Nutriband With Kindeva Drug Delivery Demonstrate Enhanced Abuse-Deterrent Characteristics for AVERSA(TM) Fentanyl

Rhea-AI Summary

Nutriband Inc. (NASDAQ:NTRB, NTRBW) announced progress in collaboration with Kindeva Drug Delivery for their AVERSA™ Fentanyl patch, an abuse-deterrent transdermal system. Recent studies confirm that Nutriband's aversive coating can be produced with standard manufacturing processes, crucial for product development. The product has a projected peak annual sales potential of $80M - $200M within five years post-launch. Nutriband aims to finalize product configuration and transfer technology to Kindeva's commercial facility in California.

Positive

• Proven progress in developing abuse-deterrent fentanyl patch with Kindeva.
• Estimated potential peak annual US sales of $80M - $200M within five years of launch.
• Unique position as the first to create a commercial manufacturing process for an abuse-deterrent transdermal patch.

Negative

• None.

ORLANDO, FL / ACCESSWIRE / October 4, 2022 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW) with Kindeva Drug Delivery have demonstrated enhanced abuse deterrence kinetics of the Company's patented lead product, Aversa™ Fentanyl, an abuse-deterrent fentanyl transdermal system, with their development and manufacturing partner, Kindeva Drug Delivery. Studies at Kindeva Drug Delivery have demonstrated that Nutriband's proprietary transdermal aversive coating can be manufactured using standard commercial transdermal manufacturing processes, which is critical to the success of the product development program. The next step is to select the final product configuration and perform technology transfer from Kindeva's R&D facility to their world-class transdermal commercial manufacturing site in Northridge, California, US.

AVERSA™ Fentanyl combines Nutriband's proprietary AVERSA™ abuse-deterrent transdermal technology and Kindeva's FDA-approved transdermal fentanyl patch (fentanyl transdermal system) and was recently estimated to have the potential to reach peak annual US sales of $80M - $200M roughly five years after launch.¹

"We are encouraged by the progress we have made working with the team at Kindeva Drug Delivery who have brought their proven experience in the development of transdermal drug delivery systems to bear on this effort," said Gareth Sheridan, CEO, Nutriband. "To our knowledge, we will be the first to develop a commercial manufacturing process for an abuse-deterrent transdermal patch. We look forward to continued progress toward completion of the technology transfer to the commercial line."

Nutriband's AVERSA™ abuse-deterrent technology can be utilized to incorporate aversive agents into transdermal patches to prevent the abuse, diversion, misuse, and accidental exposure of drugs with abuse potential. The AVERSA™ abuse-deterrent 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 those patients who really 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.

¹ Health Advances market analysis report 2022

About Nutriband Inc.

We are primarily engaged in the development of a portfolio of transdermal pharmaceutical products. Our lead product under development is an abuse deterrent fentanyl patch incorporating our AVERSA^™ abuse deterrence technology. AVERSA™ technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential.

The Company's website is www.nutriband.com. Any material contained in or derived from the Company's websites or any other website is not part of this press release.

About Kindeva

Headquartered in Woodbury, Minnesota, Kindeva Drug Delivery is a leading global contract development and manufacturing organization (CDMO) in the pharmaceutical industry. Kindeva provides unique technologies and quality services to its customers, ranging from formulation and product development to commercial manufacturing. Kindeva focuses on complex drug programs, and its current offering spans inhalation drug delivery, transdermal drug delivery, intradermal drug delivery (microneedles) and connected drug delivery. Kindeva employs approximately 1,000 people worldwide. For more information, visit www.kindevadd.com.

Forward-Looking Statements

Certain statements contained in this press release, including, without limitation, statements containing the words ‘'believes,'' "anticipates," "expects" and words of similar import, constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve both known and unknown risks and uncertainties. The Company's actual results may differ materially from those anticipated in its forward-looking statements as a result of a number of factors, including those including the Company's ability to develop its proposed abuse deterrent fentanyl transdermal system and other proposed products, its ability to obtain patent protection for its abuse technology, its ability to obtain the necessary financing to develop products and conduct the necessary clinical testing, its ability to obtain Federal Food and Drug Administration approval to market any product it may develop in the United States and to obtain any other regulatory approval necessary to market any product in other countries, including countries in Europe, its ability to market any product it may develop, its ability to create, sustain, manage or forecast its growth; its ability to attract and retain key personnel; changes in the Company's business strategy or development plans; competition; business disruptions; adverse publicity and international, national and local general economic and market conditions and risks generally associated with an undercapitalized developing company, as well as the risks contained under "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Form S-1, Form 10-K for the year ended January 31, 2020 and Forms 10-Q, and the Company's other filings with the Securities and Exchange Commission. Except as required by applicable law, we undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that may arise after the date hereof.

For more information, contact:

Investor Relations
RedChip Companies
Dave Gentry
Dave@redchip.com
1-800-RED-CHIP (733-2447)
407-491-4498

Or

Kindeva Communications
John Price
John.price@kindevadd.com
612-889-5231

SOURCE: Nutriband, Inc.

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FAQ

What is the status of Nutriband's AVERSA™ Fentanyl patch?

Nutriband is making progress on its AVERSA™ Fentanyl patch, having demonstrated the manufacturing feasibility of their abuse-deterrent technology with Kindeva.

What are the sales projections for Nutriband's AVERSA™ Fentanyl?

The AVERSA™ Fentanyl patch has an estimated peak annual sales potential of $80M - $200M in the US, projected five years after launch.

When does Nutriband plan to transfer technology for its AVERSA™ Fentanyl patch?

Nutriband plans to finalize the product configuration and perform technology transfer to Kindeva's commercial manufacturing site in California soon.

Who is collaborating with Nutriband on the AVERSA™ Fentanyl patch?

Kindeva Drug Delivery is collaborating with Nutriband in the development and manufacturing of the AVERSA™ Fentanyl patch.

What innovative technology does Nutriband's AVERSA™ Fentanyl use?

Nutriband's AVERSA™ technology incorporates aversive agents into transdermal patches to deter abuse, misuse, and accidental exposure.