Microsoft word - galantos press release english.docx
Galantos Pharma Has Sold to Neurodyn Inc.
All Assets of Memogain®, Drug Candidate for Alzheimer’s Disease
Mainz, Germany, September 10, 2013
Galantos Pharma announced today that it has sold to Neurodyn Inc. all assets related to the drug candidate Memogain®, a patented improvement of the generic Alzheimer’s drug galantamine (Razadyne, Reminyl). Plant-derived galantamine is widely prescribed to enhance cognition in mild to moderate Alzheimer's disease (AD), but has a limited capacity for brain penetration and significant side effects that limit its effectiveness. Memogain® is a lipophilic pro-drug of galantamine having much higher bioavailability in the brain, without the negative gastrointestinal side effects that limit patient acceptance. After an extensive preclinical development program, Memogain is ready to proceed into phase I clinical trials. The terms of the acquisition were not disclosed.
“We are very pleased by Neurodyn’s acquisition of the Memogain project” said Alfred Maelicke, founder and CEO of Galantos Pharma, “because Neurodyn is a champion in reformulating and repurposing generic natural products for indications with urgent medical need. By transferring Memogain to Neurodyn, we will now be able to explore in full the potential of this innovative drug candidate not only in AD but also in Parkinson’s disease.”
Memogain® is the front runner of Galantos’ strategy of developing innovative drugs for neurodegenerative diseases. After discovering that galantamine is not merely an esterase inhibitor like the other drugs of its class, but additionally acts on neuronal nicotinic receptors, the founders of Galantos decided to use this natural drug as lead structure for the synthesis of optimized variations. One key aim was to enhance the bioavailability in the brain, a second one to overcome the typical gastrointestinal side effects (nausea, vomiting, and diarrhea) of these drugs. Memogain was selected for higher efficacy and much lower side effects levels than the presently available AD drugs. In addition, Memogain has impressively demonstrated disease modifying properties in animal models of AD.
As a pro-drug of a market-approved drug, Memogain® should fulfill the requirements for fast-track regulatory approval in the US and Europe. Based on FDA’s 505(b)(2) provisions, such drug candidates can rely in part on data from existing reference drugs and may achieve market approval in as little as 30 months, with significantly fewer clinical trials and the resulting lower costs. Maelicke will join the Neurodyn team in developing Memogain along such a fast-track pathway.
About Galantos Pharma GmbH
Galantos Pharma GmbH is a privately owned German biotechnology company
founded in 2005. The company is utilizing the long-term experience and established
technology platform of the founders in the areas of natural compound synthesis,
molecular medicine and neuro-pharmacology as well as an international network of
experts for pre-clinical and clinical development of novel CNS medications.
Galantos’ shareholders are the High-Tech Gruenderfonds (HTGF), the KfW (a
Federal Government Bank), the VRP (Rhineland Palatinate Venture Capital Fund),
two funds of the Rhineland Palatinate Investment bank ISB (FIB and WFT), and the
founders Maelicke and Jordis. In addition, the company has received extensive
support by the BMBF (German Ministry for Education and Research). About Neurodyn Inc
Neurodyn (www.neurodyn.ca) is a Canadian biotechnology company focused on
identifying, validating and developing natural bioactives into both prescription drugs
and natural products for early treatment of neurological diseases. Neurodyn’s lead
technologies include ND1208, a neuroprotectant for use in early stage Parkinson’s
disease, which is incorporated into both a nutrition supplement (in market) and a US-
FDA Medical Food product (under development), Progranulin (ND602), a novel
therapeutic demonstrating pre-clinical efficacy in ALS, Parkinson’s disease,
Alzheimer's disease and Spinal Muscular Atrophy, and a natural product derived
Nerve Pain Treatment (NQ1123), which is being developed as a prescription drug for
a topical nerve pain condition. For further information:
Dr. Alfred Maelicke
GALANTOS Pharma GmbH
Hinter der Hecke 1
Tel. +49 61 36 953 9850
Fax +49 61 36 953 9851 [email protected] www.galantos.com
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