SpectrumX have significant plans to improve the quality of treatment for patients in many therapeutic areas in the coming years. The first product to reach the market is the Spectricept™ hand sanitiser (NHS approved) to be rapidly followed by the nebuliser product SPC-069.
A number of significant milestones are expected in 2021 including the qualification of the SPC-069 product as a medical device by a Notified Body in the EU. This will in turn support the Medical University Hospital Innsbruck who are leading a multi-site Phase II clinical trial for the nebulised treatment of COVID-19 patients using SPC-069. The focus of the trial is to establish that the use of the product can dramatically reduce hospitalisation stays for patients suffering from COVID-19.
To execute these licenses SpectrumX has secured a 16,000 sq ft industrial unit in Cheshire in the North West of England to serve as the production site for UK and EU distribution. There is also commitment from the Management Board to a robust and beneficial ESG (Environmental, Social and Governance) programme. As part of this programme, the company aims to be a carbon
positive biotechnology company.
Upon receipt of successful data from the trial SpectrumX will be submitting an emergency use authorisation application to both the European Medicines Agency (EMA) and the Medicines & Healthcare products Regulatory Agency (MHRA). SpectrumX are confident that results from the trial will be positive, and that the product can be brought expeditiously to the market.
The company are also enthusiastic to be working with the UK Antivirals Taskforce to provide positive output and messaging for SPC-069 to enable its uptake in the UK as a home based treatment.
SpectrumX will also be working with the health supportive Government Agencies including the Department of Health and Social Care and NHS England to demonstrate the benefits of SPC-069 for patients and to ensure funding is available for its use.
The Hospital Key Account Management team will be using the clinical evidence produced from the clinical trial to provide Health Care Professionals in the UK with empirical reasons to use SPC-069 in patients with respiratory challenges (including COVID-19). The plan is to work with Key Opinion Leaders (KOLs) in UK teaching hospital hospitals to demonstrate efficacy and utilise these KOLs to provide positive opinion for the roll out of SPC-069 in other hospital sectors. The contracting agencies in each of the home nations will also be communicated with to ensure their understanding of the product and to ensure that the product is listed for use in any required catalogue.
The distribution model is currently being defined and it is anticipated that the existing wholesaler distribution network will be utilised for movement and receipt of the product in the correct locations to ensure patient care is achieved. Commercial price points are being modelled to ensure maximum uptake and value gain for the NHS and similarly for SpectrumX.