RAMSEY, N.J. and MARIETTA, Ga., Nov. 18, 2014 (GLOBE NEWSWIRE) -- ADMA Biologics, Inc. (Nasdaq:ADMA), today announced the opening of its second plasma collection facility in Marietta, Georgia.
"Demand for plasma donation is thriving in the metro Atlanta area and our expansion into the Marietta market is poised for growth," said Cyndi Tolman, VP Plasma Operations.
"This second facility is expected to add additional plasma raw material inventory as we plan for the commercial requirements for our lead product candidate RI-002," stated Adam Grossman, President and Chief Executive Officer. "The current climate is positive for worldwide plasma products growth and industry reports suggest plasma collections are up approximately 9% in 2014."
The Marietta, GA facility is over 10,000 square feet, and has the potential to support over 50 donor beds at peak capacity. ADMA BioCenters expects to submit a Biologics License Application to the FDA by the end of 2014, which may lead to a potential approval of the center in late 2015 or early 2016, subject to the timing of the FDA's ongoing inspection schedule. This center has the potential to employ over 50 staff members. Plasma donors may be paid as much as $200 per month donating at an ADMA BioCenter.
Plasma centers provide local economies with financial resources through employment opportunities and compensation to local residents for their plasma donations. Plasma can be used for manufacturing a variety of live saving and life sustaining therapies. For information about plasma donation or to become a donor with ADMA BioCenters, please visit www.atlantaplasma.com.
About ADMA BioCenters
ADMA BioCenters is a wholly-owned subsidiary of ADMA Biologics, which operates as a source plasma collection business. ADMA BioCenters holds FDA, GHA and MFDS licenses to operate as a source plasma collection organization for both U.S. based and foreign fractionators' therapeutic plasma products manufacturing.
A typical plasma collection center can collect between 30,000 to 50,000 liters of source plasma annually. Plasma collected from ADMA BioCenters' FDA approved facility that is not used in the production of RI-002 is sold to customers under an existing supply agreement or in the open "spot" market generating revenues for the company. Additional information may be obtained from the ADMA BioCenters website: www.atlantaplasma.com.
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 targeted 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 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. 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. All patients have completed dosing requirements in the Phase III trial and continue in follow-up. The primary endpoint data will be announced prior to December 31, 2014.
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 likelihood of FDA approval of the plasma center, growth of the market in Marietta, Georgia, demand for plasma and worldwide growth of the plasma industry, accessibility of donors, value of plasma centers to the community, amounts collected and potential sales of and revenue from plasma products, 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, build out, opening and regulatory approval of plasma facilities, commercialization efforts of the Company's product candidate(s), trends relating to demand for source plasma and our ability to sustain the listing of our common stock on the NASDAQ Capital Market. 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 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, 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
Source:ADMA Biologics, Inc.