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Nutriband Inc. (NASDAQ: NTRB)
Nutriband Inc. (NASDAQ: NTRB) is engaged in the development of a portfolio of transdermal pharmaceutical products. The company's AVERSA™ technology can be incorporated into any transdermal patch and includes aversive agents to prevent abuse, diversion, misuse and accidental exposure to drugs with abuse potential, specifically opioids.
AVERSA technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, such as fentanyl, while making sure that these drugs remain accessible to patients who need them. The technology is covered by a broad intellectual property portfolio with patents granted in the United States, Europe, Japan, Korea, Russia, Canada, Mexico and Australia.
The company's business model is to apply its transdermal technology to existing FDA-approved drugs with a goal of improving safety, efficacy and patient comfort while qualifying for a limited-development regulatory pathway that reduces the number of clinical trials required for approval of new drugs.
Nutriband has three subsidiaries, including 4P Therapeutics, its clinical and regulatory subsidiary; Pocono Pharmaceutical, a contract manufacturer for a wide range of clients; and Active Intelligence, a developer of sports recovery products. This ownership of manufacturing and clinical development capabilities drastically reduces costs for AVERSA and other technologies.
In April 2024, Nutriband announced that the company had been engaged by and received a first order from Fit For Life Group, a major brand license holder. A fully executed supplier agreement is expected to follow. Nutriband's wholly owned Active Intelligence subsidiary will act as manufacturer.
The company is headquartered in Orlando, Florida.
Products
Nutriband's lead product candidate is AVERSA Fentanyl, an abuse-deterrent fentanyl transdermal patch. The company announced in March 2024 that it will submit a New Drug Application to the U.S. Food and Drug Administration seeking approval to market AVERSA Fentanyl.
Nutriband has partnered with Kindeva Drug Delivery, a leading global contract development and manufacturing organization, to incorporate Nutriband's AVERSA abuse-deterrent transdermal technology into Kindeva's FDA-approved transdermal fentanyl patch system. Because Nutriband's abuse-deterrent technology is incorporated into the fentanyl patch but is physically separate from and does not come in contact with the drug layer, the clinical trials typically needed to demonstrate safety and efficacy for a new drug formulation would not be required.
AVERSA Fentanyl has the potential to be the first and only abuse deterrent patch approved anywhere in the world. The company plans to seek an expedited review by the FDA, as has been granted for certain abuse-deterrent oral opioid products, which shortens the regulatory review period to six months from the conventional 10-month FDA review cycle for NDAs.
Nutriband's AVERSA product development pipeline also includes abuse deterrent versions of currently approved and marketed transdermal patches containing buprenorphine, an opioid used to treat opioid use disorder, and methylphenidate, a central nervous system stimulant used in the treatment of attention deficit hyperactivity disorder (ADHD). Both are labeled with FDA-required warnings for the risk of abuse and misuse, as well as warnings against accidental exposure.
Market Opportunity
Nutriband cites a market analysis report from Boston-based Health Advances, a healthcare and life sciences consulting firm. According to the report, upon FDA approval, AVERSA Fentanyl has the potential to reach peak annual sales of $200 million in the U.S.
The company further states that, should non-abuse-deterrent transdermal fentanyl products lose FDA marketing approval, AVERSA Fentanyl would have greater pricing flexibility and would have the potential to generate more than $500 million in annual revenue.
Management Team
Gareth Sheridan is Co-Founder and CEO of Nutriband. He was Ireland's 'Young Entrepreneur of the Year' in 2014 for establishing Nutriband. He has worked as a Business Mentor with 100 Minds, a social enterprise that brings together some of Ireland's top college students and connects them with a cause to achieve large charitable goals. He received a B.Sc. in Business and Management from Dublin Institute of Technology.
Serguei Melnik is Co-Founder and President of Nutriband. He has been involved in general business consulting for companies in the U.S. financial markets and setting up legal and financial frameworks for operations of foreign companies in the U.S. He previously was the COO of Florida-based Asconi Corporation. He also was a lawyer in the Department of Foreign Affairs, JSC Bank "Inteprinzbanca," in Chisinau, Moldova, and prior to that practiced law in Moldova. He is fluent in four languages.
Jeff Patrick, Pharm.D., is Chief Scientific Officer of Nutriband. He currently serves as Director of the Drug Development Institute at the Ohio State University Comprehensive Cancer Center. His prior roles included Global Vice President at Mallinckrodt Pharmaceuticals Inc.; and roles at Dyax, Myogen/Gilead, Actelion and Sanofi-Synthelabo Inc. He was a clinical pharmacist at the University of Tennessee Medical Center and a clinical assistant professor of pharmacy at the University of Tennessee College of Pharmacy.
Gerald Goodman is CFO of Nutriband. He is a certified public accountant with his own firm, Gerald Goodman CPA. He also practiced with Madsen & Associates, CPAs, and was a partner in the accounting firm of Wiener, Goodman & Company. He is also a director of Lifestyle Medical Network Inc., which provides management services to healthcare providers. He is a graduate of Pennsylvania State University, where he received a bachelor's degree in accounting.
Investment Considerations
- Nutriband's AVERSA technology has the potential to improve the safety profile of transdermal drugs susceptible to abuse, like fentanyl, while keeping these drugs accessible to patients.
- AVERSA technology can be incorporated into any transdermal patch.
- The company has a broad intellectual property portfolio protecting AVERSA, with patents granted in the U.S., Europe, Japan, Korea, Russia, Canada, Mexico and Australia.
- Nutriband announced in March 2024 that it will submit a New Drug Application to the FDA seeking approval to market AVERSA Fentanyl, its abuse-deterrent fentanyl transdermal patch.
- In April 2024, the company announced it had received a contract manufacturing order from Fit For Life Group, with a supplier agreement to follow.
Nutriband Inc. (NASDAQ: NTRB)
