Benzinga | Jul 20, 2021 07:06AM EDT

ADMA Biologics Announces Successful Completion of FDA Pre-Approval Manufacturing Facility Inspection

ADMA Biologics, Inc. (NASDAQ:ADMA) ("ADMA"), an end-to-end commercial biopharmaceutical company dedicated to manufacturing, marketing and developing specialty plasma-derived biologics, announced the United States Food and Drug Administration ("FDA") recently completed a Pre-Approval Inspection ("PAI") of the Boca Raton, FL manufacturing facility related to ADMA's application for its VanRx SA25 Workcell aseptic fill-finish machine ("VanRx"). The PAI successfully concluded with the FDA issuing zero Form 483 observations in the Agency's determination that the Company's Boca Raton, FL facility continues to operate in compliance with the principles and guidelines of Good Manufacturing Practices ("GMP") standards. The FDA's review of ADMA's VanRx regulatory filing remains ongoing, with anticipated regulatory approval in the second half of 2021.

"Through pandemic-related challenges, the successful completion of the FDA's PAI for the VanRx demonstrates our continued adherence to GMP standards and speaks to our organization's continued ability to deliver on regulatory commitments through unprecedented and challenging operating conditions," said Adam Grossman, President and Chief Executive Officer of ADMA. "With this favorable inspection outcome, we are anticipating receiving approval for the VanRx in the second half of 2021. We would like to thank the FDA for its focused engagement and collaboration in working with ADMA to meet the growing demands of the U.S. immune compromised patient community that relies on plasma-derived immune globulin products for their treatment."

"The anticipated VanRx approval will provide ADMA with internal fill-finish production capabilities for its commercial products, which is expected to translate into greater patient supply consistency, significant gross margin efficiencies, improved visibility of commercial product lot releases and, consequently, more predictable near-term revenue results. Additionally, the expected approval will enable ADMA to onboard third-party fill-finish contracts as a new and accretive revenue source. The COVID-19 pandemic has illuminated the importance and the scarcity value associated with fill-finish manufacturing capabilities and, once approved, we plan to update the market as we explore these potential new business opportunities in the periods ahead," concluded Mr. Grossman.

The VanRx fill-finish machine utilizes a state-of-the-art closed isolator design, allowing for the removal of human interventions and providing safe drug products for patients. The VanRx machine has the capability of rapidly switching between different container and closure formats, enabling aseptic filling in a variety of different fill volumes and presentation sizes. The combination of the recently FDA-approved increased BIVIGAM(r) manufacturing production scale as well as the enhanced vertical integration that will result from the anticipated approval of the VanRx machine will allow ADMA to bring its products to market faster, improve gross margins and substantially increase ADMA's end-to-end control over its critical manufacturing process.