EMAB in SLE (post 2)
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IMMU's lead product now is Emab in SLE. After UCB aborted the ALLEVIATE trial they were able to look at the first 50 patients who had either gotten high dose, medium dose, or placebo. What they found was great. Even in that small sample there was statistically significant reduction in BILAG score (the most rigorous system for measuring SLE activity) and in steroid use. SLE can be controlled with chronic steroid use, but steroid cause terrible long term side effects. A drug that reduces or eliminates the need for steroids in auto-immune disease safely is the Holy Grail. Rather than going back to a P3, UCB decided to do an advanced P2 (a phase 2B) which was the EMBLEM trial of 230 patients in 6 dose arms and a placebo arm. The trial finished in 2009, results were fully reported at EULAR conference in June 2010, and they were quite robust. At the 2400 mg dose there was again statistically significant BILAG reduction compared with placebo. UCB has designed two Phase 3 trials which will begin later this month or next month. I anticipate rapid enrollment of 1600 pts worldwide, the trial is to run for 12 months, and I expect results in mid-2012.
Compared with Benlysta, whose success has given HGSI a 5 billion dollar market cap based on a positive phase three in SLE, Emab is being used in sicker patients, and Emab is being measured by BILAG reduction, a much more rigorous metric than the SELENA scoring system that HGSI used in their P3. Assign a probability to Emab's P3 being successful, and calculate the NPV of IMMU on that alone. Isn't it much higher than 200 million dollars, which is our current market cap? Also, UCB is paying for this entirely, IMMU doesn't have to spend a dime on development of EMab in SLE. |
