Acasti Completes Acquisition of Grace Therapeutics, Inc.   

About Us

OUR STORY

Acasti is a diversified specialty pharma company with unique drug delivery capabilities and technologies to address rare and orphan diseases where there are currently significant unmet medical needs.  The Company’s proprietary formulations and drug delivery technologies are designed to improve clinical outcomes, enhance efficacy, provide faster onset of action, reduce side effects, provide more convenient delivery, and increase patient compliance. 

Acasti is initially targeting three underserved orphan diseases - Subarachnoid Hemorrhage (SAH), Ataxia Telangiectasia (A-T), and Postherpetic Neuralgia (PHN) – all with sizable patient populations and significant market opportunity. 

Acasti’s lead assets have been granted Orphan Drug Designation (ODD) status, with potential for 7-year US and 10-year EU market exclusivity.  Orphan drugs generally command premium pricing and offer the potential for a lower-risk, lower-cost pathway to drug development and commercialization.

Acasti’s utilizes formulations and compounds proven to be safe.  As such, the company is pursuing the 505(b)(2) regulatory pathway for its drug candidates, which may eliminate the need to conduct certain preclinical and clinical studies

 

The Company has a strong and growing IP portfolio with more than 40 granted and pending patents worldwide provide exclusivity beyond 2036.

Management

Jan D'Alvise

Jan D'Alvise
President and CEO

Ms. D'Alvise has extensive experience the life science industry, having held executive positions in companies commercializing pharmaceuticals, diagnostics, medical devices, and drug discovery research tools. Prior to joining Acasti in mid-2016, Ms. D'Alvise was the President and Chairman of Pediatric Bioscience. Before that, she was the CEO of Gish Biomedical, a cardiopulmonary medical device company. Prior to Gish, Ms. D'Alvise was the CEO of the Sidney Kimmel Cancer Center (SKCC), a drug discovery research institute, the Co-Founder/President/CEO/Chairman of NuGEN, Inc., and the Co-Founder and Executive VP/COO of Metrika Inc. Ms. D'Alvise built NuGEN and Metrika from technology concept through to successful regulatory approvals, product introduction and sustainable revenue growth. Prior to her experience as an entrepreneur, Ms. D'Alvise held the positions of VP of Drug Development at Syntex/Roche and Business Unit Director of their Global Pain and Inflammation business, and VP of Commercial Operations at SYVA (Syntex's clinical diagnostics division). She began her career with Diagnostic Products Corporation where she ran global sales, marketing and service. Ms. D'Alvise has a B.S. in Biochemistry from Michigan Technological University. She has completed post-graduate work at the University of Michigan, Stanford University, and the Wharton Business Schools. Ms. D'Alvise is currently on the board of Spectral Medical (EDT.TO), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as a new proprietary platform targeting the renal replacement therapy market, and The ObG Project, a private digital media company delivering real-time medical information to physicians. She has previously served on the boards of numerous private companies and non-profits.

Pierre Lemieux, Ph.D.

Pierre Lemieux, Ph.D.
Chief Operating and Scientific Officer, Co-Founder

Dr. Lemieux has been our Chief Operating Officer since April 2010 and was named Chief Scientific Officer in July 2018. Previously, Mr. Lemieux was CEO, Co-Founder and Chairman of BiolActis Inc. which he sold in 2009 to interests affiliated with the Nestlé multinational group. Mr. Lemieux joined Suprateck Pharma in 1999 as Director and Vice-President involved in the development of formulations for gene therapy on behalf of Rhone-Poulenc Rorer and Genzyme, which today are under the Sanofi banner. Prior to this, Mr. Lemieux was involved in the development of cardiovascular products at Angiotech Pharmaceuticals. Mr. Lemieux has a Ph.D. in biochemistry from Université Laval (Québec). He holds 16 patents and has authored over 50 publications. Mr. Lemieux's research was conducted at Université Laval as well as at the anti-cancer center Paul Papin D'Angers (France) and the University of Nottingham (England). His research focused on ovarian cancer and its treatment with monoclonal antibodies used to target cancer drugs. After completing his graduate studies, Mr. Lemieux joined the Oncology division of the Center for Health Research, University of Texas (U.S.). He obtained a postdoctoral fellowship from the Susan G. Komen Foundation (Breast Cancer). Mr. Lemieux has served on the boards of BioQuébec, Montreal in vivo and PharmaBio Development.

Brian D. Ford CPA-CA

Brian D. Ford CPA-CA
Chief Financial Officer

Brian D. Ford brings over three decades of financial, project management and M&A experience within the healthcare and financial industries. Mr. Ford is an accomplished CPA-CA having served both publicly traded as well as privately owned organizations. Mr. Ford has been responsible for developing business recovery strategies, negotiating M&A transactions, as well as managing quarterly and yearly accounting reports. Most recently, Mr. Ford served as Chief Financial Officer and Senior Business Advisor at a private group of Ontario based medical clinics, including the largest chronic pain management practice in Canada. During his position as CFO and Senior Business Advisor, Mr. Ford significantly improved the Company’s performance and was instrumental in preparing the Company for its Initial Public Offering. Prior to that, Mr. Ford served as Chief Financial Officer at Telesta Therapeutics. At Telesta Therapeutics, Mr. Ford helped develop a new business plan and was heavily involved in all capital transactions. Previously, Mr. Ford started his own consulting firm, Petersford Consulting, where he provided clients with finance and business risk services. Mr. Ford began his career at Ernst & Young, working his way to Principal, Business Risk Services, developing essential business plans that evaluated revenue and cost profiles supporting budget planning and understanding drivers of growth, specifically with healthcare companies. Additionally, at Ernst & Young, Mr. Ford participated in and often led teams in due diligence assignments in relation to mergers and acquisitions or the sale of a business, having extensive experience in developing financial forecasts, product and market valuation, and audits of critical accounting and processes. Mr. Ford holds a B.A. in Economics, History, and English from the University of Guelph and has a Graduate Diploma in Accounting from the University of McGill. Mr. Ford is a member of the Ontario Institute of Chartered Accountants.

Dr. George Kottayil

Dr. George Kottayil
Co-Founder of Grace Therapeutics

Dr. George Kottayil has spent over 20 years at prominent life science companies. Most recently, Dr. Kottayil was a co-founder and served as CEO of Grace Therapeutics, prior to its acquisition by Acasti in August 2021.  Previously, Dr. George Kottayil was a co-founder and president of Insys Therapeutics, Inc. and principal inventor of SUBSYS®, a sublingual fentanyl spray for the treatment of breakthrough cancer pain, which generated annual revenue of approximately $250 million during the fiscal year ended 2015. He has previously held senior positions at Unimed Pharmaceuticals Inc., which was later acquired by Solvay Pharmaceuticals, Inc., which in turn was acquired by AbbVie Inc. He has held key roles in product development and obtaining FDA approval for ANDROGEL®, which generated annual revenue of approximately $1.15 billion during the fiscal year ended 2012, as well as formulating and executing a strategy that resulted in down-scheduling of the controlled prescription drug MARINOL® by the United States Drug Enforcement Administration.

Prashant Kohli

Prashant Kohli
VP, Commercial Operations

Prashant Kohli has over 20 years of commercialization experience leading strategy, sales, marketing, and product management. Most recently, Mr. Kohli was VP, Commercial Operations of Grace Therapeutics, prior to its acquisition by Acasti in August 2021.  He has expertise crafting go-to-market plans for products with unique value proposition that address critical unmet needs. He has built, deployed, and led sales and marketing from the ground-up with significant experience in organization design, recruiting, performance management, incentive compensation, and P&L accountability. He has successfully implemented evidence-based, consultative-selling model that is rooted in deep understanding of the health ecosystem including patients, providers, health systems, government, and payers. He has also designed strategic marketing plans that generate leads and increase share-of-voice, augmenting the salesforce with digital tactics that increase reach and frequency. He has extensive commercial experience with specialty and small molecule drugs including in rare and orphan diseases. Prashant has worked at Archi-Tech Systems, Cardinal Health, IMS Health, Rosenbluth, and Dun & Bradstreet. He has a BA in Computer Science and Math, and an MBA from The Wharton School.

Board of Directors

Roderick Carter, MD

Chairman of the Board

Dr. Carter has a strong history of contributions to healthcare through clinical, research, business and people leadership. He has significant experience developing and commercializing nutraceutical and pharmaceutical products and has successfully led clinical research and business development strategies for cardiovascular and inflammation related diseases. Dr. Carter is currently Principal at Aquila Life Sciences LLC, a consulting firm he founded in April 2008 focusing on pharmaceutical development and commercialization. Prior to this, he was Vice President of Clinical Development at Reliant Pharmaceuticals, which developed the OM3 cardiovascular drug LOVAZA, and today is a wholly-owned subsidiary of GlaxoSmithKline. He also served as Executive Director at Merck and Co., USA, President and Chief Executive Officer of WellGen and Senior Medical Director at Pfizer Inc., USA. Dr. Carter received his Medical Degree from the University of Witwatersrand, Johannesburg, along with a Master of Science degree in Sports Medicine from Trinity College, Dublin.

Jan D'Alvise

President and CEO

Ms. D'Alvise has extensive experience the life science industry, having held executive positions in companies commercializing pharmaceuticals, diagnostics, medical devices, and drug discovery research tools. Prior to joining Acasti in mid-2016, Ms. D'Alvise was the President and Chairman of Pediatric Bioscience. Before that, she was the CEO of Gish Biomedical, a cardiopulmonary medical device company. Prior to Gish, Ms. D'Alvise was the CEO of the Sidney Kimmel Cancer Center (SKCC), a drug discovery research institute, the Co-Founder/President/CEO/Chairman of NuGEN, Inc., and the Co-Founder and Executive VP/COO of Metrika Inc. Ms. D'Alvise built NuGEN and Metrika from technology concept through to successful regulatory approvals, product introduction and sustainable revenue growth. Prior to her experience as an entrepreneur, Ms. D'Alvise held the positions of VP of Drug Development at Syntex/Roche and Business Unit Director of their Global Pain and Inflammation business, and VP of Commercial Operations at SYVA (Syntex's clinical diagnostics division). She began her career with Diagnostic Products Corporation where she ran global sales, marketing and service. Ms. D'Alvise has a B.S. in Biochemistry from Michigan Technological University. She has completed post-graduate work at the University of Michigan, Stanford University, and the Wharton Business Schools. Ms. D'Alvise is currently on the board of Spectral Medical (EDT.TO), a late stage theranostic company advancing therapeutic options for sepsis and septic shock, as well as a new proprietary platform targeting the renal replacement therapy market, and The ObG Project, a private digital media company delivering real-time medical information to physicians. She has previously served on the boards of numerous private companies and non-profits.

John Canan

Director

Mr. Canan is an accomplished business executive with over 34 years of strategic, business development and financial leadership experience. Mr. Canan recently retired from Merck & Co., Inc. where his last senior position was as Senior Vice-President, Global Controller, and Chief Accounting Officer for Merck from November 2009 to March 2014. He has managed all interactions with the audit committee of the Merck board of directors, while participating extensively with the main board and the compensation & benefits committee. Mr. Canan serves as a director of REV Group, a public company, where he chairs the audit committee. Mr. Canan also provides consulting services to Willow BioPharma, a Canadian start-up, engaged in the acquisition and development of legacy pharmaceutical assets. He also serves on the board of trustees of Angkor Hospital for Children, where he also chairs the audit & risk committee. Mr. Canan is a graduate of McGill University, Montreal, Canada, and is a Canadian Chartered Accountant.

Donald Olds

Director

Mr. Olds is President and Chief Executive Officer of the NEOMED Institute, an R&D organization dedicated to advancing Canadian research discoveries to commercial success. Prior to NEOMED, he was the Chief Operating Officer of Telesta Therapeutics Inc., a TSX-listed biotechnology company. In 2016, he led the successful sale of Telesta to a larger public biotechnology company. Prior to Telesta, he was President and Chief Executive Officer of Presagia Corp., and Chief Financial Officer and Chief Operating Officer of Aegera Therapeutics. At both Telesta and Aegera, Mr. Olds was responsible for raising more than $100 million in equity financing and leading regional and global licensing transactions with life sciences companies.

Mr. Olds is currently Lead Director of Goodfood Market Corp (TSX:FOOD), Chairman of Oxfam Quebec and Director of Presagia Corp. He has extensive past corporate governance experience serving on the boards of private and public for-profit and not-for-profit organizations. He holds an MBA (Finance & Strategy) and M.Sc. (Renewable Resources) from McGill University.

Vimal Kavuru, RPh

Director

Mr. Kavuru has created and led several pharmaceutical companies. Mr. Kavuru brings, in his vision and management, a broad-based understanding of the global pharmaceutical industry with expertise in strategic planning, product and business development, and operations. In addition to serving as the Chairman of the Grace board of directors, Mr. Kavuru is the founder, chairman and Chief Executive Officer of Rising Pharma Holdings, Inc., a U.S. generic pharmaceutical company, and Acetris Pharma Holdings, LLC, a generic pharmaceutical company serving U.S. government agencies. Previously, Mr. Kavuru founded Citron Pharma & Lucid Pharma, which were sold to Aceto Corporation in 2016, Casper Pharma LLC, an emerging specialty brand pharmaceutical company, and Gen-Source RX, a national distributor of generic pharmaceuticals that was acquired by Cardinal in 2014. In 2007, Mr. Kavuru also co-founded Celon Labs, a specialty oncology and critical care pharmaceutical company acquired by Zanzibar Pharma, a portfolio company of CDC Group. He is a registered pharmacist in the state of New York, holds a B.S. in Pharmacy from HKE College of Pharmacy, Bulgarga, India, and attended Long Island University, Brooklyn, New York with specialization in industrial pharmacy.

William Haseltine, PhD

Director

Mr. Haseltine is a well-respected industry leader in the medical and biotechnology fields with decades of experience. Mr. Haseltine also serves as the Chairman and President of ACCESS Healthcare International, Inc. and as the Chairman of the Haseltine Foundation for Science and the Arts. He is the founder of Human Genome Science and served as the Chairman and Chief Executive Officer for 12 years. Mr. Haseltine is also the founder and Chief Executive Officer of Demetrix, Inc., a biotechnology company specializing in pain and anxiety medications, and founder and director of X-VAX, which is developing a novel herpes simplex vaccine, in addition to more than a dozen other biotechnology companies. Mr. Haseltine was previously a professor at Harvard Medical School and the Harvard School of Public Health, where he was the founder and chairman of the Division of Biochemical Pharmacology and the Division of Human Retrovirology. He is well-known for his seminal work on cancer, HIV/AIDS and genomics, and has authored more than 200 manuscripts published in peer-reviewed journals. He is a lifetime member of the New York Academy of Sciences, a trustee of the New York Academy of Medicine, and an honorary trustee of the Brookings Institution. Mr. Haseltine holds a B.A. in chemistry from the University of California, Berkeley and a Ph.D. in biophysics from Harvard University. Mr. Haseltine has served as a director of Grace since 2018.

Scientific Advisory Boards

Scientific Advisory Boards

Harold Bays

Dr. Harold Bays is Board Certified in Endocrinology and Internal Medicine, Diplomate of the American Board of Clinical Lipidology, and Diplomate of the American Board of Obesity Medicine. He has served as an Investigator for over 500 Phase I - IV clinical trials regarding treatments for dyslipidemias, obesity, diabetes mellitus, hypertension, and other metabolic and hormonal disorders. As Medical Director and President of Louisville Metabolic and Atherosclerosis Research Center, Dr. Bays has written, or served as a contributing author to over 200 peer review scientific manuscripts and book chapters, well as over 100 scientific abstracts presented at major scientific meetings, and served as first author for a number of scientific consensus statements in Lipidology and Obesity Medicine. He is a Fellow of the National Lipid Association (FNLA), Fellow of The Obesity Society (FTOS), Fellow of the American College of Cardiology (FACC) and Fellow of the American Association of Clinical Endocrinologists (FACE). He was lead author of the National Lipid Association Annual Summary of Clinical Lipidology 2015 & 2016, co-author of the National Lipid Association Recommendations for Patient-Centered Treatment of Dyslipidemia, and Chairman of the Obesity Medicine Association Obesity Algorithm. He was Chairman of the National Lipid Association 2012 Adiposity and Dyslipidemia Consensus Conference and Chairman of the 2010 American Association of Clinical Endocrinologist Adipose Tissue Pathophysiology State of the Science Conference. Finally, Dr. Bays has received several scientific awards such as the 2016 Obesity Medicine Association "Obesity Medicine Clinician of the Year," 2015 National Lipid Association "President's Service Award," and 2014 American Society of Bariatric Physicians "Task Force Award."

Barry A. Franklin, Ph.D.

Dr. Franklin is currently director of preventive cardiology and cardiac rehabilitation at William Beaumont Hospital. He holds professorial appointments at Oakland University, William Beaumont School of Medicine and Wayne State University, Department of Physiology, School of Medicine. During his tenure at William Beaumont Hospital, the cardiac rehabilitation program and stress testing laboratories have achieved national and international recognition in the treatment and evaluation of coronary artery disease. Dr. Franklin and his associates have studied the physiologic responses to numerous occupational and leisure-time activities, as well as the primary and secondary prevention of heart disease, comprehensive cardiovascular risk reduction, obesity and metabolism, exercise testing and prescription, lipids and lipoproteins. He has served in multiple volunteer advisory roles for the American Heart Association, and was past president of the American College of Sports Medicine and American Association of Cardiovascular and Pulmonary Rehabilitation. Dr. Franklin holds various editorial board appointments with scientific and clinical journals and has written or edited nearly 600 publications, including 481 papers, 85 book chapters, and 27 books. He has received a number of honors and awards, and he lectures extensively, both nationally and internationally, on topics related to preventive cardiology and lifestyle medicine. Dr. Franklin obtained his Ph.D. in Physiology, with a minor in Health and Physical education from Pennsylvania State University.

Robert Hegele, M.D.

Dr. Hegele is a distinguished university professor at Western University, and director of London Regional Genomics Centre at Robarts Research Institute in London, Canada. He holds the Wolfe Distinguished Medical Research Chair, the Edith Schulich Vinet Chair in Human Genetics and the Blackburn Chair in Cardiovascular Research. He cares for more than 2000 patients in his lipid clinic at University Hospital, where he is a staff endocrinologist. He was among the first doctors in North America to use five medications that are now routinely prescribed to treat high cholesterol or diabetes and his laboratory discovered the molecular genetic basis of more than 20 human diseases, including familial lipid disorders and inherited diabetes. He has published over 600 papers, which have been cited more than 20,000 times in the medical literature, and he was listed in the ISI database of the top 1% of highly cited scientists in the world. Dr. Hegele has contributed to national clinical practice guidelines for lipids, blood pressure and diabetes, and to international guidelines on familial hypercholesterolemia and hypertriglyceridemia. He has trained many physicians, medical students and graduate students. Dr. Hegele obtained his medical doctorate from the University of Toronto.

Kevin C Maki, PhD, CLS, FNLA, FTOS, FACN

Kevin C Maki, PhD is the Founder and Chief Scientist for Midwest Biomedical Research (Chicago, Illinois) and MB Clinical Research (Boca Raton, Florida). He specializes in the design and conduct of clinical studies in human nutrition, metabolism and chronic disease risk factor management. Dr Maki also holds an Adjunct Faculty position teaching Biostatistics and Applied Epidemiology at DePaul University. He is a Fellow of the National Lipid Association, The Obesity Society and the American College of Nutrition, as well as a certified Clinical Lipid Specialist and Vice President of the Board of Governors for the Accreditation Council for Clinical Lipidology. Dr. Maki has participated in more than 300 clinical trials and observational studies as an investigator, consultant or statistician, and published more than 250 scientific papers, books and book chapters. He earned a PhD in Epidemiology from the University of Illinois at Chicago's School of Public Health, and an MS in Preventive and Rehabilitative Cardiovascular Health from Benedictine University.

Dr. Dariush Mozaffarian

Dariush Mozaffarian is a cardiologist, Dean and Jean Mayer Professor at the Tufts Friedman School of Nutrition Science and Policy, and Professor of Medicine at Tufts Medical School. As one of the top nutrition institutions in the world, the Friedman School's mission is to produce trusted science, future leaders, and real-world impact. Dr. Mozaffarian has authored nearly 400 scientific publications on dietary priorities for obesity, diabetes, and cardiovascular diseases, and on evidence-based policy approaches to reduce these burdens in the US and globally. He has served in numerous advisory roles including for the US and Canadian governments, American Heart Association, World Health Organization, and United Nations. His work has been featured in a wide array of media outlets including the New York Times, Washington Post, Wall Street Journal, National Public Radio, and Time Magazine. In 2016, Thomson Reuters named him as one of the World's Most Influential Scientific Minds. Dr. Mozaffarian received a BS in biological sciences at Stanford (Phi Beta Kappa), MD at Columbia (Alpha Omega Alpha), residency training in internal medicine at Stanford, and fellowship training in cardiovascular medicine at the University of Washington. He also received an MPH from the University of Washington and a Doctorate in Public Health from Harvard. Before being appointed as Dean at Tufts in 2014, Dr. Mozaffarian was at Harvard Medical School and Harvard School of Public Health for a decade and clinically active in cardiology at Brigham and Women's Hospital. He is married, has three children, and actively trains as a Taekwondo Black Belt (third degree). The Friedman School pursues cutting-edge research and education across five Divisions, several centers, and multiple academic programs. Areas of focus range from cell to society, including: molecular nutrition, human metabolism and clinical trials, nutrition data science, behavior change, community and organizational interventions, media and communication, agriculture, food systems, and sustainability, hunger and food security, humanitarian crises, and food economics and policy. Friedman School graduates are leaders in academics, US and international government, policy, advocacy, industry, public health, community service, and innovation and entrepreneurship. The School's unique breadth, engagement with the world, and entrepreneurial spirit make it a leading institution for nutrition education, research, and public impact.

GTX-101 Scientific Advisory Board

Professor of Anesthesiology, Neurology, Oncology and Psychiatry at University of Rochester School of Medicine and Dentistry

Director, Anesthesiology Clinical Research Center

Professor of Neurology at Harvard Medical School

Director, Center for Autonomic and Peripheral Nerve Disorders at Beth Israel Deaconess Medical Center

CEO, Analgesic Solutions

Clinical Associate Professor of the Department of Anesthesiology at Wake Forest University School of Medicine

President, World Institute of Pain

Chief Scientific Officer, Lotus Clinical Research

Professor of Anesthesia, at UCSF School of Medicine

Senior Scientist and Scientific Director of the California Pacific Medical Center Research Institute

GTX-102 Scientific Advisory Board

Professor of Pathology and Laboratory Medicine and Professor in Residence of Human Genetics at UCLA Geffen School of Medicine

Scientific Director, Ataxia-Telangiectasia Medical Research Foundation (1984-present)

Scientific Director, Neuromuscular Diseases Foundation (2006-present)

Professor Pediatrics at The Johns Hopkins University School of Medicine

Director, Immunodeficiency Clinic, Pediatric Immunology Laboratory, and Ataxia-Telangiectasia (A-T) Clinical Center, Johns Hopkins University

Professor of Neurology and Pediatrics at The Johns Hopkins University School of Medicine

Neurologist, Ataxia-Telangiectasia (A-T) Clinical Center, Johns Hopkins University

GTX-104 Scientific Advisory Board

PK Consultant and Founder Longstreth & Associates Inc