TimesDispatch.com | Insmed drug wins approval
TimesDispatch.com | Insmed drug wins approval


Insmed drug wins approval
Growth-hormone medicine could help the Henrico firm expand its product line

BY JEFFREY KELLEY
TIMES-DISPATCH STAFF WRITER Dec 13, 2005


Insmed Inc. said yesterday evening that federal regulators have approved its drug iPlex, propelling the Henrico County firm into a small but competitive marketplace.

The Food and Drug Administration also granted Insmed "orphan-drug" status on iPlex, used to treat children with a growth-hormone deficiency. An approved competing drug has the same status, which gives a company seven years of marketing exclusivity for drugs that treat rare diseases.

At 7:30 last night, Insmed's stock was trading at $2.32, up 55.7 percent from the day's close.

"Today marks the beginning of a new treatment paradigm for treating children with [short stature] . . . This is also an exciting transition for Insmed," Geoffrey Allan, president and chief executive of Insmed, said in a statement. iPlex is expected to launch in the second quarter next year, the company said.

Mark A. Herzog, executive director of the Virginia Biotechnology Association, and Robert T. Skunda, president and chief executive of the Virginia BioTechnology Research Park, praised the Insmed approval yesterday as a step forward for the state biotechnology arena.

Insmed is the first alumnus of the 10-year- old park to win approval of a drug, they said.


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