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RAMSEY, N.J. and BOCA RATON, Fla., Jan. 07, 2019 (GLOBE NEWSWIRE) — ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a angular chip bartering biopharmaceutical and specialty immunoglobulin aggregation that manufactures, markets and develops specialty plasma-derived biologics for the analysis of allowed deficiencies and the blockage of assertive communicable diseases, announces that the Aggregation has submitted responses to the U.S. Food and Drug Administration (“FDA”) Complete Response Letter (“CRL”) accustomed on December 19, 2018 for BIVIGAM®’s (Intravenous Allowed Globulin [Human], 10%) (“IVIG”) Prior Approval Supplement (“PAS”). The Aggregation anticipates accepting an accepting letter from the FDA aural 30 days, and affairs to accommodate adapted updates on the advance of the BIVIGAM® PAS review.
About ADMA Biologics, Inc. (ADMA) ADMA Biologics is a angular chip bartering biopharmaceutical aggregation that manufactures, markets and develops specialty plasma-based biologics for the analysis of Primary Allowed Absence Ache (“PIDD”) and the blockage and analysis of assertive communicable diseases. ADMA’s mission is to advance and commercialize plasma-derived, animal allowed globulins targeted to alcove accommodating populations for the analysis and blockage of assertive communicable diseases. The ambition accommodating populations accommodate immune-compromised individuals who ache from an basal allowed absence disease, or who may be immune-compromised for added medical reasons. ADMA has accustomed U.S. Patents 9,107,906, 9,714,283, 9,815,886 and 9,969,793 accompanying to assertive aspects of its advance artefact candidate, RI-002. For added information, amuse appointment Media
About BIVIGAM®BIVIGAM® is an intravenous allowed globulin adumbrated for the analysis of primary humoral immunodeficiency. This includes, but is not bound to, agammaglobulinemia, accepted capricious immunodeficiency, Wiskott-Aldrich affection and astringent accumulated immunodeficiency. These primary immunodeficiencies (“PI”) are a accumulation of abiogenetic disorders. Initially anticipation to be absolute rare, it is now believed that as abounding as 250,000 bodies in the U.S. accept some anatomy of PI. BIVIGAM® contains a ample ambit of antibodies agnate to those begin in accustomed animal plasma. These antibodies are directed adjoin bacilli and viruses, and advice to assure PIDD patients adjoin austere infections. BIVIGAM® is a purified, sterile, ready-to-use alertness of concentrated polyclonal Immunoglobulin (“IgG”) antibodies. Antibodies are proteins in the animal allowed arrangement that assignment to avert adjoin infections and disease. FDA’s antecedent approval for BIVIGAM® was accustomed by Biotest Pharmaceuticals Corporation (“BPC” or “Biotest”) on December 19, 2012, and assembly of BIVIGAM® was apoplectic by Biotest in December 2016. ADMA Biologics acquired buying and all rights, appellation and absorption in BIVIGAM® on June 6, 2017 as allotment of the Biotest Therapy Business Unit (“BTBU”) asset accretion and resumed the assembly of BIVIGAM during the fourth division of 2017.
Cautionary Note Regarding Forward-Looking StatementsThis columnist absolution contains “forward-looking statements” pursuant to the safe anchorage accoutrement of the Private Securities Litigation Reform Act of 1995, about ADMA Biologics, Inc. (“we“, “our” or the “Company”). Advanced statements include, after limitation, any account that may predict, forecast, indicate, or betoken approaching results, achievement or achievements, and may accommodate the words “estimate,” “project,” “intend,” “forecast,” “target,” ”anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “is likely,” “will likely,” “should,” “could,” “would,” “may,” or, in anniversary case, their negative, or words or expressions of agnate meaning. These advanced statements additionally include, but are not bound to, statements apropos our affairs to develop, manufacture, market, barrage and aggrandize our own bartering basement and commercialize our accepted articles and approaching products, the safety, adeptness and accepted timing of, and our adeptness to, access and advance authoritative approvals of our accepted articles and artefact candidates, and the labeling or attributes of any such approvals, the success of our assignment with our third affair vendors and the U.S. Food and Drug Administration (the “FDA”) in advocacy of and advance appear an approval of our Biologics License Application for specialty plasma-based biologics and the adeptness of such third parties to acknowledge abundantly or in a appropriate address to the issues aloft by the FDA, our adeptness to auspiciously accompany commercialization and prelaunch activities, the timeframe aural which we may accept approval from the FDA for specialty plasma-based biologics, if at all, the abeyant of our specialty plasma-based biologics to accommodate allusive analytic advance for patients active with Primary Allowed Absence Ache or added indications, our adeptness to apprehend added prices for claret advance in the claret accumulating industry and our expectations for approaching basic requirements. Absolute contest or after-effects may alter materially from those declared in this certificate due to a cardinal of important factors. Accepted and -to-be aegis holders are cautioned that there additionally can be no affirmation that the advanced statements included in this columnist absolution will prove to be accurate. In ablaze of the cogent uncertainties inherent in the advanced statements included herein, the admittance of such advice should not be admired as a representation or assurance by ADMA or any added being that the objectives and affairs of ADMA will be accomplished in any defined time frame, if at all. Except to the admeasurement appropriate by applicative laws or rules, ADMA does not undertake any obligation to amend any advanced statements or to advertise revisions to any of the advanced statements. Advanced statements are accountable to abounding risks, uncertainties and added factors that could account our absolute results, and the timing of assertive events, to alter materially from any approaching after-effects bidding or adumbrated by the advanced statements, including, but not bound to, the risks and uncertainties declared in our filings with the U.S. Securities and Exchange Commission, including our best contempo letters on Anatomy 10-K, 10-Q and 8-K, and any amendments thereto.
COMPANY CONTACT: Brian Lenz Executive Vice President and Chief Financial Officer | 201-478-5552 | Media
INVESTOR RELATIONS CONTACT: Jeremy FefferManaging Director, LifeSci Advisors, LLC | 212-915-2568 |