NeuClone’s vision is to increase affordability and access to life saving and life extending therapies.
Patients with cancers, autoimmune diseases or other conditions deserve access to the best of modern therapies, regardless of where they live. Creating affordable, high quality biosimilars in the right amount will form part of a global solution to improving access to medicine.
NeuClone’s team of industry experts are solely focused on developing quality, cost effective biosimilar therapeutics.
At present, we are developing a pipeline of over 20 biosimilars across a range of indications. Products will complete Phase I trials in Australia and registration in global markets.
Leveraging this diverse pipeline, NeuClone is positioning itself as a future global leader in the biopharmaceutical landscape. As a product company, we will lead development to global registration and endeavour to overcome issues of restricted biologic access.
We plan to realise this ambition in a four-step series, over the next ten years.
Our first step has been to use our proprietary technologies to generate biosimilars of over twenty monoclonal antibodies that provide broad clinical value for cancers, autoimmune diseases, and other disease areas. By virtue of a focused team of monoclonal antibody experts, state of the art robotics and analytics equipment, we have generated a broad portfolio of product opportunities that will enter the clinic continuously over the next eight years. Over 20 biosimilars are already in our pipeline, at varying stages from deep analysis of originator to successful completion of Phase I clinical trials.
Our second step involves working with strategic partners for manufacturing scale-up, biosimilarity assessments and comparative studies, cGMP clinical and commercial supply.
Step three entails clinical development of our portfolio of biosimilars, commencing with Phase I studies in Australia to de-risk our biosimilars. In addition to the high quality research environment, with world leading infrastructure and excellent Phase I facilities, there are several advantages to conducting clinical trials in Australia, including:
Speed of regulatory approvalA CTN scheme with the TGA provides more rapid entry into trials |
No pre-IND or IND submission is requiredProtocol and Investigator Brochure are reviewed by local Phase I unit Ethics Committee |
Recognition of data quality by overseas regulatory bodiesSuch as the FDA and EMA |
43.5% R&D tax incentiveThis provides cash refunds for eligible activities, including Phase I and III trials |
Our fourth step is to fund and execute Phase III clinical development on a molecule-specific basis that meets the highest regulatory standards.
This four-step strategy is based on leveraging the opportunity of a large biosimilar portfolio, to achieve our ultimate vision of increasing affordability and patient access to life saving and life extending therapies.
Our first step has been to use our proprietary technologies to generate biosimilars of twenty monoclonal antibodies that provide broad clinical value for cancers, autoimmune diseases, and other disease areas. By virtue of a focused team of monoclonal antibody experts, state of the art robotics and analytics equipment, we have generated a broad portfolio of product opportunities that will enter the clinic continuously over the next eight years. Twenty biosimilars are already in our pipeline, at stages from deep analysis of originator, to entry into Phase I in 2018.
Our second step involves partnership with Serum Institute of India, to provide access to the world’s largest biologics manufacturer by number of annual doses. Serum Institute is growing manufacturing capacity – including a new multi-building biotechnology site to meet FDA and EMA specifications – with a corporate mission to provide the most affordable biosimilars at large scale, to fulfil global patient demand.
For our Serum Institute partnered products, NeuClone holds marketing rights in developed markets, including Australia, Europe, the U.S. and more, whilst Serum Institute distributes to rest-of-world (RoW) markets. NeuClone retains global commercialisation rights for its independently developed pipeline.
Step three entails clinical development of our portfolio of biosimilars, commencing with Phase I studies in Australia to de-risk our biosimilars. In addition to the high quality research environment, with world leading infrastructure and excellent Phase I facilities, there are several advantages to conducting clinical trials in Australia, including:
Speed of regulatory approval
A CTN scheme with the TGA provides more rapid entry into trials
No pre-IND or IND submission is required
Protocol and Investigator Brochure are reviewed by local Phase I unit Ethics Committee
Recognition of data quality by overseas regulatory bodies
Such as the FDA and EMA
A 41% R&D tax incentive
This provides cash refunds for eligible activities, including Phase I and III trials
Our fourth step is to fund and execute Phase III clinical development on a molecule-specific basis that meets the highest regulatory standards.
This four-step strategy is based on leveraging the opportunity of a large biosimilar portfolio, to achieve our ultimate vision of increasing affordability and patient access to life saving and life extending therapies.
