AMRN Conference Call
Repost from Yahoo MB
Main points
- Got all 5 indications they wanted in label, including ApoB
- No increase in LDL-C in 4 grams per day.
- ApoB reduction of 9%
- Safety shows strong support. Arthralgia main side effect in 2.3% of patients. No other major events.
- sNDA for Anchor will occur before end of 2012 once REDUCE-IT underway
- 90% of market opportunity at 4 gram dose
- Significant progress to protecting commericial potential thru 2030.
- Some form of exclusivity from FDA. Either 3 year or 5 year. Will be found in orange book mid-August. Even without 5 year, they feel confident about patent protection thru 2030 and beyond.
- Early 2013 launch.
- In competent position for supply of drug.
- NCE status still in active dialogue. June 22nd meeting was a proactive meeting not a responsive one.
- My personal opinion- sounds like selling company or self-collaboration is what they're leaning towards, but CEO wouldn't comment one way or the other. Said for strategic partnership to happen, it takes away control and the agreement would have to benefit Amarin.
- 65,000-70,000 sales reps in US, and they want 200-300 reps. Going to be proactive.
- They've had all the formal meetings w/ FDA they need.
- Still in very active dialogue w/ FDA re: NCE. Wouldn't comment.
- Advantage to Lovaza- equal in efficacy in lower trig's, doesn't raise LDL-C, better side effects, reduces apoB and lowers non HDL-C. Thinks they'll expand into the market.
- No decisions on PRICING. Goal is to share shift to Vascepa. WOrking with managed care now.
- on a 0-100 scale CEO is at 95 with regards to apoB in label
- possible 2013 indication for dyslipidemia.
- Now assessing Europe. Feels can get approval, but reimbursement in Europe is different. Looking at emerging markets.
- Expects strong presence in orange book with patents.
- Lovaza trial failed for mixed dyslipidemia. AMRN expects to get indication in label.
- Might have other label movements that benefit AMRN in label
