Regarding Mubodina

[Linda Burke]

     Since some speculation has arisen regarding a possible new drug on the horizon for aHUS patients, I wanted offer the few facts I found on the topic.  On Nov. 3, 2011, the “Bio in Italy Newsletter” noted that Adienne Pharma and Biotech based in Bergamo, Italy was granted patents for Mubodina®.  The article states that this Italian company, specializing in rare disease treatment and with a number of Orphan Drug Designations granted by EMA and FDA, was granted patents in both the European Patent Office (April 2011) and the United States Patent and Trademark Office (August 2011) for ‘anti-C5 antibodies”.  Importantly, note that obtaining patents for a drug just begins the initial phases of any company’s long trek through a preclinical period of investigation, three phases of further exploration (including clinical trials), and a regulatory phase with multiple milestones …..all before any drug awarded patents can reach market for physicians to prescribe a drug for its labeled use with patients.

       According to Adienne Pharma and Biotech, “Mubodina® is a recombinant human monoclonal antibody against the Complement component C5 with an anti-inflammatory action. This molecule prevents the cleavage of C5 and inhibits the generation of inflammatory molecule C5a and of TCC lytic complex. The inhibition of component C5 preserves the immune-protection and immune-regulation of upstream components critical functions that brings to the opsonization of pathogen-mediated C3b and immune complexes cleaning.”  For more details, please check out this source at http://assobiotec.federchimica.it/default/news/bioinitaly-newslette...

[Cheryl Biermann]

I am so happy you were able to find more than I was and that your blog addressed what I forgot to include.

 

Thanks for posting what you've found, we were also assuming that if this project continues it is several years down the road and not something for consideration anytime soon as the process is very long from approval of patents to trials to market.  Based on the need for drugs to treat inflamatory diseases, I certainly hope this type of research continues.