Amarin's (AMRN) Recent FDA Meeting Suggests AMR101 Approval - MKM Partners

July 12, 2012 10:52 AM EDT
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Shares of Amarin Corporation (NASDAQ: AMRN) have been on a roller coaster of late related to the fate of AMR101. Things got more interesting after the FDA posted a June 22 meeting date with the company on its public calendar. Although no details were released, the subject of the meeting was "Orange Book Discussion," and according to many it likely decided the fate of the drug.

Since the meeting was disclosed, shares of Amarin have been under pressure: falling 5.6 percent Tuesday, another 2 percent Wednesday and now 1 percent Thursday. This as worries spread that things may have not gone that well.

However, analyst Jon LeCroy at MKM Partners has a different take. The meeting gave him increased confidence in AMR101 approval on the July 26 PDUFA date.

"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.

But drug approval is not the only thing Amarin are interested in. The FDA decision on whether or not to grant the company "New Chemical Entity" (NCE) status is just a important as it will give the comapny five years of market exclusivity.

Commenting on if AMR101 will be granted "New Chemical Entity" status, Lecroy said the Orange Book discussion would offers little insight either way.

While bears may have believed that Amarin may have been appealing a preliminary negative ruling by the FDA on NCE designation, Lecroy said don't jump to conclusions.

"It is difficult to draw any conclusions from a private meeting, and we think the meeting could have simply been to allow Amarin to state its case prior to an NCE decision, or focused on whether the existing AMR101 patents could be included in the Orange Book," he states.

Lecroy expects the NCE designation to occur in August and continue to expect the FDA to grant five-year NCE exclusivity.

MKM Partners reiterated their Buy rating and price target of $21.50.

For an analyst ratings summary and ratings history on Amarin Corporation click here. For more ratings news on Amarin Corporation click here.

Shares of Amarin Corporation closed at $14.09 yesterday.

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