Industry veteran brings broad commercial expertise in neuroscience drug development and commercialization as Alzheon advances ALZ-801 into Phase 3 as potentially the first oral disease-modifying treatment for Alzheimer’s disease
FRAMINGHAM, Mass., January 7, 2020 – Alzheon, Inc., a clinical-stage biopharmaceutical company focused on developing new medicines for patients suffering from Alzheimer’s disease (AD) and other neurodegenerative disorders, announced today that Peter N. Laivins, MBA, has been appointed Head of Commercial Strategy and Planning. Mr. Laivins brings more than 20 years of leadership in the biopharmaceutical industry, with broad expertise in business strategy and commercialization for Alzheimer’s therapies, including his experience at Pfizer launching ARICEPT® for symptomatic treatment for AD and at Elan Biopharmaceuticals leading commercial strategy for bapineuzumab as an anti-amyloid immunotherapy for AD.
“Peter brings unparalleled depth of business and commercial expertise to Alzheon, with a unique track record of shaping the Alzheimer’s commercial landscape and a career-long passion to fight this debilitating disease,” said Martin Tolar, MD, PhD, Founder, President and Chief Executive Officer of Alzheon. “Peter’s skills will be invaluable as we move our lead drug ALZ-801 into Phase 3 trials and prepare for future commercialization of potentially the first oral and well tolerated disease-modifying treatment for millions of Alzheimer’s patients and their families.”
Most recently, Mr. Laivins was the Senior Vice President of Strategic Development Program Leadership at Tesaro, Inc., with oversight of five development teams, portfolio management and competitive intelligence. Previously, at Merrimack Pharmaceuticals, he served as Senior Vice President and Head of Late Stage Development, where he led the successful clinical development, NDA submission and FDA approval of Onyvide® – the first new therapy for pancreatic cancer in two decades. Mr. Laivins’ career in neuroscience drug development includes his role as Vice President of Strategic Brand Management for Elan Biopharmaceuticals, with responsibility for the Alzheimer’s portfolio, including bapineuzumab, and the multiple sclerosis portfolio, including TYSABRI®. At Pfizer, Mr. Laivins held positions of increasing responsibility, including the Global Team Leader in Neuroscience, leading the launch of Aricept® – which achieved peak sales exceeding $3 billion. Beyond neuroscience, he also served as Group Leader for US Oncology Marketing at Pfizer. Mr. Laivins is a graduate of McGill University with a Bachelor of Science in microbiology and immunology and Master of Business Administration.
“I’m excited to join the team at Alzheon at this important juncture in Alzheimer’s drug development. Last year we saw convincing clinical validation of anti-amyloid therapy, which confirmed that targeting amyloid toxicity can slow disease progression and provide clinical improvement in patients,” said Mr. Laivins. “We believe ALZ-801 could be transformative as the first oral disease modifying treatment for Alzheimer’s and provide an important advance for patients and their families.”
Alzheon’s lead product candidate, ALZ-801, an oral anti-amyloid drug candidate that is an optimized prodrug of tramiprosate, has shown promising results in analyses of clinical data1,2 and a novel therapeutic mechanism of action.3 ALZ-801 has received Fast Track designation from the U.S. Food and Drug Administration. The clinical data for ALZ-8014 and its active agent, tramiprosate, suggest long-term clinical efficacy in AD patients with the apolipoprotein E4 (APOE4) genotype and a favorable safety profile.1,2 ALZ-801 acts through a novel enveloping molecular mechanism of action blocking the formation of toxic amyloid oligomers3 associated with the development and progression of AD.6 The cognitive improvements observed in AD patients in the tramiprosate Phase 3 studies may be attributed, in part, to the therapeutic anti-oligomer action of 3-sulfopropanoic acid (3-SPA), an endogenous substance in the human brain, discovered by Alzheon scientists, that inhibits the formation of neurotoxic beta amyloid oligomers.5 3-SPA is the primary metabolite of ALZ-801 in humans and its discovery elucidates the beneficial pharmaceutical attributes of ALZ-801, including a favorable safety profile, selectivity against beta amyloid oligomers, and excellent brain penetration. ALZ-801 increases levels of 3-SPA in the brain and augments the body’s natural mechanism for blocking the formation of toxic amyloid oligomers.5 The initial Phase 3 program for ALZ-801 will focus on patients with the homozygous APOE4/4 genotype at the Early stage of AD, with the potential for future expansion to additional Alzheimer’s populations.6
Alzheon, Inc. is committed to developing innovative medicines by directly addressing the underlying pathology of devastating neurodegenerative disorders. Our lead Alzheimer’s clinical candidate, ALZ-801, is a Phase 3-ready, first-in-class, small molecule oral inhibitor of beta amyloid aggregation and neurotoxicity – hallmarks of Alzheimer’s disease. ALZ-801 is a novel prodrug that builds on the safety and efficacy profile of the active compound tramiprosate, which has been evaluated in clinical trials involving over 2,000 Alzheimer’s patients. Our clinical expertise and technology platform are focused on developing drug candidates using a precision medicine approach based on individual genetic and biological information to advance therapies with the greatest impact for patients.
1 Abushakra et al. Journal of Prevention of Alzheimer’s Disease, 2016
2 Abushakra et al. Journal of Prevention of Alzheimer’s Disease, 2017
3 Kocis et al. CNS Drugs, 2017
4 Hey et al. Clinical Pharmacokinetics, 2018
5 Hey et al. CNS Drugs, 2018
6 Tolar et al. Alzheimer’s & Dementia, 2019
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