RSV Vaccines for the World 2013 Conference Presentation Highlights Data from ADMA Biologics’ Human and Animal Study Experience

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 announced today that data from its previous Phase II trial, compassionate use experience and testing in the cotton rat RSV animal model was presented at the 2013 RSV Vaccines for the World Conference (RSVVW). The abstract is titled: “Polyclonal human IVIG with standardized high-levels of RSV neutralizing antibodies: A summary of animal and human studies.”

The oral presentation was given during the session “RSV Protection Using Non-Vaccine Approaches.”

“The data presented at the 2013 RSVVW demonstrates the potential for offering a polyclonal immune globulin product with standardized, elevated levels of anti-RSV antibodies in immune-compromised patient populations,” stated James Mond, M.D., Ph.D., Chief Medical & Scientific Officer for ADMA Biologics. “While vaccines may offer protection to patients that have functional immune systems, vaccines are not typically given to immune-compromised patients. Polyclonal immune globulin products like ADMA’s IVIG may provide an effective alternative for patients who could benefit from passive immunity against foreign pathogens.”

Topics from the RSVVW presentation included:

  • Review of RSV mediated disease in immune-compromised hosts
  • Description of ADMA IVIG product
  • Data from 3 studies
    • Cotton rat RSV infection model, the accepted surrogate for human RSV mediated disease
    • Phase II dose finding study in immune-compromised patients
    • Compassionate human use data

Data Summary:

  • The cotton rat model demonstrated:
    • Infusion of ADMA IVIG eliminates 99% of viral load in nasal and lung tissue
    • Highly significant increases in serum RSV neutralizing titers
  • The Phase II trial demonstrated:
    • 86% of subjects with confirmed RSV infection who received high-dose regimen ADMA IVIG had a ≥4-fold rise in RSV neutralization titers (day 18, mean 9.2 fold)
    • The drug was well tolerated in all study subjects and there were no serious adverse events attributable to the drug product
  • The compassionate use experience demonstrated:
    • Majority of seriously ill patients had favorable outcomes when treated early (within 8.6 days of RSV diagnosis) (11/15 or 73% of RSV pulmonary infected patients survived)
    • All patients tested who had not received prior administration of palivizumab had >4 fold rise in RSV neutralizing titers (day 8-18)
    • The drug was well tolerated in all subjects and there were no serious adverse events attributable to the drug product

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.

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 candidate is currently being evaluated in a Phase III trial in the United States.

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, 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. 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, 201-478-5552
VP & Chief Financial Officer
info@admabio.com

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Contacts

ADMA Biologics, Inc.
Brian Lenz, 201-478-5552
VP & Chief Financial Officer
info@admabio.com