Amarin And Neopharm Announce Exclusive Commercialization Agreement for VAZKEPA® (Icos
-- Agreement Follows Recent Regulatory Approval in Israel of VAZKEPA® to Reduce the Risk of Cardiovascular (CV) Events in Adult Statin-Treated Patients at High CV Risk with Elevated Triglycerides and Other High-Risk Characteristics as Studied in REDUCE-IT –-
-- Heart Disease Second Leading Cause of Death in Men and Women Aged 45 and Older in Israel --
DUBLIN, Ireland, BRIDGEWATER, N.J and PETAH TIKVA, ISRAEL, Aug. 08, 2023 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) and Neopharm Israel announced today that the two companies have entered into an exclusive marketing and commercialization agreement for VAZKEPA® (icosapent ethyl) in the State of Israel, Gaza, West Bank and the territories of the Palestinian Authority. VAZKEPA capsules are the first prescription treatment comprised solely of the active ingredient, icosapent ethyl, a highly purified form of eicosapentaenoic acid.Under the terms of the agreement with Neopharm, Amarin has appointed Neopharm as its sole and exclusive distributor of VAZKEPA in the territory to import, register, distribute and commercialize the product, in order to ensure access to patients. Amarin grants Neopharm the right to hold under its own name the Regulatory Approvals and Regulatory filings as the Marketing Authorization Holder for VAZKEPA in this territory. Amarin will be responsible for supplying finished product to Neopharm at a transfer price paid to Amarin.
"We are excited to announce this agreement with Neopharm, a leading provider of pharmaceutical commercialization in Israel,” said Patrick Holt, President & CEO, Amarin. “Neopharm is well-positioned with its commercial capabilities, as well as its pedigree and experience in cardiology and related disease categories, to enable access to this important medicine for patients in Israel."
“The addition of VAZKEPA to our portfolio and the opportunity to serve and improve the lives of Israeli statin-treated patients suffering from cardiovascular events is a privilege,” said Efi Shnaidman, General Manager of Neopharm Israel. “We look forward to working together with Amarin in making VAZKEPA available and accessible to patients.”
The agreement follows Israel’s Ministry of Health (MOH) Pharmaceuticals Division granting regulatory approval to VAZKEPA (icosapent ethyl). The MOH issued its approval of VAZKEPA to reduce the risk of cardiovascular events in adult statin-treated patients at high cardiovascular risk with elevated triglycerides (≥150 mg/dL [≥ 1.7 mmol/L]) and either established cardiovascular disease or diabetes and at least one other cardiovascular risk factor.
According to data from the Israeli Ministry of Health, heart diseases are the second leading cause of death in Israel, in both men and women, aged 45 and older.i Heart disease accounted for about one-sixth of all male and female deaths in recent years in Israel.i
“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,” said Steven Ketchum, PhD., President, Research & Development and Chief Scientific Officer, Amarin. “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.”