BASF and Chemport Get US OK as Amarin API Suppliers
Amarin asked the US Food and Drug Administration (FDA) to recognize Chemport as a supplier last year as part of an effort to expand and strengthen its ingredient supply chain.
Six weeks later, on January 2, the firm filed a second sNDA seeking equivalent approval for BASF, which had bought its way into the omega-3 active pharmaceutical ingredient (API) business in 2012 with the acquisition of Scotland’s Equatec (subsequently renamed BASF Callanish).
Later that month BASF strengthened its position in the fatty acid supply business by buying Norwegian firm Pronova for €684m ($894m) after finally winning over reluctant shareholders.
With the US FDA sNDA approvals South Korea-based Chemport and Germany’s BASF join Japan’s Nisshin Pharma on the list of firms cleared to supply Amarin with the omega-3 fatty acid derivative, icosapent ethyl.
Gaining approval for Chemport and BASF was set as a key milestone for Amarin in 2013 by CEO Joe Zakrzewski during his presentation at the JP Morgan Healthcare Conference earlier this year.
In a statement announcing the US FDA decision, Amarain said that it intends to file a third sNDA with the agency for a fourth – as yet unnamed - icosapent ethyl supplier later this year.
In related news, Amarin announced last month that the US FDA has set a December 20 target date to complete its review of Vascepa as a treatment for high triglycerides and mixed dyslipidemia.
The drug was cleared by as an adjunct to diet and exercise for the treatment of US patients suffering with severe hypertriglyceridemia in July last year.
However, while this allowed Amarin to start shipping the drug, the US regulators reach a decision on whether or not to grant it new chemical entity status (NCE) on the basis that it is similar to GSK’s rival heart drug Lovaza, which is already on the market and for which Pronova is a key API supplier.
Amarin will hold its first quarter conference call on Thursday this week.