INDIA – Glenmark Pharmaceuticals has signed an agreement with Canadia’s biotech firm SaNOtize Research and Development Group to commercialize its Nitric Oxide Nasal spray (NONS) for Covid-19 treatment in India and other Asian markets.
Glenmark will collaborate with SaNOtize to manufacture, market and distribute this breakthrough Nitric Oxide Nasal Spray through their exclusive long-term partnership.
It expects to launch the nasal spray this year under the brand name ‘FabiSpray’ in India. ”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,” Glenmark said in a filing.
SaNOtize developed and patented a Nitric Oxide releasing solution platform technology to treat and prevent microbial infections in 2017.
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 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, the company added.
“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,” a statement issued by Glenmark said.
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.
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.
Glenmark’s partnership with SaNOtize will bring much-needed therapeutic relief to patients in India and Asia.
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