Re: Farmas USA
Hola Chicos....AMRN
Market analysis
There are 3.8 million people in the U.S. with TG level greater than 500 mg/dL. Currently, only 3.6% patients are treated with pharmaceutical medicines. This suggests that if AMR101 is approved, it could have potentially larger market share than the current $1B in LOVAZA sales. Worldwide, patients in this very high TG category are 2-3 times the U.S. market. Amarin also plans to market the drug globally. The NDA for the first indication was submitted in Q4 2011 and will receive an FDA response on 7/26/12. If approved, the Company plans to launch the product before Q1 2013.
AMR101 may also be used in people with medium-high TG level (< 500 mg/dL, >200 mg/dL). This was evaluated in the ANCHOR studies. There are 36 million adults in US in this category. Less than 4% of people in this category are currently treated with fibrates, which had $1B sales in 2011. Therefore, if AMR101 is approved, it could compete with fibrates and potentially expand the market size. Amarin has submitted a supplemental NDA (sNDA) for the second indication in June 2012 (check the date). FDA decision is pending till next year.
The preliminary data from the REDUCE-IT study group in Japan looked encouraging. More updated data will be reported toward the end of 2012. Since the trial is still years away, its potential impact is not factored into stock valuation.
Saludos
