- I don't follow larger cap names like BIIB as closely as I do the smaller companies in the BiotechDueDiligence coverage list, but I enjoy the free flowing format at the Goldman Sachs conference, so I thought I would post a few notes.
- See the Past Events page for the webcast link- they are still available as of 7/2/11, but I don't know how much longer that will be the case
- I listened for the BIIB perspective on follow on biologics (FOBs) aka biosimilars/biogenerics
- My notes are below the jump:
- speaker: George Scangos, CEO, been there a few months
- when he arrived in july- company was trying to do too many things, couldn't do core as well
- among the very best companies in protein drugs production
- cell line engineering, process development, manufacturing = strengths
- have capacity to expand biologics portfolio - have a big plant in NC, small plant in Cambridge, new one coming online in Denmark
- focus on CNS- small molecules will have to be part of this.
- It has proven hard over history for companies to be really good at both (small molecules and biologics) - so no ilusions that it will be easy - will use small in house group and collaborate w/ others around the world
- debt burden low, would be thoughtful before doing this, no specific comment
- extensive discussion of MS landscape (outside my interest/expertise..didn't take notes)
- don't see tysabri as a likely target for biosimilar development
- he thinks logical first targets are large RA drugs- huge volume, near-term patent expiration
- Biosimilars. they are coming, they will be on market, regulatory uncertainty exists but clarity improving from FDA/EU
- market uncertainty- how many for each product, how do innovators react w/ pricing
- BIIB- we have our hands full right now ("relaunch" of tysabi w/ risk stratifcaition, upcoming EU launch of ___, multiple compounds in phase 3 that could be introduced in next few years...last thing i want to do is divert thinking onto biosimilars
- US FOB guidance? FDA has made statements that make me think it will be more data driven, they want to see sophisticated analytics, then decide case by case on clinical trials. place burden on manufacturer