Encouraging Data on Sanofi/Regeneron's Alirocumab


Regeneron Pharmaceuticals Inc. (REGN) is developing fourteen human monoclonal antibodies, utilizing its VelocImmune technology. The company is developing seven of the antibodies in partnership with Sanofi (SNY). One of the most interesting candidates being developed under the partnership is alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) antibody.

The companies presented encouraging data on the candidate from a multi-center phase II study (n~100) in Japanese patients. Data revealed that treatment with alirocumab (as a combination therapy) resulted in significant reduction in low-density lipoprotein-cholesterol (LDL-C or bad cholesterol) across three doses (150 mg, 75 mg and 50 mg) compared to patients treated with placebo.

At week 12, average LDL reduction was observed to be 72% at 150 mg, 62% at 75 mg and 55% at the 50 mg dosage. The average LDL reduction in the placebo cohort was found to be only 3%.

We remind investors that in Oct 2013, Sanofi and Regeneron reported encouraging top-line data from the phase III ODYSSEY MONO (n=103) on alirocumab. The randomized, double-blind, active-controlled, parallel-group study is evaluating the efficacy and safety of alirocumab as a monotherapy over 24 weeks in patients suffering from primary hypercholesterolemia (presence of high cholesterol levels in the blood). The patients stand a moderate risk of being affected by cardiovascular diseases. Regeneron/Sanofi commenced enrolling patients in 2 other studies on alirocumab ODYSSEY CHOICE I and CHOICE II (as part of the ODYSSEY phase III program) in the final quarter of 2013 and the first quarter of 2014, respectively.

We note that Amgen (AMGN) recently reported positive phase III data on its cholesterol fighter evolocumab (AMG 145), also a PCSK9 inhibitor.  

Regeneron carries a Zacks Rank #3 (Hold). Sanofi holds a Zacks Rank #4 (Sell).  An example of a better-ranked stock is Alexion Pharmaceuticals (ALXN) carrying a Zacks Rank #1 (Strong Buy).

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