- AVERSA Fentanyl has potential to become the world’s first opioid pain patch with abuse deterrent properties, CEO states in report
- Nutriband and Kindeva Drug Delivery have formalized a strong product-development partnership and long-term commitment
- Other key steps outlined as company works to develop, scale-up manufacturing process to bring Aversa technology closer toward commercialization
In a recent report to shareholders, Nutriband (NASDAQ: NTRB) CEO Gareth Sheridan shared significant company achievements and milestones as well as his expectations for 2025 (https://ibn.fm/9K5zT). At the center of the company’s positive outlook for future is noteworthy progress made toward the commercialization of its proprietary Aversa technology, including a strong partnership with Kindeva Drug Delivery.
“Nutriband is primarily focused on working with our partner Kindeva Drug Delivery, a leading global contract development and manufacturing organization focused on drug-device combination products, to develop our lead product, AVERSA(TM) Fentanyl, which incorporates Nutriband’s AVERSA abuse-deterrent transdermal technology into Kindeva’s FDA-approved transdermal fentanyl patch,” stated Sheridan in the letter.
“AVERSA Fentanyl has the potential to become the world’s first opioid pain patch with abuse deterrent properties and is estimated to potentially reach peak annual sales of $80 million–$200 million,” he continued. “In addition, AVERSA Buprenorphine, our next candidate for AVERSA, is projected to reach peak annual sales of $70 million–$130 million. Nutriband recently performed an extensive evaluation of the commercial cost of goods of incorporating the AVERSA technology into existing FDA-approved transdermal patches and has confirmed the viability of achieving high margins that are typically found in NDA pharmaceutical products.”
Sheridan noted that Nutriband and Kindeva have formalized an exclusive product-development partnership and long-term commitment based on shared development costs in exchange for milestone payments. This agreement “solidifies a transition to commercial scale development for AVERSA(TM) Fentanyl,” he noted.
“We have confidently shifted our focus from feasibility towards commercial development in support of an NDA filing and commercialization,” Sheridan observed. “This was a very strong show of support from our partner Kindeva, which also allowed us to reduce the impact of dilution to our existing shareholders, which I stress has been and will remain a core focus of the company. This was evident through our raise of $8.4 million in April 2024 in a nonbrokered private placement primarily through existing shareholders.”
In addition to the company’s partnership with Kindeva, Sheridan noted other key steps taken as Nutriband works to develop and scale-up the manufacturing process to bring Aversa technology closer toward commercialization. Those steps have included developing and refining Nutriband’s proprietary technology for commercial scale manufacturability, establishing the commercial supply chain and validating the analytical methods required to meet U.S. Food and Drug Administration (“FDA”) regulatory standards for a pharmaceutical product.
Nutriband has also expanded the worldwide intellectual property portfolio for its AVERSA abuse deterrent technology, the shareholder report noted. That expansion has included approvals in China and its territories, Hong Kong and Macao, as well as a new patent approval in the United States.
“This improves our position to bring our leading abuse deterrent platform to market,” Sheridan explained. “We are now patented in 46 countries around the world. While initially concentrating on the U.S. market, the unmet medical need for adequate pain management is a global problem, and our goal is to make a global solution strategically targeting all major medical markets in the world.”
In the report, Sheridan outlined the company’s “ambitious yet achievable” 2025 goals. Nutriband will work on getting into the clinic to evaluate its lead product, AVERSA(TM) Fentanyl, in a pivotal Human Abuse Liability (“HAL”) clinical trial, which be key for an NDA filing. This will involve manufacturing clinical supplies using a commercial scale process as well as filing an Investigational New Drug application with the FDA. The company is also exploring new potential international partnerships for its AVERSA intellectual property and will be evaluating licensing and partnership opportunities, all while working to have the AVERSA(TM) Fentanyl product to be used in mass soon.
Sheridan also pointed out the strong revenue numbers reported by Nutriband’s Pocono Pharma subsidiary for its kinesiology tape contract manufacturing services. Company officials believe that 2025 is shaping up to be Pocono Pharma’s best year on record due to its expanding manufacturing collaboration with KT Tape, the world leader in kinesiology tape.
“Many of you have been with us from the beginning,” Sheridan concluded. “And many more joined our mission to change the pharmaceutical industry for the better by developing our AVERSA technology designed to improve the safety of easily abused transdermal drugs, such as pain medications, while making them available to patients who need them. Pain patients have been struggling with inadequate care for too long, and they deserve to be able to access the medication they need. AVERSA gives them this access. Today we are on track to be the world’s first and only abuse deterrent technology in the transdermal space targeting abusable medications such as fentanyl and buprenorphine.”
For more information, visit the company’s website at www.Nutriband.com.
NOTE TO INVESTORS: The latest news and updates relating to NTRB are available in the company’s newsroom at https://ibn.fm/NTRB
