- TR p1 "right around the corner". Will trigger 2nd milestone from $GSK
- should have 2nd GSK candidate in pipeline 2011
- $25m on acceptance for review of mipomersen NDA. SNY lists US and EU filing as impt upcoming events
- FXI p1 data late 2011 or early 2012
- EXC-011 anti-scarring candidate- next p2 dose ranging study to ID dose for p3 studies, which are currently being planned. no cost to isis
- SMA p1 late 2011 or early 2012. recently rec'd orphan drug designation
- EU filing for mipomersen will be in july
- Recent advances in GENZ commercialization plan for mipo. want to increase awareness. GENZ is "unequivocally good at" this
- FH awareness campaign - will be launched at National Lipid Association annual scientific sessions in NY- patient and doctor education.
- Recent publication in the Journal of Clinical Lipidology on "Recommendations for Screening, Diagnosis and Treatment of FH in Pediatric and Adult Patients."- click here to read the key findings
- SGLT2, APOCIII data 2011
- "in next little bit" will launch CRP p2 trials
- 3 or more new candidates will add to pipeline in 2011, several others will enter clinic this year
- ISIS will host another pipeline call later this yr
- q&a session (briefer than usual):
- metabolic division of fda has and will continue to manage mipomersen filings
- finishing planning of 12 month study w/ GENZ. Will give details once it begins. Reiterate no outcome study
- Largest component of rev is amortization of GSK upfront fee. also get frequent milestones (large one for TTR candidate selection).
- Mipo marketing plan: early diagnosis, referal to lipidologists (focus and directly mkt to lipid specialists), increase awareness of FH and increase referrals form other doctors (cardiologist, internal medicine, etc) to lipidoligists, combine w/ other thrapies
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