Nutriband Signs Commercial Development and Clinical Supply Agreement With Kindeva Drug Delivery for Aversa(TM) Fentanyl, an Abuse Deterrent Fentanyl Patch
Nutriband Inc. (NTRB) announced a commercial development and clinical supply agreement for their lead product, Aversa™ Fentanyl, with Kindeva Drug Delivery. The agreement aims to support a New Drug Application (NDA) with the FDA, replacing a previous feasibility agreement. Aversa™ Fentanyl is estimated to have the potential to reach peak annual US sales of $80M - $200M.
The agreement between Nutriband Inc. and Kindeva Drug Delivery represents a strategic move in the pharmaceutical industry, particularly within the niche of transdermal drug delivery systems. The partnership leverages Kindeva's robust manufacturing capabilities and Nutriband's proprietary AVERSA™ abuse-deterrent technology. This collaboration is poised to enhance the safety profile of opioid medications, a critical issue given the ongoing opioid epidemic.
The projected peak annual US sales for AVERSA™ Fentanyl, estimated between $80M and $200M, indicate a significant market opportunity. This estimation, however, should be viewed with caution, as the actual market uptake will depend on various factors including clinical trial outcomes, FDA approval, market competition and the evolving regulatory landscape regarding opioid medications.
From an industry perspective, the development of abuse-deterrent formulations (ADF) is a response to both public health concerns and regulatory pressures. The successful commercialization of AVERSA™ Fentanyl could set a precedent for future ADFs in the opioid market and potentially shift prescribing patterns in favor of safer alternatives. However, the cost of development and the pricing strategy for such technology-integrated pharmaceuticals could affect adoption rates and insurance coverage decisions.
The clinical supply agreement for AVERSA™ Fentanyl is a critical step towards the initiation of human abuse liability studies, which are essential for the FDA's New Drug Application (NDA) process. These studies aim to quantify the potential for abuse and help in the assessment of the drug's risk-benefit profile.
Transdermal fentanyl is a potent opioid analgesic and its abuse is a grave concern due to the risk of addiction and overdose. The integration of AVERSA™ technology could mitigate these risks by deterring abuse, potentially leading to a reduction in opioid-related adverse events. The outcome of the clinical study will be pivotal in determining the drug's market viability and could influence the FDA's decision on approval.
It is important to note that the success of AVERSA™ Fentanyl in clinical trials will not only affect its commercial prospects but also impact public health by providing a safer alternative for pain management. The long-term implications of introducing an abuse-deterrent opioid into the market could include a decrease in opioid abuse rates, although this remains speculative until long-term post-marketing studies are conducted.
The announcement of the commercial development and clinical supply agreement is likely to have immediate financial implications for Nutriband Inc., as it signals progress towards the commercialization of AVERSA™ Fentanyl. Investors and stakeholders will be closely monitoring the developments, as successful commercialization could lead to a significant revenue stream for Nutriband.
However, the financial success of AVERSA™ Fentanyl hinges on several factors, including the cost of clinical trials, manufacturing expenses and the ability to secure FDA approval. Moreover, the actual market penetration will be influenced by the competitive landscape, including existing and future opioid formulations with similar properties.
Investors should also consider the potential for patent challenges, market exclusivity periods and the impact of healthcare policies on opioid prescriptions. While the projected sales figures are promising, the actual financial performance will be contingent upon the successful navigation of these complex market dynamics.
01/05/2024 - 09:15 AM
ORLANDO, FL / ACCESSWIRE / January 5, 2024 / Nutriband Inc. (NASDAQ:NTRB)(NASDAQ:NTRBW), a company engaged in the development of transdermal pharmaceutical products, today announced it has signed a commercial development and clinical supply agreement for their lead product, Aversa™ Fentanyl, with their partner, Kindeva Drug Delivery, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products. Under this agreement, Kindeva will perform commercial manufacturing process development and manufacture clinical supplies for the human abuse liability clinical study required by the FDA in support of a New Drug Application (NDA). This new agreement replaces the previous feasibility agreement between the two companies which was focused on adapting Kindeva's commercial transdermal manufacturing process to incorporate AVERSA™ abuse deterrent transdermal technology.
AVERSA™ Fentanyl combines Nutriband's proprietary AVERSA™ abuse-deterrent transdermal technology with Kindeva's FDA-approved transdermal fentanyl patch system with the potential to become the world's first opioid patch with abuse deterrent properties.AVERSA™ Fentanyl is estimated to have the potential to reach peak annual US sales of $80M - $200M .1
"Execution of this commercial development agreement with our partner, Kindeva, will enable us to rapidly commercialize AVERSA™ Fentanyl and capitalize on its significant market potential. 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," said Gareth Sheridan, CEO, Nutriband.
"Transdermal drug-delivery technologies continue to create positive health outcomes for patients globally," said Kindeva Global Chief Commercial Officer David Stevens. "Kindeva brings more than a half a century of expertise in transdermal capabilities and innovation, and we appreciate Nutriband's expertise and partnership in this next step in development to continue to bring new solutions to patients."
1 Health Advances Aversa Fentanyl market analysis report 2022
About AVERSA™ Abuse Deterrent Transdermal Technology
Nutriband's AVERSA™ abuse-deterrent transdermal 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.
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-deterrent 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 Drug Delivery
Kindeva is a global contract development manufacturing organization focused on drug-device combination products. Kindeva develops and manufactures products across a broad range of complex drug-delivery formats, including pulmonary & nasal, injectable, and transdermal . Its service offerings span early-stage feasibility through commercial scale drug product fill-finish, container closure system manufacturing, and drug-device product assembly. Kindeva serves a global client base from its nine manufacturing and research and development facilities located in the U.S. and U.K. For more information, please 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:
Patrick Ryanpaddyr@nutriband.com / support@nutriband.com
SOURCE: Nutriband Inc.
press release on accesswire.com
What did Nutriband Inc. announce?
Nutriband Inc. announced a commercial development and clinical supply agreement for their lead product, Aversa™ Fentanyl, with Kindeva Drug Delivery.
Who is the partner in the agreement?
The partner in the agreement is Kindeva Drug Delivery, a leading global contract development and manufacturing organization (CDMO) focused on drug-device combination products.
What is the estimated potential peak annual US sales for Aversa™ Fentanyl?
The estimated potential peak annual US sales for Aversa™ Fentanyl is $80M - $200M.
What is the purpose of the agreement with Kindeva?
The agreement with Kindeva aims to support a New Drug Application (NDA) with the FDA for Aversa™ Fentanyl.
Who is the CEO of Nutriband Inc.?
The CEO of Nutriband Inc. is Gareth Sheridan.
