Glenmark inks agreement with Canadian biotech SaNOtize to commercialize Nitric Oxide Nasal Spray for COVID-19 treatment in India and other Asian markets

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Glenmark Pharmaceuticals Ltd

02 Aug, 2021, 12:56 IST

  • Nitric oxide (NO) has antimicrobial properties with direct proven effect on SARS-CoV-2
  • Nitric Oxide Nasal Spray (NONS) has been tested in healthy volunteers and patients as part of UK and Canada clinical trials1 
  • Study suggests that the NONS is highly effective in reducing viral load in COVID -19 patients and reduces onward transmission
  • Glenmark's exclusive long term partnership with SaNOtize to manufacture, market and sell NONS extends to India, Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam
  • Phase III clinical trial for NONS is expected to be completed, followed by commercial launch under the brand name FabiSpray® in India, by fourth quarter of the calendar year 2021.

MUMBAI, India and VANCOUVER, BC, Aug. 2, 2021 /PRNewswire/ -- Glenmark Pharmaceuticals, a research-led, global integrated pharmaceutical company and Canadian biotech firm SaNOtize Research & Development Corp. today announced an exclusive long term strategic partnership to manufacture, market and distribute its breakthrough Nitric Oxide Nasal Spray (NONS) for COVID-19 treatment in India and other Asian markets including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam.

In March 2021, SaNOtize's clinical trials showed NONS was a safe and effective antiviral treatment to prevent the transmission of COVID-19, shorten its course, and reduce the severity of symptoms. In the first 24 hours, NONS reduced the average viral load by around 95%, and then by more than 99% within 72 hours. It has been tested in healthy volunteers and patients as part of UK and Canada clinical trials.

Available in the form of a simple nasal spray, it is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs. It is based on nitric oxide (NO), a natural nano-molecule with proven anti-microbial properties, and which has a direct effect on SARS-CoV-2, the virus causing COVID-19.

In early July 2021, Glenmark presented a proposal to the Subject Expert Committee of CDSCO for emergency approval for import and marketing of the nasal spray. The committee has recommended a Phase III clinical trial to be conducted in Indian patients in the weeks to follow. The Phase III clinical trial for NONS is expected to be completed, followed by commercial launch under the brand name FabiSpray® in India, by fourth quarter of the calendar year 2021.

"Our efforts since the beginning of COVID-19 have been to provide patients with safe and effective treatment options to fight the disease. This partnership with SaNOtize closely aligns with Glenmark's focused approach against COVID-19 and will help reduce the burden of the pandemic in the region," said Glenn Saldanha, Chairman & MD, Glenmark Pharmaceuticals Ltd. He further added, "It also marks another valuable in-licensing opportunity for us in our key therapy area of respiratory medicine, as well as the possibility to globally supply the product to SaNOtize and its partners outside of our territory. Glenmark will ensure timely and widespread access to this effective nasal spray, which we hope will bring much needed relief to patients across the region and the wider world."

"COVID-19 and its various variants are proving to be a challenge to contain despite the rapid - and critical - development of vaccines," said Dr. Gilly Regev, CEO & Co-founder of SaNOtize. "SaNOtize is excited to collaborate with Glenmark in providing broader, easier and affordable access to its treatment. In joining forces with Glenmark, SaNOtize can accelerate the efforts to have its antiviral nasal spray available as a self-administered, first line of defence against COVID-19 during the current pandemic and to help prevent future outbreaks."

NONS is one of the few novel therapeutic treatments, outside of expensive monoclonal antibodies, that is proven to reduce SARS-CoV-2 viral load in humans.2 NONS has already received a CE mark in Europe, which is an equivalent of marketing authorization in case of a Medical Device (CE mark confirms that the medical device meets certain "essential requirements" of the European General Medical Devices Directive and is safe for the intended purpose). By virtue of the CE mark, SaNOtize has permission to launch NONS in the EU. NONS is also approved and being sold in Israel and Bahrain, under the name enovid™.

SaNOtize developed and patented a Nitric Oxide Releasing Solution platform technology (NORS™) to treat and prevent microbial infections in 2017. Glenmark's partnership with SaNOtize will bring in much needed therapeutic relief to patients in India and Asia.

About Glenmark Pharmaceuticals Ltd

Glenmark Pharmaceuticals Ltd. (GPL) is a global research-led pharmaceutical company with presence across Generics, Specialty and OTC business with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology and oncology. It ranks among the world's top 50 Generics and Biosimilars companies (Top 50 Company Rankings, 2020, from Informa's Generics Bulletin). The company has been listed in the Dow Jones Sustainability Index (DJSI), under the category of emerging markets for the third consecutive year in a row. DJSI is one of the world's most respected and widely accepted sustainability benchmarks globally with only the top ranked companies in terms of Corporate Sustainability within each industry are featured in the index. For more information, visit www.glenmarkpharma.com

About SaNOtize

SaNOtize Research & Development Corp. is a biotech company based in Vancouver, BC working to commercialize the multi-faceted antimicrobial properties of a liquid that produces nitric oxide. The company has developed and patented a Nitric Oxide Releasing Solution platform technology (NORS™) to treat and prevent microbial infections.

References:

1 SaNOtize's "revolutionary" Covid-19 nasal spray bolstered by Phase II trial data. Available at https://www.clinicaltrialsarena.com/news/sanotize-nasal-spray-reduces-covid-19-viral-load-uk-clinical-trail/

2 SaNOtize's "revolutionary" Covid-19 nasal spray bolstered by Phase II trial data. Available at https://www.clinicaltrialsarena.com/news/sanotize-nasal-spray-reduces-covid-19-viral-load-uk-clinical-trail/

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