ADMA Biologics Completes Enrollment of Phase III Study for RI-002

RAMSEY, N.J.--()--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 completion of enrollment for its Phase III clinical study of RI-002. This study is designed to evaluate the efficacy and safety of RI-002 as a novel immune globulin for the treatment of patients who are affected by Primary Immune Deficiency Diseases (PIDD). ADMA expects to have preliminary Phase III data in the fourth quarter of 2014.

“It is exciting to follow ADMA Biologics as they progress through their Phase III pivotal trial with a novel immune globulin product for the PIDD patient community,” said Dr. Richard L. Wasserman, Clinical Professor of Pediatrics, University of Texas Southwestern Medical School, Director of Pediatric Allergy and Immunology, Medical City Children's Hospital and lead Principal Investigator of ADMA’s Phase III trial. “The availability of a high titer immune globulin product such as RI-002, indicated for use in the immune deficient population will be a welcome addition to the currently available therapies.”

“We are very pleased to announce that recruitment for our Phase III clinical study has been completed,” stated, Adam Grossman, President and Chief Executive Officer of ADMA. “This is a significant milestone for our lead product candidate and puts the company in a good position to report preliminary Phase III data during the fourth quarter of 2014. We are sincerely appreciative of our participating investigators who are leaders in the PIDD community for their enthusiasm and efforts as they continue to move our study forward.”

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 (eg. 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.

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 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, 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.

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,” “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, and commercialization efforts of the Company's product candidate(s). 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, 2012, as filed with the Securities and Exchange Commission on March 6, 2013 and our other filings with the US Securities and Exchange Commission including, among other things, that any preliminary data will, if and when available, be encouraging, positive or will otherwise lead to an effective or approved product. 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 to 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.

Contacts

ADMA Biologics, Inc.
Brian Lenz, CPA,201-478-5552
Vice President & Chief Financial Officer
www.admabiologics.com
info@admabio.com

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Contacts

ADMA Biologics, Inc.
Brian Lenz, CPA,201-478-5552
Vice President & Chief Financial Officer
www.admabiologics.com
info@admabio.com