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Regeneron Pharmaceuticals Inc. (REGN - Analyst Report) is developing fourteen human monoclonal antibodies, utilizing its VelocImmune technology. The company is developing seven of the antibodies in partnership with Sanofi (SNY - Analyst Report). 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 - Analyst Report) 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 - Analyst Report) carrying a Zacks Rank #1 (Strong Buy).

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