- I have just recently started to assemble coverage of Amarin on BiotechDueDiligence (and recently bought my first shares) - here is the link to the AMRN research page under construction.
- Visit the Upcoming Events and Past Events pages for schedules, links, and my notes for all the companies I cover.
- My notes from the webcast are below:
- SPA's took 3-9 months additional time to complete in exchange for "additional certainty"
- AMR101 differentiation vs current products: lack of increased LDL levels, and see decreases in other atherogenic lipids
- Fenofibrates have substantial safety concerns...described as "melting the liver" and elevated liver enzymes
- Triglyceride levels of 200-499 mg/dL represent 36m patients in the US. Lovaza is not approved for this indication because of the issue with LDL increases
- We don't have an answer as to why AMR101 doesn't increase LDL. Perhaps related to the fact that DHA degrades 10x faster than EPA (Lovaza is a mix of DHA and EPA, AMR101 is >96% EPA)
- The NDA acceptance date is over Thanksgiving weekend.
- Previous outcome studies:
- Niacin plus statin (AIM HIGH) - Failed
- Fenofibrates plus statin (ACCORD) - Failed
- Lovaza plus statin - "I'm told the study did not show a benefit"
- Japanese EPA study (JELIS) - we are in the process of repeating these positive data with our REDUCE-IT trial
- Total worldwide patient populations for each of the discussed indications is 2-3x that of US
- Supply chain - now have 3 API, 2 encapsulation, and 2 packaging suppliers, and plan to continue to add to this number.
- Intellectual Property (IP): believe we are well-positioned for multiple patents through 2030 or later. We have 16 applications within 11 patent families, plus many more ex-US
- $126m cash on hand 9/30/2011 with 136m shares outstanding plus 11m options and 21m warrants
New Chemical Entity (NCE) status
- We won't know the answer until the FDA approves the drug
- We were asked to do toxicology studies consistent with NCE
- EPA is not on the market, and is different vs EPA/DHA (Lovaza)
- We are doing 5 year outcome study - we would like to think that we wouldn't be asked to do it if we aren't getting something out of it.
- This issue "is out of our hands"
- We have had positive discussions with our advisiors, but this process just has to run its course.
- About half of our patent applications have published
- It is not about any one patent, but is an IP portfolio, plus trade secrets and other barriers to market entry.
1) 5 year NCE exclusivity
2) 3 year market exclusivity
3) none of the above
Supply Chain - is it sufficient at this point?
- 3 suppliers, all are pretty capable (located in Japan, South Korea, and Europe)
- We believe these can support 1000 metric tons of production
- Each 1000 metric tons corresponds to about $1.2-1.3b in revenues