Neurodyn Inc. has acquired from Galantos Pharma GmbH, Mainz, Germany (galantos.com) all assets related to their Alzheimer’s prescription drug candidate – Memogain®. Memogain® is a prodrug of Galantamine and has completed an extensive preclinical development program and is ready to proceed into Phase 1 clinical trials in late 2013. The pro-drug greatly enhances delivery of galantamine to the brain and is expected to offer decisive advantages over drugs currently available for AD that are limited by very modest improvements in cognition, adverse effects which limit adherence, and no significant disease modification. The expected medical benefits of Memogain® include significantly greater effectiveness as a cognition enhancer and absence of dose-limiting gastro-intestinal side effects.
“We are very pleased to complete this acquisition. Memogain® is a significant improvement over existing Alzheimer’s drugs, and is staged for immediate entry into clinical trials. It has the potential to follow a fast-track regulatory pathway in both the US and Europe,” said Kenneth Cawkell, Neurodyn CEO.
Memogain® is a patented improvement on the generic drug, galantamine, (Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine). Galantamine, a plant-derived compound, is widely prescribed to enhance cognition for the treatment of mild to moderate Alzheimer's disease, but has a limited capacity for brain penetration and significant side effects that limit its effectiveness. Memogain® was developed to have a much higher bioavailability in the brain, without the negative gastro-intestinal side effects that limit patient acceptance.
Neurodyn will also investigate the potential for Memogain® to decrease the amyloid plaque burden associated with Alzheimer’s disease and to induce new cell growth in regions of the brain affected by the disease.
Sales of galantamine are currently in excess of $500 million per year. The worldwide Alzheimer’s drug market is currently estimated to exceed $4.2 billion and is growing rapidly due to the aging demographic. Current drugs on the market have significant side effects which limit their effectiveness and reduce their usefulness.
The revenue potential for Memogain® could extend beyond the current galantamine market share due to the urgent medical need for Alzheimer’s drugs that have increased efficacy and decreased side effects compared to the current anti-dementia drugs.
Neurodyn Inc. (www.neurodyn.ca) is a Canadian biotechnology company focused on identifying, validating and developing natural bioactives into both prescription drugs and natural products for the early treatment of neurological diseases. Neurodyn examines historically-proven natural products to discover key bioactives which can either be reformulated or repurposed to provide more effective treatments for neurological conditions.
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.
Galantos Pharma GmbH (www.galantos.com) is a German biotechnology company founded in 2005 by Professors Alfred Maelicke (Mainz) and Ulrich Jordis (Vienna). Both have been intimately involved in the original development of galantamine, and in bringing the drug to market. Realizing the limited brain penetration of the plant-derived drug galantamine, they set out to develop a pro-galantamine with much higher bioavailability in the brain and without compliance-compromising gastro-intestinal side effects. In addition, their new drug candidate Memogain® has the potential of both neuroprotection and disease-modification. Prof. Maelicke will continue with Neurodyn as Managing Director Europe
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