December 28, 2016
By Alex Keown, BioSpace.com Breaking News Staff
TARRYTOWN, N.Y. – After suffering a setback in 2016, Regeneron could be poised for a turnaround in the new year and it hinges on correcting manufacturing problems that caused regulators to block approval of a new drug to treat rheumatoid arthritis.
Shares of Regeneron took a hit following the FDA’s rejection and fell overall about 8 percent during the last quarter, Benzinga reported, citing an Argus report. Overall, company stock was down nearly 30 percent for the year, the report said. However, investors will be pleased to note that the Argus analysts gave the stock a buy rating based on the potential of its pipeline, which includes the likelihood of the approval of the rejected rheumatoid arthritis drug.
In October, the U.S. Food and Drug Administration spurred sarilumab, the rheumatoid arthritis drug Regeneron was co-developing with French drugmaker Sanofi. The FDA’s Complete Response Letter did not cite any concerns of efficacy or safety of sarilumab, an investigational interleukin-6 receptor (IL-6R) antibody. Data from a Phase III trial released in March showed that sarilumab outperformed AbbVie ’s Humira.
The FDA objected to the drug due to certain deficiencies identified during a routine good manufacturing practice inspection of the Sanofi Le Trait facility in France where sarilumab is filled and finished. Sanofi said it was addressing the issues cited, which are one of the last steps in the manufacturing process. Once the issues are addressed, both companies said they intend to seek a way to bring the drug to market. If approved sarilumab is expected to generate $557 million in annual revenue by 2022, according to analysts’ projections.
Earlier this month, Regeneron and Sanofi filed for approval of Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis with the European Medicines Agency.
Bringing sarilumab to market in 2017 is something that will strengthen Regeneron, analyst Jacob Kilstein said, according to Benzinga. But the drug company, which has been booming in recent years, has plenty of other tools in its pipeline that will spur the company next year.
In his prediction, Kilstein said Regeneron would benefit from sarilumab, but would still continue to be led by its main product, Eylea for age-related macular degeneration. Sales of Eylea grew 16 percent in the third quarter. In addition to the AMD drug, Regeneron also has the solid-performing anti-cholesterol drug Praluent in its arsenal.
Regeneron also has another drug it hopes to bring to market, Dupixent, for treatment of atopic dermatitis. If that drug is approved, it could generate up to $800 million in annual revenue, Kilstein said. The FDA is expected to rule on Dupixent in March.
Earlier this month, Regeneron continued the expansion of its physical footprint in New York’s Hudson Valley by acquiring a 76-acre site. The site will allow the company to expand its office space and is also expected to provide additional research space to advance the company’s pipeline. Last year, the company invested $150 million in its Tarrytown plant to expand its research and development capacities. That was in addition to work it added to its upstate New York campus at a cost of about $150 million.
For the past two years, the company has expanded with the addition of nearly 1,500 employees. In 2015 alone, the company hired 1,200 employees worldwide, with about 950 for its New York locations.
