FDA delays fish oil ruling Amarin is angling for

Amarin ($AMRN) in July nailed down FDA approval for its fish oil product Vascepa, but the agency can't seem to bring itself to designate it a new chemical entity, which would give Vascepa two more years of market exclusivity. 

The company's shares took a 5% blow today, FierceBiotech reports, after the company reported that the FDA has again delayed a decision on whether it will get the coveted 5 years of protection instead of just three. 

Adam Feuerstein at TheStreet says the company has been fighting a negative decision with a phalanx of lawyers, knowing that if it is left with just three years, it faces generic competition almost immediately.

Amarin calls Vascepa a drug that can be used--along with exercise--to fight high levels of blood fat that can lead to stroke and heart attack. While the drug will come up against GlaxoSmithKline's ($GSK) Lovaza, it doesn't have the possible side effect of elevating levels of bad cholesterol. 

This is Amarin's first approved product, but with the right partner to market it, Citi Investment Research forecasts that the drug could reach peak sales of $2.6 billion. That would put it ahead of GSK's Lovaza and Abbott's ($ABT) Tricor and Trilipix. That is, of course, if it doesn't get a buyout offer that suits its mood. Analysts are suggesting that AstraZeneca ($AZN) or Pfizer ($PFE) might be interested. 

Even without a partner, analysts think Vascepa could generate $1.5 billion a year for Amarin, 50% more than sales of Lovaza. The excitement stems from its clinical trial where Vascepa lowered triglyceride levels 33% compared with a placebo in patients with baseline levels greater than 500 mg/dl.

- here is TheStreet's piece
- get more from FierceBiotech

Suggested Articles

The future may be uncertain for AZ’s Imfinzi in first-line lung cancer, but its targeted med Tagrisso now boasts a green light in that setting.

Ultragenyx is back with another FDA nod, this time for Crysvita to treat X-linked hypophosphatemia in patients one year and older.

Roche got a two pieces of good Hemlibra news early this week—and what's good for Hemlibra must be good for Roche.