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

By Gareth Macdonald contact

- Last updated on GMT

iStock/Bet_Noire
iStock/Bet_Noire

Related tags: Immune system

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.

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