AGORDON
There is one very troubling section in your post:
“Vascepa has no approved competitors in China for its FDA-approved indication for CRR. As of the Latest Practicable Date, only one competing generic was marketed in China with only one approved indication, TG reduction in severe HTG (500 mg/dL) adult patients. This competing generic has not been approved for persistent CRR,”
V’s R-IT patents are completely unenforceable in the US, what makes you think the fact the competing generic is not approved for the CRR indication will have any meaning in China? If there is a competing gV available in China then I foresee a significant problem.
Also, IIRC from research I did a couple years ago, new drugs take at least 2 years before being covered by government insurance (just like in Canada and EU) and they typically get a 60-70% discount compared to US and EU pricing because they know they are offering volume unmatched by any other market.
Amarin has rarely mentioned China in the past 3 years and has never given any financial guidance for China and I suspect that is because the chances that a Chinese sourced, Chinese manufactured and Chinese sold gV is very high. Remember, Teva’s API source is China, unlike all other sources. China built and opened a hospital in 2 weeks, how long do you think it will take them to mass produce IPE?
I give absolutely no weight to Chinese revenue when estimating total global sales.
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