Biotech Values

[DonShimoda]

XOMA Notes from RBC Capital Markets Global Healthcare Conference

Update on Ph3 Uveitis Trials

Eyeguard A (in active setting) data is expected at YE.
Eyeguard B (in behcets) data is expected mid-14.
Eyeguard C (maintenance setting) data is expected Q1 14.

Servier is reponsible for the first $50M in trial costs after which expenses are split 50/50. Based on discussions with the FDA, the company feels an NDA can be filed with results from any two of the three Ph3 trials. XOMA maintains rights in the US and Japan and fully intends to commercialize Gevokizumab in US. The 150,000 US pts are treated by approximately 170 specialists which lends itself to a very targeted salesforce. While the company did not discuss its pricing/commercialization plans, they intend to price Gevokizumab as a "biologic" (which I assume to mean $$$) and feel that uveitis could be a very large market for Gevokizumab .

The CEO touched on Servier's 21 patient follow-on trial that preceded the Eyeguard B Ph3 trial. While the data has not been published, the results from this trial precipitated Servier's decision to move quickly to Ph3.

As far as the Ph2 PoC trials go, the company was "encouraged" by the recently announced results (#msg-83122761) from the Ph2 acne vulgaris trial however feel that a higher dose/frequency will be needed in this indication. The company is currently assessing the commercial path forward.

Ph2 data from the Erosive Osteoarthritis of the Hand trial is anticipated mid-2013. This is a large (4 million) market with few treatments options. The company hopes that the PoC data will demontrate that this indication is driven by IL-1B (#msg-83091229) and, if so, feel it could represent the second significant opportunity for Gevokizumab.

In December, the company announced, in partnership with the National Eye Institute, a third (#msg-83091342) Ph2 PoC trial. The trial is in non-infectious anterior scleritis and data is expected by year end.

One interesting development is that the company is currently pursuing several ultra-orphan indications which, if successful, could potentially bring Gevokizumab to market even earlier than the 2015 time-frame in Uveitis.

Once again the company confirmed its desire to advance the XMET A and S program to the point where it can be partnered. The company re-iterated its interest in developing XMET D (the insulin receptor antagonist) on its own.

The company did not provide an update on the partnering status of the Servier licensed ACE inhibitor.