BEDMINSTER, NJ (
) -- Two items on
up for discussion: First, we now have a confirmed date for the Vascepa "ANCHOR" FDA advisory panel. Second, the misguided reasons Amarin bulls are so excited about a fixed-dose combination of Vascepa and a cholesterol-lowering statin.
Mark your calendars for Oct. 16. The FDA has scheduled an advisory panel to review Amarin's request to expand Vascepa's label to include treatment of mixed dyslipedemia -- the so-called blockbuster "ANCHOR" indication.
The scheduling of an FDA panel isn't a big surprise. On June 6, Amarin President John Thero told investors at a conference that the
company was already prepping for just such a meeting
In its announcement, Amarin trotted out a paid consultant to explain that the FDA panel is routine and expected because a prescription-grade fish oil has never before been considered as a treatment for patients with mixed dyslipidemia.
There's some truth to that spin but I tend to believe FDA is convening this panel because it's wary of expanding Vascepa's use without definitive proof that fish oil reduces the risk of heart attack, strokes and other cardiovascular events.
Amarin is conducting a large cardiovascular outcomes trial of Vascepa, dubbed Reduce-IT, but results won't be known until 2016.
I expect many of the experts, most notably the cardiologists, sitting on the Oct. 16 FDA panel will
want to see Reduce-It trial data before agreeing to expand Vascepa's use
. Too many large studies of fish-oil have failed recently to show any significant cardiovascular benefit for patients.
Before today, Amarin bulls had insisted FDA would approve Vascepa for the Anchor indication because the application and the Reduce-It study are covered under a Special Protocol Assessment agreement. That argument no longer holds water.
Speaking of Amarin bulls, the
has been filled lately with optimistic chatter about pending results from a pharmacokinetic (drug blood level) study assessing a fixed-dose combination of Vascepa plus a statin.
Amarin is expected to announce results from this phase I, proof-of-concept study before the end of the summer. The company's long-suffering supporters believe positive data will be the springboard for a Big Pharma partnership, perhaps even an acquisition.
I don't buy it. The only advantage of a single-pill combining Vascepa with a statin is convenience -- and that's not enough to make Big Pharma interested.
It was long thought combining something with a statin was a strategy Big Pharma could use to retain sales to stave off lost sales from patent expiration. That gimmick hasn't worked. (See Merck: Vytorin)
(AZN - Get Report)
is the only large drug company with a branded statin (Crestor) on the market. Might AstraZeneca be interested in trying the single-pill combination strategy? Perhaps, but AstraZeneca bought Omthera Pharmaceuticals and its prescription-grade fish oil pill Epanova. AstraZeneca has no need for Amarin or Vascepa.
And what about
(PFE - Get Report)
? A lot of Amarin bulls believe Pfizer will buy Amarin to resurrect the Lipitor franchise. Doubtful. Lipitor is already generic. The days of blockbuster Lipitor sales are over. Even if Pfizer was foolish enough to partner up with Amarin, insurance companies will not reimburse for a premium-priced combo product when separate generic atorvastatin and Vascepa are available. Insurance companies don't care about convenience.
And to answer the inevitable follow-up question: Generic drug manufacturers don't market drugs.
I leave readers with an updated stock chart showing the chasm between Amarin's shareholder losses and the gains made by the biotech sector since Vascepa's approval.
Amarin shares were down 10 cents to $6.50 in Wednesday trading.
-- Reported by Adam Feuerstein in Boston.