RAMSEY, N.J., June 11, 2015 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), a late-stage biopharmaceutical company developing specialty plasma-based biologics for the treatment and prevention of certain infectious diseases, announced that it has initiated a collaboration with the Jeffrey Modell Foundation (JMF), a global nonprofit organization dedicated to patients with Primary Immunodeficiencies (PI). There are more than 250 genetic defects that are classified under the PI umbrella. The National Institutes of Health (NIH) estimates that at least 500,000 Americans are affected, many of whom are undiagnosed. JMF programs focus on early diagnosis and meaningful treatments through research, physician and patient education, public awareness, government advocacy, patient support and newborn screening.
"We are honored to have the opportunity to work closely with the Jeffrey Modell Foundation, a globally recognized patient advocacy organization devoted to PI patient awareness," stated Adam Grossman, President and CEO of ADMA Biologics. "Our corporate mission is to provide advanced therapies for immunocompromised patients and that is truly aligned with the focus of the Jeffrey Modell Foundation. Through our efforts in developing RI-002 as an alternative to current IVIG therapy, as shown in our positive Phase III trial, and with the anticipated submission of our Biologics License Application, we hope to provide the PI community with an alternative therapeutic treatment to the current options. It is an honor to be able to partner with such a caring and devoted patient advocacy organization."
"The Jeffrey Modell Foundation is pleased to collaborate with ADMA Biologics' strategic patient advocacy function," stated Fred Modell, President & Co-Founder. "ADMA is thinking outside of the box and developing a therapy which is different from existing therapies available for the PI community. All of us at the Jeffrey Modell Foundation are encouraged to see their progress and look forward to working closely with the company as they submit RI-002 to the FDA and seek to bring this solution to patients who will have alternative treatments made available. Our global database of patients, physicians and academic institutions will be an invaluable resource for ADMA to access and if possible, treat PI patients who are in need of a differentiated option for their PI therapy."
Vicki Modell, Co-Founder of the Jeffrey Modell Foundation welcomes this new alliance saying, "We are proud to work with ADMA Biologics. We believe in their mission, and in the potential for this work to change the lives of so many individuals. We are optimistic and hope to bring our energy and our commitment to this collaboration."
About Jeffrey Modell Foundation (JMF). JMF was established in 1987 by Vicki and Fred Modell as a nonprofit organization in memory of their son Jeffrey, who died at the age of fifteen from complications of Primary Immunodeficiency, a genetic condition that is chronic, serious and often fatal. JMF is a global patient organization devoted to early and precise diagnosis, meaningful treatments and ultimately, cures through clinical and basic research, physician education, patient support, advocacy, public awareness and newborn screening. The Jeffrey Modell Foundation Centers network includes over 600 physicians at over 200 academic institutions in over 200 cities, approximately 80 countries in 6 continents. As part of this strategic alliance, ADMA will have access to the Jeffrey Modell Foundation's Global Databases of over 140,000 patients who have varying forms of PI.
For more information, please visit the JMF website at: http://www.info4pi.org/.
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. Data review indicates that the polyclonal antibodies that are present in RI-002 support the ability of this product to prevent infections in immune-compromised patients. ADMA's analysis demonstrated that the Phase III trial has met the primary endpoint with no serious bacterial infections (SBI) reported. These results are below the requirement specified by FDA guidance of ≤ 1 SBI per patient-year.
This press release contains "forward looking statements" pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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," "is 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 interpretations of final data, possible characteristics of RI-002, acceptability of RI-002 for any purpose by physicians patients or payers, timing and ability of a filing with the FDA of a BLA, likelihood and timing of FDA action with respect to any further filings by the Company, results of the clinical development, continuing demonstrations of safety, comparability of results of RI-002 to other comparably run IVIG trials, improvements in clinical outcomes, market data and incidence of infection, 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, risks as to whether final and secondary data will be accepted as 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, whether we will develop any new products or expand existing ones, whether we will receive FDA approval of our new facility, whether there may be changes in regional and worldwide supply and demand for source plasma, whether we will be able to attract sufficient donors and operate our 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, whether we will meet any timing targets expressed by the Company, and other risks and uncertainties described in our filings with the U.S. Securities and Exchange Commission, including our most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. 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
Released June 11, 2015