PAA has made a key appointment and signed new manufacturing deals. Pic: Getty Images
Health & Biotech
Special Report: Leading clinical stage biotech PharmAust has marked a significant milestone in its journey towards commercialisation of its lead drug monepantel to treat motor neuron disease/amyotrophic lateral sclerosis (MND/ALS) with the appointment of Dr Herbert Brinkman as head of manufacturing.
PharmAust (ASX:PAA) says Brinkman has more than 30 years of product development and manufacturing experience in the pharmaceutical industry and has successfully launched nine products in the US across oncology, metabolic, dermatology and endocrinology therapeutic areas.
Brinkman has contributed to filing 21 abbreviated new drug applications (ANDAs) for various semi-solid and parenteral products and is also an inventor on 14 patents.
His expertise includes current good manufacturing practice (cGMP) systems applied to API manufacture/drug product manufacture and addressing regulatory issues.
Brinkman’s previous position was executive director of product development at NASDAQ-listed Arcutis Biotherapeutics, where he was responsible for the successful commercial launch of ZORYVE (roflumilast).
CEO Dr Michael Thurn says Brinkman has considerable expertise in product development, manufacturing, and launching pharmaceutical products and his appointment is significant for PAA.
“PharmAust is only one clinical study away from potentially receiving either accelerated or full approval of monepantel for the treatment of MND/ALS,” he says.
“Our GMP manufacturing capabilities must be appropriately scaled and robust to support accelerated approval and the rapid rollout of products once approved.
“I very much look forward to working with Herb as the Company positions itself as a leading developer of neurodegenerative medicines.”
PAA says it has also inked manufacturing process development deals with Syngene International and Catalent Pharma Solutions, global leaders in GMP manufacture and commercial supply of pharmaceutical products.
Under the agreements Syngene will manufacture 60kg of GMP monepantel consisting of one 15kg engineering batch followed by three 15kg process validation batches designed to validate the GMP manufacturing process, support product registration and prepare PAA for commercial supply.
Catalent will be responsible for the GMP manufacture of three registration batches, totalling more than a million tablets, which will be required to support product registration and facilitate commercial scale-up activities.
The product manufactured will be used to support the upcoming pivotal registration Phase 2/3 clinical study of monepantel to treat MND/ALS.
The manufacturing process development agreements are anticipated to be followed by a commercial supply agreement.
Chief operating officer John Clark says PAA is delighted to have partnered with Syngene and Catalent to meet its GMP manufacturing requirements,
“Syngene has successfully developed a new scalable and reproducible GMP manufacturing process for monepantel that will be the subject of future patent applications.
“Catalent was responsible for successfully reformulating monepantel into a solid tablet dosage form, and we look forward to continuing our longstanding relationship with them both”.
In further good news, PAA earlier this month announced Macquarie University had given the go-ahead to conduct an open-label extension study of monepantel in patients with MND/ALS.
The study’s overarching objective is to assess the long-term safety and tolerability of MPL as well as the biomarkers and efficacy endpoints of 12 patients who took part in the Phase 1 MEND study.
This article was developed in collaboration with PharmAust, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
