Glenmark companions with Canadian biotech agency SaNOtize to convey nasal spray for Covid to Asia

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A nasal spray to combat SARS-CoV-2 in the upper respiratory tract, this is the new product that the drug manufacturer Glenmark Pharmaceuticals through its latest alliance with the Canadian biotech company SaNOtize Research & Development Corp.

The exclusive, long-term alliance enables Glenmark to manufacture, market and market SaNOtize’s Nitric Oxide Nasal Spray (NONS) for Covid-19 in India and other Asian markets such as Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos expel. Myanmar, Sri Lanka, Timor-Leste and Vietnam.

Glenmark has applied for regulatory approval for the product and will conduct advanced clinical trials in India. It is expected to hit the market in the last three months of 2021, expanding its existing basket of Covid-19 products, including the antiviral favipiravir.

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In March 2021, SaNOtize’s clinical trials showed that NONS was a safe and effective antiviral treatment to prevent the transmission of Covid-19, shorten the course, and reduce the severity of symptoms. In the first 24 hours, NONS reduced the average viral load by about 95 percent and then within 72 hours by more than 99 percent, according to a statement from Glenmark.

It has been tested on healthy volunteers and patients in clinical trials in the UK and Canada.

“It comes in the form of a simple nasal spray and is designed to kill the virus in the upper respiratory tract and prevent it from incubating and spreading to the lungs. It is based on nitric oxide (NO), a natural nanomolecule with proven antimicrobial properties that has a direct effect on SARS-CoV-2, the virus that causes Covid-19, ”the company said in a statement.

SaNOtize’s “revolutionary” Covid-19 nasal spray is backed by Phase II study data, it added.

Local trials

At the beginning of July 2021, Glenmark submitted a proposal to the CDSCO’s technical committee for an emergency permit for the import and marketing of the nasal spray. The committee has recommended that a phase III clinical trial be conducted in Indian patients in the coming weeks.

The Phase III clinical trial for NONS is expected to be completed in the fourth quarter of calendar year 2021, followed by the commercial launch under the brand name FabiSpray® in India.

Glenn Saldanha, chairman and managing director of Glenmark Pharmaceuticals, said this was another valuable in-licensing opportunity in the important therapeutic area of ​​respiratory medicine, as well as the opportunity to ship the product to SaNOtize and its partners outside of our territory worldwide.

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“Glenmark will ensure timely and widespread access to this potent nasal spray that we hope will bring much-needed relief to patients across the region and around the world,” he said.

“Covid-19 and its various variants are proving to be a challenge that needs to be contained, despite the rapid – and critical – development of vaccines,” said Dr. Gilly Regev, CEO and Co-Founder of SaNOtize. “SaNOtize is excited to work with Glenmark to provide wider, easier and more affordable access to its treatment. By working with Glenmark, SaNOtize can accelerate efforts to provide its nasal antiviral spray as a self-administered first line of defense against Covid-19 during the current pandemic and prevent future outbreaks. “

NONS is one of the few novel therapeutic treatments aside from expensive monoclonal antibodies that have been shown to reduce the SARS-CoV-2 viral load in humans. NONS has already received a CE mark in Europe, which equates to market approval.

NONS is also approved and sold in Israel and Bahrain under the name enovidTM. In 2017 SaNOtize developed and patented a Nitric Oxide Releasing Solution Platform technology (NORSTM) for the treatment and prevention of microbial infections.