ADMA Biologics Highlights Expanded Intellectual Property Portfolio for Specialty Plasma Derived Immune Globulins Targeted Against Respiratory Infections

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Mar 03, 2020
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Company Offers Assistance with Coronavirus Global Health Initiatives

Company Receives Notification from USPTO Regarding Extension to Its Issued Patents Related and Applied to Composition and Therapeutic Use of Immune Globulin; Extension Expected to Publish in 1H2020

RAMSEY, N.J. and BOCA RATON, Fla., March 03, 2020 (GLOBE NEWSWIRE) -- ADMA Biologics (“ADMA”), 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, today announced that it has received another Notice of Allowance from the U.S. Patent and Trademark Office (USPTO) for a patent application related to its intellectual property portfolio encompassing immunoglobulin plasma pool compositions used in the manufacturing of ASCENIV™. ADMA is the exclusive owner of intellectual property encompassing certain immunotherapeutic, immunoglobulin (IG & IVIG) compositions for the prevention and treatment of a wide variety of respiratory infections, including certain strains of coronavirus.

“We are pleased to announce the continued enhancement and strengthening of our patent estate focused on plasma derived immune globulins for the treatment and prevention of respiratory viral infections,” said Adam Grossman, President and Chief Executive Officer of ADMA. “This most recent notice of patent allowance by the USPTO is very timely in the midst of the reported global coronavirus epidemic. We are pleased to be one of the leading plasma products companies focused on developing novel and patentable approaches for the use of immune globulins to treat and prevent respiratory infections and illness caused by viral pathogens.”

ADMA’s commercially available immune globulin products, intellectual property, and the Company’s deep understanding of specialty antibody-rich immune globulins focused on respiratory pathogens provide ADMA a unique position to collaborate with government agencies, vaccine manufacturers and other parties in the fight to combat emerging infectious disease including the global coronavirus epidemic.

ADMA’s issued patents include proprietary immunotherapeutic compositions comprised of plasma derived immune globulin which has higher than normal titers for respiratory pathogens including respiratory syncytial virus (RSV), multiple strains of coronavirus (OC43 and V229E), parainfluenza virus 1, parainfluenza virus 2, influenza A virus, influenza B virus, and metapneumovirus. These patents also include methods of using an immune globulin composition to treat or prevent any type of respiratory viral infection including upper respiratory tract infections and lower respiratory tract infections.

There is relevant, published scientific literature that describes meaningful antibody family cross-reactivity among many respiratory viruses, including various strains of coronaviruses, and that immunological memory of human humoral antibodies can be stimulated between different strains of coronaviruses.

Reports in the media are emerging from China regarding the positive clinical results yielded by the use of plasma components as a therapy used for treating COVID-19 infected patients. The therapy in these reports describe that plasma is obtained from patients who have recently recovered from the COVID-19 infection. This information strongly supports ADMA’s patented technology platform for the use of immunoglobulins derived from appropriate hyperimmune plasma, whether naturally occurring antibodies or vaccine-induced, for treating respiratory viral infections for immune compromised patients and other vulnerable patient populations.

About ADMA Biologics, Inc. (ADMA, Financial)

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: ASCENIV™ (immune globulin intravenous, human – slra 10% liquid) for the treatment of primary humoral immunodeficiency (PI); BIVIGAM® (immune globulin intravenous, human) for the treatment of PI; and NABI-HB® (hepatitis B immune globulin, human) to provide enhanced immunity against the hepatitis B virus. 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 “estimate,” “project,” “intend,” “forecast,” “target,” “anticipate,” “plan,” “planning,” “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 the launch and commercialization of ASCENIV and its ability to help appropriate patients in the U.S. 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:

Brian Lenz

Executive Vice President and Chief Financial Officer | 201-478-5552 | www.admabiologics.com

INVESTOR RELATIONS CONTACT:

Sam Martin

Managing Director, Argot Partners | 212-600-1902 | [email protected]

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