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ADMA Biologics Enters Mfg. and Supply Agreement

To produce and sell plasma-derived intermediate fractions.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

ADMA Biologics has entered into a 5-year manufacturing and supply agreement with an undisclosed partner to produce and sell plasma-derived intermediate fractions from ADMA’s U.S. FDA-approved Immune Globulin (IG) manufacturing process.
 
“A core element of our business strategy is to leverage and maximize the revenue we generate from the available manufacturing capacity at our FDA-approved plasma-derived products production facility. Through the production of our own marketed assets, BIVIGAM, ASCENIV and NABI-HB, we will now be able to generate additional revenue over and above the sales of the FDA-approved drugs themselves,” said Adam Grossman, president and chief executive officer, ADMA. “Based on current production and forecasted market sales volumes, we estimate that these additional revenues from the sale of these fractions will add between $5 million and $10 million to our annual revenues for 2020 and 2021 respectively.
 
“Depending on future plant capacity utilization and potential expansion, as well as our forecasted IG production ramp, we believe this contract has the potential to generate between $10 million and $20 million per year from 2022 through 2024. We are proud to be an emerging partner of choice for plasma-derived intermediate fractions and we look forward to providing high quality products to this new partner and delivering the highest level of service and value to all of our customers to support our overall growth objectives.”
 
Plasma contains many therapeutic proteins which control a number of processes and functions in the body. With ADMA’s FDA-approved manufacturing process, which the company uses to produce its three FDA-approved and marketed immune globulins, other non-IG proteins that are valuable for other functions in our bodies (also known as fractions) are removed. These fractions are used as the starting raw material to produce other plasma-derived biologics such as Factor VIII, Albumin, C1 Esterase Inhibitor and Alpha 1 anti-trypsin among others.
 
With this newly executed agreement, ADMA is now able to further maximize the revenue per liter of plasma fractionated in its Boca Raton, FL plant and sell these fractions so they may be processed by a third party into their own therapeutic products under their own licensed manufacturing processes.
 
ADMA owns and operates a 400,000 liter annual capacity plasma fractionation and purification facility located in Boca Raton, FL.  This manufacturing plant is licensed by the U.S. FDA. In addition to manufacturing its three FDA-approved products BIVIGAM, ASCENIV and NABI-HB at this facility, ADMA provides contract manufacturing services for pharmaceutical and biotech companies as well as produces and sells plasma-derived intermediate fractions.

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