Last yesterday Amarin revealed that the US Food and Drug Administration (FDA) has cancelled the special protocol assessment (SPA) status given to the ANCHOR clinical trial. The drugmaker had planned to use the results from the study to expand the indication of its omega-3 heart pill, Vascepa.
The firm – which announced a round of cost cutting measures when the results of the FDA review came in a few weeks back – has not yet issued a statement on the cancellation of the SPA status.
Whether or not the FDA’s latest decision has scuppered Amarin’s efforts once and for all remains to be seen. But what it clear is that at least two of the firm’s active pharmaceutical ingredient (API) suppliers plan to fulfil orders.
Before the cancellation in-Pharmatechnologist.com asked French contract manufacturing organisation (CMO) Novasep – one of four omega-3 suppliers Amarin has lined up – if the US regulator's rejection of Vascepa would change anything.
A spokeswoman for the firm, which is building a new production facility at its site in Mournex to support the contract – told in-Pharmatechnologist.com that: “As previously stated, Novasep is currently building a manufacturing facility. The schedule is on track to supply Vascepa API to Amarin starting in 2014.”
She added that: “Novasep will supply the ingredient for the Vascepa drug that was launched in early 2013 in the US for treating patients suffering very high triglycerides (above 500 mg/dL). The prescriptions are growing, product needs are thus increasing.“
When asked if Amarin would have to pay a penalty if it cancels the order, the spokesperson responded that “As a general rule, Novasep's confidentiality policy prevents us from disclosing details on contracts we sign with our customers.”
Novasep’s response echoes what BASF, another of Amarin’s API suppliers, told us at CPhI in Frankfurt last week. Amarin’s other API suppliers – South Korea’s Chemport and Japan’s Nisshin Pharma – did not respond to request for comment.