Amarin Corp Plc (AMRN)

[Laurent Maldague]

From the Hikma reply brief:

Nor does Amarin acknowledge that the article
quoted another doctor who “did not praise Vascepa or MARINE, but instead
dismissed MARINE’s significance because typical increases in LDL-C with
Lovaza were ‘modest’ and ‘not that big an issue,’ especially since Lovaza ‘works
well with statins.’” Appx42-43 (quoting Appx88650).

...
That is especially true here since severe
hypertriglyceridemia is “rare,” and statins were “extremely well tolerated.”
Appx88309, Appx1408-1409(809:21-810:14) (Heinecke).

...

It was not until JELIS taught in 2007 (one year before the alleged invention)
that EPA is “a promising treatment for prevention of major coronary events,” that
there was a major commercial incentive to pursue pure EPA in the United States.
Appx88633; Appx2697(1903:5-17) (Toth). The market for cardiovascular-riskCase: 20-1723 Document: 49 Page: 52 Filed: 06/16/2020
39
reduction is considerably larger than that for severe hypertriglyceridemia.


Singers reply:


Defendants are also wrong to downplay (at 37) the importance of having a
single drug to treat severe hypertriglyceridemia, repeating their rejected arguments that
adding a statin to Lovaza® was sufficient. But doctors strongly prefer using a single
drug, as opposed to multiple drugs, because patients often stop taking the coprescribed drug. (Appx1412–13 (Heinecke).) Defendants’ answer is also of no
comfort to those patients who couldn’t tolerate statins or who needed them to lower
their pre-existing LDL-C levels yet received no benefit from the statins other than to
offset the LDL-C increases caused by their treatments for severe hypertriglyceridemia.
(Appx2352–2353 (Toth).)

https://amarincorp.gcs-web.com/static-files/9e6e919b-3f59-460a-9731-26ee137c70b6