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PRESS RELEASE
Biotest AG continues cooperation with ADMA Biologics, Inc. for the RSV hyperimmunoglobulin RI-002
- Biologic Licence Application submitted to Food and Drug Administration after successful phase III trial
Dreieich, September 30, 2015. In accordance with the license agreement entered on December 31, 2012 Biotest AG (Biotest) made a milestone payment following ADMA Biologics, Inc., New Jersey, USA, (ADMA) submission of the Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) for their most advanced product RI-002. RI-002 is a specialty plasma-derived, polyclonal, intravenous immunoglobulin (IVIG) derived from human plasma containing naturally occurring polyclonal antibodies to respiratory syncytial virus (RSV).
Biotest has acquired the license of the ADMA product for Europe and other markets. In addition to the marketing and sales license our subsidiary Biotest Pharmaceuticals Corp., Boca Raton, USA, provides ADMA with manufacturing services and plasma supply.
ADMA is pursuing an indication for the use of this specialty intravenous immunoglobulin product for the treatment of patients diagnosed with Primary Immune Deficiency Disease (PIDD) and intends to commercialize specialty plasma-based biologics for the treatment and prevention of certain infectious diseases.
"We are very pleased to have Biotest as a partner," stated Adam Grossman, President and CEO of ADMA. "The milestone funds received under the existing license agreement will be earmarked for ADMA's ongoing commercialization 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."
"Biotest has confidence in ADMA and its mission to bring novel, advanced therapies derived from human plasma for the immune-compromised patients to market. 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 Plasma Alliances and Protein Supply, Biotest AG. "We look forward to continuing our long-term relationship with ADMA as well as providing ADMA with plasma and manufacturing services."
About ADMA Biologics, Inc.
ADMA is a 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 submitted to the FDA on July 31, 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 (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 submitted to the FDA on July 31, 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.
About Biotest
Biotest AG is a provider of plasma proteins and biological drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of clinical immunology, haematology and intensive medicine. Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In addition Biotest develops monoclonal antibodies in the indications of rheumatoid arthritis and cancer of plasma cells, which are produced by recombinant technologies. Biotest has more than 2,100 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.
Biotest AG, Landsteinerstr. 5, 63303 Dreieich, www.biotest.de
Dr. Monika Buttkereit
tel.: +49 (0) 6103 801-4406,
email: investor_relations@biotest.de
Securities' ID No., ISIN ordinary shares: 522720, DE0005227201
Securities' ID No., ISIN preference shares: 522723, DE0005227235
Listing: Prime Standard
Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover, Munich, Stuttgart
Disclaimer
This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.
