Biotech Values

[DewDiligence]

Hi, Elmono—sorry for the belated reply.

>>You probably know that plasma derived antithrombin is made commercially available in Europe under the trade name ATnativ by Baxter. What I just learned is that another big, but to me relatively unknown company, by the name of Grifols is marketing plasma derived antithrombin under three different brand names. Their most advanced en newest product (in terms of safety, side effects and shelf-live)is called Abinex (You can check out their website). This made me wonder about the real market potential for Atryn in Europe, since Abinex can probably be used off-label for the same indications as Atryn. I believe that Grifols might also want to target the US market with this product. I am curious about your view on this.<<

Please see #msg-7221666 for a list of commercially-available plasma AT products (including prices) compiled by Norman Klein. All of these products suffer from the risks of any plasma-derived protein. I would not worry unduly that one of these products might become approved in the U.S., where plasma to make these products is in short supply to begin with, as evidenced by the lack of availability of Thrombate from Talecris Biotherapeutics.

>>Another thing I learned is that the EMEA CHMP Blood Group Working Party will probably evaluate the MA application of GTCB and those guys will not convene as early as half september (you can check out the EMEA website for this), so I find it very hard to believe that the CHMP will make a recommendation before half October<<

A good observation.

>>The last thing you should check out is the following site:
http://www.fda.gov/cber/summaries.htm
Please take a look at the presentations of Dick Scotland, Chris Healey and Rainer Seitz and let me know if you found these informative. I did.<<

Yes, they were. Dr. Scotland’s presentation was essentially the same one given at GTCB’s annual shareholders’ meeting in May. Regards, Dew