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 the European Patent Office (EPO) has issued European Patent No. 3375789, to the Company. This patent relates to the treatment and prevention of S. pneumonia infections, and in particular, to standardized hyperimmune globulins containing elevated antibody titers for a plurality of S. pneumoniae serotypes. This EPO granted patent complements ADMA’s existing U.S. Pat. Nos. 10,259,865 and 11,084,870.
“This European patent, which augments ADMA’s existing U.S. patent estate, highlights the Company’s emerging position as a thought leader in the development and commercialization of hyperimmune globulins which, we believe, will attract additional collaborators interested in pursuing these areas of significant unmet medical need,” stated Adam Grossman, President and Chief Executive Officer of ADMA. “The EPO’s issuance of the S. pneumonia patent, together with our previously granted U.S. patents, provides protection for the potential development of a S. pneumonia hyperimmune globulin. Despite widespread availability of U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)-approved vaccines, all-cause pneumonia is among the leading causes globally of vaccine preventable illness and deaths, particularly among vulnerable patient populations, including the immune compromised and the elderly. It is in this patient population that we believe a pneumococcal hyperimmune globulin will find significant medical utility and prove to be a favorable end-market if successfully developed.”
Mr. Grossman continued: “ADMA continues to aggressively pursue its proprietary, therapeutic technologies and associated intellectual property (IP). In addition to its marketed and pipeline hyperimmune respiratory syncytial virus (RSV) immune globulin (IG) and hyperimmune S. pneumonia IG products, today’s announcement underscores ADMA’s capabilities to develop, commercialize and protect its tailored IG pools technology, containing for example, one or more antibodies that are added or ‘spiked’ into an IG pool. We believe this novel, exciting therapeutic approach has the potential to significantly accelerate and expand the development of hyperimmune globulins into a variety of infectious disease categories and therapeutic indications. The Company will continue to explore these and other hyperimmune development opportunities, and we are confident ADMA’s unique IP estate will provide significant value and IP breadth to a strategic partner possessing its own commercial product IP.”
Regarding the ‘spiking’ of monoclonal antibodies into IG, this approach was recently referenced during the FDA’s Blood Products Advisory Committee (BPAC) meeting on November 4, 2021. Specifically, panelists discussed escape mutants for Hepatitis B virus (HBV) and how current vaccines and antiviral medications may not cover these emerging strains. FDA discussions evolved into the possibility of using IG with monoclonal antibodies to combat and protect from emerging mutant strains, the very same platform ADMA has positioned itself over the past several years to develop, commercialize and protect.