Update on Sanofi/REGN's Alirocumab

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One of the most interesting candidates at Sanofi (SNY)/ Regeneron Pharmaceuticals, Inc. (REGN) is alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) antibody. Alirocumab works by blocking the PCSK9 pathway to lower lowdensity lipoprotein-cholesterol (LDL-C) cholesterol levels.

Sanofi and Regeneron have collaborated with the American College of Cardiology (ACC) for alirocumab. As per the terms of the agreement, the ACC will help in clinical research and identify patients for the phase III ODYSSEY OUTCOMES trial on alirocumab.

We note that ODYSSEY OUTCOMES is part of the ODYSSEY phase III program (n>23,000). The program includes at least 12 trials. Enrollment has been completed in most of the trials except ODYSSEY CHOICE I, ODYSSEY CHOICE II and ODYSSEY OUTCOMES.

We remind investors that in Oct 2013, Sanofi and Regeneron reported encouraging top-line data from 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.

Data from the study revealed that 24 weeks of treatment with alirocumab lowered levels of low-density lipoprotein-cholesterol (LDL-C/ bad cholesterol) by 47.2% compared to a 15.6% reduction witnessed in patients treated solely with Merck & Co. Inc.’s (MRK) cardiovascular drug Zetia (ezetimibe: 10 mg). Patients in the alirocumab arm injected themselves with 75 mg of the candidate every 14 days. The dosage was doubled at the 12th week of the study in patients with LDL cholesterol levels exceeding 70 mg/dl at week 8. However, the high dose was not needed in the majority of patients.

Successful development of this cholesterol fighter would boost the companies’ top line significantly as the cardiovascular market offers significant commercial potential. Moreover, the available statin therapies fail to bring the LDL cholesterol at acceptable levels in many patients. We note that AMG 145 is another cholesterol management phase III candidate. AMG 145 is also a PCS K9 antibody.

Both Sanofi and Regeneron carry a Zacks Rank #3 (Hold). Some better-ranked stocks include Vanda Pharmaceuticals, Inc. (VNDA) carrying a Zacks Rank #1 (Strong Buy).

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