- Amarin is not a company that I cover with a full research page at BiotechDueDiligence, not do I own the stock.
- However, I have started to research this company's story, and I know this company is popular with biotech investors lately, so I'll share my webcast notes below.
- As always, check the Upcoming Events page for future catalysts and webcasts, and check the Past Events page for links to my webcast notes from all stocks I follow.
- We believe in AMR-101 we have the safest, most efficacious unpartnered asset available
- MARINE population >500 mg/dL triglycerides, 4 million patient population, $4-5b market versus Lovaza, Omacor
- ANCHOR 200-499 mg/dL, 35 million patients, $40b market, Lovaza doesn't compete in this market. Mostly is a phenofibrate (tricor, trilipix) market, but not well penetated due to side effects, only 4% treatment with prescription products
- 150-199 mg/dL triglycerides borderline, 35m patients...will require outcome study
- Total of all three populations represents 1/3 of adult Americans
- 18000 patient successful outcome study in Japan on top of statins. Multiple drugs have failed this sort of study including Lovaza, phenofibrates, Zetia
- Advantages vs Lovaza - no LDL issues, HDL goes down more, better side effect profile
- we believe the development and progression of triglyceride therapy will follow as and come after cholesterol therapy
- seek best in class treatment for >500 group, first in class for 250-499 group
- 3 SPA's - each take 3-12 months to get done with FDA.
- commercialization - considering multiple options on way to NDA [presumably sale of company, partnership, or build own commercial infrastructure]
- Initial problem with omega 3 therapies - saw equivalent increase in LDL levels as decrease in triglycerides
- phenofibrates - when taken with higher dose of statins, they get less effective, and have significant liver issues. EPA/AMR-101 is opposite, "1+1=4" synergistic effect
- ANCHOR - primary prescribers are cardioloigsts, endocrinologists, lipidologists, some primary care. 1:50 of US population covered by MARINE trial population in NDA to be filed by end of 3q2011 (this was subsequently filed/announced on 9/26/2011)
- outcome trial - less than $25m in expenses in next 18 months, very mangebale with our current cash (currently negotiating with CRO to run this trial, estimate total cost $100-125m)
- 53% reduction in triglycerides seen in the 1000 pts in GELIS trial that were in 150 mg/dL and above group. Our outcome study will be 8000 pts
- commercial strategy for launch - parallel processing all options. We have a quite cost-competitive global supply chain - 3 suppliers right now. well positon for patents through 2030, 10 patent families, 14 total applications. Continue to evolve IP situation over the rest of this year and ealy 2012.
- ANCHOR safety/efficacy will be submitted in first NDA. hope to be able to make argument to have both indications approved next year as enrollment progresses in outcome trial.
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