Fidelis Animal Health
Committed to providing high-quality animal welfare solutions
Fidelis Animal Health, Inc., offers exceptional expertise in the acquisition, development, and marketing of unique pharmaceutical formulations that meet specialized veterinary needs.
Fidelis Animal Health is a privately held U.S.-based company serving the world from the Northeast pharmaceutical corridor:
- Company headquarters is located in New Jersey.
- Supply chain sources and manufacturing sites and operations are in full compliance with current Good Manufacturing Practices (cGMPs) regulated by the FDA and DEA.
- Dedicated to providing products that are indexed by the FDA.
Management Team
An experienced team of pharmaceutical professionals from all areas of business expertise lead day-to-day operations at Fidelis. Our leaders are committed to delivering innovative, high-quality pharmaceutical solutions to fulfill specialized veterinary needs that protect animal welfare and meet the highest standards of care.
Michael Wells
Chairman and Chief Executive Officer
Michael Wells has had a long and distinguished career as an entrepreneur, healthcare investor and chief executive. He is the founder and Managing Director of Princeton Biopharma Capital Partners which he created for the purpose of providing growth capital to emerging health care companies. He is also the acting Chairman and CEO of Fidelis Animal Health and non-executive Chairman of Kaleo, both portfolio companies of Princeton Biopharma Capital. Prior to creating his investment company, he was the founder and CEO of Aton Pharma, a pharmaceutical company focused on rare diseases. For his part in creating and growing this company he was named an Ernst & Young Entrepreneur of the Year in 2009 and in 2010 the company was acquired by Valeant Pharmaceuticals. After selling Aton Pharma, he partnered with Cerberus Capital Management and invested in Covis Pharma Sarl where he was a board member for five years. In 2020, Covis was sold to Apollo. His career began at Merck & Co. where he held a range of sales and marketing positions over eight years.
Cynthia Davis
Chief Financial Officer and General Manager
With more than 20 years of experience leading financial operations for pharmaceutical and healthcare company start-ups, Cynthia is right at home directing all facets of finance, accounting, reporting, and operations at Fidelis. As she oversees Fidelis’ financial operations in this time of rapid growth, Cynthia draws on her senior-level entrepreneurial experience, most recently as principal and financial lead at TotalBio Solutions consulting for start-up lifescience and high-tech enterprise clients. Prior to that, she served as global controller for Quantum Global Technologies, experience she is drawing on as she helps Fidelis expand its reach. As vice president of finance and treasury and other senior finance positions for Discovery Laboratories, she led treasury, special-purpose financing, risk management, and facility activities. Additionally, she completed due diligence review for acquisitions and capital expenditures as the biotech company prepared for commercialization. Holding a BS degree in business administration from Delaware Valley University, Cynthia also puts her skills to good use to support local youth organizations, e.g., serving as founder and past chair of the Plumstead (PA) Baseball Association Fundraising and Sponsorships Committee.
Barry Levinson, PhD
Co-Founder, Chief Development Officer
Barry Levinson, PhD, serves as Chief Operating Officer with Fidelis Animal Health. Dr. Levinson has over 35 years of biotech and pharmaceutical industry experience combined with a distinguished scientific career. He previously served as VP Business Development at Valeant Pharma (now Bausch Health) and was a founding employee, VP Business Development and Chief Scientific Officer at Aton Pharma. At Aton, he identified and acquired several key products and put in place its international partnerships. In addition, he was responsible for recognizing opportunities to expand the application of Aton’s products to new medical uses, and spearheaded R&D programs to develop these new indications. Before Aton, Barry was Founder and President of Park Life Science Advisory, LLC, a life sciences consulting firm, and prior to that was at consulting firm CPP Advisors (now Apeiron Partners), and the Life Sciences Group at KPMG Corporate Finance, LLP, an investment bank. For the decade prior, Barry held increasingly senior positions in cardiovascular research and then in business development at Berlex Laboratories, the US subsidiary of Schering A.G. (now Bayer Healthcare Pharmaceuticals). He began his corporate career at biotech startup Ecogen, where he founded its Protein Biochemistry Group, and served as the company’s Radiation Safety Officer. Dr. Levinson received his PhD and Master’s degrees in Molecular Biophysics and Biochemistry from Yale University, and was granted his Bachelor of Arts, with highest honors, in Biochemistry from Princeton University. He serves on the Fidelis Board of Directors as well as that of Covis Pharmaceuticals, and is a Managing Director of Princeton Biopharma Capital Partners.
Susan Witham
Senior Vice President, Regulatory Affairs and Quality
If there ever was a one-source expert for all matters related to pharmaceutical regulatory affairs, quality assurance/quality control, and working with the FDA, Susan Witham is it. Bringing 30+ years of experience in these areas, Susan leads the Fidelis team through all facets of regulatory compliance and quality. Susan has a strong track record of successful new product applications and has advised a number of companies in regulatory-related matters. Her accomplished pharmaceutical career includes a variety of senior executive roles in regulatory and quality at Kremers Urban Pharmaceuticals (now Lannett), Shionogi Inc, and Adams Respiratory Therapeutics, as well as positions with Columbia Labs, Aventis Pharmaceuticals, Johnson & Johnson Consumer Products, and Novartis. Her expertise and guidance are instrumental as Fidelis continues to develop and expand our pharmaceutical-grade pain management solutions in animal health and welfare. In her role at Fidelis, Susan finds it rewarding to guide the approval of high-quality products that make it easier for research institutions to comply with the latest regulatory guidelines in animal care as well.
Steven Leary, DVM
Chief Medical Officer
Steven Leary, DVM, DACLAM, serves as Chief Medical Officer with Fidelis Animal Health. He received his DVM from Iowa State University and postdoctoral training in laboratory animal medicine and comparative pathology from Johns Hopkins University. Dr. Leary has 40 years’ experience, including serving as director at the University of Alabama at Birmingham and Washington University in St. Louis. He served on the AAALAC Council, as president of ACLAM, and as chair of the AVMA Animal Welfare Committee and Panels on Euthanasia, Humane Slaughter, and Depopulation. He is past recipient of the ISU Stange Award, Charles River Prize, and AALAS Griffin and Nathan R. Brewer awards.
Fidelis Pharmaceuticals Delivers Unique and Innovative Veterinary Pharmaceuticals to Address Unmet Animal Health Needs
Leaders in Long-Acting Pain Management
Fidelis Animal Health is committed to researching and developing new, cutting-edge solutions for animal health.
- Ethiqa XR® is our first FDA-indexed innovation (900-014)
- View Ethiqa XR Product Labeling
BOXED WARNING
Abuse Potential
ETHIQA XR contains buprenorphine, an opioid that exposes humans to risks of misuse, abuse, and addiction, which can lead to overdose and death. Use of buprenorphine may lead to physical dependence. The risk of abuse by humans should be considered when storing, administering, and disposing of ETHIQA XR. Persons at increased risk for opioid abuse include those with a personal or family history of substance abuse (including drugs or alcohol) or mental illness (e.g., depression).
Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with accidental exposure to or with misuse or abuse of ETHIQA XR. Monitor for respiratory depression if human exposure to buprenorphine occurs. Misuse or abuse of buprenorphine by swallowing, snorting, or injecting poses a significant risk of overdose and death.
Accidental Exposure
Because of the potential for adverse reactions associated with accidental exposure, ETHIQA XR should only be administered by veterinarians, veterinary technicians, or laboratory staff who are trained in the handling of potent opioids. Accidental exposure to ETHIQA XR, especially in children, can result in a fatal overdose of buprenorphine.
Risks From Concurrent Misuse or Abuse with Benzodiazepines or Other CNS Depressants
Concurrent misuse or abuse of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
See HUMAN SAFETY WARNINGS for detailed information.
Important Safety Information
For Rats, Mice, and Ferrets:
Only administer Ethiqa XR® by subcutaneous injection. Ethiqa XR is not intended for intravenous, intra-arterial, intrathecal, intramuscular, or intra-peritoneal injection. Do not use in animals with pre-existing respiratory compromise.
Do not house rats on wood chip-type bedding after administration of Ethiqa XR. Pica involving wood chip type bedding can be lethal.
Ethiqa XR may cause sedation, decreased blood pressure, decreased heart rate, decreased gastrointestinal mobility, and respiratory depression. Use caution with concomitant administration of Ethiqa XR with drugs that cause respiratory depression. Animals should be monitored for signs of decreased cardiovascular and respiratory function when receiving Ethiqa XR.
The safety of Ethiqa XR has not been evaluated in pregnant, lactating, neonatal, or immune-compromised animals.
For Humans:
Not for use in humans. Keep out of reach of children and pets.
Ethiqa XR contains buprenorphine, a Schedule III controlled substance with an abuse potential similar to other Schedule III opioids, which may lead to overdose and death.
Ethiqa XR should be handled appropriately to minimize the risk of misuse, abuse, addiction, and criminal diversion, including restriction of access, the use of accounting procedures, and proper disposal methods as appropriate to the laboratory setting and as required by law.
Ethiqa XR should only be handled and administered by a veterinarian, veterinarian technician, or laboratory staff trained in the handling of potent opioids. Wear protective clothing when administering Ethiqa XR to avoid direct contact with human skin, eyes, oral, or other mucus membranes which could result in absorption of buprenorphine and adverse reactions.
For more information, consult the Prescribing Information including the Boxed Warning.