FDA approval for both ASCENIV and BIVIGAM provides for storage conditions at room temperature (25°C) for up to 4 weeks during the first 24 months of the approved 36-month shelf life.
Improve inventory management and facilitate product management to patients
ASCENIV and BIVIGAM Ambient Storage Conditions Approval Effective Immediately, Available for Market by U.S. Healthcare Providers
RAMSEY, NJ & BOCA RATON, Fla., December 13, 2022 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”) is an end-to-end commercial biopharmaceutical company . The company dedicated to manufacturing, marketing and developing specialized plasma-derived biologics today announced that the U.S. Food and Drug Administration (“FDA”) has approved both ASCENIV and BIVIGAM for 36 months at room temperature (25 °C). Storage conditions for a maximum of 4 weeks during the first 24 months of shelf life. Room temperature approval applies to all existing HIS ASCENIV and BIVIGAM lots currently in the commercial supply chain, as well as future production of ASCENIV and BIVIGAM.
“With the approvals announced today, we anticipate reaching more customers who would otherwise be inaccessible due to limited cold storage space and cold chain capacity constraints. supply chain constraints,” said Adam Grossman, ADMA’s president and chief executive officer. “The approval of ASCENIV and BIVIGAM room temperature storage is a significant enhancement to the market entry offerings for each product and should provide more versatile use and inventory control by providers.”
The newly approved shelf-stable labels for ASCENIV and BIVIGAM are effective immediately and the products will be marketed to healthcare providers and patients in the United States.
About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is an end-to-end commercial company dedicated to the manufacture, marketing and development of specialty plasma-derived biologics to treat immunocompromised patients at risk for infection and other patients at risk for certain infectious diseases. A biopharmaceutical company. ADMA currently manufactures and markets his three U.S. Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immunodeficiencies and the prevention of certain infections. (PI); ASCENIV™ (intravenous immunoglobulin, human – slra 10% liquid) for the treatment of PI; and NABI-HB® (Hepatitis B immunoglobulin, human) enhances immunity against hepatitis B virus To do. ADMA manufactures its immunoglobulin products at its FDA-approved plasma fractionation and purification facility in Boca Raton, Florida. Through its subsidiary, ADMA BioCenters, ADMA also operates as an FDA-cleared source plasma collector in the United States, providing a portion of the plasma for the manufacture of its products. ADMA’s mission is to develop specialized plasma products targeted at niche patient populations for the treatment and prevention of specific infectious diseases and for the management of immunocompromised patient populations suffering from or potentially immunocompromised. to manufacture, market and develop human immunoglobulins derived from Weakened immunity for other medical reasons. ADMA holds U.S. Patents 9,107,906, 9,714,283, 9,815,886, 9,969,793, 10,259,865, and European Patent No. 3375789, among others, relating to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.
About Asenib™
ASCENIV (Intravenous Immunoglobulin, Human – slra 10% Liquid) is a plasma-derived polyclonal intravenous immunoglobulin (IVIG). ASCENIV was approved by the U.S. Food and Drug Administration (FDA) in April 2019 for adults and adolescents (ages 12-17). ASCENIV combines normal source plasma and respiratory syncytial virus (RSV) plasma from tested donors using ADMA’s proprietary patented plasma donor screening method and our proprietary microneutralization assay. Manufactured using a blended, regulated plasma pool design. ASCENIV contains naturally occurring polyclonal antibodies, proteins that the body’s immune system uses to neutralize microorganisms, such as bacteria and viruses, to prevent infection and disease. ASCENIV is protected by U.S. Patents 9,107,906, 9,714,283, and 9,815,886. Certain data and other information about ASCENIV can be found by visiting www.asceniv.com. Information about ADMA and its products can be found on the company’s website at www.admabiologics.com.
About Vibigum®
BIVIGAM (Intravenous Immunoglobulin, Human – 10% Liquid) is a plasma-derived polyclonal intravenous immunoglobulin (IVIG). BIVIGAM was approved by the FDA in May 2019 and is indicated for the treatment of primary humoral immunodeficiencies (PI), including but not limited to the following groups of inherited disorders: X-linked and congenital agammaglobulin. hematuria, generalized variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiency. BIVIGAM contains a broad range of antibodies similar to those found in normal human plasma. These antibodies are directed against bacteria and viruses and help protect her PI patients from serious infections. BIVIGAM is a purified, sterile, ready-to-use preparation of concentrated human immunoglobulin antibodies. Specific data and other information regarding BIVIGAM or ADMA and their products can be found on our website at www.admabiologics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 regarding ADMA Biologics, Inc. and its subsidiaries (collectively, the “Company” or “Company”). I’m here. Forward-looking statements include, but are not limited to, statements that may predict, forecast, suggest or imply future results, performance or achievements. “expect”, “believe”, “will”, “likely”, “likely”, “should”, “could”, “would”, “possible” There is, or in each case, their negative words, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, the anticipated benefits and significance of FDA’s room temperature storage approval. Actual events or results may differ materially from those described in this press release due to a number of important factors. Current and future security holders are cautioned that there can be no assurance that the forward-looking statements contained in this press release will prove to be accurate. Except to the extent required by applicable law or regulation, ADMA undertakes no obligation to update any forward-looking statement or to announce revisions to any forward-looking statement. Forward-looking statements are subject to a number of risks, uncertainties and other factors that may cause actual results or the timing of certain events to be expressed or implied by the forward-looking statements. may differ significantly from Risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Forms 10-K, 10-Q, and 8-K, and any amendments thereto.
Company contact:
skyler bloom
Senior Director of Business Development and Corporate Strategy | 201-478-5552 | sbloom@admabio.com
Investor Relations Contact:
Michelle Pappanastos
Managing Director, Argot Partners | 212-600-1902 | michelle@argotpartners.com
