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ADMA will acquire BPC’s plasma-based fractionation and purification plant in Boca Raton, FL and plans to resolve issues at the facility noted in an FDA warning letter.
ADMA Biologics, a late-stage biopharmaceutical company that develops, manufactures, and intends to commercialize specialty plasma-based biologics for the proposed treatment of immune deficiencies and prevention of certain infectious diseases, signed a definitive agreement to acquire certain manufacturing and therapy-related assets from Biotest Pharmaceuticals Corporation (BPC), a wholly-owned subsidiary of Biotest AG, the company announced on Jan. 23, 2017. The transaction, subject to customary closing conditions, including shareholder approval, is expected to close during the first half of 2017.
ADMA’s lead product candidate, RI-002, is manufactured at BPC’s facility in Boca Raton, Florida. ADMA has been working closely with BPC on resolving certain issues at this facility in connection with deficiencies identified by 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 US. This transaction will allow ADMA to work directly with the FDA in efforts to obtain US regulatory approval for RI-002 and remediate the outstanding warning letter at the manufacturing facility,” stated Adam Grossman, president and CEO, director and founder of ADMA Biologics, in a press release. “Through this transformative transaction, 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. We believe the plasma industry and market are poised for growth in the coming years, as such, ADMA believes that it has secured a prime place for it and its stockholders to reap the rewards associated with marketing novel plasma derived therapies.”
James Mond, MD, PhD, chief medical and scientific officer of ADMA Biologics, stated in the press release, “Since the receipt of the CRL for RI-002 this past July, ADMA has been working to find a solution to the issues which would result in the most expeditious way to obtain FDA regulatory approval for RI-002. With the experience of our management team and board of directors in the plasma products industry, BPC and Biotest AG have conveyed their belief that ADMA is the ideal company to lead the efforts for the resolution of the warning letter at the plant as well as harnessing the potential of the assets and championing the BPC product portfolio.”
ADMA will be acquiring facilities including two buildings in Boca Raton, FL that 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. The acquisition also includes certain employees and a contract manufacturing and services agreement for a third party’s licensed hyperimmune globulin product.
As part of the transaction, Biotest will receive equity interest in ADMA’s issued and outstanding capital stock, and ADMA will transfer ownership to BPC of its two wholly-owned plasma centers in Norcross, Georgia and Marietta, Georgia, effective January 1, 2019. Biotest AG will maintain its existing distribution rights granted for RI-002 in Europe, the Near and Middle East, and selected other territories, and a right of first offer to BPC for the distribution of potential future ADMA developed plasma based products in the territories.