Jefferies Sees Chance of NCE Minor Delay on Amarin's (ARMN) Vascepa, But Another Positive Surfaces
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Price: $14.07 -0.57%
Rating Summary:
6 Buy, 12 Hold, 2 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
Rating Summary:
6 Buy, 12 Hold, 2 Sell
Rating Trend: = Flat
Today's Overall Ratings:
Up: 13 | Down: 14 | New: 11
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Analysts at Jefferies weighed in on Amarin Corporation (NASDAQ: AMRN) following last night's second quarter conference call, most importantly on the company's dialogue with the FDA on gaining New Chemical Entity (NCE) exclusivity for Vascepa.
The firm noted while an NCE decision is still expected in mid-August, there is the possibility of a delay due to the uniqueness of Vascepa's case. That said, they see a minor delay as immaterial. "Ultimately, we see a potential minor delay of 1-2 months as having no material impact on our valuation thesis, which is largely driven by current patent protection well into the 2020s with upside from 2030 patents," analyst Thomas Wei said.
Separate from the call, Wei noted another minor positive for the company. The FDA has added Vascepa to its list of approved drugs considered cardiovascular medications, he said. Notably, Lovaza is not on the list of 29 drugs includes those belonging to the anti-hypertensive, anti-clotting, anti-lipid, and anti-arrhythmic drug classes.
"Investors have raised concerns that the initial Vascepa label does not include mixed dyslipidemia data (from ANCHOR) while Lovaza's label does, which could be an early commercial impediment to competitive detailing," Wei comments. "While we do not see this as having any material impact on the NCE debate, we would view this as a positive for how the FDA views Vascepa's clinical benefit prior to granting a potential ANCHOR indication and for the commercial prospects.
Wei is maintining his Buy rating and $28 price target on AMRN.
For an analyst ratings summary and ratings history on Amarin Corporation click here. For more ratings news on Amarin Corporation click here.
The firm noted while an NCE decision is still expected in mid-August, there is the possibility of a delay due to the uniqueness of Vascepa's case. That said, they see a minor delay as immaterial. "Ultimately, we see a potential minor delay of 1-2 months as having no material impact on our valuation thesis, which is largely driven by current patent protection well into the 2020s with upside from 2030 patents," analyst Thomas Wei said.
Separate from the call, Wei noted another minor positive for the company. The FDA has added Vascepa to its list of approved drugs considered cardiovascular medications, he said. Notably, Lovaza is not on the list of 29 drugs includes those belonging to the anti-hypertensive, anti-clotting, anti-lipid, and anti-arrhythmic drug classes.
"Investors have raised concerns that the initial Vascepa label does not include mixed dyslipidemia data (from ANCHOR) while Lovaza's label does, which could be an early commercial impediment to competitive detailing," Wei comments. "While we do not see this as having any material impact on the NCE debate, we would view this as a positive for how the FDA views Vascepa's clinical benefit prior to granting a potential ANCHOR indication and for the commercial prospects.
Wei is maintining his Buy rating and $28 price target on AMRN.
For an analyst ratings summary and ratings history on Amarin Corporation click here. For more ratings news on Amarin Corporation click here.
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