Melbourne - Starpharma (ASX: SPL, OTCQX: SPHRY) announced today it had received confirmation that the VIRALEZE antiviral nasal spray has been successfully registered for sale in Europe, including in the UK.
This registration allows for the marketing of VIRALEZE across the European Economic Area (EEA), which includes the 27 countries of the EU, the UK, plus the European Free Trade Association (EFTA) countries, with a combined population of approximately 520 million.
VIRALEZE is an easy to use antiviral nasal spray. It contains SPL7013 (astodrimer sodium), which has been shown in laboratory studies to inactivate a broad spectrum of respiratory viruses, including >99.9% of coronavirus SARS-CoV-2 (the virus that causes COVID-19).
SPL7013 has been shown to be virucidal, rapidly inactivating >99.9% of SARS-CoV-2 within 60 seconds.
SPL7013 has also been shown to have activity against other important respiratory viruses including influenza viruses, respiratory syncytial virus (RSV), and other cold-causing coronaviruses in laboratory studies. VIRALEZE can be stored at room temperature and does not require cold storage or specialised transportation.
The European launch of VIRALEZE is on track and the product is expected to be available for sale online, direct to European and UK consumers next month. Preparations for launch are well advanced with the manufacture of launch batches underway. A roll-out of VIRALEZE to European pharmacies is planned, and in parallel, Starpharma is undertaking discussions with B2B customers (e.g. aged care, health care, travel providers, etc.), as well as with potential commercial partners seeking sales and marketing rights.
The European registration of VIRALEZE and the regulatory dossier will be used as the basis for obtaining further marketing approvals for the product as soon as practicable in other countries, including in Australia.
Dr Jackie Fairley, CEO of Starpharma commented: 'Starpharma is pleased to have successfully developed a product that has the potential to assist with the fight against the global COVID-19 pandemic. We are delighted to have completed registration of VIRALEZE in the UK and Europe ahead of our original schedule and acknowledge the support of local and international specialist laboratories who have assisted Starpharma with the development of VIRALEZE. We have already undertaken substantial launch preparations, including manufacturing in Europe, to ensure VIRALEZE is available to consumers and businesses as early as possible. Starpharma is focussed on making the product as widely available as possible, with further registrations and roll-out planned.'
'We know from consumer research conducted with the Boston Consulting Group, that VIRALEZE has strong appeal for European consumers across all age groups. The spray is easy to use and convenient - and works rapidly, without being absorbed into the bloodstream. If you are about to walk into the supermarket, you would use it. The same is true for public transport, elevators, planes, bars and restaurants,' added Dr Fairley.
VIRALEZE topical antiviral nasal spray is complementary to other prevention measures such as PPE and vaccines and has special relevance where social distancing is not possible such as crowded environments and certain workplaces.
Starpharma acknowledges the $1 million in funding for the development of VIRALEZE provided by the Australian Government's Medical Research Future Fund (MRFF) Biomedical Translation Bridge (BTB) Program, with support from UniQuest. Delivered by MTPConnect, the Australian Government's BTB program is a $22.3 million MRFF initiative that provides up to $1 million in matched funding to nurture the translation of new therapies, technologies and medical devices through to proof of concept to turn innovative medical ideas into reality.
About VIRALEZE - easy to use antiviral nasal spray
VIRALEZE is an easy to use antiviral nasal spray, which can be stored at room temperature and does not require refrigeration.
VIRALEZE is an easy to use antiviral nasal spray. It contains SPL7013 (astodrimer sodium), which has been shown in laboratory studies to inactivate a broad spectrum of respiratory viruses, including >99.9% of coronavirus SARS-CoV-2 (the virus that causes COVID-19).
SPL7013 has been shown to be virucidal, inactivating >99.9% of SARS-CoV-2 within one minute. SPL7013 has also been shown in laboratory studies to have activity against other important respiratory viruses including influenza viruses, respiratory syncytial virus (RSV), and other human coronaviruses. Based on the effectiveness of VIRALEZE against multiple viruses, including drug-resistant strains, the product is expected to retain activity against the SARS-CoV-2 strains being reported in the UK, South Africa and elsewhere. VIRALEZE can be stored at room temperature. The product does not require cold storage or specialised transportation.
The nasal cavity is the primary site where SARS-CoV-2 (COVID-19) becomes established, before spreading to the lungs^. 'Spike' proteins on the surface of these viruses that come into contact with VIRALEZE are trapped by SPL7013. This interaction is 'virucidal' - the virus is irreversibly blocked and can no longer infect mucosal cells, thereby providing a physical barrier to respiratory viruses in the nasal cavity. These 'blocked' viruses are then eliminated naturally through the nasal mucus. ^Hou et al., 2020, Cell 182, 429-446
SPL7013 is included in products licensed in >160 countries, approved in >40 countries and available for sale in the UK, Europe, South East Asia, Australia and New Zealand.
About Starpharma
Starpharma Holdings Limited (ASX:SPL, OTCQX:SPHRY) is a global biopharmaceutical company and a world leader in the development of new pharmaceutical and medical products based on proprietary polymers called dendrimers, with programs for COVID-19, DEP drug delivery and VivaGel. Starpharma has developed VIRALEZE, an antiviral nasal spray for COVID-19, which is complementary to vaccines and other preventative measures such as distancing and PPE. VIRALEZE is registered in the UK/Europe, with launch of product expected in Q1 CY2021. SPL7013 is utilised in approved products - the VivaGel condom and VivaGel BV. VivaGel BV has been licensed in >160 countries, is approved in >40 countries and available in for sale in the UK, Europe, South East Asia, Australia and New Zealand.
As a leading company in dendrimer based drug delivery, Starpharma's proprietary drug delivery platform technology, DEP, which is being used to improve pharmaceuticals, to reduce toxicities and enhance their performance. There are numerous internal and partnered programs underway to develop DEP versions of existing drugs, particularly in the area of anti-cancer therapies. DEP partnerships include oncology programs with AstraZeneca, with Merck in the area of Antibody Drug Conjugates (ADCs), with Chase Sun in the area of antiinfectives and other world leading pharmaceutical companies Starpharma's partnered DEP programs have the potential to generate significant future milestones and royalties.
Contact:
Grant Titmus
Tel: +61 419 388 161
Email: grant@sumitmedia.com.au
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