NLS Pharmaceutics in Licensing Deal for Sanorex With Novartis

By Chris Wack

NLS Pharmaceutics Ltd. said it has entered into a license agreement with Novartis Pharma AG to obtain, on an exclusive basis in the U.S., all of the available data referred to and included in the original NDA for Sanorex mazindol submitted to the Food and Drug Administration in February 1972.

The clinical-stage pharmaceutical company said the agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, formulation data and know-how for all products containing mazindol as an active substance, and all post-marketing clinical studies and periodic safety reports from 1973 forward.

NLS has obtained the same rights on an non-exclusive basis in all territories outside of the U.S, except for Japan, with the right to cross-reference the Sanorex NDA with non-U.S. regulatory agencies in the licensed territories. The agreement includes the right to sublicense or assign the license to third parties, subject to such third parties meeting certain obligations.

NLS Pharmaceutics shares were up 81% to $5.14 in premarket trading.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

March 12, 2021 08:29 ET (13:29 GMT)

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