Jefferies Comments on Amarin (AMRN) Following Management Meetings; Bullish on AMR101, Sees No FDA Regulation Risk
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Rating Summary:
6 Buy, 12 Hold, 2 Sell
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Up: 13 | Down: 16 | New: 3
Rating Summary:
6 Buy, 12 Hold, 2 Sell
Rating Trend:
Up
Today's Overall Ratings:
Up: 13 | Down: 16 | New: 3
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Jefferies issued comments on Amarin Corp. (Nasdaq: AMRN) following a meeting with management recently. The firm maintained a Buy rating and $25 price target on Amarin.
Jefferies remains positive on Amarin's lead drug for high triglycerides, AMR101. Though concerns whether intellectual property will keep exclusivity through 2016 or 2030 depends on Hatch-Waxman regulation as well as patent issuances, Jefferies doesn't see the issue as an "insurmountable barrier for prospective pharma partners, and AMRN management indicated confidence in positive progress on its IP portfolio in the near-term, which [Jefferies] now believe[s] is related to a recent interview with a US Patent and Trademark Office (PTO) examiner."
Meetings with Acasti Pharmaceuticals' management also gave Jefferies no indications that the regulatory standard for triglyceride lowering drugs has changed. Acasti develops CaPre, which is a competing drug to AMR101. Jefferies commented, "Acasti will
be initiating two Phase 2 trials shortly, with data expected by mid-2012. Of note, Acasti management shared recent regulatory feedback from informal discussions with the FDA that indicate no change in the regulatory standards for approval of a triglyceride lowering therapy. As a reminder, AMRN signed two special protocol assessments for the MARINE and ANCHOR indications in 2009, in which the FDA would consider approval of AMR101 on the basis of changes in triglyceride levels in short-term studies, as opposed to full outcome studies measuring the impact on cardiovascular mortality and morbidity endpoints."
Finally, Jefferies has an update on '889 MARINE use patent. Recently, a paper -- the Okumura paper -- was filed with the U.S. Patent and Trademark Office (PTO) on Epadel (another purified omega-3 drug), additional materials on Lovaza, and a declaration from Dr. Howard Weintraub. Jefferies notes: "Of particular note, the Okumura paper on Epadel addresses a key argument made by the PTO in its recent rejection of ‘889: the PTO believed that a decline in LDL-chlesterol with AMR101 could have been predicted from prior data on a non-HDL-c decline in a historical study of Epadel. In contrast, the Okumura paper shows that Epadel caused an 8.4% increase in LDL-c, despite a decline in non-HDL-c. The filing references a phone interview with the examiner on Sept 19, and AMRN’s summary of the interview suggests a constructive dialogue with the PTO: “Although no formal agreement was reached, the Office indicated that Applicant’s proposed submission addressed the issues raised in the Office Action." It took only 56 days for the examiner to issue the most recent letter, which means that the next PTO decision point on ‘889 could come in late 2011-early 2012."
Click here for more analyst color on Amarin, or here for a ratings history.
Amarin shares are trading 1.9 percent higher Friday afternoon.
Jefferies remains positive on Amarin's lead drug for high triglycerides, AMR101. Though concerns whether intellectual property will keep exclusivity through 2016 or 2030 depends on Hatch-Waxman regulation as well as patent issuances, Jefferies doesn't see the issue as an "insurmountable barrier for prospective pharma partners, and AMRN management indicated confidence in positive progress on its IP portfolio in the near-term, which [Jefferies] now believe[s] is related to a recent interview with a US Patent and Trademark Office (PTO) examiner."
Meetings with Acasti Pharmaceuticals' management also gave Jefferies no indications that the regulatory standard for triglyceride lowering drugs has changed. Acasti develops CaPre, which is a competing drug to AMR101. Jefferies commented, "Acasti will
be initiating two Phase 2 trials shortly, with data expected by mid-2012. Of note, Acasti management shared recent regulatory feedback from informal discussions with the FDA that indicate no change in the regulatory standards for approval of a triglyceride lowering therapy. As a reminder, AMRN signed two special protocol assessments for the MARINE and ANCHOR indications in 2009, in which the FDA would consider approval of AMR101 on the basis of changes in triglyceride levels in short-term studies, as opposed to full outcome studies measuring the impact on cardiovascular mortality and morbidity endpoints."
Finally, Jefferies has an update on '889 MARINE use patent. Recently, a paper -- the Okumura paper -- was filed with the U.S. Patent and Trademark Office (PTO) on Epadel (another purified omega-3 drug), additional materials on Lovaza, and a declaration from Dr. Howard Weintraub. Jefferies notes: "Of particular note, the Okumura paper on Epadel addresses a key argument made by the PTO in its recent rejection of ‘889: the PTO believed that a decline in LDL-chlesterol with AMR101 could have been predicted from prior data on a non-HDL-c decline in a historical study of Epadel. In contrast, the Okumura paper shows that Epadel caused an 8.4% increase in LDL-c, despite a decline in non-HDL-c. The filing references a phone interview with the examiner on Sept 19, and AMRN’s summary of the interview suggests a constructive dialogue with the PTO: “Although no formal agreement was reached, the Office indicated that Applicant’s proposed submission addressed the issues raised in the Office Action." It took only 56 days for the examiner to issue the most recent letter, which means that the next PTO decision point on ‘889 could come in late 2011-early 2012."
Click here for more analyst color on Amarin, or here for a ratings history.
Amarin shares are trading 1.9 percent higher Friday afternoon.
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