ADMA Biologics Announces FDA Approvals of Extended Room Temperature Storage Conditions for ASCENIV & BIVIGAM

FDA Approval Provides for Room Temperature (25°C) Storage Conditions for up to 4 Weeks at Any Point During the 36-Month Approved Shelf Life

Extends the Prior Room Temperature Storage Allowance for the Full 36-months for ASCENIV and BIVIGAM

Provides for Improved Inventory Management and Ease of Product Administration to Patients

Approval of Extended Ambient Storage Conditions for ASCENIV & BIVIGAM is Immediately Effective and Now Commercially Available to U.S. Healthcare Providers

RAMSEY, N.J. and BOCA RATON, Fla., March 11, 2024 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics, today announced the United States Food and Drug Administration’s (“FDA”) approval for its supplemental Biologics License Applications (BLAs) for both ASCENIV and BIVIGAM to extend the approved 4-week room temperature (25°C) storage conditions during the first 24 months of shelf life, to allow for a 4-week room temperature storage at any time during the entire 36-month approved shelf life. The room temperature approval applies to all existing ASCENIV and BIVIGAM lots currently in the commercial supply chain as well as to future production of ASCENIV and BIVIGAM.

“With the FDA-approved extension of room temperature storage conditions, the Company expects to reach more customers who were previously inaccessible due to limited refrigeration space and cold chain capacity constraints,” said Adam Grossman, President and Chief Executive Officer of ADMA. “We believe that this added storage flexibility for both ASCENIV and BIVIGAM will meaningfully enhance our products’ market offerings, enabling more versatile utilization and better inventory management for providers.”

The newly approved extension of room temperature storage conditions for both ASCENIV and BIVIGAM is immediately effective, and both products are commercially available to U.S. healthcare providers and patients.

About ADMA Biologics, Inc. (ADMA)

ADMA Biologics is an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty biologics for the treatment of immunodeficient patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three United States Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM (immune globulin intravenous, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV (immune globulin intravenous, human – slra 10% liquid) for the treatment of PI; and NABI-HB (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. ADMA manufactures its immune globulin products at its FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates as an FDA-approved source plasma collector in the U.S., which provides its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty biologics, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases and management of immune compromised patient populations who suffer from an underlying immune deficiency, or who may be immune compromised for other medical reasons. ADMA holds numerous U.S. and foreign patents related to and encompassing various aspects of its products and product candidates. For more information, please visit www.admabiologics.com.