UPDATE 1-Insmed drug shows equivalence to Amgen's Neupogen
(New throughout; adds NEW YORK dateline)
By Lewis Krauskopf
NEW YORK, July 10 (Reuters) - Insmed Inc (INSM.O) said on Thursday its version of Amgen Inc's (AMGN.O) drug Neupogen, for boosting white blood cells, showed equivalence in a small study, moving Insmed closer to developing a generic form of the biotechnology drug.
Insmed said it would meet with the U.S. Food and Drug Administration to discuss starting a late-stage study of its drug, INS-19.
The small Richmond, Virginia-based company -- whose shares rose to 44 cents, or 12 percent, in midday trading -- said it believed it was the first U.S. company to report human bioequivalence data for a generic biotech drug, which are also known as "follow-on biologics."
Unlike pills and capsules produced chemically, no U.S. regulatory pathway has been approved to allow generic copies of many biotechnology medicines that are infused or injected, but lawmakers have been weighing legislation that would create such a pathway.
Insmed Chief Executive Geoffrey Allan said the company was developing its product in parallel to the legislative process.
"If we wait until the regulatory pathway is more clearly defined, we'll simply lose time," Allan said in an interview. "If the regulatory pathway comes along in 2009, we will be halfway through our clinical studies. We'll be ahead of the game."
Allan said the bioequivalence study, which involved 32 volunteers, is the "benchmark" type of study used in the generic industry to prove similarity of a drug.
Allan said the company was in "active discussions" with possible partners to help commercialize its product. Neupogen patents begin expiring in 2012, he said, potentially paving the way for generic versions.
"There's no reason why we shouldn't be able to get the trials conducted and the applications submitted for approval to meet that date," Allan said.
Insmed also said on Thursday it intends to start bioequivalence studies in the fourth quarter for a drug that has demonstrated comparability to Neulasta, Amgen's newer white-blood-cell booster.
