ADMA Biologics, Inc., a late-stage biopharmaceutical company, has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for US patent application 14/592,721 pertaining to its lead product candidate RI-002, a specialty plasma-based biologics for the treatment and prevention of infection, especially in the primary immunodeficiency (PI) population.
The patent entitled 'Compositions and Methods For The Treatment of Immunodeficiency' is an important step towards commercialising ADMA's novel technology, including its lead product candidate RI-002.
"ADMA is extremely pleased to have received a notice of allowance for this application related to its specialty plasma-based biologics. This patent is not only an important milestone in building an intellectual property portfolio, it is also an important step towards commercialising our novel technology, including our lead product candidate RI-002," stated Adam Grossman, president and chief executive officer of ADMA Biologics.
A Notice of Allowance is issued after the USPTO makes a determination that claims in a patent application are deemed to represent patentable subject matter.
RI-002 is a specialty plasma-derived, polyclonal, Intravenous Immune Globulin (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 US Food and Drug Administration guidance of = 1 SBI per patient-year.
PIDD is a class of inherited genetic disorders that causes an individual to have a deficient or absent immune system due to either a lack of necessary antibodies or a failure of these antibodies to function properly. PIDD patients are more vulnerable to infections and more likely to suffer complications from these infections. According to the World Health Organisation, there are over 150 different presentations of PIDD. As patients suffering from PIDD lack a properly functioning immune system, they typically receive monthly, outpatient infusions of IGIV therapy. Without this exogenous antibody immune support, these patients would be susceptible to a wide variety of infectious diseases. PIDD has an estimated prevalence of 1:1,200 in the United States, or approximately 250,000 people.