ADMA Biologics Expands Global Regulatory Approval Presence and Announces FDA Approval to Commence Hepatitis B Plasma Collections

Rhea-AI Summary

ADMA Biologics, Inc. (NASDAQ: ADMA) has received approval from the Korean Ministry of Food and Drug Safety for its Kennesaw, Georgia plasma collection center to sell source plasma in South Korea. This approval, alongside FDA approval for a Hepatitis B immunization program at the center, marks a significant regulatory milestone for ADMA. These advancements align with ADMA's strategy to enhance its global presence and secure its supply chain for plasma-derived biologics, aimed at treating immune deficiencies and infectious diseases.

Positive

• Approval from Korean Ministry of Food and Drug Safety for source plasma sales in South Korea.
• FDA approval for Hepatitis B immunization program at Kennesaw plasma center.

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• None.

RAMSEY, N.J. and BOCA RATON, Fla. and KENNESAW, Ga., March 03, 2021 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA”), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, today announced that its plasma collection center located in Kennesaw, Georgia received approval from the Korean Ministry of Food and Drug Safety (MFDS) for the sale of source plasma into South Korea. In conjunction with the South Korean approval, ADMA additionally announced the Kennesaw plasma collection center received FDA approval to implement a Hepatitis B immunization program, enabling ADMA to collect source plasma from donors immunized with an FDA-licensed Hepatitis B vaccine.

“These approvals demonstrate ADMA’s strict adherence to the regulatory requirements of the global plasma community and build upon the significant regulatory milestones already achieved by our Company in 2021,” said Adam Grossman, President and Chief Executive Officer of ADMA Biologics. “The approvals announced today further enhance our existing global presence as a source plasma provider, which includes the United States and now South Korea. Our BioCenters expansion strategy remains comfortably on track, and these approvals represent another important step towards our objective of further securing our raw material supply chain and enhancing our end-to-end control of manufacturing operations.”

About ADMA BioCenters

ADMA BioCenters is an FDA licensed facility specializing in the collection of human plasma used to make special medications for the treatment and prevention of diseases. Managed by a team of experts who have decades of experience in the specialized field of plasma collection, ADMA BioCenters provides a safe, professional and pleasant donation environment. ADMA BioCenters strictly follows FDA regulations and guidance and enforces cGMP (current good manufacturing practices) 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 manufacturing, marketing and developing specialty plasma-derived 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 a portion of its blood plasma for the manufacture of its products. ADMA’s mission is to manufacture, market and develop specialty plasma-derived, 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 has received U.S. Patents: 9,107,906, 9,714,283, 9,815,886, 9,969,793 and 10,259,865 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” pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. (“we,” “our” or the “Company”). Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain such words as “intend,” “target,” “plan,” “expect,” “believe,” “will,” “is likely,” “will likely,” “should,” “could,” “would,” “may,” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements also include, but are not limited to, statements about ADMA’s objective of further securing its raw material supply chain and enhancing its end-to-end control of manufacturing operations. Actual events or results may differ materially from those described in this document due to a number of important factors. Current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the 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 the 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 most recent reports on Form 10-K, 10-Q and 8-K, and any amendments thereto.

COMPANY CONTACT:
Skyler Bloom
Director, Investor Relations and Corporate Strategy | 201-478-5552 | sbloom@admabio.com

INVESTOR RELATIONS CONTACT:
Sam Martin
Managing Director, Argot Partners | 212-600-1902 | sam@argotpartners.com

 

FAQ

What recent approvals did ADMA receive?

ADMA received approval from the Korean Ministry of Food and Drug Safety for the sale of source plasma in South Korea and FDA approval for a Hepatitis B immunization program.

How does the approval benefit ADMA?

The approvals enhance ADMA's global presence and secure its raw material supply chain for plasma-derived biologics.

What is the significance of the Kennesaw plasma center's approvals?

They enable ADMA to expand operations in international markets and strengthen its plasma collection capabilities.

What products does ADMA manufacture?

ADMA manufactures plasma-derived biologics for treating immune deficiencies, including BIVIGAM®, ASCENIV™, and NABI-HB®.