Amarin's (AMRN) Day In the Sun Arrives
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Price: $0.86 -2.27%
Rating Summary:
6 Buy, 12 Hold, 2 Sell
Rating Trend:
Up
Today's Overall Ratings:
Up: 11 | Down: 12 | New: 13
Rating Summary:
6 Buy, 12 Hold, 2 Sell
Rating Trend:
Up
Today's Overall Ratings:
Up: 11 | Down: 12 | New: 13
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D-day has arrived for Amarin (Nasdaq: AMRN). Tomorrow, July 26th, is the PDUFA date for AMR101, a purified fish oil product that reduces reduces high triglycerides levels. Maybe just as important is New Chemical Entity (NCE) determination, which could comes in the weeks following the decision.
Analysts are mostly positive on approval.
"Given a robust data set in very high TG reduction, a clean safety profile and agency experience with other prescription and OTC fish oil products, we see a very high likelihood for a first-pass approval," analysts Chris Schott at JPMorgan recently wrote. Even if approval is not immediately given, a delay in approval would likely be minor and revolve around non-clinical issues that could be fairly easily resolved, the firm believes.
On an NCE determination, Schott sees a determination made in the weeks following approval and they are anticipating AMR101 will receive 5-year NCE data exclusivity. This would be "incremental positive," he said. That said, "NCE exclusivity as becoming less relevant for the stock given the product’s rapidly evolving patent portfolio, which could extend to 2030 and should provide sufficient protection from generic entry."
Following approval there could be significant strategic value for AMR101, the analyst said. The company has disclosed three potential pathways for commercializing the product: sell, partner, self-launch. The firm's numbers assumes a self-launch but "we see clear strategic value for AMR101 and believe the asset would be attractive to a range of pharma companies." He sees AMR101 as a potential $1+ billion product opportunity.
MKM Partners analyst Jon LeCroy is also positive on approval, citing the recent disclosure of an "Orange Book Discussion" with the FDA. "Because the meeting contained high-level FDA personnel and would likely be unnecessary if AMR101 were not going to be approved in the near term, we view it as a positive signal for the approval of AMR101 on the July 26 PDUFA date," Lecroy stated. He sees NCE designation occurring in August and sees five-year NCE exclusivity.
JP Morgan's Schott has an Overweight rating and $22 price target and MKM's Lecory has a Buy rating and $21.50 price target.
Shares of AMRN are flat at $14.80 in mid-day trading.
Analysts are mostly positive on approval.
"Given a robust data set in very high TG reduction, a clean safety profile and agency experience with other prescription and OTC fish oil products, we see a very high likelihood for a first-pass approval," analysts Chris Schott at JPMorgan recently wrote. Even if approval is not immediately given, a delay in approval would likely be minor and revolve around non-clinical issues that could be fairly easily resolved, the firm believes.
On an NCE determination, Schott sees a determination made in the weeks following approval and they are anticipating AMR101 will receive 5-year NCE data exclusivity. This would be "incremental positive," he said. That said, "NCE exclusivity as becoming less relevant for the stock given the product’s rapidly evolving patent portfolio, which could extend to 2030 and should provide sufficient protection from generic entry."
Following approval there could be significant strategic value for AMR101, the analyst said. The company has disclosed three potential pathways for commercializing the product: sell, partner, self-launch. The firm's numbers assumes a self-launch but "we see clear strategic value for AMR101 and believe the asset would be attractive to a range of pharma companies." He sees AMR101 as a potential $1+ billion product opportunity.
MKM Partners analyst Jon LeCroy is also positive on approval, citing the recent disclosure of an "Orange Book Discussion" with the FDA. "Because the meeting contained high-level FDA personnel and would likely be unnecessary if AMR101 were not going to be approved in the near term, we view it as a positive signal for the approval of AMR101 on the July 26 PDUFA date," Lecroy stated. He sees NCE designation occurring in August and sees five-year NCE exclusivity.
JP Morgan's Schott has an Overweight rating and $22 price target and MKM's Lecory has a Buy rating and $21.50 price target.
Shares of AMRN are flat at $14.80 in mid-day trading.
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