Replies to post #344616 on Amarin Corp Plc (AMRN)

[johngnatt]

@marjac I can not emphasize enough that generic drugs have to meet the same standards as original patented drug. FDA routinely analyzes drug formulations to ensure they meet the standards. Generic companies do not mess around. The cost of non-compliance is quite severe. They can just shut down the plant and every product at the plant will be shut down. The time it takes to get into compliance again is very long.

Hikma will not dole out an inferior product that does not meet FDA standards. It is just not worth their time and money to cheat. This is a wrong focus.


However, I do have a question for you about the Reduce-It patent.

Based on what we know to date, what is the most compelling evidence to show induced infringement. Does the AstraZeneca v Apotex case shed some light?

Hikma has removed everything that is suggestive of induced infringement, including the AB rating from their promotion.
However, they are definitely relying on the FDA orange book for the doctors to prescribe the GV.

The insurance will also be approving the GV based on the FDA orange book.

The LEGAL question that I have for you is this:

Does Hikma's reliance on FDA orange book AB rating for the drug to be used as alternateive to Vascepa suggestive of induced infringement?

[johngnatt]

@marjac @captbeer

I was not aware of the MSDS label that HIKMA has on its website.

https://www.west-ward.com/~/media/Files/wwsite/Products/SDS/Icosapent%20Ethyl%20Capsules%20-%20SDS.ashx

Capt, I read your write-up with great interest. This is what I have to offer. Based on what Hikma has posted publicly, the drug should be withdrawn for the market immediately. FDA need to take action RIGHT NOW.

Give the fact that Hikma claims that the maximum content
of EPA at 100% purity is 80% based on the mSDS , there is no way that this can meet the requirement for FDA bioeqivalence.
The 90% confidence interval for geometric mean bioequvalence states:
90% Confidence Interval (CI) acceptance criteria is
80.00-125.00% for the test/reference ratio for all
three parameters AUCt, AUCinf, and Cmax

If the max composition of API is 80%, there is NO WAY this can meet the 80-125% range. It is mathematical and statistically impossible

Every capsule should have exactly 1000 mg of content and API should be exactly 800 mg in each capsule.

For all practical purposes the HIKMA product is mislabeled and misbranded and need to be pulled off immediately.


Section 502 of the Federal Food, Drug and Cosmetic Act
(FFDCA) contains provisions on misbranding including some that relate to false or misleading labeling. A device’s labeling misbrands the product if:

Its labeling is false or misleading in any particular;
It is in package form and its label fails to contain the name and place of business of the manufacturer, packer, or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count;