Smith-Magenis Syndrome

Grant of Its Newest U.S. Patent Expands Anavex’s Intellectual Property Portfolio in Neurologic IndicationsNEW YORK, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, announced today it was granted new U.S. Patent No. 11,839,600 entitled “NEURODEVELOPMENTAL DISORDER THERAPY” from the United States Patent and Trademark Office (USPTO) for its patent application number 17/890,083. Anavex’s newest patent expands coverage of ANAVEX®2-73 (blarcamesine) therapy to ameliorate various conditions associated with loss-of-function mutations of the gene encoding methyl-CpG binding protein (MeCP2). The patent claims protect use of ANAVEX®2-73 (blarcamesine) to address a range of symptoms exhibited by patients suffering from neurodevelopmental and neurological conditions related to McCP2, such as abnormal breathing, abnormal cardiac function, abnormal feeding, abnormal choking, weight gain failure, abnormal sleep, seizures, abnormal gadolinium-enhancing lesions. Such conditions are frequently associated with diseases such as Rett syndrome, autism spectrum disorder, multiple sclerosis, cerebral palsy, Angelman syndrome, Williams syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), childhood disintegrative disorder, Smith-Magenis syndrome, non-syndromic mental retardation, idiopathic neonatal encephalopathy, and idiopathic cerebral palsy. This newest patent is expected to remain in force at least until January 2037, not including any patent term extension. “This new patent on use of ANAVEX®2-73 (blarcamesine) in ameliorating difficult symptoms associated with loss-of-function gene mutations of MeCP2 will be important for Anavex, further reinforcing our already strong position providing novel and effective therapies for debilitating neurodevelopmental and neurological diseases,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. He further added: “We are pleased with the continued development of the patent portfolio for ANAVEX®2-73 (blarcamesine). The grant of this new patent to Anavex further demonstrates our strong overall commitment to protecting the innovation and commercial opportunity of our product portfolio.” About Neurodevelopmental Disorders Neurodevelopmental disorders refer to a group of conditions that affect the way the brain and nervous system develop. These disorders can cause changes to thinking, feeling, language, and physical abilities like movement and coordination. Neurodevelopmental conditions typically start before adulthood and may continue into adulthood. They are often associated with social impairments and difficulties in communication.1 The number of people globally with developmental intellectual disability was estimated at 107.62 million according to IHME, Global Burden of Disease (2019).2 About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. For Further Information:Anavex Life Sciences Corp.Research & Business DevelopmentToll-free: 1-844-689-3939Email: info@anavex.com Investors:Andrew J. BarwickiInvestor Relations Tel: 516-662-9461Email: andrew@barwicki.com 1 https://www.empowerbh.com/blog/what-are-neurodevelopmental-disorders/2 https://ourworldindata.org/neurodevelopmental-disorders

NEW YORK, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders including Alzheimer’s disease, Parkinson’s disease, Rett syndrome and other central nervous system (CNS) disorders, announced today it was granted new U.S. Patent No. 11,839,600 entitled “NEURODEVELOPMENTAL DISORDER THERAPY” from the United States Patent and Trademark Office (USPTO) for its patent application number 17/890,083. Anavex’s newest patent expands coverage of ANAVEX®2-73 (blarcamesine) therapy to ameliorate various conditions associated with loss-of-function mutations of the gene encoding methyl-CpG binding protein (MeCP2). The patent claims protect use of ANAVEX®2-73 (blarcamesine) to address a range of symptoms exhibited by patients suffering from neurodevelopmental and neurological conditions related to McCP2, such as abnormal breathing, abnormal cardiac function, abnormal feeding, abnormal choking, weight gain failure, abnormal sleep, seizures, abnormal gadolinium-enhancing lesions. Such conditions are frequently associated with diseases such as Rett syndrome, autism spectrum disorder, multiple sclerosis, cerebral palsy, Angelman syndrome, Williams syndrome, pervasive developmental disorder not otherwise specified (PDD-NOS), childhood disintegrative disorder, Smith-Magenis syndrome, non-syndromic mental retardation, idiopathic neonatal encephalopathy, and idiopathic cerebral palsy. This newest patent is expected to remain in force at least until January 2037, not including any patent term extension. “This new patent on use of ANAVEX®2-73 (blarcamesine) in ameliorating difficult symptoms associated with loss-of-function gene mutations of MeCP2 will be important for Anavex, further reinforcing our already strong position providing novel and effective therapies for debilitating neurodevelopmental and neurological diseases,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. He further added: “We are pleased with the continued development of the patent portfolio for ANAVEX®2-73 (blarcamesine). The grant of this new patent to Anavex further demonstrates our strong overall commitment to protecting the innovation and commercial opportunity of our product portfolio.” About Neurodevelopmental Disorders Neurodevelopmental disorders refer to a group of conditions that affect the way the brain and nervous system develop. These disorders can cause changes to thinking, feeling, language, and physical abilities like movement and coordination. Neurodevelopmental conditions typically start before adulthood and may continue into adulthood. They are often associated with social impairments and difficulties in communication.1 The number of people globally with developmental intellectual disability was estimated at 107.62 million according to IHME, Global Burden of Disease (2019).2 About Anavex Life Sciences Corp. Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative and neurodevelopmental disorders, including Alzheimer's disease, Parkinson's disease, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 (blarcamesine), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate that restores cellular homeostasis by targeting sigma-1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. ANAVEX®3-71, which targets sigma-1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at . You can also connect with the Company on Twitter,Facebook, Instagram, and LinkedIn. Forward-Looking Statements Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. For Further Information: Anavex Life Sciences Corp. Research & Business Development Toll-free: 1-844-689-3939 Email: info@anavex.com Investors: Andrew J. Barwicki Investor Relations Tel: 516-662-9461 Email: andrew@barwicki.com 1 2

The med will be Vanda's third drug on the commercial market. Vanda Pharmaceuticals has a new commercial asset under its belt after striking a deal to buy certain rights to Johnson & Johnson’s multiple sclerosis med Ponvory for $100 million. Vanda secured U.S. and Canadian rights to the daily oral selective sphingosine-1-phosphate receptor 1 (S1P1R) modulator from J&J’s Actelion subsidiary. Ponvory was approved in 2021 to treat relapsing forms of multiple sclerosis and could be a potential treatment for a group of inflammatory and autoimmune disorders, including psoriasis and ulcerative colitis, Vanda said in its Thursday press release. The buy is a “significant milestone” for Vanda, CEO and chairman Mihael H. Polymeropoulos, M.D., said in a statement. The deal "expands our commercial portfolio and gives us access to a versatile immune response modifier that can potentially have broad application in treating a number of autoimmune-based disorders," the chief added.  J&J's sale of certain Ponvory rights comes after Fierce Pharma in February reported that the pharma company had laid off some members of its multiple sclerosis sales team. The drugmaker has yet to reveal sales figures for Ponvory. As for Vanda, the drug adds to its current commercial portfolio of Hetlioz for non-24-hour sleep-wake disorder and Smith-Magenis syndrome-related sleep disturbances, plus schizophrenia treatment Fanapt.   On the horizon for Vanda is gastroparesis med tradipitant, which, if approved, would be the first novel drug for the condition in over four decades. The FDA accepted the company's approval application earlier this month and set a decision date for next September. Hetlioz and Fanapt are also due for FDA decisions on potential label expansions next year. Meanwhile, Vanda has spent the last few years quarreling with the FDA over its 2019 rejection of Hetlioz in jet lag disorder. Earlier this year, a Washington D.C. district court sided with Vanda and ordered the FDA to release relevant records.