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."
Conference Call
Insmed's management team will host a conference call this morning at 11:00 a.m.
EDT. To participate in the conference call dial 888-972-9928 or 212-547-0158
(international), password: INSMED. A live audio feed of the web cast can be
accessed through the Investor Relations link on the Company's website at
www.insmed.com. A telephonic replay of the call will be available for one week
at 888-562-2768 or 402-998-1435 (international). A web replay of the call will
be available through the Investor Relations website beginning at 2:00 p.m. EDT.
Insmed Incorporated, based in Richmond, VA, is a biopharmaceutical company
focused on the development of drug candidates for the treatment of metabolic
diseases and endocrine disorders. For press release and other Company
information, visit our website at http://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.
