efficacy results failed to corroborate those reported in several previous studies.

In recently completed clinical trials in patients with PCOS, INS-1 was safe and well tolerated but did not achieve statistical significance on its primary efficacy measures. Although an overall increase in ovulation rates was not achieved, an increased number of pregnancies occurred in the INS-1 treated patients. The company is currently evaluating the clinical relevance of this observation and whether it warrants further investigation.

“Obviously, we are disappointed with these results,” said Geoffrey Allan, Ph.D., president and chief executive officer of Insmed. “Nevertheless, we believe we have an impressive pipeline, an outstanding clinical development team and several exciting Phase II projects. We will now direct our resources toward advancing these promising programs.”