Regeneron Investors Get Jitters From False Praluent Data
January 7, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Investors recently got jittery about Regeneron Pharmaceuticals on the basis of inaccurate and essentially non-existent information.
Some investors apparently used the Freedom of Information Act to take a look at side effect data to be found in the U.S. Food and Drug Administration (FDA)’s Adverse Event Reporting System (FAERS). FAERS collects information from physicians and patients about what might be possible side effects of a drug.
What these investors thought they saw were eight suicides by patients on Regeneron’s new cholesterol drug, Praluent. Amgen has a similar new drug, Repatha, and there were no cited suicides.
The problem with this report is that it was false. Only one suicide had been reported and then that single report was repeated for a total of six reports.
The FDA’s statement said, “A search of the FAERS database for Praluent identified one case (with multiple duplicate reports—six reports in total) of completed suicide in a patient receiving Praluent. Given the presence of confounding factors including a history of depression, a causal association between the drug and the event could neither be concluded nor ruled out.”
The FDA went on to say that there was a seventh report of suicide, but it is also probably a duplicate of the first one. There was also an eighth report of suicide, but the FDA determined that the patient never received Praluent.
“This is a classic overreaction to what is not a reliable source of information,” Steven Nissen, chairman of cardiology at the Cleveland Clinic, told Forbes. “These kinds of spontaneous reports don’t help us very much.”
Nissen also points out that even if the suicide reports were verified, that doesn’t necessarily correlate to a problem with the drug.
FAERS is a decent monitoring system for alerting the FDA to potential problems, especially rare side effects, but, Matthew Herper writes in Forbes, “they are problematic because it is easy for distraught relatives or physicians to blame a patient’s death for something unrelated to a drug.”
“Bottom line: Caution is urged in interpreting these data,” Sanjay Kaul told Forbes. Kaul, with Cedars-Sinai Medical Center, regularly advises the FDA. “In my opinion, they are not actionable, at least for medical use.”
Regeneron has been strong for the last year, for the most part. Shares traded on March 4, 2015 for $413.04, rose to a high of $592.40 on Aug. 5, 2015, dropped sharply on Sept. 29, 2015 to $451.82, and rose back to $587.09 on Nov. 18, 2015. Shares are currently trading for $506.76.
The company has plenty going for it besides Praluent, which has the potential to be a blockbuster. The Motley Fool notes the company’s stock rose more than 32 percent last year and has a lot to look forward to this year. The company’s eye drug, Eylea, is doing very well and received several new approvals in 2015. Sales were up 53 percent in the third quarter alone. Praluent has been approved by the FDA and by the European Union and is just starting to sell.
Regeneron has two drugs in late-stage clinical trials. One is sarilumab for arthritis, and the other is dupilumab, for eczema and asthma. Both are likely to be submitted to regulators this year.