Regeneron/Sanofi Presents Encouraging Alirocumab Data
Regeneron Pharmaceuticals Inc. (REGN) and partner Sanofi (SNY) announced encouraging results from four phase III studies (ODYSSEY long term, ODYSSEY COMBO II, ODYSSEY FH I and ODYSSEY FH II) on alirocumab. The data was presented at the ESC Congress 2014.
The candidate is being developed for the treatment of patients suffering from hypercholesterolemia. Results from the ODYSSEY long term study revealed that patients treated with alirocumab recorded a 61% reduction in LDL-C levels from baseline compared to an increase of 1% in the placebo group after 24 weeks. After 52 weeks, reduction in LDL-C levels was much higher in the alirocumab group compared to the placebo group.
Alirocumab lowered LDL-C levels from baseline with greater efficacy when compared to Merck & Co. Inc.’s (MRK) Zetia (ezetimibe) in the ODYSSEY COMBO II study. Results from the other two studies (ODYSSEY FH I and ODYSSEY FH II) presented at this year’s ESC Congress also corroborated the efficacy of alirocumab in lowering LDL-C levels from baseline when compared to placebo.
Regeneron and Sanofi now intend to submit regulatory filings for their anti-cholesterol candidate in the U.S. and EU by year end. The companies are looking to get a priority review status for alirocumab in the U.S.
Regeneron is developing 14 human monoclonal antibodies, utilizing its VelocImmune technology. The company is developing seven of the antibodies in partnership with Sanofi. Alirocumab, a proprotein convertase subtilisin/kexin type 9 (PCSK9) antibody, is one of the key candidates under the agreement.
Our Take
We are encouraged by the companies’ progress with alirocumab. Successful development of alirocumab would boost the top line of both companies significantly as the cardiovascular market offers significant commercial potential. We expect investor focus to remain on alirocumab going forward.
Regeneron carries a Zack Rank #5 (Strong Sell). A better-ranked stock in the health care sector is Amgen Inc. (AMGN) carrying a Zacks Rank #1 (Strong Buy).
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