The agreement for VAZKEPA capsules comes after approval from Israel’s Ministry of Health (MOH) Pharmaceuticals Division.
The approval of these capsules has been granted for reducing cardiovascular events risk in adults who previously received statins and are at high cardiovascular risk with elevated triglycerides (≥150 mg/dL [≥ 1.7 mmol/L]).
It is also used to treat patients with diabetes and having at least one other cardiovascular risk factor.
Amarin chief scientific officer and Research and Development president Steven Ketchum said: “The regulatory approval of VAZKEPA in Israel marks continued progress in our effort to bring this product to patients with residual cardiovascular risk around the world.
“We are proud of this important milestone in that effort, and that patients in Israel will soon be able to access this important therapeutic option to address their residual cardiovascular risk.”
As per the terms of the deal, Amarin has appointed Neopharm as its sole as well as exclusive distributor of the capsules in the territory for importing, registering and commercialising the product.
Neopharm will also have the rights to hold under its own name the regulatory approvals and filings, as VAZKEPA’s marketing authorisation holder in this territory.
Amarin will supply finished product to Neopharm.
VAZKEPA capsules include active ingredient, icosapent ethyl, a highly purified form of eicosapentaenoic acid.
Icosapent ethyl is sold under the brand name VASCEPA in Canada, Lebanon, and the United Arab Emirates.