[This presentation is from a few months ago but I have RIGL back on my watch list and wanted to catch up on things. There were some notable disclosures from this presentation, as reflected below.]
1. R788 for RA which is now partnered with AZN and in Phase 3 is now generally referred to as FosD. Although the prior post detailing the AZN deal just generally referred to RIGL receiving stepped-up double-digit royalties on FosD sales, the CEO specifically disclosed during this presentation that RIGL will be entitled to royalties on FosD sales that start at 20% in the U.S. and scale up to 35%. This is quite a deal for RIGL, IMO, especially considering the fact that they don't have to spend another dime on the drug's development or the ultimate marketing if the drug makes it to market (i.e., RIGL is not required to co-promote FosD to receive these royalties).
2. Trials for FosD against lupus will follow the start of the Phase 3 for RA and oncology trials will also start in 2011.
3. RIGL believes that FosD may inhibit bone damage in RA patients faster than TNF inhibitors, which would be a big differentiating point in the marketplace.
4. AZN will be testing FosD in 3000 patients in the double-blind pivotals and in double that number of patients in the additional sub-studies, including Phase 3b trials. AZN anticipates a 6,000 - 10,000 patient safety database at the time the FosD NDA submission is approved. This will be the biggest single indication Phase 3 trials that AZN has ever done, including cardiovascular trials.
5. RIGL is partnered with PFE for R343, an inhaled SYK inhibitor that targets asthma. PFE will be presenting Phase 2 results later this year that show that the drug "worked" and will be moving into Phase 2b later this fall. RIGL is entitled to additional milestones on drug development and, ultimately, mid double-digit royalties if the drug makes it to market.
6. RIGL expects to initiate Phase 1 trials for R348, its JAK3 inhibitor, this year targeting transplant rejection. Actual trials testing the drug in transplant rejection patients are targeted for 1Q11. RIGL expects there to be advantages in the transplant rejection population for a drug that is specific for JAK3 as opposed to also hitting JAK2.
7. RIGL expects to commence Phase 1 trials in early 2011 for its PKC theta inhibitor where they are targeting MS. This is a completely novel mechanism and RIGL expects the drug to be an oral once/day small molecule drug. The drug works better than anything they've seen in pre-clinical MS models but these models are not as predictive for drug activity in humans as models used for other diseases.
8. RIGL also is developing ACVR2B for muscle atrophy and R481 (adiponectin for T2DM/muscle metabolism). These drugs will enter the clinic in late 2011 and early 2012. ACVR2B activates fast-twitch muscle fibers and is downstream of the myostatin pathway. R481 is an oral agonist of adiponectin, which is widely applicable in muscle metabolism. R481 is apparently the first oral molecule to trigger this pathway.
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