Biotech Values

[iwfal]

XOMA - CC notes (quickly written but hopefully intelligible):

1) Dropping EOA at this point - but looking at data to see if there is anything interesting. (e.g. There was an AUSCAN trend in the high CRP EOA six month data for the higher baseline VAS subgroup. (this is in line with a predict I made earlier).) But clearly they have more interesting targets in their Proof of Concept program.

2) Uveitis enrollment for general noninfectious uveitis (EYEGUARD A/C) - Servier is continuing to open sites for Uveitis trials. Of countries with approvals in Nov all but one have now started trial operations. And Servier has now grown planned number of countries from 19 to 23. Company still plans to have completed trials by end of 2014 - but made it very clear that it depends heavily on some of the recently operational countries (e.g. Brazil).

3) FDA feedback on what it would take to file for Behcets is that they would need US data (of the 3 on-going Uveitis ph 3's Behcets is the only one with no US enrollment. My comment: No surprise that this would be FDA request.). Company claimed the trial would not have to be large since the ph ii data showed such a large acute response (70 pct). Company noted that it is conceivable that they would be able to run trial in the acute population and get to filing for Behcets in early 2015. (I have doubts - Eyeguard A in uveitis is having very hard time enrolling because it is difficult to find acute uveitis patients in US. So unless Behcets is substantially more dramatic form of disease... (might be - have to check). Further commentary - I think that they are pursuing Behcets because they want approval in ultra orphan first. But I think they may actually have a better chance in PG than in Behcets just because of the aforementioned difficulties. PG is larger, appears to have fewer treatment options, they are already talking to trial sites and treatment duration is limited. Regardless... I think no matter what path they choose it will be difficult to beat the accelerating EYEGUARD A/C trials.)

5) Scleritis PoC trial - couldn't say anything due to non-disclosure agreement with investigator org. (Given likely shared etiology with uveitis I'd expect similar success. FWIW)

6) Behcets trial - they were crystal clear for the first time that they specifically address in their protocol one of my previously stated key concerns. The protocol requires that the treating MDs in the Behcets trial have to step down steroids in a pre-determined manner. They are not relying on physician desire to get patients off of steroids. (Presumably the protocol for EYEGUARD C is similar - since the trials are very similar except for patient population.)

General other commentary by me:

a) on PR disclosure of Servier's on-going PoC trials. The Giant Cell Arteritis indication is one of the newly disclosed indications they are pursuing - and that appears to be fairly common. Perhaps 100k patients in US as best I can tell.

b) At this point I think they have high probability of success in uveitis and Pyoderma Gangrenosum and other neutrophilic dermitosis diseases. Total population around 250k in US. The only questions are what percent do they capture (there will be competition in uveitis - but probably not much in other indications) and how much $ per patient (which will depend somewhat on how they roll out the approvals).