January 29, 2016
By Mark Terry, BioSpace.com Breaking News Staff
Tarrytown, N.Y.-based Regeneron Pharmaceuticals, Inc. recently filed with the town of East Greenbush, N.Y. to build a second campus in Rensselaer County.
East Greenbush is a suburb of Tarrytown, where the company is headquartered. It employs approximately 1,200 people in East Greenbush, which is the location of a manufacturing facility that makes Eylea, a drug to treat macular degeneration.
The filing indicates the new location would include 208,000 square feet of warehouse space, 110,000 square feet of office and research space, as well as two 82,500-square-foot manufacturing buildings. Although nothing had been specifically stated regarding job creation, the Albany Business Review notes that the plans include a 456-car parking garage and additional parking for up to 1,100 more vehicles.
The company recently began expanding its Tarrytown facility, adding an additional 70,000 square feet of space. That expansion is priced at $15.3 million. In November, company Leonard Schleifer announced that Regeneron planned to invest $150 million in its headquarters.
Earlier this month, investors got jittery about the company’s stock on the basis of inaccurate and essentially non-existent information. Some investors used the Freedom of Information Act to look at side effect data in the U.S. Food and Drug Administration (FDA)’s Adverse Event Reporting System (FAERS). FAERS collects data from doctors and patients about possible drug side effects.
The investors interpreted the data as showing that eight patients on the company’s cholesterol drug, Praluent, committed suicide. However, the data was false. Only one suicide had been reported and that single report was repeated for a total of six reports. The FDA also stated that there was no apparent link between the suicide and use of the drug at this time.
Also, the seventh report was a duplicate of the first, and the eighth report was a separate suicide, but 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 at the time. “These kinds of spontaneous reports don’t help us very much.”
Overall, Regeneron is doing very well, as evidenced by its expansion plans. Praulent has the potential to be a blockbluster. Eylea is doing well in the market place 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 the European Union and is just starting to sell.
The company also has two drugs in late-stage clinical trials. One is dupilumab, for eczema and asthma, the other is sarilumab for arthritis. On Jan. 8, Regeneron and Paris-based Sanofi announced that the FDA had accepted sarilumab for review for its Biologics License Application (BLA). The target action date is Oct. 30, 2016.
Dupilumab has been given a “Breakthrough Therapy” status by the FDA. It was developed based on research by Emma Guttman-Yassky of the Icahn School of Medicine at Mount Sinai. It is currently in Phase III clinical trials.
Of its East Greenbush expansion, Regeneron issued a statement on Wednesday, saying, “We are in the early stages of planning for a second campus and have met with the East Greenbush Planning Board with preliminary plans for a three-story building with office and lab space, a warehouse and parking areas. The size and scope of the project have not yet been finalized.”
Company has been on something of a downturn lately, although it’s jumped points so far today. On Aug. 5, 2015, shares traded for $592.40, dropped to $451.82 on Sept. 29, and rose back up to $587.09 on Nov. 18. On Jan. 28, shares traded for $415.11. Shares are currently trading for $434.83.
