Insmed Inc (INSM)

[read_this_n0w]

Orphan drug status for TRCA and INSM

Insm orphan drug application approved during MAY 17th 2006 news issue after a 30 day review time

TERCICA orphan drug application approved during APRIL 6th news issue after a 87 day review

----------------------
TRCA:
http://www.emea.europa.eu/pdfs/human/comp/12557206en.pdf

Mecasermin, from Tercica Europe Limited, for treatment of primary insulin-like growth factor-
1 deficiency due to molecular or genetic defects (review time: day 87)
-----------------------------
INSM
http://www.emea.europa.eu/pdfs/human/comp/18025106en.pdf


Mecasermin rinfabate, from Insmed Europe Ltd., for treatment of primary insulin-like growth
factor-1 deficiency due to molecular or genetic defects (review time: day 30)




Now all this gets even more interesting.. apparently the US news did reach the US as well
because additional questions were presented, and TRCA was asked an opinion there..
so were there additional questions for TRCA where there are none yet for INSM?
(considering INSM was rushed through the COMP panel in 30 days, where TRCA was held up for 87 days)


http://www.emea.europa.eu/pdfs/human/biosimilar/8916606en.pdf
How does that fit into things than?
Doc. Ref: EMEA/89166/2006

the DATE of this pdf creation is:
(found in document properties ->description in adobr acrobat pro)
Created : 13-6-2006 at 10:54:45
Last modified: 13-6-2006 at 12:09:45

Hmmmmmm
So this new discussion is AFTER insmed was approved as orphan designation as well..and after insmed should have been moved to the CHMP agenda as well..



Any opinion there people?