Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) on Tuesday announced a significant expansion of its manufacturing capacity through a new agreement with FUJIFILM Diosynth Biotechnologies to manufacture and supply bulk drug products of Regeneron’s commercial biologic medicines at their Holly Springs, North Carolina, campus.
Regeneron, already one of the world’s largest biologics manufacturers, will nearly double its U.S. large-scale manufacturing capacity by accessing Fujifilm’s new biopharmaceutical facility.
With technology transfer beginning immediately and a 10-year term, the total investment is estimated to exceed $3 billion.
Also Read: FDA Sets The Countdown: Regeneron’s Eylea HD Could Be Headed For Major Expansion
“Regeneron is an American success story, with over 80 percent of our workforce and assets in the U.S. and all of our FDA-approved medicines invented in our New York laboratories…” said Leonard Schleifer, Board co-Chair, president and CEO of Regeneron.
“FUJIFILM Diosynth Biotechnologies will be bringing additional capacity online in 2025, 2026 and beyond as it completes the current $7 billion of expansion projects underway in both Europe and United States,” said Toshihisa Iida, director, corporate vice president, general manager of Life Sciences Strategy Headquarters and Bio-CDMO Division, FUJIFILM Corporation, Japan.
Regeneron continues to invest heavily in its New York State operations. An approximately $3.6 billion expansion of its Tarrytown campus is underway, creating 1,000 full-time, high-skill jobs and expanding research, preclinical manufacturing, and support facilities.
In addition, the company is constructing a brand new fill/finish manufacturing facility in Rensselaer, New York. It has acquired an over 1 million-square-foot property in Saratoga Springs, New York, for production support activities and, potentially, additional manufacturing capacity.
Regeneron has added more than 7,000 jobs in the past five years, most of which are high-paying R&D and manufacturing jobs based in the U.S.
Regeneron’s ongoing and planned investments in New York and North Carolina infrastructure and manufacturing are expected to total more than $7 billion.
On Friday, the U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for the addition of extended dosing intervals (up to every 24 weeks) for Regeneron’s Eylea (aflibercept) Injection 8 mg across all approved indications.
The CRL did not identify any issues with the safety or efficacy of Eylea HD in its approved indications and dosing regimens. The FDA did not agree with Regeneron’s proposal to add additional extended dosing intervals (greater than every 16 weeks, which is the maximum dosing interval currently indicated in the label). Regeneron is evaluating the FDA’s decision.
On Friday, the FDA approved Regeneron and Sanofi SA (NASDAQ:SNY) partnered Dupixent (dupilumab) for adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment.
Price Action: REGN stock is up 4.2% at $585.25 at last check Tuesday.
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