- Isis Pharma $ISIS presented 6/9/11 at the Jefferies healthcare conference. Click here for the complete ISIS research page with detailed info on every Isis program.
- Here are my notes:
- Mipomersen: EU regulatory filing "next month", US FDA NDA "shortly thereafter"
- Will include info on >700 pts in mipomersen dossier, >100 over 1 yr
- Sanofi SNY/Genzyme GENZ are "far along in planning to launch this drug next yr"
- mipo liver side effect- no Hy's law cases or bilirubin changes (these would be more cause for concern). Elevated liver enzyme levels tended to decrease with continued tx- effect is also associated with the pharmacology of lipid lowering
- Longer-term extension studies- modest increases in liver fat deposits seen in small # of pts is associated with rapid LDL reduction, over time this stabilizes and in most cases go back down
- Company is exploring opportunities to present this new data at scientific conference in very near future
- Confirms plan to add 3-5 new drugs to pipeline by ye2011
- New pipeline charts- gray bars represent where they think the drugs will be in next 12 months (I will update the pipeline charts with the new images by therapeutic area on the ISIS research page)
- CRP p2 trials will start this yr (rheumatoid arthritis [RA] and multiple myeloma [MM] following stem cell transplant)
- ApoCIII p1 trial should provide evidence of target lowering and triglyercide lowering
- FXI hope to get activity data from p1 later in 2011
- Four type 2 diabetes drugs, each with unique mechanisms of action (MOA), can work individually or together
- FGFR4 p1 early 2012
- Eli Lilly $LLY survivin drug- expect p2 to finish up this yr w/ data this yr or early 2012
- eIF-4E and HSP27 p2 recruitng and going well
- STAT3 p2 late 2011 or early 2012
- TTR p2 2012
- SMN drug "about to start p1"
- GlaxoSmithKline $GSK first drug into p1 in less than 18 months, earned $48m so far. This deal has allowed expansion of Isis's rare disease efforts
- TTR drug has market of >50k pts worlwide
- Excalliard EXC-001- p3 planning is underway. But plan to do an additional p2 dose ranging studies. There is no approved drug for skin scarring. Estimate as $1.5b US market
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