ADMA Biologics Announces Positive Top-Line Phase III Data for Primary Immune Deficiency Disease (PIDD) Patients
(Thomson Reuters ONE) -
RI-002 Phase III Study Achieves Primary Endpoint
RAMSEY, N.J., Dec. 3, 2014 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc.
(Nasdaq: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 its
lead product candidate RI-002 has demonstrated positive Phase III results and
successfully achieved its primary endpoint.
"This is a tremendous milestone for our Company and for immune compromised
patients," stated Adam Grossman, President & CEO of ADMA Biologics. Mr. Grossman
continued, "We are proud and encouraged that based upon the initial review, RI-
002 has met its primary endpoint of preventing serious bacterial infections such
as bacterial pneumonia, osteomyelitis and bacterial sepsis in immune compromised
PIDD patients."
The Phase III US based clinical study enrolled 59 patients with diagnosed
primary immune deficiency disease (PIDD) who received the investigational
product, RI-002 for 12 months.
While final data from the study will be reported during the first quarter of
2015, preliminary analysis indicates that treatment with RI-002 resulted in no
serious bacterial infections (SBI) observed in study subjects during the
trial. This is well under the Food and Drug Administration (FDA) requirement of
less than or equal to 1 SBI per patient-year and therefore the trial
successfully achieved its primary endpoint.
Secondary endpoints include incidence of all infections (serious & non-serious),
lost days of work or school, hospitalizations, emergency room visits and
antibiotic use among others. Data on these secondary endpoints is expected to be
provided during the first quarter of 2015.
"ADMA Biologics IVIG (RI-002) is formulated to meet FDA requirements. It is
noteworthy that the Company will, in addition, ensure that each lot of ADMA
Biologics IVIG (RI-002) contains standardized, high-levels of neutralizing
antibodies to RSV," stated Richard Wasserman, MD, Clinical Professor of
Pediatrics, University of Texas Southwestern Medical School, Director of
Pediatric Allergy and Immunology, Medical City Children's Hospital and one of
the lead investigators for the ADMA-003 Phase III clinical trial evaluating RI-
002.
Dr. Wasserman continued, "The preliminary data analysis demonstrated that the
trial met its primary endpoint and there were no reported acute serious
bacterial infections during the 59 patient-years of primary immunodeficiency
patient treatments during this study. This IVIG product will be a very welcome
addition for a segment of the primary immunodeficiency population because of its
unique antibody profile."
Dr. Jordan Orange, Chief of Immunology, Allergy, and Rheumatology, Professor of
Pediatrics at Baylor College of Medicine, and the Director of the Center for
Human Immunobiology at Texas Children's Hospital stated, "It is encouraging to
see that ADMA Biologics is moving the peg for immune globulin research and
advancing our understanding of polyclonal antibodies and IVIG products for the
PIDD population. As a member of ADMA Biologics' Scientific Advisory Board, I
look forward to examining future results from the various secondary endpoints."
Dr. James Mond, Chief Medical & Scientific Officer for ADMA Biologics stated,
"Over 750 infusions of RI-002 into 59 patients were well tolerated with no
reported serious adverse events attributable by investigators to the study drug.
The safety profile of RI-002 is similar to that of other immune globulin
products and is well characterized in this study. We are grateful to all the
investigators and patients for their time, effort and collaboration with our
clinical trial. We believe that this positive data will enable ADMA to file for
FDA BLA approval for RI-002 as a treatment for patients with Primary Humoral
Immune Deficiency."
In this Phase III trial, measurements of key secondary endpoints including
trough levels of IgG were made. The pharmacokinetic profile of total IgG was
measured and met required criteria. This pharmacokinetic component of Study
ADMA-003 was consistent with the requirements for the pharmacokinetic
characterization of IVIG as specified in FDA's 2008 Guidance for Industry:
Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune
Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral
Immunodeficiency. The Company plans to report on additional secondary endpoints
when the data is available.
ADMA is currently assembling its BLA for planned submission to FDA during the
first half of 2015.
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. 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, 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 IGIV product for
treatment of patients diagnosed with primary immune deficiency diseases, or
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. Preliminary review indicate
that the polyclonal antibodies that are present in RI-002 support the ability of
this product to prevent infections in immune-compromised patients. Preliminary
analysis demonstrated that the Phase III trial has met the primary endpoint with
no serious bacterial infections (SBI) reported. These results are well below the
requirement specified by FDA guidance of less than or equal to 1 SBI per
patient-year.
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 timing of availability of final data,
possible characteristics of RI-002, acceptability of RI-002 for any purpose,
results relating to secondary endpoints, final data relating to RI-002,
likelihood and timing of FDA action with respect to any further filings by the
Company, results of the clinical development, the availability of 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, commercialization efforts of the Company's product candidate(s) and
trends relating to demand for source plasma. Forward-looking statements are
subject to many risks and uncertainties that could cause our actual results and
the timing of certain events 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 final or secondary 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 the FDA will accept
our data, permit us to submit a BLA, grant a license, or approve RI-002 for
marketing, whether we will meet any of our clinical or regulatory milestones,
develop any new products or expand existing ones, receive FDA approval of our
new facility, changes in regional and worldwide supply and demand for source
plasma, whether we will be able to attract sufficient donors and operate the new
facility effectively or profitably, whether we can sell our plasma in the
marketplace at prices that will lead to adequate amounts of revenue, whether we
will be able to sustain the listing of our common stock 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 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.
CONTACT: Brian Lenz
Vice President and Chief Financial Officer
201-478-5552
www.admabiologics.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: ADMA Biologics, Inc. via GlobeNewswire
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