It demonstrates the potential of Lr-Et-EPA WITHOUT GENERIC COMPETITION in the U.S.
Exactly. One only need go back to @CaptBeer charts showing the trajectory of scripts, post-Reduce-It. I shudder to think about where we would be today.
A lot has happened since then, and there are a lot of challenges to re-claiming that same pace (no salesforce, the mineral oil issue, other new competing CVD products, etc.), but I still believe the new formulation is our Way Back (I just thought of our new internal tagline for Lr-EtEPA 🤣).
The new formulation will always compete with generic EPA on price. gV sets an absolute price ceiling on the product If its not cheaper than generic it wont get insurance coverage and wont have sales. Its just that simple. Its only viable in the US if they can use less API and have a cogs that generics cant possibly touch. And dont forget Mochidas 15% cut of the margin.
Generics will also file for a generic form of Lr quickly after launch and force Amarin to defend the patent in court. Its what they do. All regulatory exclusivity on EPA is gone in the US unless Amarin can get 3 years with a new indication linked to the new formulation when approved. Regulatory exclusivity is the only thing that stops generics from their patent busting ways.
If youre talking a new indication thatll be years for a phase 3 and dilution.
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