Advancing therapies that address unmet medical needs

About Benuvia

Benuvia Therapeutics Inc. is a pharmaceutical company focused on developing and commercializing novel therapies for rare diseases.

We are committed to developing therapies that have the potential to improve the quality of life for children and adults with unmet medical needs. Our pipeline is based on nearly a decade of clinical research involving more than two hundred patients across a dozen clinical studies.

Pipeline

We have a broad pipeline of clinical stage product candidates targeting rare and orphan diseases including rare seizures and Prader–Willi syndrome. Our lead product candidate has proven to be generally safe and well tolerated in both acute and long-term use with preliminary evidence showing its effectiveness in multiple therapeutic areas1.

Infantile Spasms

  • discovery
  • non-clinical
  • phase 1
  • phase 2
  • phase 3

Childhood Absence Epilepsy

  • discovery
  • non-clinical
  • phase 1
  • phase 2
  • phase 3

Prader-Willi Syndrome

  • discovery
  • non-clinical
  • phase 1
  • phase 2
  • phase 3

Opioid Dependence

  • discovery
  • non-clinical
  • phase 1
  • phase 2
  • phase 3

Rare Pediatric Epilepsy

  • discovery
  • non-clinical
  • phase 1
  • phase 2
  • phase 3
  1. 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.

Regulatory milestones

Research Collaborations:

  • 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

Products

Our products are manufactured by Benuvia Manufacturing. The company has over 100,000 square feet of state-of-the-art research, development and manufacturing space across two cGMP facilities in Chandler, Arizona and Round Rock, Texas. Benuvia Manufacturing’s facilities are DEA and FDA registered production sites and are fully regulated and compliant with all DEA, EPA, and OSHA 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.

Management Team

Todd C. Davis

Executive Chairman

Todd C. Davis has more than 30 years of operational...

 

Todd C. Davis

Position: Executive Chairman

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.

Rupert Haynes

Chief Operating Officer

Rupert Haynes has more than 25 years of pharmaceutical and...

 

Rupert Haynes

Position: Chief Operating Officer

Rupert Haynes has more than 25 years of pharmaceutical and orphan disease experience. He has held senior marketing and commercial leadership roles at large pharmaceutical and small biotech companies in the United States and Europe. His expertise includes both early and late-stage pipeline development and clinical development and formulations.

Prior to Benuvia, Mr. Haynes served as Head of Global Marketing at GW Pharmaceuticals. In this role, Mr. Haynes oversaw the strategic development of the company’s cannabinoid portfolio with a focus on neurological, neurodegenerative and neuropsychological conditions. At GW, Mr. Haynes was also responsible for the strategic planning & development of Epidiolex®, an FDA-approved cannabidiol, for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome. Previously, he held senior commercial leadership positions at Sobi, UCB Pharma, Bristol-Myers Squibb Ltd, UK, and Pharmacia & Upjohn Ltd, UK. Mr. Haynes received a B.Sc from Oxford Brookes University.

Thrimoorty Potta

VP, Research & Development

Thrimoorty Potta has more than 15 years of extensive product...

 

Thrimoorty Potta

Position: VP, Research & Development

Thrimoorty Potta has more than 15 years of extensive product development experience in both branded and generic pharmaceuticals across a broad range of technologies and dosage forms. As 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 the product launch. Mr. Potta’s team has launched several drug products and handled the submission of several IND’s and NDA’s. Prior to Benuvia, Mr. 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. Mr. Potta received a Master’s in pharmaceutical chemistry and a PhD in pharmaceutics and post-doctoral research in chemical engineering from Arizona State university. He serves as an Editorial Advisory Board Member of Recent Patents on Drug Delivery & Formulation.

Karon J. Morell

Compliance, Technical Operations Advisor

Karon J. Morell’s professional career spans over 50 years with...

 

Karon J. Morell

Position: Compliance, Technical Operations Advisor

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

Kevin Laliberte, Pharm.D

  • 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

Kevin Laliberte, Pharm.D

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...

Deborah Lee, MD, PhD

  • 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

Deborah Lee, MD, PhD

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...

Contact Us

Benuvia Therapeutics Inc.

444 South Ellis Street
Chandler, AZ 85224
info@benuvia.com

For General Inquiries:

(480) 581-1385

For Product Information or to Report a Product Complaint or Adverse Event:

(844) 558-8289 or
MedInfo.Benuvia@apcerls.com

For Partnering:

If you are interested in initiating partnering discussions with the Benuvia team, please email partnering@benuvia.com

For Media:

media@benuvia.com