Ramsey, N.J., Boca Raton, Fla., and Laurel, Md., Nov. 16, 2023 (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 plasma-derived biologics, today announced that it has acquired U.S. Food and Drug Administration (“FDA”) Tenth ADMA BioCenters plasma collection facility in Laurel, Maryland, approved. The plasma collection facility will become operational and begin source plasma collection in the first half of 2023.With today’s announcement of FDA approval, the facility is now licensed to introduce human-derived plasma into interstate commerce for further production in the United States
“The successful expansion of ADMA’s plasma collection network achieves the company’s goal of self-sufficiency in plasma supply, supports continued revenue growth goals, and further enhances ADMA’s profitability prospects. This approval demonstrates the tireless commitment of the BioCenters team, and we thank the FDA for their efforts and expedited review of the Biologics License Application (“BLA”) in Laurel, Maryland,” said Adam Grossman, President and Chief Executive Officer of ADMA.
“This landmark achievement has been years in the making, and we commend our dedicated staff for making this achievement possible from a time and budget perspective. We now anticipate that our network of fully FDA-licensed plasma collection centers will support our IG portfolio Rapidly growing production needs,” said Brian Lenz, executive vice president, chief financial officer and general manager of ADMA BioCenters.
This new, state-of-the-art plasma collection center features automated registration, high-tech collection equipment designed to shorten the donation process, free Wi-Fi in the donor collection area, and personal flat-screen TV donation stations with cable channels in every room and trained and certified staff that prioritize donor comfort and safety. At full capacity, the plasma center is expected to have 50 trained medical staff. The center is licensed to use the state-of-the-art Haemonetics NexSys Persona® plasma collection system.
To learn more about the ADMA BioCenters donation process and to schedule an appointment, please visit: www.admabiocenters.com or in person at 12647 Laurel Bowie Rd., Laurel, MD 20708.
About ADMA Biocenter
ADMA BioCenters is an FDA-licensed network that collects human plasma for use in the manufacture of specialty drugs to treat and prevent disease. Managed by a team of experts with decades of experience in the plasma collection profession, ADMA BioCenters provides a safe, professional and enjoyable donation environment. ADMA BioCenters strictly adheres to FDA regulations and guidelines and implements cGMP (Current Good Manufacturing Practice) in all its facilities. For more information about ADMA BioCenters, please visit www.admabiocenters.com.
About ADMA Biologics, Inc. (ADMA)
ADMA Biologics is an end-to-end commercial biopharmaceutical company engaged in the manufacture, marketing and development of specialty plasma-derived biologics for the treatment of immunocompromised patients at risk for infection and others at risk for certain infectious diseases. ADMA currently manufactures and markets three U.S. Food and Drug Administration (FDA)-approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases: BIVIGAM® (Intravenous Immunoglobulin, Human), for the treatment of Primary humoral immunoglobulin immunodeficiency (IP); ASCENIV™ (Intravenous Immunoglobulin, Human – SLRA 10% Liquid) is used to treat PI; and NABI-HB® (Hepatitis B Immune Globulin, Human) is available Enhance immunity against hepatitis B virus. ADMA manufactures its immunoglobulin products at its FDA-licensed plasma separation and purification facility in Boca Raton, Florida. Through its ADMA BioCenters subsidiary, ADMA also operates in the United States as an FDA-approved source plasma collector to provide plasma for the manufacturing of its products. ADMA’s mission is to manufacture, market and develop plasma-derived human immunoglobulins specifically targeted to specific patient populations for the treatment and prevention of certain infectious diseases and the management of immunocompromised patient populations with underlying immunodeficiency or who are at risk of immunodeficiency . Immunocompromised due to other medical reasons. ADMA has been issued U.S. patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 and European Patent No. 3375789, among others, related to certain aspects of its products and product candidates. For more information, please visit www.admabiologics.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 regarding ADMA Biologics, Inc. and its subsidiaries (collectively, “ADMA,” “we,” “our,” or the Company”). Including, but not limited to, any statements that may predict, foresee, indicate or imply future results, performance or achievements, and may contain words such as “anticipate”, “intend”, “goal”, “plan” etc. “Expect”, “Believe” , “will”, “likely”, “might be”, “should”, “could”, “would”, “could”, or in each case, its negative or a word or expression of similar meaning . These forward-looking statements also include, but are not limited to, statements regarding ADMA’s future operating performance (including, without limitation, revenue growth), plasma supply self-sufficiency and production needs. Actual events or results may differ from those described in this release due to a number of important factors. differ materially. Current and potential 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. ADMA does not undertake to update any statements, except to the extent required by applicable law or rule. forward-looking statements or the obligation to announce revisions to any forward-looking statements. Forward-looking statements are subject to a number of risks, uncertainties and other factors that may cause our current results and the timing of certain events to differ from the forward-looking statements. Any future results expressed or implied differ materially, including, but not limited to, the risks and uncertainties described in our filings with the Securities and Exchange Commission, including our most recent Forms 10-K, 10-Q and 8-K report and any amendments thereto.
Company contact information:
Skylar Bloom
Senior Director of Corporate Strategy and Business Development | 201-478-5552 | sbloom@admabio.com
Investor Relations Contact:
Sam Martin
Argot Partners Managing Director | 212-600-1902 | sam@argotpartners.com
