ADMA Biologics, Inc., a late-stage biopharmaceutical company that develops, manufactures, and intends to commercialise specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, has received a milestone payment from Biotest Aktiengesellschaft (Biotest AG) as a result of the filing of its Biologics License Application (BLA) with the US Food and Drug Administration (FDA), in accordance with the license agreement entered into on December 31, 2012.
Biotest AG is a provider of plasma proteins and biological drugs. "Biotest has confidence in ADMA and its mission to bring novel, advanced therapies to market that are derived from human plasma for immune compromised patients. We recognize there is an unmet medical need for immune-compromised patients who can truly benefit from a product like ADMA's RI-002," stated Dr. Martin Reinecke, senior vice president of Plasma Alliances and Protein Supply, Biotest AG.
"We look forward to continuing our long-term relationship with ADMA as well as continuing to provide ADMA with manufacturing services and plasma supply."
"We are very pleased to have Biotest as a partner. The milestone funds received under the existing license agreement will be allocated to ADMA's ongoing commercialisation efforts for RI-002. We are grateful for the long-term relationship with Biotest and the services they provide to us as we continue to prepare for the potential approval and commercial launch of RI-002 in the second half of 2016," stated Adam Grossman, president and CEO of ADMA Biologics.
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 (IGIV) 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.
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.