Replies to post #192111 on Biotech Values

[DewDiligence]

REGN/SNY—FDA’s statistics reviewer is critical of dataset’s inability to quantify efficacy difference between low and high doses.

[DewDiligence]

FDA briefing docs for AMGN’s Repatha panel:

http://t.co/jWAaa9o1Ku

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/EndocrinologicandMetabolicDrugsAdvisoryCommittee/ucm450071.htm

[DewDiligence]

SNY/REGN—FDA panel backs Praluent with reservations in 13-3 vote:

http://www.wsj.com/articles/fda-panel-backs-cholesterol-drug-but-raises-concerns-1433884972

A Food and Drug Administration advisory panel recommended that the agency approve the cholesterol-lowering drug Praluent, the first of a wave of such cardiovascular drugs [PCSK9] expected to raise billions of dollars in revenue and perhaps alter the treatment of cardiovascular disease.

But many panelists said the use of the drug should be limited to certain high-risk groups, such as people with very high cholesterol for genetic reasons because of a condition called familial hypercholesterolemia.

The committee voted 13-3 in favor of Praluent, from France’s Sanofi and Regeneron Pharmaceuticals Inc. But enough panelists expressed caution about the evidence in the companies’ studies, and so it may take longer than the industry would like to get these medicines widely used.

[DewDiligence]

SNY/REGN diss AMGN in today’s PR on Praluent results in Japanese patients:

http://finance.yahoo.com/news/regeneron-sanofi-announce-phase-3-020000500.html

Notably, almost all patients reached their LDL-C target levels while remaining on the 75 mg dose, avoiding the need for overtreatment.

The word, overtreatment is a thinly-veiled disparagement of AMGN’s Repatha, which has only one dosing choice (rather than Praluent’s two doses).