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GALANTOS
GENETICS GMBH |
Business Development
This is an outstanding opportunity to license or purchase a drug development project ready for immediate entry into clinical trials:
Memogain® is a patent-protected New Chemical Entity that as pro-drug dramatically enhances the brain bioavailability of the market-approved Alzheimer drug Galantamine (Reminyl®). The expected medical benefits of Memogain include
Memogain® is synthesized in a single manufacturing step from Galantamine. The cGMP process development and manufacturing of the drug substance is presently contracted to Carbogen/Amcis (Switzerland), and cGMP material sufficient to complete clinical phase I is in stock. Memogain is formulated as intranasal spray, with the Drug Product preparation contracted to Archimedes (UK). If expanded to industrial scale, the COGS for Memogain® is expected to be similar to that of Galantamine. GLP-preclinical development is completed, permitting to begin clinical phase I within the next few months at CHDR, Leiden (NL). A complete preclinical package including Investigator’s Brochure, drug product material and phase Ia (SAD) study protocol has been produced. Memogain® is expected to offer decisive advantages compared to current AD drugs that are limited by only small and transient improvements in cognition, compliance impeding side effects and no significant disease modification. Memogain may become a key player in the AD drug market that currently has a world-wide size of around US$ 4.5 billion per year, and is forcasted to grow further, due to expected improvements in early diagnosis, and a further aging population in the industrialized countries.
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