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Regardless, by combining EPA with their drug, Gilead has a novel patentable therapy.
Edit: For example, Amarin has a patent for an all-in-one capsule of a statin-containing capsule with an EPA center. Amarin can patent the invention without taking another company's product. Does it mean Amarin can make it? No. Amarin would need a patent of a statin or permission/license from a statin patent holder.
Edit 2: I just want to emphasize, this works both ways. If Gilead discovers their drug works better with Vascepa, they would need doctors to prescribe them together or license Vascepa from Amarin if they wanted to make an all-in-one drug. Does this make sense?
Amarin may have the data, but patents in the US are approved on a first-to-file basis. Besides, patents can come in many flavors. Amarin is still free to file a patent for treatment using Vascepa only, whereas Gilead may file theirs as a combination with their proprietary drug.
Patents grant applicants with the right to EXCLUDE, not a right to MAKE. You could submit a patent today using Vascepa, that if approved, would prevent Amarin from manufacturing your patented product. It's a strategy commonly employed by patent trolls. Of course, you would need Amarin's permission (usually through a licensing agreement) to use Vascepa to make your patented product.
As for a supply of Vascepa, they probably source it from a wholesaler like any other pharmacy, not necessarily through a partnership with Amarin.
If you are asking about the product, Gilead has a patent to treat non-alcoholic fatty liver disease using a compound or the compound combined with a peroxisome proliferator-activated receptor alpha (PPARa) agonist or fish oil.
If you are asking why one company has another company's product in their patent, it's because patents grant the applicant with the right to EXCLUDE not the right to MAKE. For example, you are free to file a patent for a product that included Vascepa. If the patent were approved, that does not mean you could make the product (you would need a license from Amarin first), but it does prevent Amarin from manufacturing your patented product (google "patent trolls" for an example). Does that make sense?
In summary, I would not over interpret the inclusion of Vascepa in the patent. They use "fish oil" which could be Vascepa or DHA. I'm assuming they specifically refer to Vascepa by trade name because it's what they are using in their clinical trial (https://clinicaltrials.gov/ct2/show/NCT02781584?term=Vascepa&cond=NASH&draw=2&rank=2). Which again, is not indicative of anything because they could have obtained Vascepa on their own rather than through a partnership with Amarin.
BB pointed out yesterday that the stock was acting weird because it was trading around $22.5. Today it's doing the same thing and has been almost flat around $20. There is something really strange going on, which is why I've been sharing ways to file complaints for others who feel the same.
Even if nothing comes of it, at least someone will have taken a closer look at the events surrounding this report.
Does that mean he has a copy of the full report that he could share with us? I would be very interested in reviewing the what the analyst disclosed as conflicts of interest.
Using complaint forms provided by regulatory bodies as they were intended for is nothing to be ashamed of. That's what they are there for.
Edit: To put it in perspective, if you eat out at restaurant and the next day you feel ill, you will report it to your county health department or if you see a doctor, they will report it for you. Even if you are wrong, it starts a paper trail that may lead to a investigation if it turns out that other people file similar reports. It's not, "pissing into the wind."
Thanks! That article is what convinced me to file a complaint. His price target of $7 is only 1.5x his estimate of $2B, when annual revenue is already estimated at $400M on a very small proportion of the population with the current label. Something is very strange about that math...
Not looking to sue. I only asked that conflicts of interest be investigated because as the links I provided show, regulators are aware of the influence that these analysts have on the market and hold them to strict rules.
It is referring to how the drug is cleared by the body and not a side effect of the drug on the liver. Most drugs are metabolized by enzymes in the liver, so oftentimes, patients with liver disease have decreased ability to metabolize drugs and clear them. Hope this helps!
Edit: I'm on my phone so referencing my sources is challenging, but if you want to learn more, the info should be in Vascepas FDA label insert or googling "pharmacokinetics" should give you the answer you're looking for.
Primary and secondary prevention patients as defined by the REDUCE-IT study can be summarized as,
Primary: Patients with diabetes and risk factors for cardiovascular disease (i.e. prevention of cardiovascular disease)
Secondary: Patients with cardiovascular disease (i.e. prevention of additional cardiovascular disease)
As you pointed out, the REDUCE-IT definition of primary prevention patients is a very narrow definition of primary prevention and is a reason for the AdCom as shown by this discussion,
The discussion that ensued over how to incorporate these populations into the label is probably why it sounded like these definitions were not being used uniformly.
Disclosure: I am still long AMRN. I am only submitting this article because it is behind a paywall but is currently the only article that reports the rationale of the committee members, which I thought might be of interest to others. Keep in mind, some will be the same members as tomorrow.