ADMA Biologics (ADMA) Grants FDA Approval for Its Ninth Plasma Collection Center, Located in Dallas, GA
ADMA Biologics, Inc. (NASDAQ:) (“ADMA” or the “Company”), an end-to-end commercial biopharmaceutical company dedicated to the manufacture, marketing, and development of specialty plasma-derived biological products, announced today that it has received US Food and Drug Administration (“FDA”) approval for its ninth ADMA BioCenters plasma collection facility located in Dallas, GA. This plasma collection facility became operational and began collection of source plasma in the third quarter of 2022. With the approval of the FDA announced today, this facility is now licensed to collect, and introduce human source plasma to interstate commerce for further manufacture in the US
“The successful expansion of the ADMA plasma collection network supports the Company’s goal of achieving self-sufficiency in plasma supply, sustainable revenue growth goals, and further enhances the prospects for the Company’s continued profitability. The approval is testament to the BioCenters team’s tireless commitment, and we are grateful to the FDA for its effort and prompt review of the Dallas, GA Biologics License Application (“BLA”), which came before ADMA’s anticipated approval date,” said Adam Grossman, President and CEO of ADMA.
“With nine FDA-licensed plasma collection centers, we are well on our way to achieving our stated corporate goal of having a total of ten FDA-approved plasma collection centers, collecting both normal-source plasma and hyperimmune plasma, by the end of 2023,” said Brian Lenz, Executive Vice President, Chief Financial Officer, and General Manager, ADMA BioCenters.
This new state-of-the-art plasma collection center features automatic registration, high-tech collection equipment designed to streamline the donation process, free Wi-Fi wireless network in donor collection areas, individual flat-screen TVs with cable at every donor station, and highly trained and certified staff who prioritize donor comfort and safety. At full capacity, the plasma center hopes to maintain a staff of 50 highly trained healthcare workers. The center is approved 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 visit in person at 4075 Charles Hardy Pkwy, Suite 148 Dallas, GA 30157.
About ADMA BioCenters
ADMA BioCenters is an FDA licensed facility that specializes in the collection of human plasma used to make specialty drugs for the treatment and prevention of disease. Managed by a team of experts with decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and fun donation environment. ADMA BioCenters strictly follows FDA regulations and guidelines and enforces cGMP (current good manufacturing practice) in all of 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 dedicated to the manufacture, marketing, and development of specialty plasma-derived biologics for the treatment of immunodeficient patients at risk of infection and others at risk of certain infectious diseases. ADMA currently manufactures and markets three plasma-derived biologics that are approved by the United States Food and Drug Administration (FDA) for the treatment of immunodeficiency and prevention of certain infectious diseases: BIVIGAM® (intravenous immune globulin, human) for the treatment of primary humoral immunodeficiency (PI); ASCENIV™ (intravenous immune globulin, human – slra 10% liquid) for the treatment of PIs; and NABI-HB® (hepatitis B immune globulin, human) to enhance immunity against the hepatitis B virus. ADMA manufactures its immune globulin products in an FDA-licensed plasma fractionation and purification facility located in Boca Raton, Florida. Through its subsidiary ADMA BioCenters, ADMA also operates as an FDA-approved source plasma collector in the US, providing a portion of its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market, and develop specialized plasma-derived human immune globulin targeted at specific patient populations for the treatment and prevention of certain infectious diseases and management of immunocompromised patient populations who suffer from underlying immune deficiencies, or who may be immune compromised for other medical reasons. ADMA has received US 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.
Note of Caution 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, “ADMA”, “we”, “our”, or “the Company”). Forward-looking statements include, without limitation, any statement that can predict, estimate, indicate, or imply future results, performance, or achievements, and may contain words such as “anticipate”, “intend”, “target”, “plan”, “expect”, “believe”, “would”, “most likely”, “likely”, “should”, “could”, “will”, “may”, or, in each case, negative words, or words or expressions that have a meaning similar. These forward-looking statements also include, but are not limited to, statements regarding ADMA’s future operating results (including, but not limited to, revenue growth); expansion plans and goals to operate ten or more FDA-approved plasma collection centers by the end of 2023; our path to profitability; the supply of the Company’s plasma and the ability to become self-sufficient plasma; and the number of staff expected at the Dallas, GA facility. Actual events or results could differ materially from those described in this press release due to a number of important factors. Current and prospective securities holders are cautioned that no guarantee can be made that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable law or regulation, ADMA has no obligation to update any forward-looking statements or post revisions to any forward-looking statements. Forward-looking statements are subject to many risks, uncertainties and other factors that could cause our actual results, and the timing of certain events, to differ materially from any future results expressed or implied by such forward-looking statements, including, but not limited to, the risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our recent reports on Forms 10-K, 10-Q, and 8-K, and any amendments thereto.
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