ADMA Biologics, a late-stage biopharmaceutical company that develops, manufactures, and intends to commercialize specialty plasma-based biologics for the treatment of immune deficiencies and prevention of certain infectious diseases, has acquired certain manufacturing and therapy-related assets from Biotest Pharmaceuticals, a wholly-owned subsidiary of Biotest AG.

ADMA’s lead product candidate, RI-002, is manufactured at Biotest’s facility in Boca Raton, FL. ADMA has been working closely with Biotest on resolving certain issues at this facility in connection with deficiencies identified by the U.S. Food and Drug Administration (FDA) in ADMA’s Complete Response Letter (CRL) for RI-002 (July 2016).  RI-002 is a specialty plasma-derived, polyclonal, intravenous immune globulin (IGIV).  ADMA is pursuing an indication for the use of this specialty IGIV product for treatment of patients diagnosed with Primary Immune Deficiency Disease (PIDD).

“Upon the completion of this transaction, ADMA believes it will be uniquely positioned to offer a fully vertically integrated plasma products and immune globulin platform in the U.S.,” said Adam Grossman, president and chief executive officer, director and founder, ADMA Biologics. “This transaction will allow ADMA to work directly with the FDA in efforts to obtain U.S. regulatory approval for RI-002 and remediate the outstanding Warning Letter at the manufacturing facility.”

ADMA is acquiring property, facilities, laboratories, equipment and certain employees located at Biotest’s Boca Raton, FL, properties, which are comprised of two commercial buildings totaling ~126,000 square feet. The buildings house a fully equipped plasma fractionation and purification plant of FDA licensed biologics, testing laboratories, office space, ambient and cold storage warehouses, as well as a commercial scale monoclonal antibody production facility.

As part of the deal ADMA is also acquiring FDA licensed products including Nabi-HB (hepatitis B immune globulin, human) and Bivigam (immune globulin intravenous, human), as well as a contract manufacturing and services agreement for a third party’s licensed hyperimmune globulin product.

“We believe that combining these acquired assets with our innovative immune globulin intellectual property will afford ADMA an expedited and less costly pathway for exploring additional hyperimmune globulin product candidates, as well as other potential plasma derived products,” said Mr. Grossman. “We believe the plasma industry and market are poised for growth in the coming years.”