Our core mission:Conquering the threat of antibiotic resistance
Antibiotic resistance is on the rise. New resistant strains of common bacteria are emerging and spreading globally. As a result, morbidity, mortality, and healthcare costs are all increasing.1 UTILITY therapeutics is dedicated to identifying, developing, and launching effective antibiotic treatment options for resistant infections.
New options are on the way to tackle treatment-resistant UTIs
Urinary tract infections (UTIs) are among the most common bacterial infections worldwide and are becoming increasingly resistant to multiple antibiotics.2,3 Multi-drug resistant strains of Escherichia coli (E coli), the most common cause of UTIs, are rapidly rising in hospital and community settings.4 Extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae are categorized as a serious threat by the Centers for Disease Control and Prevention.5
Our mission is driven by our aspirational vision: a world in which resistance is no longer an obstacle to curing infections
Antibiotic resistance in UTIs negatively impacts patient outcomes and adds significantly to the economic burden of treatment. In the outpatient setting, resistant UTIs are associated with a high rate of treatment failure, requiring additional rounds of treatment and/or hospitalization.6 Over a period of 13 years, as the rate of resistance continued to grow, the number of UTIs requiring hospitalization increased by 76%, dramatically driving up treatment costs.7
Mecillinam and its pro-drug pivmecillinam are beta-lactams with a unique mechanism of action (MOA) and very low rates of resistance. They have been available globally and are recommended as first-line treatment for UTIs.8,9 However, neither drug has been approved for use in the United States, where the rate of ESBL-producing strains of E coli has been steadily on the rise.
UTILITY therapeutics is pursuing a New Drug Application (NDA) submission to the Food and Drug Administration for pivmecillinam tablets for treatment of uncomplicated UTIs. A development program for mecillinam IV in the treatment of complicated UTIs is also underway.
Meet Our Team
Board of Directors
Alan Roemer is an entrepreneurial life sciences executive and board member who has launched 3 biotechnology companies, raised over $1.5 billion in private and public capital, and consummated 3 IPOs. Mr Roemer was a founding leadership team member of Roivant Sciences, where he served in various senior management roles responsible for Finance and Operations and Corporate Development. He also served as Chief Financial Officer of Axovant Sciences, a Roivant subsidiary. Prior to launching Roivant and Axovant, Mr Roemer was a Managing Director of the Trout Group, and he previously served as Chief Financial Officer and Treasurer of Zelos Therapeutics and was a Vice President of Pharmasset (acquired by Gilead). Mr Roemer is a Director and Audit Committee Chair of NexImmune, a Trustee of the Helene Fuld College of Nursing, and a Management Committee Member of DC Brau Brewing. He previously served as a director of SomPharmaceuticals (acquired by Amryt Pharma).
Mr Roemer received a BSBA from Georgetown University and MBA and MPH degrees from Emory University’s Goizueta Business School and Rollins School of Public Health.
Morten Sommer, PhD, is the co-founder of several biotech companies working within fields of drug development, industrial biotechnology, and microbiome research. Dr Sommer is also a Professor and Scientific Director at the Technical University of Denmark with a lab of 20+ PhDs and postdoctorates working primarily in the field of antibiotic resistance and the human microbiome. Dr Sommer is the inventor on 20+ issued patents and patent applications and author of scientific papers in journals such as Science, Cell, and Nature. In 2017, Dr Sommer earned the honor of being named a “Top 10 under 40 in Biopharma Research and Business” by Genetic Engineering and Biotechnology News.
Dr Sommer holds a PhD in Biophysics from Harvard University from the laboratory of Professor George Church.
Rasmus Toft-Kehler, PhD, is the CEO of AntibioTx and the co-founder and board member of multiple biotech companies. Prior to entering biotech, Dr Toft-Kehler worked in mergers and acquisitions (Goldman Sachs and Gudme Raaschou), management consulting (Booz Allen Hamilton), and as a board member for a family owned enterprise until it was successfully sold in 2005. Dr Toft-Kehler is the inventor of 5+ patents and is currently completing a quantitative PhD on serial entrepreneurship. His research has been published in leading scientific and entrepreneurship journals such as Nature Reviews Microbiology and the Journal of Business Venturing.
Dr Toft-Kehler holds a business degree from New York University and Copenhagen Business School and an executive degree from Harvard Business School.
Andrew Davis has served as the Chief BD/M&A Officer at iNova Pharmaceuticals since September 2017, leading all company transactions and serving as a member of the company’s executive team. In 2016, Mr Davis served as the Head of Oncology Business Development at Merck. Prior to Merck, Mr Davis served as the SVP of Business Development at Valeant Pharmaceuticals (now Bausch Health Companies), a global pharmaceutical, consumer products, and medical device company, where he led all business transactions from 2014 to December 2016. Before that, Mr Davis held positions of increasing responsibility within the Business Development function within Valeant Pharmaceuticals. Prior to joining Valeant, he served as a management consultant at McKinsey & Co. focused on the healthcare space from 2007 to 2012.
Mr Davis received his BA in Economics from Boston University in Boston, Massachusetts.
Larry Edwards has served as a Director, President, and Chief Executive Officer of La Jolla Pharmaceutical Company since 2020. From 2015 to 2020, he served in various positions at Tetraphase Pharmaceuticals, Inc., most recently serving as Chief Executive Officer. Previously, Mr Edwards served as Senior Director of Marketing of the Gram-negative Franchise of Cubist Pharmaceuticals, Inc. (acquired by Merck), and multiple ascending leadership roles during more than 15 years at Merck. Mr Edwards also serves on the board of directors at Clarametyx Biosciences.
Mr Edwards received a BS degree in business and healthcare administration from Ohio University.
Anders Kronborg has been serving as Executive Vice President of Global Finance and Business Services, IT and Legal, at LEO Pharma A/S since October 1, 2015. Mr Kronborg has more than 20 years of senior financial management experience. His focus was on the operating and financial development of Kinnevik’s portfolio of companies. He started his career with the Kinnevik group in 2007. Mr Kronborg served as the Chief Financial Officer at Metro International S.A. from September 2008 to April 2012, and served as the Chief of Staff until September 2008 and Executive Vice President since 2007. He joined Metro International S.A. in December 2007. He served as the Chief Executive Officer and President at Metro International S.A. Prior to Metro, he gained extensive experience from the financial operations of media businesses. He served as the Chief Financial Officer at TV 2 | Danmark A/S and held numerous executive positions with Berlingske Media (Berlingske Tidende). He served as Chief Financial Officer at DR, the Danish Broadcasting Corporation. He was also associated with Berlingske Media A/S. He is a Member of the Board of Metro International. He served as a Non-Executive Director of Black Earth Farming Limited. Mr Kronborg served as a Non-Executive Director of Millicom International Cellular SA from December 2012 to May 2013.
Mr Kronborg holds a Master of Science in Economics from Copenhagen University.
Leadership Team
UTILITY therapeutics is led by a strong team of industry leaders highly experienced in the launch and commercialization of anti-infectives in the United States and abroad
Tom Hadley is the President and Chief Executive Officer of UTILITY therapeutics and has 30 years of experience commercializing drugs and devices with both multinational and start-up pharmaceutical companies. He has extensive experience in preparing and executing numerous highly successful commercial launches across multiple therapeutic areas spanning both primary care and specialty markets in the United States and globally. Most recently, Mr Hadley served as Head of Market Strategy/Development at EyePoint Pharmaceuticals where he also led marketing and sales. Before joining EyePoint, Mr Hadley served as the GVP, General Manager of the Primary Business Unit at Horizon Pharmaceuticals. Prior to Horizon, Mr Hadley was Head of Marketing for Salix Pharmaceuticals, a business unit of Bausch Health. While at Bausch, he also served as VP of Marketing for Dermatology.
Mr Hadley received his BS in Marketing from Seton Hall University in South Orange, New Jersey.
Lutz Wevelsiep, PhD, is the Vice President of Regulatory Affairs at UTILITY therapeutics and has more than 25 years of experience in international Regulatory Affairs across Europe and the United States with multinational and start-up companies. His experience includes EU decentralized and centralized procedures, product development from phase 1 through marketing authorization, as well as particular expertise in anti-infectives. He has prepared and managed various health authority interactions with FDA, EMA, and EU national agencies. Dr Wevelsiep spent 16 years as Head of Global Regulatory Affairs at Basilea Pharmaceutica. His track record includes successful completion of the European marketing authorization applications for Isavuconazole (Cresmba®), Ceftobiprole (Zevtera®), and Alitretinoin (Toctino®).
Dr Wevelsiep holds a PhD and Postdoc in Chemistry from the Max-Planck Institute in Germany.
Anne Santerre Henriksen, PhD, is the Acting Executive Vice President of Development at UTILITY therapeutics. Dr Henriksen specializes in anti-infectives, with more than 20 years of experience in the pharmaceutical industry. Her industry experience spans medical affairs, research, clinical development, scientific communication, and business development. Dr Henriksen serves as the medical expert for phase 1 and phase 2 clinical trials and has conducted extensive work on evaluation of microbiological data and microbiology expertise for both new and existing antibiotics. She brings significant experience in the design of clinical trials for antibiotics and analysis of results.
Dr Henriksen holds a PhD in Microbiology and Biotechnology from Institut National des Sciences Appliquées de Toulouse.
Anita Das, PhD, has more than 20 years of experience as a biostatistician. Dr Das has significant expertise in the field of anti-infective development and in-depth knowledge of clinical trial design, including determining appropriate endpoints, conduct, and analysis. She previously served in senior positions in Contract Research Organizations, the pharmaceutical industry, and academia. Dr Das has worked on more than 30 phase 2 and 3 studies of antibiotics and antifungals in acute bacterial skin and skin structure infections (ABSSSI), community-acquired bacterial pneumonia (CABP), complicated urinary tract infection, uncomplicated urinary tract infection, complicated intra-abdominal infection, resistant pathogens, nosocomial pneumonia (HAP/VAP), bacteremia, and candidemia/invasive candidiasis, leading to successful new drug applications for several antibiotics, including ceftaroline, tedizolid, dalbavancin, eravacycline, lefamulin, and omadacycline. She also has extensive experience with regulatory interactions and has participated in 7 FDA Advisory Committees. She was a member of the BioMarkers Consortium of the Foundation of the National Institutes of Health, which provided recommendations to the FDA on endpoints for ABSSSI, CABP, and HAP/VAP studies.
Dr Das has a PhD in Epidemiology from George Washington University and an MS in Statistics from the University of Maryland, Baltimore County.
Nina Aabenhus Kromann is the Acting Head of CMC at UTILITY therapeutics. Ms Kromann specializes in CMC with more than 20 years’ experience in the pharmaceutical industry. Her roles within the industry span research, development, QC, regulatory CMC, and management. Ms Kromann acts as senior CMC specialist as well as Head of CMC. She has extensive experience within both small molecules and biologics and has worked with CMC of antibiotics for the past 5 years. She brings significant experience in all aspects of CMC as well as relations to CMOs.
Ms Kromann holds a master’s degree in Biology from University of Copenhagen and has previously worked with Novo Nordisk, LEO Pharma, ALK-Abelló, Jacobsen Pharma, and MedTech Advice.
Claus Maxel Henriksen, PhD, is the Acting Head of Project Management at UTILITY therapeutics. Dr Henriksen brings more than 20 years of professional experience working within the international pharmaceutical and food ingredient industries in various line management and project management positions (Chr. Hansen A/S, Novo Nordisk A/S, F. Hoffmann-La Roche). Dr Henriksen has successfully led and managed numerous cross-disciplinary projects. He brings significant experience with business excellence and process design and optimization, as well as academic authorship of numerous journal articles in the fields of microbial physiology and metabolism.
Dr Henriksen holds a PhD in Biotechnology from Technical University of Denmark.
Peter Aksel Villadsen is a co-founder of UTILITY therapeutics and an industry executive with years of experience in strategy development, digital transformation, and business model innovation. Mr Villadsen is a Vice President and member of the Global Management Team at GN Hearing. Prior to joining GN Hearing, Mr Villadsen spent nearly 20 years working across various functional areas of the pharmaceutical industry, most recently as a Global Vice President at LEO Pharma. Mr Villadsen is also the co-founder and board member of several companies, academic advisory boards, and nonprofit initiatives.
Mr Villadsen holds a master’s degree in Economics of International Strategy and Governance as well as a bachelor’s degree in Commercial Law from Copenhagen Business School. Mr Villadsen also earned an executive degree from IMD Business School in Lausanne and has trained in health economics at Oxford University.
John Krayacich is Senior Vice President and Head of Global Business Development at LEO Pharma where he is responsible for in-licensing, out-licensing, divestments, and Mergers and Acquisitions. Prior to LEO, Mr Krayacich was Vice President, Strategic Planning and Business Development and Licensing at Novartis Pharmaceuticals Corporation. Before assuming his role at LEO, Mr Krayacich spent over 25 years with large multinational healthcare companies, including Pfizer and Warner-Lambert/Parke-Davis, where he held positions of increasing responsibility for global and in-country business development, strategic planning, project management, drug development, and sales/marketing. He also held the position of President and CEO for 2 early stage biotechnology development companies, Marinus Pharmaceuticals and Ambrose Pharmaceuticals.
Mr Krayacich earned his honors BS degree and an MS degree in Physiology, as well as an MBA from the Ivey Business School at The University of Western Ontario, Canada.
Scientific Advisory Board
Keith A. Rodvold, PharmD, received his Bachelor of Science in Pharmacy (1978) and Doctor of Pharmacy (1980) degrees from the University of Minnesota. He completed his research fellowship in clinical pharmacokinetics and pharmacology at St. Paul-Ramsey Medical Center and the University of Minnesota (1980-1981) and was a Clinical Pharmacy Specialist at St. Joseph’s Hospital in Marshfield, Wisconsin, from 1981 to 1984. Dr Rodvold was appointed as an Assistant Professor in the Department of Pharmacy Practice at the University of Illinois Chicago (UIC) in 1984, was promoted to the rank of Associate Professor with tenure in 1989, and to the rank of Professor in 1994. In 2020, Dr Rodvold was appointed the title of UIC Distinguished Professor. He is also a Professor of Pharmacy in Medicine in the College of Medicine at UIC.
Dr Rodvold is currently conducting research in the area of clinical pharmacokinetics and pharmacodynamics of anti-infective agents for infectious diseases. Dr Rodvold has authored more than 200 original research and review publications and 60 book chapters, and has edited 6 textbooks. The American College of Clinical Pharmacy presented Dr Rodvold with the 2003 Russell R. Miller Award in recognition of his sustained and outstanding contributions to the literature of clinical pharmacy. Dr Rodvold is a former member of the Anti-Infective Drug Advisory Committee and Pediatric Drug Advisory Subcommittee for the United States Food and Drug Administration. He is an active member of numerous professional societies and has been elected Fellow of the Infectious Diseases Society of America, American College of Clinical Pharmacology, and American College of Clinical Pharmacy.
Lindsay Nicolle, MD, is a Professor Emeritus in the Department of Internal Medicine at the University of Manitoba. She was previously Professor of Internal Medicine and Medical Microbiology at the University of Manitoba and a Consultant in Adult Infectious Diseases at the Health Sciences Centre and Winnipeg Regional Health Authority. She is a past Chair of the Department of Internal Medicine at the University of Manitoba and has contributed to many national and international committees including past chair of the Health Canada Nosocomial Infections Steering Committee from 1994 to 2005, past President of the Canadian Infectious Diseases Society, member of the Board for the Community and Hospital Infection Control Association and the Canadian Society for Clinical Investigation, chair of the Long Term Care Committee and Annual Meeting Planning Committee, and secretary of the Society of Health Care Epidemiology of America. She was the Editor-in-chief of the Canadian Journal of Infectious Diseases and Medical Microbiology for 20 years and is a former Chair of the Canadian Drug Expert Committee for CADTH. She is currently Chair of the University of Manitoba Biomedical Research Ethics Board and a consultant in adult infectious diseases for Manitoba Health, Seniors and Healthy Living. She is a Fellow of the Canadian Academy of Health Sciences, the Infectious Diseases Society of America, and the Society of Healthcare Epidemiology of America.
Dr Nicolle’s research interests have been in urinary tract infection, hospital-acquired infections, antimicrobial resistance, and infections in long-term care facilities, and she has published extensively in these fields. She has contributed to the development of many national and international consensus documents and practice guidelines relevant to aspects of antimicrobial resistance and infection prevention and control.
David P. Nicolau, PharmD, FCCP, FIDSA, is the Director of the Center for Anti-Infective Research and Development at Hartford Hospital in Hartford, Connecticut. After graduating from Northeastern University, he completed a residency in hospital pharmacy at Boston University Medical Center. After receiving his PharmD from the Medical University of South Carolina, Dr Nicolau completed a residency in adult internal medicine at the university’s affiliated hospital and a fellowship in Infectious Diseases at Hartford Hospital.
Dr Nicolau’s research activities involve a wide range of preclinical drug development studies to assess the in vitro potency, in vivo efficacy, and toxicity profiles of novel compounds. He has been a principal investigator for phase 1 to 4 studies, as well as Investigational New Drug Applications. Dr Nicolau is also widely recognized for his efforts focusing on the development of antimicrobial utilization strategies to improve outcomes and reduce the cost of care in infected patients. Dr Nicolau’s investigations are reported in over 800 publications, 550 abstracts, and 1200 local, national, or international presentations.
Keith Kaye, MD, MPH, is a Professor of Medicine in the Division of Infectious Diseases and Department of Medicine at University of Michigan Medical School. He is the Director of Research for the Division of Infectious Diseases. He has devoted his career to the prevention and effective management of healthcare-associated infections. In addition to serving in a variety of quality improvement and administrative roles in infection prevention, antimicrobial stewardship, and quality and patient safety, he has served on national and international clinical guidelines committees.
In addition to his clinical work, Dr Kaye’s research interests include the development of antimicrobial resistance, particularly among gram-negative organisms; prevention of healthcare-associated infections; management of hospital-acquired infections in the elderly; and innovative approaches to antimicrobial stewardship. He has a long and consistent record of federal funding for research pertaining to management and prevention of multi-drug resistant organisms and healthcare-associated infections, including groundbreaking clinical trials.
Dr Kaye received his medical degree from the University of Pennsylvania and completed his Internal Medicine residency and Infectious Diseases fellowship at Beth Israel Deaconess Medical Center in Boston, MA. During fellowship, Dr Kaye earned a Masters in Public Health from the Harvard School of Public Health. Dr Kaye has authored over 300 peer-reviewed articles and 20 book chapters and has presented original research at national and international conferences. Dr Kaye is a past President of the Society for Health Epidemiology of America (SHEA). He is a recognized expert in healthcare epidemiology and antimicrobial resistance and has been invited to speak on these topics at venues throughout the world.
Ian Friedland, MD, is currently a consultant, focusing on advising companies on early and late development of anti-infective products. He completed his general medical and pediatric training in South Africa (University of the Witwatersrand, Johannesburg) and completed his pediatric infectious disease fellowship at UT Southwestern Medical Center in Dallas. He served as the chief medical officer at Achaogen from 2014 to 2017, where he was responsible for leading the clinical development, regulatory strategy, and medical affairs functions. As CMO and consultant he led the successful filing of plazomicin. Prior to Achaogen, Dr Friedland headed the clinical development of numerous antibiotics at Cubist Pharmaceuticals. He has worked in the pharmaceutical and biotechnology industry for 20 years, at both large pharma (Merck, J&J) and several small biotech companies, leading clinical development teams of several important antibiotics and has played a pivotal role in the development and regulatory submission in the US, EU, and other regions of new drugs including ertapenem, caspofungin, doripenem, alvimipan, fidaxomicin, ceftolozane/tazobactam, and plazomicin, in addition to supporting many marketed anti-infective agents. He is a frequent participant in FDA/FNIH/PhRMA infectious disease working groups. He is an author on over 100 peer-reviewed journal articles and book chapters.
Thomas Lodise, PharmD, PhD, is a Professor at Albany College of Pharmacy and Health Sciences, Albany, New York. He is also an infectious diseases clinical pharmacy specialist at the Stratton VA Medical Center, Albany, New York. Integrating his dual interests in research and patient care, his overall research goal is to quantitatively enhance our current understanding of antimicrobial exposure-response relationships in patients with invasive bacterial infections. His research encompasses 3 interrelated domains: pharmacokinetics (PK)/pharmacodynamics (PD), epidemiology, and outcomes. He has published over 190 peer-reviewed articles in numerous medical and pharmacy journals. He is a scientific editor for Pharmacotherapy and is an editorial board member for Antimicrobial Agents and Chemotherapy, Open Forum Infectious Diseases, Antibiotics, and Diagnostic Microbiology and Infectious Diseases. He is the current chair of the PK Special Emphasis Panel for the Antibacterial Resistance Leadership Group (ARLG) (https://arlg.org), an initiative funded by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH).
Jason Pogue, PharmD, is a Clinical Professor in the Department of Clinical Pharmacy at the University of Michigan College of Pharmacy and an Infectious Diseases Clinical Pharmacist at Michigan Medicine. Prior to this position he spent just over a decade at the Detroit Medical Center (DMC) as an Infectious Diseases Clinical Pharmacist at Sinai-Grace Hospital and as the co-chair of the Antimicrobial Stewardship Committee at the DMC.
Dr Pogue received a bachelor degree in Chemistry from Gannon University, before obtaining his doctor of pharmacy degree from the University of Pittsburgh. He then completed a PGY-1 pharmacy residency at the University of Pittsburgh Medical Center followed by an Infectious Diseases PGY-2 Residency at the University of Michigan Health Systems. His research interests focus on epidemiology and management of multi-drug resistant gram-negative organisms and antimicrobial stewardship.
Dr Pogue is a recognized leader in gram-negative resistance and antimicrobial stewardship as evidenced by his significant contribution of over 100 peer-reviewed articles, over 100 abstracts, multiple book chapters, and presentations at numerous national and international conferences. Dr Pogue is the immediate past president of the Society of Infectious Diseases Pharmacists (SIDP) and is an executive committee member of The United States Committee on Antimicrobial Susceptibility Testing (USCAST) where he is intimately involved with antimicrobial susceptibility breakpoint setting.
References: 1. Antibiotic resistance. World Health Organization. July 2020. Accessed January 12, 2021. https://www.who.int/news-room/fact-sheets/detail/antibiotic-resistance 2. Flores-Mireles AL, Walker JN, Caparon M, Hultgren SJ. Urinary tract infections: epidemiology, mechanisms of infection and treatment options. Nat Rev Microbiol. 2015;13(5):269-284. doi:10.1038/nrmicro3432 3. Critchley IA, Cotroneo N, Pucci MJ, Mendes R. The burden of antimicrobial resistance among urinary tract isolates of Escherichia coli in the United States in 2017. PLoS One. 2019;14(12):e0220265. doi:10.1371/journal.pone.0220265 4. Lob SH, Nicolle LE, Hoban DJ, Kazmierczak KM, Badal RE, Sahm DF. Susceptibility patterns and ESBL rates of Escherichia coli from urinary tract infections in Canada and the United States, SMART 2010-2014. Diagn Microbiol Infect Dis. 2016;85(4):459-465. doi:10.1016/j.diagmicrobio.2016.04.022 5. Antibiotic resistance threats in the United States 2019. Centers for Disease Control and Prevention. December 2019. Accessed January 18, 2021. https://www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf 6. Dunne MW, Snow K, Mehta R. Failure of empiric treatment of uncomplicated urinary tract infection (UTI) associated with resistant pathogens. Poster presented at: American Society of Microbiology and Infectious Diseases; June 20-24, 2019; San Francisco, CA. 7. Simmering JE, Tang F, Cavanaugh JE, Polgreen LA, Polgreen PM. The increase in hospitalizations for urinary tract infections and the associated costs in the United States, 1998-2011. Open Forum Infect Dis. 2017;4(1):ofw281. doi:10.1093/ofid/ofw281 8. Spratt BG. The mechanism of action of mecillinam. J Antimicrob Chemother. 1977;3(suppl B):13-19, 21-22. doi:10.1093/jac/3.suppl_b.13 9. Dewar S, Reed LC, Koerner RJ. Emerging clinical role of pivmecillinam in the treatment of urinary tract infection in the context of multidrug-resistant bacteria. J Antimicrob Chemother. 2014;69(2):303-308. doi:10.1093/jac/dkt368