Amarin Asks US FDA to OK Novasep as Vascepa API Supplier
The Ireland based drugmaker asked the US Food and Drug Administration (FDA) to approve Novasep’s subsidiary Finorga SAS as an active pharmaceutical ingredient (API) supplier in a supplemental New Drug Application (sNDA) filed late yesterday.
The US FDA has already cleared Germany’s BASF, South Korea’s Chemport and Japan’s Nisshin Pharma as suppliers, but gaining similar status for Novasep would allow Amarin to cut what it charges for its fish oil pill according to CEO Joseph Zakrzewski.
“The Novasep submission represents an additional step toward the goal of expanding our global supply chain to support expected Vascepa demand, diversify our supply base and ensure cost-efficient supply.
“As previously stated, the continued addition of these suppliers will potentially lead to API cost reductions of up to 50% or more and help us reach a steady state gross margin as a percentage of product revenues in the high seventies to low eighties."
Previous submissions have taken the US regulator between five and six months to review and approve. Amarin predicted that Novasep’s plant in Mourenx, France will be approved and manufacturing API sometime in 2014.
A Novasep spokeswoman told in-Pharmatechnologist.com that: “It is usual for pharmaceutical companies to have multiple supply sources for an active pharmaceutical ingredient (API). It is part of a good risk-based approach.
She also confirmed that it will produce the API at its facility in in Mourenx, under cGMP conditions and added that US authorities are expected to visit the site soon.
“Novasep and Amarin anticipate the production site, in Mourenx, France, to be audited by FDA in the near future,” she explained, adding that “This supplemental New Drug Application was submitted after Novasep proved production batch consistency to FDA .”
Demand, indications and partnering
In the US Vascepa was approved as an adjunct to diet and exercise for patients suffering severe hypertriglyceridemia in July 2012 and has been available to patients since February this year.
Since then, according to Amarin’s second quarter financial results, the drug has been prescribed around 58,000 times - 10,484 between February and March and prescribed 47,335 times between April and June – and generated revenue of $5.5m (€4.1m).
Seeking approval for Novasep as an additional supplier fits with Zakrzewski’s suggestion that: “Since the end of Q1, revenues, prescription levels, prescribing physicians and lives covered under Tier 2 have all more than doubled."
Adding another supplier is also in keeping with Amarin’s on-going efforts to gain approval for Vascepa as a treatment for patients with lower triglyceride levels - between 200-499 mg/dL - which is a much bigger population than that covered by the drug’s current indication.
The US FDA is due to reach a final decision on December 20 which, if positive, would probably prompt an increase in production.
Whether Amarin would have the financial clout to fund the launch of Vascepa for another indication is unclear. According to its most recent set of financials the firm has $149m in cash and cash equivalents in its coffers.
If this is not enough another option would be to team with a larger player and – in that context – Amarin’s efforts to broaden and strengthen its supplier base may prove to be attractive to a potential partner.
Amarin did not respond to a request for comment.