Company: NCEL
Filing Date: 2025-09-03
Form Type: F-4/A
Source: 0001213900-25-084157
Chunk: 375

Company: NewcelX Ltd.
Filing Date: 2025-09-03
Form: F-4/A
Chunk 375
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, patients must be at least 18 years of age and have been diagnosed with narcolepsy with cataplexy. As agreed with the FDA, NLS intends to submit the NDA for Quilience as a new NDA. Nevertheless, a large amount of the original NDA data will be used for this submission. To license the original mazindol data, NLS entered into an agreement with Novartis in March 2021 to obtain all preclinical and clinical data for studies previously conducted on mazindol by Novartis. This data may potentially provide NLS another avenue to streamline and/or reduce the costs of its preclinical and clinical programs. NLS’s ability to rely on the FDA’s previous findings of safety studies published in the scientific literature, and the extent to which licensed innovator data may be utilized will depend on NLS’s ability to demonstrate a scientific bridge to Mazindol ER from the previous formulation. In November 2022, NLS launched an individual Paid -forNamed Patient Program, or NPP, to provide access to Mazindol ER for the treatment of IH in Europe where this medication would not otherwise be available for this indication in certain countries. The NPP for IH was launched in the United Kingdom and NLS was expected to expand to other countries including France, Italy and Switzerland. This NPP was terminated in May 2023 for lack of performance of Calcog (Caligor Coghlan Ltd.), the service provider in charge of the development and execution of this program in Europe. NLS partnered with a third -partypharmaceutical company to expand access, early access and compassionate use programs to provide treatment of IH with Mazindol ER where it would otherwise not be available. In January 2023, NLS announced a technology patent grant covering Mazindol ER for treatment of ADHD and IH in Hong Kong. In October 2024, NLS announced its patent grant covering Mazindol ER for the treatment of heroin dependence in Japan. This further supports NLS’s global strategy with key patents granted the following major markets: Hong Kong, Japan, South Korea, the U.S., Europe & Canada. Compassionate Use Objectives in CDH 1 in Europe While “compassionate use” originally was understood to imply that the drug product is supplied for free, there is a growing understanding with policymakers, payers and patient organizations, that paid -forCUPs are justifiable. In Europe and other regions of the world (excluding the United States),