DuchemBio Co. (CEO: Kim Jong-woo), the first Korean company that produced dementia diagnostic radiopharmaceuticals "Neuraceq,” has teamed up with U.S. biotechnology firm Accera to introduce a treatment for the Alzheimer’s disease to the nation.
The Colorado-based Accera, a private company supported by international consumer brand giant Nestle SA, has specialized in degenerative brain diseases such as Alzheimer's disease and dementia.
Unlike other introductions of global new drugs that usually takes two to three years after overseas approvals, the contract between DuchemBil and Accera is aimed to introduce the therapy, now scheduled for phase 3 clinical trials, upon the U.S. FDA’s approval of it around 2021. It also seeks various cooperation with the large domestic hospitals by conducting joint clinical tests, the Korean company said.
Accera failed to secure the clinical significance of the efficacy after three years of phase 3 clinical trials this past February. The U.S. company, however, has discovered a modified formula from phase 2 clinical trials reduced the active ingredients in blood noticeably, is now preparing for another phase 3 trials using the original formula.
DuchemBio듀켐바이오, which obtained the domestic license for the diagnosis of Alzheimer's disease for the first time in Asia in December 2014, currently takes up more than 90 percent of the local diagnostic market and is supplying valuable clinical aid to leading dementia hospitals in the nation.
“As the only company that possesses the global GMP-level dementia diagnostic radiopharmaceutical manufacturing and supply chain, the stable supply of radiopharmaceuticals, which is essential for finding the right patient population in clinical trials for therapeutic effects, has helped us attain good contract contents,” a company official said.
|This graphic compares a healthy brain with an Alzheimer disease-ridden one.|
Since the development of radiopharmaceuticals (diagnosis of beta-amyloid) to help diagnose Alzheimer's disease, multinational pharmaceutical companies have focused on the development of therapeutic drugs by eliminating or blocking beta-amyloid, the causative agent of Alzheimer's disease, he noted.
Accera’s dementia drug has a mechanism to improve the cognitive function of dementia patients by directly supplying Ketone, the only alternative energy source in the brain, to patients with a demented brain damaged by brain cells due to lack of glucose metabolism.
In particular, Accera's dementia treatments are based on materials extracted from natural food ingredients and showed good tolerability in humans. The formulations under clinical testing may even have a synergic effect on the efficacy of new pharmaceuticals developed for patients with dementia when they are applied together because of the activation of intact brain cells.
DuChemBio is planning to apply for domestic approval in 2020, including preclinical, phase 1 and 2 clinical data provided by Accera, and possibly introduce the product in Korea even before the approval by the U.S. Food and Drug Administration.
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