Novartis-Molecular Partners COVID Drug Could Be Approved in Weeks

By Paul Arnold

January 11, 2022

ZURICH (Reuters) - Swiss drugmaker Novartis and partner Molecular Partners could have an experimental drug on the market within several weeks to treat COVID-19 patients, officials from the two companies said on Monday.

"The emergency marketing authorization application can be filed now," Molecular Chief Executive Patrick Amstutz told Reuters. "That starts now. It won't happen overnight. It will take a couple of weeks."

The antibody-like therapy developed by Molecular, called ensovibep, has met its main target in a phase II trial. In the Novartis-supervised trial, the drug - which is an engineered protein designed to bind to multiple sites on the viral receptor binding domain - led to a reduction in viral load with all viral variants, including Omicron.

Novartis will exercise an option to acquire the rights to the drug and assume responsibility for further development, manufacturing and distribution. In return, Molecular will receive a payment of 150 million Swiss francs ($162 million) plus a 22% share of sales.

A Novartis spokesperson said the group plans to apply to the U.S. Food and Drug Administration (FDA) for emergency approval of ensovibep before the end of January.

Under the Emergency Use Authorization protocol, approval is possible within weeks instead of months.

Amstutz saw an advantage in efficacy already in the low dosage of 75 milligrams. "That is much lower than other antibody drugs," he said. "Therefore you need less injection volume and you get more doses with the same manufacturing volume."

The drug, which is now administered as an infusion, can thus be used as a single injection, he added. He expected Novartis to work on an injectable formulation.

With the 150 million Swiss franc payment from Novartis, Molecular was financed into 2025 and will spend some of the funds on developing cancer drugs, he said.

($1 = 0.9249 Swiss francs)

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