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oc631

06/23/11 10:36 PM

#122216 RE: mcbio #122213

I've never thought much about BCRX. How many clinical trials has peramivir already failed? I remember the one from several years ago where they claimed the needles weren't long enough or something. Seemed like a joke to me. Also, gout is becoming an increasingly crowded field and they are behind a lot of people. Not sure of anything that differentiates their gout drug from the competition.




They are also developing a HCV nucleoside analog sans the prodrug strategy which I doubt should be taken seriously.
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flatlander_60048

06/23/11 10:59 PM

#122221 RE: mcbio #122213


Thanks for the response mcbio.
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How many clinical trials has peramivir already failed? I remember the one from several years ago where they claimed the needles weren't long enough or something. Seemed like a joke to me. Also, gout is becoming an increasingly crowded field and they are behind a lot of people.
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However, I'm not aware of Phase 3 Peramivir failures since the drug has been introduced intravenously. Based on a google search, it appears that the drug was not effective when administered intramuscular. Is that what you were referring to? I have to believe that BCRX has moved beyond that since CDC purchased Peramivir under the emergency use provision during the 2009 pandemic and is paying for the ongoing Phase III. It is also on the market in Japan and Korea. However, they appear to have monetized the royalty stream provided by their partners. Seems like BCRX blew the opportunity to complete the phase III during the 2009 pandemic when the study was much easier to enroll. Perhaps the FDA discussions had not progressed far enough to determine the structure of the clinical trials. Now it will take considerable time to enroll enough subjects to meet the endpoint.

With regard to gout, now that NVS' Ilaris is out of the picture, who beyond RDEA (Phase 2B) and SVNT are active in developing or marketing gout medications. Krystexxa from SVNT has a listed SE of severe allergic reaction, so there appears to be room for competition. Supposedly the gout market is large and growing. This appears to be another sad statement about health care trends in the developed markets.

The attached slide show from today's BCRX presentation suggests that BCX4208 is synergistic with the current standard of care and it doubled the number of patients achieving goal(from 40% on SOC to 80% with BCX4208). Unfortunately, tolerability info was not presented.

http://files.shareholder.com/downloads/BCRX/1300517143x0x477334/57e002ad-c2f6-4231-9cfb-0342fdcfa02e/BCRX Wells Fargo Healthcare Conf Handouts FINA

For now there does not appear to be strong reason other than valuation to get serious. At a market cap of $175M, BCRX will be an extremely cheap play if global pandemic fears ramp up. Remember 2012 is right around the corner! Just joking.

Thanks
FL