Starpharma’s COVID-19 nasal spray to be ready for market next quarter

Starpharma Holdings Limited (ASX:SPL) (OTCMKTS:SPHRF) has made strong commercial and regulatory progress with its VIRALEZE™ COVID-19 nasal spray which is on-track to be registered and ready for market next quarter. The EU regulatory dossier is more than 90% complete and the company is ahead of schedule with its plans. VIRALEZE™ will be marketed as an antiviral nasal spray for SARS-CoV-2 (the coronavirus that causes COVID-19) as well as other important respiratory viruses, such as influenza and RSV. First manufacturing in January The company plans to initiate the manufacturing of first batches of VIRALEZE™ in January 2021 and is building an inventory of components and raw material to support the rapid roll-out. Launch and marketing preparations are in the advanced stages, including discussions with pharmacy chains, B2B customers, qualitative and quantitative consumer market research, while partnering discussions are continuing in parallel. The company expects VIRALEZE™ to form the part of a range of preventative measures, such as masks and other PPE, to further reduce risk of infection and is complementary to COVID-19 vaccines. “Highly appealing to consumers” Starpharma CEO Jackie Fairley said: “We know from the positive market research that VIRALEZE™ has the ability to restore confidence and encourage people to resume everyday professional and recreational activities. “Our market research also shows that the compelling features and convenience of VIRALEZE™ are highly appealing to consumers”. “The distribution challenges of COVID-19 vaccines are well documented including the timing of wide-spread availability and adoption. Complement other strategies Fairley said: “Even after a vaccine becomes widely available, social distancing, PPE and other measures will continue to be important and VIRALEZE™ complements other prevention strategies, including vaccines. “In November, the World Health Organisation stated that someone died every 17 seconds from COVID-19 in Europe. “It is with the greatest urgency that Starpharma is working to make this product ready for market as quickly as possible in the first quarter CY2021.” Pre-launch commercialisation Starpharma’s pre-launch commercialisation activities for VIRALEZE™ are well advanced with input from Boston Consulting Group (BCG), focusing initially on direct to consumer and B2B channels to facilitate the entry to market and is also continuing partnering discussions in parallel. Europe will be the first geographic region for the VIRALEZE™ launch. Starpharma plans to leverage the European registration to roll-out VIRALEZE™ into other markets including Australia as quickly as possible. Clinical trial The company is conducting a clinical study in healthy volunteers to be completed next quarter to support commercialisation activities for VIRALEZE™, noting that this study is not a requirement for registration. Further validation of the product in the form of the antiviral mechanism of action studies for SPL7013 has been completed at the prestigious Scripps Research Institute, which confirms that SPL7013 achieves potent inhibition of SARS-CoV-2 ‘spike protein’ binding (>90%) to the cell target. Blocking and targeting of spike proteins is the approach taken in the development of many COVID-19 vaccines, including by Moderna and Pfizer The broad-spectrum antiviral activity of VIRALEZE™ is a compelling differentiating feature and Starpharma is continuing to build additional efficacy data in other respiratory viruses to further broaden the product claims for VIRALEZE™. The company is leveraging the extensive data already available for the active (SPL7013) in VIRALEZE™.