NLS Pharmaceutics in Licensing Deal for Sanorex With Novartis
13 March 2021 - 12:44AM
Dow Jones News
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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