Firebrick Pharma is an Australian pharmaceutical developer, which was founded in 2012 by Dr Peter Molloy and Dr Stephen Goodall with the mission to develop a nasal spray that killed all the germs (viruses or bacteria) responsible for respiratory infections, such as the common cold. After nearly 10 years of development and testing, our first product is now in the final stages of development and is called Nasodine® Nasal Spray*.
Nasodine Nasal Spray contains the broad-spectrum antimicrobial agent, povidone-iodine. In clinical studies, Nasodine has been shown to be well-tolerated as a four-times-daily nasal spray. Patents have been filed worldwide on its use as a treatment and preventative for the common cold.
If approved, Nasodine will be a first-in-class nasal spray medicine that targets the cause of colds, where they start in the nose.
*Nasodine Nasal Spray is not yet approved for sale in Australia.
The Firebrick breakthrough
In treating respiratory viral illnesses, such as the common cold, the challenge has always been that the infection of the nasal passages can be caused by any one of 200 or more viruses from at least six major groups. While 'rhinovirus' is responsible for most common cold infections, other groups of viruses can cause colds, including some coronaviruses*, influenza virus, parainfluenza virus, RSV and metapneumovirus. In a small percentage of cases, bacteria also can be responsible, including species of Haemophilus, Streptococcus and Moraxella.
The problem is that we rarely know the infectious culprit and some microorganisms can mutate to evade targeted approaches such as vaccines. At Firebrick, we took an innovative approach, using a well-established broad-spectrum antimicrobial agent, called "povidone-iodine" that has been shown to rapidly inactivate (kill) the germs that can cause colds, and yet has been shown to be safe for nasal use (when used as directed). What’s more, because of its non-selective mode of action, it is virtually impossible for germs to develop resistance to it.
The new povidone-iodine nasal spray, called Nasodine® Nasal Spray, is designed to kill the germs (whether viruses or bacteria) that cause colds, in the nasal passages where the infection starts.
* These are seasonal coronavirus strains that cause cold symptoms, not to be confused with pandemic strains, such as SARS-CoV-2, which causes COVID-19. There is no published evidence that Nasodine® Nasal Spray can reduce the transmission risk or severity of COVID-19.
Firebrick Pharma incorporated by Peter Molloy and Stephen Goodall with the mission to create a broad-spectrum antimicrobial nasal spray to treat the common cold.
Product development commences.
Australian patent filed.
Australian patent granted and international patent filings commence. Formulation development commences in Melbourne laboratories.
Series A funding closes; product development accelerates.
Product formulation, packaging and manufacturing development completed; viral inactivation studies confirm activity.
Safety testing models indicate product is safe for nasal use; new patents filed; Series B funding closes. Phase 1 and Phase 2 trials completed.
Series C funding, Phase 3 trial completed, new patent filed.
Series D (pre-IPO) funding closes; Australian registration dossier filed for Nasodine; new patents granted.
COVID-19 pilot human study completed; IPO prospectus lodged with ASIC.
Firebrick Pharma listed on the Australian Securities Exchange (ASX) under the ASX code “FRE”.
Phase 2 trial of Nasodine in COVID-19 commences in South Africa.
Phase 3 confirmatory trial for the common cold commences.
To deliver evidence based, effective products to market.
Firebrick is an exciting and fun company to work for. We have a can-do spirit and are future focused. We believe that success comes to those who are enjoying what they are doing.
We uphold the highest standards of integrity. We are honest, ethical and transparent.
The health and safety of our consumers is always at the fore and we are committed to delivering high quality products. We strive to uphold strong ESG principles (Environmental, Social & Governance) in our operations and decision making.
We are courageous, reward creative thinking and applaud experimentation. We strive to generate new solutions to unmet needs.
Our culture is based on openness, tolerance and collaboration. We are flexible, respectful and recognise that we achieve more when we work together.
Firebrick board and management
Founder & Executive Chairman, BSc, MBA, PhD
Peter Molloy is a qualified microbiologist and biochemist who built a successful career in the pharmaceutical industry, initially at Faulding (Aust) and then at Pharmacia (Pfizer), where he was Managing Director of Australia/NZ operations and later International Vice President for Strategic Marketing. During his career, he launched 23 new pharmaceutical products and executed 40 international licensing or distribution deals. Subsequently, he was CEO of four biotech companies in US and Australia, including two ASX-listed firms. As CEO of antiviral drug development company, Biota Holdings Limited (2002-2005), the company’s market value grew from $30m to around $300m. Subsequently, as founding CEO of Race Oncology (2016-2020), the company's market value grew from $12m to more than $400m during 2021. He obtained his BSc from University of Melbourne, his MBA from University of Adelaide, and he holds a PhD in biotechnology business. He is also a Fellow of the Australian Institute of Company Directors.
Founder, Director & COO, BAppSc, MAppSc, MBA, PhD
Stephen Goodall has a successful track record in intellectual property, pharmaceutical development, manufacturing, regulatory strategy and clinical development. He was instrumental in developing the intellectual property that underpins the Firebrick patent. Previously, he was Chief Operating Officer of Viralytics, which was later acquired in 2018 for $500 million by the US big pharma company, Merck. Prior to Viralytics, he was the Director of Pharmaceutical Development at Vapotronics, where he managed all aspects of inhaled drug development and formulation and before that, Director of Development at AGEN Biomedical for 11 years. He is a founder of Firebrick and co-inventor on Firebrick patents. He has extensive experience in the preclinical, IND, regulatory and human clinical phases of drug development. He also has an impressive background in process development, production scale-up and GMP manufacturing for pharmaceuticals.
Professor Phyllis Gardner MD
Non Executive Director
Professor Phyllis Gardner is based in California and is a tenured Professor of Medicine at Stanford University; she is also on the Board of Fellows of Harvard Medical School. She obtained her Doctor of Medicine degree from Harvard Medical School, trained in internal medicine at Massachusetts General Hospital and completed research fellowships in Pharmacology at Columbia University and University College, London. After moving to Stanford in 1984, Phyllis was an active scientific researcher, with her expertise bridging medicine, pharmacology and drug delivery systems. After ten years in academia, she became interested in entrepreneurship, founding several biopharma ventures. From 1994 to 1998, she served as Principal Scientist and Head of Research at ALZA Corporation; and from 1999 to 2015, she was a partner at Essex Woodlands Health Ventures, a leading US venture capital firm focused on life sciences. She has been a director on numerous boards of US public biotech firms, including Aronex, Aerogen, Pharmacyclics, BioMarin, Corium, Revance and Cohbar.
Non Executive Director
Between 1990 and 1997, Dr Treagus graduated with an MB ChB (Medicine and Surgery, First class with Honours), MPharmMed (Master of Medicine) and an MBA (Master of Business Administration) from universities in South Africa. After a period as Medical Director for Wyeth-Ayerst (now Pfizer), in 1998 he became Commercial Director of Aspen Pharmacare in South Africa, where he was responsible for all sales, marketing and business development for pharmacy and consumer products. Between 2002 and 2006, he was General Manager of Sigma Pharmaceuticals in Melbourne, responsible for all sales, marketing and business development, then from 2006 to 2012 was Managing Director and CEO of Acrux (ACR), the market value of which increased 10-fold during his tenure. Between 2013 and 2020, he was Executive Chairman of Neuren Pharmaceuticals (NEU), and its market value increased 6-fold during his tenure. Dr Treagus is also Executive Chairman and Founder of BTC Health (BTC).
Professor Peter Friedland
Chief Medical Officer, MBBCh MMed FRACS FCS (SA)
Professor Peter Friedland is the Company’s Chief Medical Officer. Prof Friedland is an ENT (ear, nose and throat) specialist, professor at the University of Western Australia and professor at the University of Notre Dame, Fremantle. He holds several appointments, including Chair in Otolaryngology Head and Neck Surgery at the University of Western Australia, and memberships of the board of the Australian Society of Otorhinolaryngology Head & Neck Surgery at Royal Australian College of Surgeons (RACS), the Panel of Clinical Experts for the Australian Government Department of Health, and the MBS (Medical Benefit Schemes) National ENT Taskforce. Prof Friedland is a surgeon-scientist at Sir Charles Gairdner Hospital and Joondalup Health Campus. He is currently engaged in multidisciplinary clinical research in head and neck cancer, hearing loss rehabilitation and nasal disease. In the last decade, he has published more than 70 peer reviewed scientific articles and delivered more than 150 conference presentations and invited lectures. Prior to immigrating to Australia in 2009, he was clinical head of the ENT department at the University of Witwatersrand, Donald Gordon Medical Centre, Johannesburg, South Africa. Prof Friedland was appointed Mr. Nelson Mandela’s ENT specialist from 2000 to 2009.
Chief Scientific Officer, BSc (Hons), PhD
Dr Simon Tucker is a virologist with decades of pharmaceutical R&D management experience. He previously led teams at GD Searle (US) focused on new antivirals including influenza and HIV, where he was a member of the team responsible for the discovery of the HIV protease inhibitor, amprenavir. He subsequently led the Gene Therapy Group at the University of Glasgow (UK), before joining Biota Pharmaceuticals, the world-leading antiviral drug developer at the time. As Vice President of Research at Biota he oversaw the research and IP portfolios, managed the R&D strategy and execution, and was directly involved in multiple licensing deals, collaborative projects with major pharmaceutical companies and the discovery and progression of clinical candidates. He led the teams that discovered zanamivir (Relenza), the world’s first neuraminidase inhibitor for treatment of influenza, as well as the world’s first point of care diagnostic test for influenza A and B. He also presided over the discovery and development of candidate drugs for the common cold (vapendavir), RSV and hepatitis C . He is a founder & former CEO at 360biolabs and is currently Chairman of Jumpstart-Fertility, an international biotech focused on drugs to address female infertility.
Head of Regulatory Affairs, BSc (Hons), MBioethics, PhD
Dr Monique Baldwin is a highly experienced regulatory affairs professional with a track record of success across multiple therapeutic areas, covering small to large multinational pharmaceutical companies (Novartis, GSK, CLINUVEL, CSL). Monique has a PhD in Life Sciences from the University of Newcastle and a master’s degree in Bioethics from Monash University. Responsible for the development and implementation of local and global regulatory strategies, Monique has worked closely with drug substance and drug product manufacturers, supported clinical programs across several international regulatory jurisdictions. Monique is passionate about ethics, which has led to her participation in research ethics (public and private healthcare institutions), and ongoing educational interests in bioethics at an academic level.