Glenmark Pharmaceuticals and SaNOtize Research & Development have announced an exclusive long-term strategic partnership to manufacture, market and distribute its 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, a statement from Glenmark said.
It also said that in March 2021, SaNOtize’s clinical trials showed NONS was a safe and effective anti-viral 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 per cent and then by more than 99 per cent within 72 hours. It has been tested in healthy volunteers and patients as part of the 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 nanomolecule with proven anti-microbial properties, and which has a direct effect on SARS-CoV-2, mentioned the statement.
It notified that in early July 2021, Glenmark presented a proposal to the Subject Expert Committee of the Central Drugs Standard Control Organization (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 the fourth quarter of the calendar year 2021.
Glenn Saldanha, Chairman and MD, Glenmark Pharmaceuticals, said, “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 focussed approach against COVID-19 and will help reduce the burden of the pandemic in the region.”
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 the much-needed relief to patients across the region and the wider world.”
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. It has already received a CE mark in Europe, which is an equivalent of marketing authorisation 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. It is also approved and being sold in Israel and Bahrain, under the name enovidTM, said the statement.
Dr Gilly Regev, CEO and co-founder, SaNOtize, said, “COVID-19 and its various variants are proving to be a challenge to contain, despite the rapid and critical development of vaccines. 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 anti-viral nasal spray available as a self-administered, first line of defence against COVID-19 during the current pandemic and to help prevent future outbreaks.”