RAMSEY, N.J., Nov. 03, 2015 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to commercialize specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, today announced that a poster for its IVIG product (RI-002) entitled “Protection Against Palivizumab Resistant RSV with an IVIG Containing High Titer Anti RSV Neutralizing Antibodies,” will be presented at the upcoming 2nd International Primary Immunodeficiencies Congress, being held November 5-6, 2015 in Budapest, Hungary.
The poster will present data comparing the efficacy of palivizumab to that of RI-002, an IVIG that contains high titer anti-RSV neutralizing antibodies and which prevents RSV infections in the cotton rat after infection with a strain that is resistant to palivizumab. The data also demonstrates the presence of higher anti- RSV neutralizing activity in RI-002 as compared to that which is present in palivizumab in this animal model.
Poster Number: 62
Poster Title: Protection Against Palivizumab Resistant RSV with an IVIG Containing High Titer Anti RSV Neutralizing Antibodies
Poster Viewing Dates: November 5-6, 2015
Presentation Time: 12:30 pm-2:00 pm
The abstract and poster can be found on the ADMA Biologics website (www.admabiologics.com) under the drug development tab, abstracts, posters and publications.
About ADMA Biologics, Inc.
ADMA is a late-stage biopharmaceutical company that develops, manufactures and intends to commercialize specialty plasma-based biologics for the treatment and prevention of Primary Immune Deficiency Disease (PIDD) and certain infectious diseases. ADMA's mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases. The target patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disease, or who may be immune-compromised for medical reasons. ADMA’s lead product candidate, RI-002, has completed a Phase III clinical trial in patients with PIDD and has met the primary endpoint. A BLA for RI-002 was accepted by the FDA on September 18, 2015. The company has received U.S. Patent 9,107,906. For more information, please visit the company's website at www.admabiologics.com.
About RI-002
ADMA's lead product candidate, 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 intravenous immune globulin (IVIG) product for treatment of patients diagnosed with 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 present in RI-002 support its ability to prevent infections in immune-compromised patients. ADMA’s analysis demonstrated that the Phase III trial met the primary endpoint with no serious bacterial infections (SBI) reported. These results more than meet the requirement specified by the FDA guidance of = 1 SBI per patient-year. A BLA was accepted by FDA on September 18, 2015.
About Primary Immune Deficiency Disease (PIDD)
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 Organization, 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.
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The poster will present data comparing the efficacy of palivizumab to that of RI-002, an IVIG that contains high titer anti-RSV neutralizing antibodies and which prevents RSV infections in the cotton rat after infection with a strain that is resistant to palivizumab. The data also demonstrates the presence of higher anti- RSV neutralizing activity in RI-002 as compared to that which is present in palivizumab in this animal model.
Poster Number: 62
Poster Title: Protection Against Palivizumab Resistant RSV with an IVIG Containing High Titer Anti RSV Neutralizing Antibodies
Poster Viewing Dates: November 5-6, 2015
Presentation Time: 12:30 pm-2:00 pm
The abstract and poster can be found on the ADMA Biologics website (www.admabiologics.com) under the drug development tab, abstracts, posters and publications.
About ADMA Biologics, Inc.
ADMA is a late-stage biopharmaceutical company that develops, manufactures and intends to commercialize specialty plasma-based biologics for the treatment and prevention of Primary Immune Deficiency Disease (PIDD) and certain infectious diseases. ADMA's mission is to develop and commercialize plasma-derived, human immune globulins targeted to niche patient populations for the treatment and prevention of certain infectious diseases. The target patient populations include immune-compromised individuals who suffer from an underlying immune deficiency disease, or who may be immune-compromised for medical reasons. ADMA’s lead product candidate, RI-002, has completed a Phase III clinical trial in patients with PIDD and has met the primary endpoint. A BLA for RI-002 was accepted by the FDA on September 18, 2015. The company has received U.S. Patent 9,107,906. For more information, please visit the company's website at www.admabiologics.com.
About RI-002
ADMA's lead product candidate, 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 intravenous immune globulin (IVIG) product for treatment of patients diagnosed with 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 present in RI-002 support its ability to prevent infections in immune-compromised patients. ADMA’s analysis demonstrated that the Phase III trial met the primary endpoint with no serious bacterial infections (SBI) reported. These results more than meet the requirement specified by the FDA guidance of = 1 SBI per patient-year. A BLA was accepted by FDA on September 18, 2015.
About Primary Immune Deficiency Disease (PIDD)
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 Organization, 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.
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