PharmAust appoints industry veteran to spearhead manufacturing ahead of critical MPL trial

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By Imelda Cotton - 
PharmAust ASX PAA Herbert Brinkman appointment

Clinical-stage biotechnology company PharmAust (ASX: PAA) has strengthened its management team with the appointment of Dr Herbert Brinkman as head of manufacturing.

Dr Brinkman has more than 30 years of product development and manufacturing experience in the pharmaceutical industry and has helped file and commercially launch nine products in the US market encompassing oncology, metabolic, dermatology and endocrinology therapeutics.

He has contributed to the filing of 21 abbreviated new drug applications for various semi-solid and parenteral products and is the inventor on 14 patents.

His expertise includes current good manufacturing practice (GMP) systems applied to active pharmaceutical ingredient and drug product manufacture and addressing regulatory issues.

Prior to joining PharmAust, Dr Brinkman was executive director of product development at US company Arcutis Biotherapeutics, where he was responsible for the successful commercial launch of Zoryve (roflumilast) for plaque psoriasis and seborrheic dermatitis.

Pivotal time

Chief executive officer Dr Michael Thurn said Dr. Brinkman’s appointment comes at a pivotal time in the fast-track development of lead drug monepantel (MPL) for the treatment of patients with motor neurone disease / amyotrophic lateral sclerosis.

“We are one clinical study away from potentially receiving accelerated or full approval of MPL [and] Herb is a significant appointment as he has considerable expertise in product development, manufacturing and launching pharmaceutical products,” he said.

“I very much look forward to working with Herb as we position PharmAust as a leading developer of neurodegenerative medicines.”

Manufacturing agreements

PharmAust has secured manufacturing process development agreements with US companies Syngene International and Catalent Pharma Solutions for the production of MPL.

Under the agreements, Syngene will manufacture 60 kilograms of the drug, consisting of a 15kg engineering batch and three 15kg process validation batches, to validate the GMP manufacturing process, support product registration and prepare PharmAust for commercial supply.

Catalent will be responsible for the manufacture of three registration batches totalling more than one million tablets, which will be required to support product registration and facilitate commercial scale-up activities.

The manufactured product will also be used to support the key registration Phase 2/3 MPL clinical study.

Both agreements are expected to be followed by commercial supply contracts.