Capstone Announces Authorization of Biosimilar Human Insulin for IV Infusion in Canada and EU

Innovative Presentation Developed in Partnership with Medical Products Leader

ROSEMONT, Ill., Nov. 29, 2022 /PRNewswire/ -- Capstone Development Services Company LLC ("Capstone") announced today that a biosimilar version of human insulin received authorization from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) and a Notice of Compliance from Health Canada. The product is the only ready-to-use insulin for IV infusion. It received approval from the U.S. Food and Drug Administration (FDA) in 2019.

Capstone's affiliate, Celerity Pharmaceuticals, developed the product in partnership with a leading medical products company. The ready-to-use insulin is formulated as an IV infusion in a flexible plastic container using human insulin in 0.9% Sodium Chloride injection to be administered to patients in hospitals and other acute care settings. It helps lower blood glucose by facilitating uptake of glucose into muscle and fat cells and by simultaneously inhibiting glucose output from the liver.

These authorizations mark the 17^th and 18^th regulatory approvals Capstone has gained for products developed in partnership with global pharmaceutical and medical organizations since its founding in 2013. Celerity funded, developed and led the approval process of the product. After gaining EU CHMP and Health Canada approvals, Celerity transferred ownership of the product to its medical products partner.

Dan Robins, Ph.D., president, Capstone, said:
"We are honored to be part of successfully developing this innovative presentation of insulin to advance our partner's goal of introducing medicines that help promote efficiency for clinicians and provide patients with a better experience."

About Capstone
Capstone was founded in 2013 by Water Street Healthcare Partners, a strategic investor focused exclusively on health care. The company leads development, manages regulatory services and achieves timely approval of health care products through partnerships with global pharmaceutical and medical companies. To date, Capstone has developed and gained regulatory approvals on 18 products in the U.S., EU and Canada. The company has two additional products filed for regulatory approval to support its partners with bringing new and affordable health care products to market. For more information, visit capstonedevservices.com.

SOURCE Capstone