The response rate for Cinryze in acute is over 93%. Berinert (CSL) data in acute is quite good as well. Rhucin isn't going to work 100% of the time, so you must be splitting hairs or making it up as you go along.
Does CSL work in laryngeal and abdominal HAE? Pharmings does.
CSL product is pooled plasma isn't it -- they don't like the viral contam risk
In the U.S. Rhucin will have to break CSL's Orphan status to get on the market at all. And even then, I'd expect Rhucin US sales to be de minimis.
Of course, I am not privy to any information under a CDA so I haven't seen the FDA minutes, but I have always been told by all management that the FDA views human recombinant a separate drug to pooled plasma, they both have separate BLA filings,
There would be 3 companies splitting the smaller acute market (CSL, Dyax, Pharming) and Rhucin isn't sufficiently differentiated.
I think dyax is dead if Rhucin gets approved here. The data is better and dyax had cases of Anaphylactic Shock.
In Europe not only are C1's available but also Firazyr which is a pretty good drug for acute yet only sold $6M worth in 2009. I'd expect Rhucin sales to be less than Firazyr.
At investigator meetings no one wanted to use pooled plasma, in EU there is a larger concern of viral contamination compared to here. they have had more problems with viral contimination.
Firazyr causes a bee-sting like reaction. docs know it missed the primary endpoint in the randomized trial and Shire is having difficulty even recruiting patients.
