Amid New Patent, Amarin's (AMRN) Vascepa Might Still See Competition
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Price: $6.60 -0.3%
Rating Summary:
9 Buy, 3 Hold, 0 Sell
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Today's Overall Ratings:
Up: 8 | Down: 12 | New: 30
Rating Summary:
9 Buy, 3 Hold, 0 Sell
Rating Trend:
Up
Today's Overall Ratings:
Up: 8 | Down: 12 | New: 30
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Amarin Corp. (Nasdaq: AMRN) shares are lower on the session following at least one analyst firm taking a bearish stance on its patent protection for Vascepa.
According to Summer Street analyst Bart Classen, patent coverage on Amarin's Vascepa remains "very narrow". The implication is that a generic form of the drug could be submitted which isn't covered by the patents, then submitted for FDA approval using a 505(b)(2)* application, a variant of the 505(b) new chemical entity (NCE) app.
The generic pharmas may be able to skip over doing large pivotal studies if submitted under the 505(b)(2) app, noted Classen.
Currently, investors in Amarin are banking on whether or not the FDA will grant Vascepa five years of exclusivity as a new chemical entity (NCE).
On Tuesday, Amarin was issued a patent covering the pharmaceutical composition of Amarin's Vascepa (icosapent ethyl) capsules based on U.S. Patent Application Serial No. 12/769,885.
Shares of Amarin are down 1.7 percent as investors chew over the potential competition risk. Amarin shares closed 7 percent higher last week.
* According to the FDA, "A 505(b)(2) application is one for which one or more of the investigations relied upon by the applicant for approval "were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted" (21 U.S.C. 355(b)(2))."
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According to Summer Street analyst Bart Classen, patent coverage on Amarin's Vascepa remains "very narrow". The implication is that a generic form of the drug could be submitted which isn't covered by the patents, then submitted for FDA approval using a 505(b)(2)* application, a variant of the 505(b) new chemical entity (NCE) app.
The generic pharmas may be able to skip over doing large pivotal studies if submitted under the 505(b)(2) app, noted Classen.
Currently, investors in Amarin are banking on whether or not the FDA will grant Vascepa five years of exclusivity as a new chemical entity (NCE).
On Tuesday, Amarin was issued a patent covering the pharmaceutical composition of Amarin's Vascepa (icosapent ethyl) capsules based on U.S. Patent Application Serial No. 12/769,885.
Shares of Amarin are down 1.7 percent as investors chew over the potential competition risk. Amarin shares closed 7 percent higher last week.
* According to the FDA, "A 505(b)(2) application is one for which one or more of the investigations relied upon by the applicant for approval "were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted" (21 U.S.C. 355(b)(2))."
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