Alpha Cognition Announces Partner China Medical System Has NDA Accepted in China for the Review of ZUNVEYL® (Benzgalantamine) for Alzheimer's Disease
VANCOUVER, British Columbia & DALLAS — Alpha Cognition Inc. (Nasdaq: ACOG) ('Alpha Cognition' [ACI], or the 'Company'), a biopharmaceutical company developing novel therapies for debilitating neurodegenerative disorders, today announced China Medical System Holdings Limited (CMS) New Drug Application (NDA) for ZUNVEYL has been accepted by the National Medical Products Administration of China (NMPA) for review for the treatment of mild-to-moderate Alzheimer's dementia.
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'We are pleased to announce the NMPA acceptance of the ZUNVEYL New Drug Application, marking a significant milestone in our mission to bring innovative treatments to patients in need,' said Michael McFadden, Chief Executive Officer of Alpha Cognition. 'This acceptance reflects the strength of our partnership with CMS and the dedication of our team. We look forward to working closely with our partner throughout this important review process as we move one step closer to potentially delivering this important therapy to the Asia market.'
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Alpha Cognition will rely on successful regulatory and commercial expertise of CMS in the Chinese market and will benefit financially from advances in China and other Asia territories. The Company is eligible to receive regulatory, sales milestones, and royalties should ZUNVEYL be approved for marketing in China and other Asia territories.
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According to the epidemiological study results published in the Lancet Public Health, there are about 7.93 million patients with mild-to-moderate Alzheimer dementia in China. With the intensifying aging trend, the number of patients and the consequent disease burden will further increase in the future. The Company anticipates additional progress across other countries with regulatory advancement and ZUNVEYL commercial approvals.
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About Alpha Cognition Inc.
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Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and cognitive Impairment with mild Traumatic Brain Injury ('mTBI'), for which there are currently no approved treatment options.
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ALPHA-1062 (benzgalantamine) formulated as a delayed release oral tablet (ZUNVEYL ®), is FDA approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ZUNVEYL's active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia, and as a sublingual formulation for cognitive Impairment with mTBI.
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ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults.
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IMPORTANT SAFETY INFORMATION
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CONTRAINDICATIONS
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ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred.
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WARNINGS AND PRECAUTIONS
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Serious Skin Reactions
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: Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of ZUNVEYL tablets). If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered.
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Anesthesia
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: See Drug Interactions Section
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Cardiovascular Conditions:
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Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction.
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Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope.
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Gastrointestinal Conditions
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: Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding.
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Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL.
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Genitourinary Conditions:
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Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction.
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Neurological Conditions:
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Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL.
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Pulmonary Conditions:
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Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions.
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ADVERSE REACTIONS
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The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite.
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DRUG INTERACTIONS
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Use with Anticholinergics:
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Galantamine has the potential to interfere with the activity of anticholinergic medications.
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Use with Cholinomimetics and Other Cholinesterase Inhibitors:
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A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol.
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USE IN SPECIFIC POPULATIONS
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Pregnancy:
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Based on animal data may cause fetal harm.
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Hepatic Impairment:
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In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended.
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Renal Impairment:
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In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended.
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These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information.
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Forward-looking Statements
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This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company's current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'objective,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'target,' 'seek,' 'contemplate,' 'continue' and 'ongoing,' or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the potential benefits of the licensing agreement for the development and commercialization of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand, the Company's timing and planned activities to launch ZUNVEYL in the U.S. and China, the timing for the Company's planned corporate update call, the potential timing for the availability of ZUNVEYL in the U.S. and China, the potential future developments of ZUNVEYL in China, the potential market size for ZUNVEYL in China, the Company's business strategy for the launch of ZUNVEYL in China, the market size and demand for ZUNVEYL in China, the Company's potential growth opportunities in China, the timing and results of the Company's milestone payments for China, the Company's regulatory submissions in China, and the potential regulatory approval and commercialization of the Company's products in China. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company's intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company's filings with Canadian securities regulatory authorities and available at www.sedar.com and the Company's filings with the United States Securities and Exchange Commission (the 'SEC'), including those risk factors under the heading 'Risk Factors' in the Company's Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at www.sec.gov. These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.
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