ADMA Biologics Forms Scientific Advisory Board with Expertise in Immune Deficiencies, Infectious Diseases and Transplantation
RAMSEY, N.J.--(BUSINESS WIRE)--ADMA Biologics, Inc. (OTCQB: ADMA), a late-stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, today announced the formation of its Scientific Advisory Board (SAB) with the following appointments: R. Michael Blaese, M.D., Roy F. Chemaly, M.D., M.P.H., John DeVincenzo, M.D., Richard O’Reilly, M.D., Jordan S. Orange, M.D., Ph.D., and E. Richard Stiehm, M.D.
“Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency”
“We are honored to have thought leaders in the fields of immunology, infectious diseases and transplantation join our scientific advisory board. The appointment of our SAB members comes at an opportune time for ADMA, as we continue to make progress in our Phase III clinical study. We currently have administered more than 70% of the forecasted number of infusions to patients, while approximately one third of patients have received all infusions and have completed the study. Our SAB will be helpful in advising the company as we review the data obtained from the Phase III trial and prepare for our Biologics License Application (BLA) submission during the first half of 2015,” stated Adam Grossman, President and Chief Executive Officer of ADMA Biologics.
“Each of these physicians is a thought leader in their respective disciplines and their counsel will be invaluable as they serve as advisors to ADMA for our current product candidate as well as support our efforts in the area of additional novel therapies and unique specialty immune globulins for the immune compromised and transplant populations,” commented James J. Mond, M.D., Ph.D., Chief Medical and Scientific Officer of ADMA Biologics.
Abbreviated biographies of our recently appointed SAB members are as follows, which can also be found at: http://www.admabiologics.com/corporate-info/scientific-advisory-board:
R. Michael Blaese, M.D., is the medical director of the Immune Deficiency Foundation (IDF), Towson, Maryland. Prior to going to work for the IDF, Dr. Blaese spent more than 30 years at the National Institutes of Health (NIH) researching and developing treatments for immune deficiencies.
Roy F. Chemaly, M.D., M.P.H., is a professor in the department of infectious diseases, infection control and employee health, division of internal medicine at The University of Texas, MD Anderson Cancer Center. Dr. Chemaly is board certified, specializing in infectious diseases and has published extensively on infections in immunocompromised hosts such as stem cell transplant patients. He is also the director of Infection Control and Antimicrobial Stewardship Programs.
John DeVincenzo, M.D. is a practicing pediatric infectious disease specialist, Professor of Pediatrics and Professor of Microbiology, Immunology, and Biochemistry at the University of Tennessee School of Medicine. His research focuses on understanding the pathogenesis of Respiratory Syncytial Virus (RSV) directly in children and using this understanding to develop therapeutic and prevention strategies against this virus. He is the author of over 140 original published abstracts and papers on this subject. Dr. DeVincenzo has conducted numerous clinical trials in children defining the role of prevention and therapeutic applications of monoclonal antibodies targeting RSV in infants and the immune suppressed.
Richard O’Reilly, M.D. is the chair of the department of pediatrics at Memorial Sloan Kettering Cancer Center. Dr. O’Reilly oversees all aspects of the clinical, medical education, and research endeavors. Dr. O’Reilly’s clinical expertise is in bone marrow transplantation and the treatment of children with congenital and acquired immunological deficiencies, with particular expertise in treating genetic diseases that impair hematopoiesis — the formation of blood cells, as well as pediatric leukemias. Dr. O’Reilly also is an authority on transplantation immunology and cellular therapies.
Jordan S. Orange, M.D., Ph.D. is the chief of immunology, allergy, and rheumatology, professor and section head for immunology, allergy and rheumatology in the department of pediatrics at Baylor College of Medicine, and the director of the Center for Human Immunobiology at Texas Children’s Hospital. Dr. Orange is a board-certified pediatrician and allergist/immunologist with a clinical specialty in primary immunodeficiency disease. Dr. Orange has focused his research efforts upon Primary Immunodeficiency, Immunoglobulin, NK cell deficiency and the cell biology of human NK cell defenses.
E. Richard Stiehm, M.D. is a distinguished research professor of pediatrics emeritus at the University of California, Los Angeles. Dr. Stiehm served as Chief of the Division of Pediatric Immunology/Allergy/Rheumatology from 1969 to 2003 and a graduate of the University of Wisconsin and its Medical School. Dr. Stiehm has been the training director for over fifty fellows in allergy and immunology and his research interests include primary immunodeficiency, neonatal immunology, immunoglobulin therapy, pediatric rheumatology and pediatric HIV infection. He is the author of over 500 articles and chapters and is the chief editor of Immunologic Disorders in Infants and Children editions I through V and an editor of Stiehm’s Immunodeficiency (in press).
About ADMA Biologics, Inc.
ADMA is a late stage biopharmaceutical company that develops, manufactures, and intends to market specialty plasma-based biologics for the treatment and prevention of 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 also operates ADMA Bio Centers Georgia, Inc., an FDA-licensed and GHA-certified source plasma collection facility located in Norcross, Georgia, which provides ADMA with a portion of its blood plasma for the manufacture of RI-002. For more information, please visit the Company’s website at www.admabiologics.com.
About ADMA’s lead product candidate RI-002
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, CMV, measles, tetanus etc.), as well as high levels of antibodies targeted to respiratory syncytial virus, or 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 component of IGIV products. Polyclonal antibodies are proteins produced by B-cells that are used by the body’s immune system to neutralize microbes such as bacteria and viruses. The polyclonal antibodies that are present in RI-002 are expected to prevent infections in immune-compromised patients. The product is currently being evaluated in a Phase III trial in the United States. The pivotal Phase III study design follows the published FDA’s “Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency” (Center for Biologics Evaluation and Research June 2008). The primary endpoint in the Phase III study, as described in the FDA’s guidance for industry, provides for a reduction in the incidence of serious infections to less than one per year in each subject receiving IGIV. The secondary endpoint is safety and includes other data collection points including antibody titers for certain agents, including RSV antibody levels at various time points after infusion. ADMA’s protocol has been developed in accordance with the FDA’s Guidance for Industry (June 2008), and if successful data is obtained, the Company believes that this single Phase III trial and complete BLA submission should lead to FDA approval for RI-002. ADMA expects to have preliminary data from the pivotal Phase III clinical trial during the fourth quarter of 2014. Once data is available, the Company expects to file a BLA with the FDA during the first half of 2015 in accordance with the FDA’s guidance for industry. The FDA could approve ADMA’s BLA within approximately one year of filing, and potential first commercial sales could occur as early as the first half of 2016.
Cautionary Statement Regarding Forward-Looking Information
This press release contains “forward looking statements.” Forward-looking statements include, without limitation, any statement that may predict, forecast, indicate, or imply future results, performance or achievements, and may contain the words “estimate,” “project,” “intend,” “forecast,” “target,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “will likely,” “should,” “could,” “would,” “may” or, in each case, their negative, or words or expressions of similar meaning. These forward-looking statements include, but are not limited to, statements concerning the timing, progress and results of the clinical development, the availability of preliminary data, the reporting of data, regulatory processes, potential clinical trial initiations, potential investigational new product applications, biologics license applications, expansion plans, the achievement of clinical and regulatory milestones, build out, opening and regulatory approval of plasma facilities, commercialization efforts of the Company's product candidate(s) and the potential listing on the NASDAQ Capital Market. Forward-looking statements are subject to many risks and uncertainties that could cause our actual results to differ materially from any future results expressed or implied by the forward-looking statements, including, but not limited to, the risks listed under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2013, as filed with the U.S. Securities and Exchange Commission on March 28, 2014 and our other filings with the U.S. Securities and Exchange Commission including, among other things, risks as to whether any preliminary data will, if and when available, be encouraging, positive or will otherwise lead to an effective or approved product, whether we will be able to demonstrate efficacy or gain necessary approvals to market and commercialize any product, whether we will meet any of our clinical or regulatory milestones, open any new facilities, successfully list our securities on the NASDAQ Capital Market and whether we will meet any timing targets expressed by the Company. Therefore, current and prospective security holders are cautioned that there also can be no assurance that the forward-looking statements included in this press release will prove to be accurate. In light of the significant uncertainties inherent in the forward-looking statements included herein, the inclusion of such information should not be regarded as a representation or warranty by ADMA or any other person that the objectives and plans of ADMA will be achieved in any specified time frame, if at all. Except to the extent required by applicable laws or rules, ADMA does not undertake any obligation to update any forward-looking statements or to announce revisions to any of the forward-looking statements.