Snoretox Awarded “Barrier to Innovation” Waiver by the FDA CVM (USA Federal Drug Agency).

Innovative Australian Drug receives Break-through Therapy “Barrier to Innovation” Waiver by the FDA CVM  (USA Federal Drug Agency).

The FDA CVM is the FDA’s veterinarian department.

The assessment criteria are

  • Innovation: a drug must be highly innovative, novel, a medical break-through.
  • Efficacy: Is there sufficient information for proof of concept in a validated in vitro system or in the target animal or an animal model of the target animal (e.g., laboratory rodent species)?
  • Small-Medium Company: Is the company below $20 million in market size.

 

We were able to satisfy the criteria and examiners with a detailed application outlining the scientific evidence, they do not give these out lightly.

This success adds serious credibility to our dealings with the government, regulators and the market.

I would like to thank our USA FDA CVM Consultants Schafer and Associates for all their assistance and guidance to date.

a/Prof Anthony Sasse,

What others are saying

Board Appointments Announced

Australian headquartered and globally focussed emerging biotech, Snoretox Pty Ltd is pleased to announce the establishment of its inaugural Board of Directors. Snoretox is developing tetanus toxin antibodies intended to address improvement in conditions affected by lax muscle tone and neuromuscular control.

Dr Tony Sasse, Founder of Snoretox said that the discovery program, undertaken by the Company in partnership with RMIT University, was ready to pivot to development and upscaling with a view to entering the clinic. Status of the intellectual property portfolio and early stage investment discussions are very positive. Snoretox will seek to undertake as much as possible of the critical path with Australian researchers, clinicians and development partners to advantage the Australian community.

I am very pleased with the foundation of the Board and am confident that the inaugural Board of Directors, partners and colleagues offer complementary skills that will facilitate the further development and commercialisation of the Company’s assets Dr Sasse said.

The inaugural Board members are:

Dr Tony Sasse

Tony Sasse is the Founder of Snoretox Pty Ltd and is a consulting Pulmonologist in rural Australia who saw first the power of the tetanus toxin molecule whilst working in a remote hospital in India, where he treated many cases of Tetanus. He is also an Adjunct Associate Professor at RMIT University

Professor Peter Smooker

Peter Smooker is a very experienced biotechnologist, and for the past 20 years has headed a Biotechnology laboratory at RMIT University. His main area of study is the structure and function of useful proteins, and as such directed the development of the exciting muscle-toning drugs in a long-standing collaboration with Snoretox.

Mr John Mitchell

John Mitchell has a diverse business/governance background in local government and community governance. He has extensive experience in dealing with large industries, small/medium enterprises, community groups, environmental and education organisations and regulatory authorities.

Dr Dennis Feeney

Dennis Feeney is the Founder of Venture Technology Group and is experienced in drug development and commercialisation in the settings of global pharma and biotech.

 

Further details about the Company and Board may be found here https://snoretox.com/

Dr Natasha Monin – About

Dr Natasha Monin is an accomplished Medical Executive with over 26 years experience in Biopharma and healthcare industries across AUS/NZ and Asia Pacific Region (Japan, China, S Korea, India, Taiwan/HK) with the last 10 years as Regional APAC Medical Director. A physician, Dr Monin is currently employed with UCB BioPharma as a Global Medical Learning Partner in Neurology. She serves on Snoretox board in a private capacity.

With specific interest in clinical development, product life-cycle strategies, business development, medical affairs and physicians medical learning, Natasha combines extensive international experience in strategic and operational leadership roles across Australia and Asia Pacific region.

Dr Monin has built a strong scientific expertise in a rich portfolio across a range of biologic and chemical entities in neurology, immunology (RA, SpA, Lupus), oncology, cardiovascular, women health, and anaesthesia. She acts as a Scientific Advisory Committee Member and clinical grants reviewer at the Cure Brain Cancer Foundation (AUS)

 

Professor Peter Smooker – About

Professor Peter Smooker is a very experienced Biotechnologist, having undertaken a PhD at Monash University, a Post-Doctoral position in Berlin and for the past 20 years has headed a Biotechnology laboratory at RMIT.

His main area of study is the structure and function of useful proteins, and as such directed the development of the exciting muscle-toning drugs in a long-standing collaboration with Snoretox.

Dr Thomas McLean – About

Dr Thomas McLean is an early career researcher with a background in immunology and microbiology.

He has devoted his research career so far to studying protein toxins with the aim of re-purposing naturally occurring molecules as useful therapeutics.

Thomas obtained a Bachelor of Science degree at Melbourne University and holds a Master’s degree in Biotechnology and a PhD in Applied Biotechnology from RMIT University. He has been a member of the Snoretox research team based at RMIT University for seven years.

Dr Dennis Feeney – About

Dr Dennis Feeney’s post-doctoral career has seen him serving in executive board-level leadership roles within affiliates of global Pharma companies and publicly listed Biotech companies, leading the development of therapeutics, devices and diagnostics in global pharmaceutical and biotech environments, and strategic advisory functions across corporate governance, asset development, commercialisation and personnel.

Building on an extensive career in Biotech and Life Sciences, Dr Feeney established a life science consultancy in 2003 which evolved to become Venture Technology Group (VTG) delivering end to end professional services, expert advice, engagement and support to achieve successful development and commercialisation of drug, device and diagnostic assets globally.

Dr Feeney holds a research Master’s degree in Science from the University of Western Australia; a Certificate in Health Economics from Monash University, and a PhD in Medicine from University of Sydney where he continues to serve as a Mentor in the Genesis commercialisation program in the Business School.

Adjunct Professor Anthony Sasse – About

a/Prof Anthony Sasse is a consulting Pulmonologist in rural Australia who saw first the power of the tetanus toxin molecule whilst working in a remote hospital in India, where he treated many cases of Tetanus.

He has held the position of Director of Intensive Care and Director of Sleep study Diagnostic units in Australia, served a tour of duty with the Australian Army and attends the Presbyterian Church. He has published many articles in the field of sleep medicine, including the identification of venlafaxine as a useful drug in cataplexy. He holds an adjunct Professorship at RMIT University, Melbourne, Australia, and is responsible for the inception of this project; the development of novel tetanus toxin molecules for human and veterinarian use in low tone muscle disorders such as snoring, sleep apnoea, cosmetic muscle toning, ectropion and ptosis, sphincter and pelvic floor muscle toning, and general limb muscle toning.