Advancing therapies for rare and underserved diseases
Benuvia Therapeutics Inc. is focused on financing and developing low-risk assets with high clinical value to improve the quality of life for patients with rare and underserved diseases.
We seek partnerships to support the late-stage development and commercialization of our pipeline. Benuvia markets SYNDROS®, our U.S. Food & Drug Administration-approved cannabinoid drug. Through our affiliate, Benuvia Manufacturing, we operate a state-of-the-art Research & Development and cGMP manufacturing facility.
We have a broad pipeline of clinical stage product candidates targeting rare and underserved diseases. Our pipeline is based on nearly a decade of clinical research across a dozen clinical studies. We seek partners to support the future development of these candidate assets through the 505(b)2 pathway.
* In the process of developing IP collaborations with external institutions.
Legacy: Investigator-Initiated Studies have been planned for Autism, Schizophrenia, cocaine dependence and anxiety in Anorexia and Bipolar Disorder
- Clinical Study Report I NS011-15-054, “A Phase 2 Open-Label Study to Assess the Efficacy and Safety of Cannabidiol Oral Solution for the Treatment of Refractory Infantile Spasms with Optional Long-Term Safety” – May 23, 2017
* The clinical trials were previously conducted under sponsored collaborations with external institutions.
- Canadian Institutes of Health Research
- Children’s Hospital of Philadelphia
- Johns Hopkins University
- Miami Children’s Hospital
- National Institutes of Health
- Rady Children’s Hospital-San Diego
- University of Kansas Medical Center
- UC San Diego School of Medicine
- UCLA Semel Institute for Neuroscience and Human Behavior, David Geffen School of Medicine
- University of California San Francisco Medical Center
- University of Chicago Medical Center
- University of Montreal
Our products are manufactured by our affiliate, Benuvia Manufacturing. The business has 83,000 square feet of state-of-the-art Research & Development and cGMP manufacturing facility in Round Rock, Texas. Benuvia Manufacturing’s facilities are U.S. Food & Drug Administration and U.S. Drug Enforcement Administration registered production sites, and are fully regulated and compliant with both agencies’ requirements. You can learn more about our approved products below.
SYNDROS® (dronabinol) oral solution, CII, 5 mg/mL is a prescription medicine approved by the U.S. Food and Drug Administration (FDA) to help improve nausea and vomiting caused by anti-cancer medicine (chemotherapy) in adults whose nausea and vomiting have not improved with usual anti-nausea medicines and loss of appetite (anorexia) in adults with AIDS (Acquired Immune Deficiency Syndrome) who have lost weight.
Todd C. Davis has more than 30 years of operational and investment experience in the pharmaceutical and life science industries. He has led over $3 billion in healthcare deals including growth equity, structured debt and royalty acquisitions throughout his career. Mr. Davis has also led, structured and closed more than 40 intellectual property licenses, as well as hybrid royalty-debt deals. Prior to Benuvia, he held senior leadership roles at RoyaltyRx Capital, Healthcare Royalty Partners and Apax Partners. Previously, he held general management, business development, and licensing roles at Elan Pharmaceuticals and commercial and operational roles at Abbott Laboratories.
Mr. Davis is a Navy veteran, holds an MBA from Harvard University, and a BS from the U.S. Naval Academy. He currently serves on the board of BioDelivery Sciences International, Ligand Pharmaceuticals and Palvella Therapeutics.
Dr. Thrimoorthy Potta has over 15 years of branded and generic pharmaceutical product development leadership experience across a broad range of technologies and dosage forms. As Benuvia’s VP, Research & Development, he leads all operations in the development of liquid orals, sublingual sprays, intranasal sprays, inhalation aerosols, and solid dosage forms, from inception to product launch. Dr. Potta’s team has launched several drug products and managed the submission of several INDs and NDAs. Prior to Benuvia, Dr. Potta held R&D leadership positions at some of the most successful generic pharmaceutical companies, including Sun Pharmaceutical Industries Ltd. and Gland Pharma, Ltd. He has authored and co-authored more than 20 peer-reviewed publications and has several patents. Dr. Potta earned his Masters in Pharmaceutical Chemistry, his Ph.D. in Pharmaceutics and conducted his post-doctoral research in Chemical Engineering at Arizona State University. He serves as an Editorial Advisory Board Member of Recent Patents on Drug Delivery & Formulation.
Karon J. Morell’s professional career spans over 50 years with 27 of them in executive leadership roles in the biotech, tissue, medical and pharmaceutical industries. Ms. Morell has deep compliance, clinical, regulatory, quality affairs, manufacturing, and technical operational expertise. Over the course of her career, she has successfully led diverse teams globally, achieved international agency product and facility approvals and has never received a U.S. FDA or International FDA inspection observation or finding.
Prior to Benuvia, Ms. Morell held senior positions in compliance, regulatory, quality affairs and operations for Suneva Medical and its predecessor company for 12 years. During her tenure at the firm, Ms. Morell was responsible for the oversight of the company’s California corporate manufacturing facility for Artefill (now Bellafill) and its German facility which produced the critical raw component Polymethyl methacrylate (PMMA). Previously, Ms. Morell served as VP of Compliance, Regulatory, Quality Systems, Assurance & Control and as Tissue Bank Director at IsoTis Orthobiologics (now Integra LifeSciences). At IsoTis, she was instrumental in re-classifying some of the company’s biological human tissue products as medical devices. Prior to IsoTis, she held senior quality and regulatory roles at Medegen Medical Products, Nobel Biocare and Newport Medical Instruments.
Ms. Morell received a BS in Business Management from Southern California University.
Clinical Advisory Board
- Orphan Drug Development Executive
- 18 years of experience in clinical development, regulatory, development, nonclinical, and supply chain
- Exemplary record advancing products from development to regulatory approvals globally
- Senior Vice President & Company Officer, Dova Pharmaceuticals
- Vice President, United Therapeutics Corp – managed preclinical, Phase I, 2 and 3 studies
- Doctor of Pharmacy, University of Michigan, Ann Arbor
- Post Doctorate and Fellowship at UNC, Chapel Hill
- Pediatric Medical Neurologist
- Associate Professor of Neurology & Clinical Associate Professor of Pediatrics, Tulane University School of Medicine
- Merck – regulatory expertise; Baxter Global Pharmacovigilance – 3 years in clinical development with Phase 3 trials
- Lundbeck – oversaw Phase 3 trials in epilepsy; Takeda – led studies in epilepsy and rare genetic syndromes
- Expert reviewer for the EU Commission. author of several peer reviewed articles as well as the book “Is My Brain Broken?”, a guidebook for children with neurologic disorders
- PhD Molecular Biology, UCLA
- Post doctorate fellowships in neuroscience at Max-Planck-Institüt, Stanford, and Peripheral Nerve Center, Mayo
- MD, Mayo Medical School with residency in Child Neurology at Mayo Graduate School