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ADMA Biologics Receives Patent Issuance Pertaining to the Treatment of Immunodeficiency

01-Sep-2015 | Source : AG-IP News | Visits : 3852
RAMSEY, N.J. - ADMA Biologics Inc., a late-stage biopharmaceutical company, announced in a press release that the US Patent and Trademark Office (USPTO) has issued United States Patent 9,107,906. The patent titled, 'Compositions And Methods For The Treatment of Immunodeficiency' relates to the use of human plasma immunoglobulin compositions containing select antibody titers specific for a plurality of respiratory pathogens; methods of identifying human donors and donor samples for use in the compositions; methods of manufacturing the compositions; and methods of utilizing the compositions by prophylactic and or therapeutic treatments (e.g. passive immunization). The term of the newly issued patent extends to January 2035.

"The issuance of ADMA's patent validates the differentiated, unique and novel way ADMA approaches immune globulin products.  ADMA's goal is to ensure adherence to all FDA standards and produce an IG product with consistent lot to lot potency of polyclonal anti pathogen antibodies," stated Adam Grossman, President and CEO of ADMA Biologics. "This is a major milestone for our company as it provides us the ability to protect our lead product candidate and at the same time supports development of a wide range of other therapeutic IG products for patients with immunodeficiency and related diseases. The company will continue to aggressively pursue additional proprietary rights encompassing this technology."

ADMA's lead product candidate, RI-002 is a specialty plasma-derived, polyclonal, Intravenous Immune Globulin, or IGIV, derived from human plasma containing naturally occurring polyclonal antibodies (e.g., Streptococcus pneumoniae, H.influenza type B, Cytomegalovirus (CMV), measles, tetanus, etc.) as well as standardized, high levels of antibodies to respiratory syncytial virus (RSV). ADMA is pursuing an indication for the use of this specialty IGIV product for treatment of patients diagnosed with primary immune deficiency diseases, or PIDD.

Polyclonal antibodies are the primary active component of IGIV products. Polyclonal antibodies are proteins that are used by the body's immune system to neutralize microbes, such as bacteria and viruses. Data review indicates that the polyclonal antibodies that are present in RI-002 support the ability of this product to prevent infections in immune-compromised patients. ADMA's analysis demonstrated that the Phase III trial has met the primary endpoint with no serious bacterial infections (SBI) reported. These results more than meet the requirement specified by the U.S. Food and Drug Administration, or FDA, guidance of ≤ 1 SBI per patient-year.
 
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