Amarin cleared a significant hurdle Thursday in realizing its blockbuster ambitions for the fish oil-based pill Vascepa, gaining a unanimous recommendation for label expansion from an expert panel convened by the Food and Drug Administration.
The drug is now approved to cut triglyceride levels in a narrow patient population. The committee voted to expand that to include risk reduction for cardiovascular events, such as heart attacks. The FDA is not wedded to the panel's advice but typically follows it.
The 16-0 vote pleased the New Jersey-based pharma and its investors, with shares rising as much as 6% Friday morning. But critical questions remain on the language of the label and how Amarin plans to capitalize on Vascepa's market opportunity as the FDA's decision deadline of Dec. 28 nears.
BioPharma Dive talked with Amarin CEO John Thero in a phone interview shortly after conclusion of the advisory committee Thursday evening. Thero, who has been at the company for a decade, talked about his perspective on licensing partnerships, pricing and commercial ambitions for Vascepa.
The following interview was lightly edited and condensed for clarity.
BIOPHARMA DIVE: What's your reaction to the advisory committee's reaction?
THERO: This is a positive step forward in what's been, for me, a 10-year journey to introduce a new generation of cardiovascular risk reduction therapy. We're looking forward to what we anticipate to be upcoming label negotiations with the FDA. And then, from there, educating healthcare professionals on how they can improve the care of their at-risk patients with Vascepa.
You've previously outlined plans to double the sales force from 400 to 800 representatives and boost direct-to-consumer advertising. What are the other priorities for 2020 on Vascepa commercialization?
THERO: First, we need to get an approval [in the U.S. for label expansion]. We've got a PDUFA date of December 28.
We will be transitioning from a promotional effort that's largely been based upon a niche indication to triglyceride lowering, which is a biomarker-based indication, into an indication, assuming approval, that's for cardiovascular risk reduction.
When I got involved here more than 10 years ago, this was what we understood doctors were looking for. There'll be a lot of education to do anytime you're creating a new treatment paradigm. We'll be looking to do that constructively, through sales force expansion, through medical education, through various forms of promotional outreach.
With a new label, do you anticipate raising Vascepa's list price? Particularly considering ICER found the drug to be cost-effective. (Vascepa's current list price is $303.65 for a 30-day supply for the 1-gram dose)
THERO: ICER rarely has unanimous cost-effectiveness conclusions against all of the scenarios that they evaluate. It's hard to complain about an analysis where we're positive even against their most stringent criteria.
That being said, ICER only included in their analysis a portion of the cardiovascular event reduction that was demonstrated in REDUCE-IT.
We are looking forward to this weekend at the annual scientific sessions of the American Heart Association, there are seven separate presentations related to Vascepa, the population that Vascepa addresses and one of those is in regard to cost effectiveness. That is being done by a group likely to take a bit more of a comprehensive review of cost analysis.
It is good to have a cost-effective drug. Our view is that if we're trying to treat millions of patients, we should have a drug that is affordable and we're proud that Vascepa is available to patients who have commercial insurance for, on average, $3 per per month. If we can make it affordable, we can treat many patients and that's our goal, to try to help as many patients as possible.
Just to be clear, is there a possibility for a list price increase next year, considering the new indication?
THERO: The net price of our drug has not changed in the last five years. We think that continuing to make the drug affordable for patient care is the right positioning for this product.
Reading between the lines there, I'm not hearing that the list price will definitely stay in the same in 2020.
THERO: The pricing that we have today we believe is an affordable price for the product, and we look forward to getting the label expansion and helping as many patients as possible. This is really a volume opportunity, not a pricing opportunity.
Have there been any discussions or considerations of partnering with a bigger pharma company to co-promote Vascepa? Or are you fully confident with the 800 sales reps as sufficient?
THERO: In Canada, we are partnered with HLS Therapeutics. In Europe, we will consider partnering. We have a partner in China and the Middle East.
The medical community's key opinion leaders are very supportive of what we're doing. We believe that with the results that we have and the experience that we have amongst our team, that we're very capable of growing this opportunity into a multi-billion dollar product.