BMO Capital analyst Jim Birchenough reiterated his Market Perform rating and $381 price target on Regeneron Pharma (NASDAQ: REGN) following briefing document last Friday for the June 9 Advisory Committee meeting on REGN/Sanofi's PRALUENT. Birchenough said while the document appears to be highly positive on PRALUENT’s efficacy in LDL-C lowering and safety profile, the analyst notes risk to labeling for statin intolerance.

"... FDA noted disappointing CV outcomes for some LDL-C lowering agents. FDA seems to have a particular concern with PRALUENT monotherapy in “statin-intolerant” patients (ALTERNATIVE study population). FDA reasoned that many patients in this population may have symptoms entirely unrelated to statin (evidenced by the fact that 70% of patients receiving blinded treatment of LIPITOR 20mg completed the study); therefore, FDA believes the language of “statin-intolerant” in the labeling could cause some patients to prematurely abandon statin, a drug with established CV outcomes. FDA believes the language of “maximally tolerated statin” could encompass patients whose maximally tolerated dose is no statin at all. FDA also reminded the committee that with full approval the agency will not have the regulatory leverage to require evidence from the CV outcomes study."

"While FDA's comments are clearly positive/constructive, we believe that broad approval is expected. From our perspective, prospects for narrowing the definition of statin intolerance poses downside risk, and regardless of FDA panel's opinion on CV outcomes requirements, we believe that launch will be slow pending that data."

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Shares of Regeneron Pharma closed at $539.40 yesterday.