June 9, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Shares of Tarrytown, N.Y.-based Regeneron Pharmaceuticals, Inc. have been halted while the U.S. Food and Drug Administration (FDA) considers the company’s application for approval for its cholesterol lowering drug Praluent (alirocumab).
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) is meeting today to discuss the company’s Biologics License Application.
Praulent has been developed in partnership with Paris-based Sanofi . It was named one of five “summer blockbuster” drugs likely to come out this year.
The drug has also been accepted for review via a Marketing Authorization Application in the European Union. The drug is a monoclonal antibody that targets proprotein convertase subtilisin/kexin type I (PCSK9) and was studied in more than 5,000 patients, including 10 Phase III ODYSSEY trials.
“In our view, the primary driver [for Regeneron] remains Praluent, for which we anticipate a positive AdCom vote on June 9 and approval by the July 24 PDUFA date,” wrote Joshua Schimmer, an analyst for Piper Jaffray, in a note May 21. “However, we anticipate launch costs will outstrip sales growth and there is risk around the Amgen patent suit. Regeneron has one of the richest pipelines in all of biotech.”
On March 15, Regeneron and Sanofi announced the 18-month results of a Phase III trial of the compound that studied in 2,341 high-risk patients with high cholesterol.
“These results demonstrated the durable efficacy for Praluent when added to the maximally-tolerated statin therapy and further reinforce its generally consistent safety profile,” said Jennifer Robinson, director of the Prevention Intervention Center and professor in the department of Epidemiology & Medicine at the University of Iowa in a statement.
“Additionally, the post hoc analysis of major cardiovascular events represents an important finding for Praluent—we look forward to results from the ongoing ODYSSEY OUTCOMES trial, which is prospectively evaluating the potential of Praluent to reduce cardiovascular events.”
The findings are promising, without being definitive. However, the positive results should make it easier for regulators to grant approval based on how well they reduce cholesterol levels.
“It helps the companies developing these drugs,” said Steve Nissen, chief of cardiology at the Cleveland Clinic a statement, “to reassure the Food and Drug Administration that early approval, based on cholesterol-lowering benefits, is not a risky proposition.” Nissen was not involved in either study.
When Will Pfizer’s Breakup Happen?
Speculation that the revamping of Pfizer Inc. ’s internal business structure could happen as soon as this year has biotech wondering just when this Big Pharma company could see changes.
Last week an analyst with J.P. Morgan said he thinks there will be a much faster timeline than most of Wall Street had predicted for Pfizer’s stated mission to refocus its efforts on new medicines.
Pfizer initially announced in 2012 that it would be shedding units that were non-essential to that goal. It then promptly sold its nutrition silo to Nestle for $11.85 billion, which was rapidly accompanied by a public spin-off of its animal health business for $2.2 billion.
“While a Pfizer break-up would likely be a 2017 event, we see potential catalysts in 2015-2016,” said Chris Schott, an analyst at J.P. Morgan. “Three years of audited financial statements (2014-2016) are required before any part of Pfizer can be spun off, and we also see 2017 as an attractive time for action as investors see Pfizer’s innovative pipeline clearly contributing to growth and the established business having transitioned to a more stable profile.”
BioSpace wants to know what you think: Will Pfizer be a changed company by the end of 2015?
