By Paul Arnold
ZURICH (Reuters) – Swiss drugmaker Novartis and partner Molecular Partners could have experimental drug Ensovibep on the market within weeks to treat COVID-19 patients, officials from the two companies said on Monday.
“The emergency marketing authorisation 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 therapy developed by Molecular has met its main target in a phase II trial. In the Novartis-supervised trial, Ensovibep led to a reduction in viral load in 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 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 Authorisation protocol, approval is possible within weeks instead of months.
(Reporting by Paul Arnold, writing by Mike Shields, editing by Silke Koltrowitz)
