Welcome to our dedicated page for Nutriband news (Ticker: NTRBW), a resource for investors and traders seeking the latest updates and insights on Nutriband stock.
Company Overview
Nutriband Inc. is a specialized pharmaceutical company based in Oviedo, Florida, that focuses on cutting-edge transdermal and topical technologies. The company has built its expertise around developing a portfolio of innovative transdermal products, with a primary focus on its abuse-deterrent technology known as AVERSA. This proprietary technology integrates aversive agents into transdermal patches to prevent abuse, misuse, diversion, and accidental exposure of drugs with high abuse potential, such as opioids and stimulants.
Core Business and Product Portfolio
The centerpiece of Nutriband’s portfolio is its lead product under development, an abuse-deterrent fentanyl patch that incorporates AVERSA technology. By employing a unique coating mechanism that leverages taste aversion, the patch is designed to deter the oral abuse of potent medications while ensuring that patients in need retain access to essential pain management solutions. The company also extends its technological expertise to other product categories, including transdermal consumer goods and a mosquito repellent patch, evidencing a diverse application of its platform.
Innovative Technology and Intellectual Property
Nutriband’s AVERSA technology is at the forefront of addressing the challenges posed by the global opioid crisis. The unique methodology of incorporating aversive agents, such as the well-known bitter compound Bitrex®, into patches is underpinned by a robust international intellectual property portfolio, with patents granted in 46 countries. This extensive protection not only reinforces the company’s market position but also demonstrates its commitment to innovation and drug safety.
Strategic Partnerships and Operational Excellence
The company has established strategic alliances with prominent partners in the pharmaceutical and manufacturing sectors. Its collaboration with Kindeva Drug Delivery enables Nutriband to integrate its abuse-deterrent technology into FDA-approved transdermal systems, thereby optimizing the manufacturing and regulatory pathway for its lead products. Additionally, Nutriband’s subsidiary, Pocono Pharma, bolsters its contract manufacturing services, distributing a variety of products to major retail channels across the United States.
Market Position and Business Model
Nutriband positions itself within a highly specialized niche of the pharmaceutical industry, focusing on transdermal applications that enhance drug safety while combating abuse potential. The company generates revenue primarily through the sale of its consumer transdermal products and contract manufacturing services, coupled with the anticipated benefits from its innovative abuse-deterrent technology. By streamlining regulatory processes and leveraging a single Phase 1 trial for its abuse-deterrent product, Nutriband demonstrates a pragmatic approach to market entry while ensuring rigorous compliance with safety standards.
Commitment to Safety and Market Impact
At its core, Nutriband is dedicated to addressing critical public health challenges by improving the safety profile of transdermal pharmaceutical products. The incorporation of AVERSA technology into products such as a fentanyl patch not only aims to reduce the risk of misuse and diversion but also helps prevent accidental exposure, which is particularly important in vulnerable populations. This dual focus on efficacy and safety underscores the company’s role in mitigating the impact of drug abuse while supporting the legitimate medical needs of patients.
Conclusion
Overall, Nutriband Inc. represents a blend of technological innovation, strategic operational partnerships, and a deep commitment to enhancing drug safety. Its comprehensive approach in leveraging abuse-deterrent transdermal technology sets it apart in a competitive industry. Investors and analysts looking for insights into innovative pharmaceutical strategies will find Nutriband’s focus on sustainable, safety-driven solutions to be of considerable significance.
Nutriband Inc. (NASDAQ:NTRB) has received a Notice of Allowance from the USPTO for its AVERSA™ trademark, a key component of its abuse-deterrent transdermal patch technology. The company's lead product, AVERSA™ Fentanyl, is progressing towards commercial manufacturing scale-up in partnership with Kindeva Drug Delivery. Nutriband plans to file an IND application with the FDA, preceding pivotal studies to demonstrate the abuse-deterrent properties of AVERSA™ Fentanyl.
The upcoming human abuse potential study will compare AVERSA™ Fentanyl to a current fentanyl patch without abuse-deterrent features. Preliminary studies indicate AVERSA™ technology's high resistance to manipulation. A market analysis projects potential peak annual U.S. sales of $80 million to $200 million for AVERSA™ Fentanyl, highlighting its significant market potential in abuse-deterrent pharmaceuticals.
Nutriband has provided an update on its Aversa Fentanyl product development program. The company, in collaboration with Kindeva Drug Delivery, has progressed in developing the commercial manufacturing process for a transdermal fentanyl patch incorporating Nutriband's AVERSA™ abuse-deterrent technology. This follows a feasibility agreement and a commercial development and clinical supply agreement between the two companies.
Kindeva has validated analytical methods for handling aversive agents required for the product. Nutriband plans to file an Investigational New Drug (IND) application with the FDA, including chemistry, manufacturing, and clinical study protocols for a Phase 1 human abuse potential study, which is pivotal for the New Drug Application (NDA) process. No Phase 2 or Phase 3 trials are needed.
The AVERSA Fentanyl patch aims to prevent drug misuse while ensuring accessibility for patients in need, with potential peak annual US sales estimated between $80 million to $200 million.
Nutriband reported Q1 revenues of $408,532, highlighting a 219% YoY increase in sports tape sales via its Pocono Pharma subsidiary. The company is leveraging penetration pricing to secure deals with major brands like KT Tape, Reebok, Adidas, and New Balance.
In Q1, Nutriband completed an $8.4M private placement at $4 per share, bringing its cash position to $8,347,739 as of April 30, 2024.
The company is advancing its AVERSA line, targeting a Q1 2025 NDA filing for AVERSA Fentanyl, projected to achieve peak annual sales of $80-$200M. AVERSA Buprenorphine could reach up to $130M in annual sales.
Nutriband (NASDAQ:NTRB), a developer of transdermal pharmaceuticals and technology, will host an exclusive live investor webinar on May 30, 2024, at 4:15 p.m. ET.
Organized by RedChip Companies, the event will feature Chairman Serguei Melnik and CEO Gareth Sheridan, who will provide insights into the company's current operations and future milestones.
Investors can register for the free webinar and submit questions beforehand or during the live session.
Nutriband announced the appointment of Sergei Glinka to its board of directors. Glinka, an experienced business leader, brings a wealth of experience from his roles in major European companies. The Glinka family has invested $4.5 million in Nutriband via a private placement in April 2024, which totaled $8.4 million. Nutriband aims to use these funds to complete the FDA approval process for its AVERSA™ technology. AVERSA™, currently patented in 45 countries, is projected to reach peak annual US sales between $80 million and $200 million. The global opioid market was valued at $22.8 billion in 2022.
FAQ
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