Amarin Corp Plc (AMRN)

[HDGabor]

i

"London, May 22, 2020 – Hikma Pharmaceuticals PLC (Hikma), the multinational generic pharmaceutical company, today announces that its wholly owned U.S. subsidiary Hikma Pharmaceuticals USA Inc. has received approval from the US Food and Drug Administration (FDA) for its Icosapent Ethyl Capsules, 1 gm, the generic equivalent to Vascepa® [1]."

I feel that the above sentence is almost equivalent to FDA's AB-rating.

"Almost" (as AB is the most common TE code)... but is not entirely. A generic could be a products that FDA considers not to be therapeutically equivalent to other pharmaceutically equivalent products. These generics get a "Bx" code ... "Ax" (AB) code is not the one and only possible TE code.

Hikma's PR:

"Vascepa® is a prescription medicine that is indicated, in part, as an adjunct to diet to reduce triglyceride levels in adult patients with severe ( 500 mg/dL) hypertriglyceridemia."

The "full" PR is

LONDON, Sept. 3, 2020 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces that the US Court of Appeals for the Federal Circuit today upheld a ruling by the US District Court for the District of Nevada finding that Hikma's generic version of Vascepa®1 (icosapent ethyl) 1gm does not infringe any valid claim of six key Amarin-owned patents. Hikma received FDA approval for the product in May 2020 and is working towards a launch.

Vascepa® is a prescription medicine that is indicated, in part, as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. According to IQVIA, US sales of Vascepa® were approximately $1.1 billion in the 12 months ending July 2020.

"We are very pleased with the Federal Circuit's swift decision and to be one step closer to launching a generic version of this important medicine for US patients and healthcare providers, helping us to continue putting better health, within reach, every day," said Brian Hoffmann, President of Hikma Generics. "Today's decision demonstrates Hikma's ability to successfully challenge patents on important medicines and to provide value to our customers and millions of patients across the United States."

It was release separately from the above, at different time ... and (other than "one step closer to launching a generic version") about the legal case only.

The term "in part" is interesting to me.

Well, it could be seen as they definitely omitted the R-IT indication from the PR ... easier to interpret as the case was about the MARINE (referred) indication than the case was about the MARINE (referred) indication only but "Hey, it is good for other indication also" ... look it up.

I think it is far-fetched to combine two different PR but if these would be combined I still see as far from inducement (by circumstantial evidence).

But looks like Hikma would be on the safest side ... both PR are available on independent news site (or by a direct Google search for Hikma media) only but are not by Hikma / Press release section.

Best,
G