ADMA to buy US Biotest plant and fix problems that derailed RI-002

24-Jan-2017 - Last updated on 24-Jan-2017 at 15:15 GMT

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ADMA Biologics has agreed to buy production assets from the CMO whose manufacturing deficiencies saw the US FDA reject its lead candidate, RI-002, last year.

New Jersey-based ADMA announced the deal on January 21.

ADMA explained it will take charge of fixing the manufacturing problems at Biotest Pharmaceuticals Corporation’s (BPC) site in Boca Raton, Florida which were cited in a complete response letter (CRL) issued in July.

CEO, Adam Grossman, said: “This transaction will allow ADMA to work directly with the FDA in efforts to obtain US regulatory approval for RI-002.”

RI-002 – which is a plasma-derived, polyclonal, intravenous immune globulin (IGIV) – is being developed for the treatment of Primary Immune Deficiency Disease (PIDD).

In addition to the facility, the deal includes all exclusive rights to Biotest’s plasma-derived approved therapies Nabi-HB and BIVIGAM, the investigational product CIVACIR and $5m (€4.6m) worth of inventory.

ADMA will also take over a manufacturing contract for a third party’s licensed hyper-immune globulin product, details of which were not disclosed.

Financials

In addition, the agreement will see Biotest Pharmaceuticals’ German owner – Biotest AG - pay ADMA a consideration of $40m for 50% of its capital stock.

Biotest will also become owner of two of AMA’s plasma centers in Norcross, Georgia and Marietta, Georgia, in 2019.