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ADMA Biologics Announces Commercial Relaunch and its First Commercial Sales of BIVIGAM® | SEBIO

ADMA Biologics Announces Commercial Relaunch and its First Commercial Sales of BIVIGAM®

Posted by on Aug 26, 2019

BOCA RATON, FL. & RAMSEY, N.J. –  ADMA Biologics, Inc. (NASDAQ: ADMA) (“ADMA” or the “Company”), a vertically integrated commercial biopharmaceutical and specialty immunoglobulin company that manufactures and markets three approved plasma-derived biologics for the treatment of immune deficiencies and the prevention of certain infectious diseases, announces the commercial relaunch and its first commercial sales of BIVIGAM®.

As previously reported, BIVIGAM® had a Biologics License Application (“BLA”) manufacturing change Prior Approval Supplement (“PAS”) approved by the United States Food and Drug Administration (“FDA”) on May 9, 2019, enabling ADMA to resume marketing BIVIGAM® to US- based prescribers and healthcare professionals. BIVIGAM® is approved for the treatment of patients diagnosed with primary humoral immunodeficiency (“PI”). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (“CVID”), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

“We are very excited to have received the timely FDA PAS approval allowing ADMA to reintroduce BIVIGAM® to market for PI patients in efforts to address their ongoing medical needs and to address reported US market Intravenous Immune Globulin (“IVIG”) supply constraints. BIVIGAM’s® relaunch is a result of the culmination of many important milestones, and we are grateful for the efforts of our dedicated staff at ADMA and of the FDA, which have enabled us to bring BIVIGAM® to market. ADMA looks forward to working with our distribution partner and the physician community as we are prepared and committed to provide a continuous supply of BIVIGAM® to PI patients,” stated Adam Grossman, President and Chief Executive Officer.

Mr. Grossman continued, “As we have previously communicated to our stakeholders, the manufacturing, testing and final packaging for a complex biologic product like BIVGAM typically takes anywhere from six to nine months and sometimes longer to deliver to customers and end users. ADMA believes it is doing everything in its power to ramp up production to a steady state to ensure the continuity of care for patients, while continuing to operate in accordance with the FDA’s quality regulations and expectations. We want caregivers and patients to know that ADMA’s top priority remains unchanged: providing safe, high-quality and efficacious products.”

BIVIGAM® will be available through BioCare SD, our authorized distributor. Prescribers and healthcare professionals interested in purchasing BIVIGAM® for use with their PI patients should contact BioCare SD directly at 800-304-3064 or by visiting their website at www.BioCareSD.com.


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