Last week the US Food and Drug Administration (FDA) cancelled the special protocol assessment (SPA) status given to the ANCHOR clinical trial Amarin had hoped to use to convince the agency to approve an extension to Vascepa’s indication.
The news – which followed two weeks after an FDA approval panel voted against approving the extension – was seen by most observers as scuppering Amarin’s efforts to gain prescription status for a broader group of cardiac patients.
Whether these observations prove to be accurate will only become clear on December 20 when the FDA is scheduled to announce its final decision.
Chemport continues to supply
What is clear at this stage is that the majority of the companies Amarin had lined up to provide it with pharma-grade omega-3 in the event the Vascepa indication was extended will keep supplying the ingredient.
In-Pharmatechnologist.com has already confirmed that Amarin’s agreements with both German chemicals firm BASF and French active pharmaceutical ingredient (API) and contract manufacturer Novasep will keep shipping omega-3.
And now a third supplier – South Korea’s Chemport – has told us that it too will send omega -3 to the Ireland-based drugmaker.
A spokesman for the firm told us that: “We are not affected by the FDA’s decision and we are supplying to Amarin according to the agreement.
The firm – which makes its ingredients at a facility in the city of Naju in the South West of the country – is the third of four suppliers Amarin had lined up.
The fourth –Japan’s Nisshin Pharma – has not yet responded to a request for additional information.
Amarin has enrolled 6,000 patients in another clinical program called REDUCE-IT – which examines Vascepa as an adjunct to statins in patients at high risk of cardiovascular events – and is due to update on progress during its third quarter earnings call tomorrow.