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Replies to #84894 on Biotech Values
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rkrw

10/12/09 10:30 AM

#84900 RE: genisi #84894

It got approved for facial and abdominal attacks. Theoretically could vphm get approval for laryngeal attacks or attacks elsewhere? I don't think they'll bother regardless. Just seems strange the fda put in technically restrictive indications.
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DewDiligence

03/19/11 1:46 AM

#116667 RE: genisi #84894

CHMP approves VPHM’s Cinryze for prophylaxis and acute treatment of HAE, including self administration:

http://finance.yahoo.com/news/ViroPharma-Announces-Positive-prnews-3962393730.html?x=0&.v=1

In the US, Cinryze was approved for prophylaxis in Oct 2008 (#msg-32795311); however, Cinryze for the acute indication is blocked by CSL’s Berinert, which has marketing exclusivity until 2016 stemming from an orphan designation and FDA approval in Oct 2009 (#msg-42409618).