Mfg News: Regeneron, Ultragenyx & ProKidney 

A roundup of manufacturing news from Regeneron, Ultragenyx and ProKidney. Highlights below. 

* FDA Issues Complete Response Letter to Regeneron Over Mfg Issues  
* Ultragenyx Opens New Gene-Therapy Mfg Facility 
* ProKidney To Purchase Cell-Therapy Mfg Facility 

FDA Issues Complete Response Letter to Regeneron Over Mfg Issues    
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Regeneron Pharmaceuticals, a Tarrytown, New York-based bio/pharmaceutical company, for the company’s biologics license application for aflibercept 8 mg due to an ongoing review of inspection findings at a third-party filler. The company reports that the CRL did not identify any issues with the aflibercept 8 mg clinical efficacy or safety, trial design, labeling or drug-substance manufacturing, and that no additional clinical data or trials have been requested. 

Aflibercept 8 mg is an investigational drug being developed by Regeneron and Bayer for treating wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. Aflibercept (in other dosage amounts) is the active pharmaceutical ingredient in Regeneron’s and Bayer’s Eylea, a drug already approved for treating wet-age-related macular degeneration, diabetic macular edema, diabetic retinopathy, macular edema following retinal vein occlusion, and retinopathy of prematurity, an eye disease in pre-mature infants. Regeneron holds US rights for Eylea; the company posted 2022 US net product sales of $6.2 billion for the drug. Bayer holds rights outside the US and posted 2022 sales for the drug of EUR 3.2 billion ($3.5 billion).  In the US, Regeneron maintains exclusive rights to Eylea injection and aflibercept 8 mg. Bayer has licensed exclusive marketing rights outside of the US, where the companies share equally the profits from sales of Eylea and future sales of aflibercept 8 mg following any regulatory approvals. 

Source: Regeneron 

Ultragenyx Opens New Gene-Therapy Mfg Facility 
Ultragenyx Pharmaceutical, a Novato, California-based bio/pharmaceutical company developing products for rare genetic diseases, has opened a new gene-therapy manufacturing facility in Bedford, Massachusetts.  

The new facility is 110,000 square feet and was built on a 10.7-acre site. The company plans to hire 120 employees to staff the facility. Ultragenyx currently employs more than 350 people in Massachusetts across its sites in Bedford, Woburn, and Cambridge – more than a quarter of its global workforce. 

Source: Ultragenyx Pharmaceutical 

ProKidney To Purchase Cell-Therapy Mfg Facility 
ProKidney, a clinical-stage bio/pharmaceutical company, has agreed to purchase a 210,000-square-foot cell-therapy manufacturing facility and approximately 22 acres of land in Greensboro, North Carolina, for $25.5 million.  

The facility will support future commercial manufacturing needs for React, the company’s renal autologous cell therapy, currently in Phase III development for treating diabetic chronic kidney disease.  

Under the purchase agreement, ProKidney will pay approximately $25.5 million in cash for the facility and property. The transaction is expected to close by the end of June 2023, subject to customary closing conditions. The company says it plans to make investments in the facility through 2028 to prepare for potential commercial-scale manufacturing. 

Source: ProKidney