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.

Related news

Related products

show more

Facilities: Grangemouth, UK

Facilities: Grangemouth, UK

Piramal Pharma Solutions | 28-Jun-2021 | Insight Guide

The Piramal Pharma Solutions site in Grangemouth, UK offers development, clinical & commercial scale manufacture of bio-conjugates including Antibody...

Facilities: Aurora, Canada

Facilities: Aurora, Canada

Piramal Pharma Solutions | 28-Jun-2021 | Insight Guide

The Piramal Pharma Solutions facility in Aurora Canada offers development, clinical and commercial GMP manufacturing of Active Pharmaceutical Ingredients...

Integrated Solutions for Accelerated Time to Market

Integrated Solutions for Accelerated Time to Market

Piramal Pharma Solutions | 08-Jun-2021 | Technical / White Paper

Facing capacity constraints? Lock in your program now! With 14 sites around the world providing diverse services ranging from discovery to drug substance...

Related suppliers

Follow us

Products

View more

Webinars