Nutriband Lead Product Aversa(TM) Fentanyl May Reach Peak Annual Sales of $80-200 Million Based on Market Assessment by Leading Healthcare Consulting Firm

Rhea-AI Summary

Nutriband Inc. (NASDAQ:NTRB, NTRBW) has completed a market assessment for its lead product, Aversa™ Fentanyl, an innovative abuse-deterrent fentanyl transdermal system. Conducted by Health Advances, the analysis suggests that Aversa has the potential for peak annual US sales ranging from $80-200 million within five years post-launch. The company aims to follow a 505(b)(2) NDA regulatory path towards FDA approval, targeting a safer alternative amidst rising concerns over opioid abuse. This product may redefine the transdermal fentanyl market by introducing crucial safety features.

Positive

• Aversa Fentanyl has potential peak annual US sales of $80-200 million within five years.
• The product intends to address significant unmet patient needs in opioid treatment.
• Market analysis by Health Advances confirms a strategic opportunity for Aversa Fentanyl.
• The development follows a regulatory path towards a 505(b)(2) NDA, aimed at FDA approval.

Negative

• The approval of Aversa Fentanyl is contingent on successful clinical trials and FDA review.
• There are risks and uncertainties inherent in developing a new pharmaceutical product.

ORLANDO, FL / ACCESSWIRE / January 5, 2022 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of transdermal pharmaceutical products has completed the market assessment and commercialization strategy for its lead product candidate, AVERSA^™ Fentanyl, an abuse deterrent fentanyl transdermal system.

The company engaged leading healthcare consulting company Health Advances to assess the market opportunity and commercial strategy for Aversa™ Fentanyl, which has the potential to be the world's first fentanyl transdermal system with abuse deterrent properties. Once approved by the United States FDA, Aversa Fentanyl will be priced competitively with generic fentanyl patches and may reach peak annual US sales of $80-200 million roughly five years after launch.¹ Additional potential market opportunity may be available if Aversa Fentanyl drives the entire transdermal fentanyl market towards abuse deterrent patches similar to what occurred in the extended-release oral opioid market. The company is also considering developing the product for strategic international markets as protected by its global abuse deterrent patent portfolio.

Currently the transdermal fentanyl market in the United States is comprised of generic ANDA products that do not have any abuse deterrent properties. The FDA response to the opioid crisis includes a goal to expand access to abuse-deterrent formulations to discourage abuse as outlined in the FDA's Opioid Action Plan.² Development of Aversa Fentanyl will follow a regulatory path towards a 505(b)(2) NDA with a clinical program to establish abuse deterrent claims.

‘Health Advances was able to confirm the significant unmet patient need for Aversa Fentanyl based on rigorous primary and secondary market research accompanied with deep experience in the abuse deterrence space. We are excited to execute on our plan to bring Aversa^™ Fentanyl to market' said Gareth Sheridan, CEO, Nutriband. ‘Improving the safety profile of easily abused transdermal drugs such as fentanyl, while making sure that these drugs remain accessible to those patients who really need them is the driving force for our company.'

¹ Health Advances market analysis report December 2021

² FDA Opioids Action Plan https://www.fda.gov/drugs/information-drug-class/fda-opioids-action-plan

About Aversa™ Fentanyl
Aversa™ Fentanyl, our lead product under development, is an abuse deterrent fentanyl patch incorporating our AVERSA^™ abuse deterrence technology. Aversa™ Fentanyl has the potential to be the world's first fentanyl transdermal system with abuse deterrent properties.

About Aversa™ Transdermal Technology

Aversa™ transdermal technology can be incorporated into any transdermal patch to prevent the abuse, misuse, diversion, and accidental exposure of drugs with abuse potential. The technology is based on incorporating aversive agents into the patch that do not contact the drug matrix.

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. The company is also engaged in contract research and development services and the manufacture of transdermal products

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.

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

SOURCE: Nutriband, Inc.

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FAQ

What is Aversa Fentanyl and its market potential?

Aversa Fentanyl is an abuse-deterrent fentanyl transdermal system with potential US peak annual sales of $80-200 million.

Who conducted the market assessment for Aversa Fentanyl?

The market assessment was conducted by leading healthcare consulting firm Health Advances.

What regulatory path is Nutriband pursuing for Aversa Fentanyl?

Nutriband is following a 505(b)(2) NDA regulatory path towards FDA approval for Aversa Fentanyl.

What is Nutriband's strategy regarding abuse-deterrent formulations?

Nutriband aims to lead the market in abuse-deterrent fentanyl products amid the growing opioid crisis.