News Feature | November 25, 2014

Sanofi, Regeneron Present Alirocumab Data At AHA

By Estel Grace Masangkay

Pharma partners Sanofi and Regeneron announced results from six late-stage trials of alirocumab, an investigational drug being developed for its potential to lower down low-density lipoprotein (LDL) cholesterol. The companies presented the data at the American Heart Association 2014 meeting in Chicago.

Alirocumab is a fully human monoclonal antibody (mAB) jointly developed by Sanofi and Regeneron that targets PCSK9 (proprotein convertase subtilisin/kexin type 9). PCSK9 is a naturally occurring protein that prevents the liver from properly removing LDL cholesterol from the blood.

The six trials namely ODYSSEY LONG TERM, COMBO I, ALTERNATIVE, OPTIONS I, OPTIONS II, and HIGH FH, all met their primary efficacy endpoint of significant reduction in LDL-C at 24 weeks compared to placebo and standard therapy. The studies investigated alirocumab in hypercholesterolemic patients who ran a high cardiovascular (CV) risk, had heterozygous familial hypercholesterolemia (HeFH), which is an inherited form of high cholesterol, and/or possessed a history of intolerance to two or more statins. Patients who received alirocumab experienced a mean reduction in LDL-C from baseline in the range of 36 to 62 percent depending on the study compared to comparator treatment Zetia’s reduction range of 0.5 to 23 percent. Zetia is marketed by rival pharma firm Merck.

“It's a more potent and more effective lipid lowering drug, getting patients to goal by a 10-fold higher amount. It just blows (Zetia) away,” said Dr. Patrick Moriarty, the study's lead investigator who presented the trial results at AHA.

“In these trials patients treated with alirocumab achieved significant and robust LDL-C reductions compared to baseline. New interim results from ODYSSEY LONG TERM provide further support for alirocumab’s consistent safety profile, including in more than 500 patients who achieved LDL-C levels lower than 25 mg/dL,” said Jennifer Robinson, Director of the Prevention Intervention Center, Professor at the Departments of Epidemiology & Medicine, College of Public Health at the University of Iowa.

The companies said regulatory filings are in line to be submitted to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) by the end of the year.

Earlier this month, partners Sanofi and Regeneron also posted positive results from a mid-stage trial of dupilumab, an investigational treatment for patients with unmanaged moderate-to-severe asthma.

The results are welcome news to Sanofi’s investors, some of whom expressed alarm at the sudden firing of the company’s CEO. Sanofi also said it could launch up to 18 new drugs by the end of 2020, garnering a potential profit of over $37.6 billion in the first five years of sales. The company anticipates launching up to six new drugs next year.