MindMed Announces Issuance of New Patent for MM120 Orally Disintegrating Tablet (ODT)

Rhea-AI Summary

MindMed (NASDAQ: MNMD) has been granted a new patent by the USPTO for its MM120 (lysergide) orally disintegrating tablet (ODT) formulation. This patent, extending protection until 2041, covers the pharmaceutical formulation, manufacturing methods, and treatment applications for MM120 ODT. The formulation incorporates Catalent's Zydis® ODT technology, which MindMed believes will offer pharmacological advantages including faster absorption, improved bioavailability, and reduced gastrointestinal side effects.

MM120 is currently in clinical development for generalized anxiety disorder (GAD) and shows potential for treating other brain health disorders. MindMed holds exclusive rights to the Zydis technology for lysergide in several key markets. CEO Rob Barrow emphasized the importance of this patent in extending IP protection and highlighting the unique properties of the MM120 ODT formulation.

Positive

• New patent extends MM120 intellectual property protection until 2041
• MM120 ODT formulation potentially offers improved absorption, bioavailability, and reduced side effects
• Exclusive rights to Zydis technology for lysergide in key markets
• MM120 in clinical development for generalized anxiety disorder (GAD) with potential for other brain health disorders

Negative

• None.

Pharmaceutical Industry Analyst

The issuance of a new patent for MM120 Orally Disintegrating Tablet (ODT) is a significant milestone for MindMed. This patent extends the company’s intellectual property (IP) protection to 2041, covering the pharmaceutical formulation, methods of manufacturing and treatment methods for MM120. The adoption of Catalent’s Zydis® ODT technology, known for its fast-dissolve properties, is expected to enhance pharmacological advantages such as more rapid absorption, improved bioavailability and reduced gastrointestinal side effects. This could position MM120 ODT as a more attractive treatment option for generalized anxiety disorder (GAD) and potentially other brain health disorders.

From an industry perspective, having a robust IP portfolio is essential for maintaining a competitive edge, especially in the biopharmaceutical sector where R&D cycles are lengthy and expensive. Extending patent life to 2041 provides a substantial runway for both clinical development and eventual commercial exploitation, safeguarding the company’s innovations against generic competition.

The fact that MindMed holds exclusive rights to the Zydis technology for various global markets, including the US, UK and EU, further strengthens its market position. This exclusivity could potentially block competitors from using similar fast-dissolving technologies for lysergide formulations, giving MindMed an upper hand in treatment options for mental health disorders.

Market Research Analyst

MindMed’s new patent issuance could have significant implications for its market value and future growth prospects. By securing IP protection until 2041, the company ensures a prolonged period of market exclusivity, which can attract investors looking for long-term growth potential. This patent's focus on an advanced formulation that offers improved bioavailability and reduced side effects could also make the product more appealing to both patients and healthcare providers, potentially driving higher adoption rates once it reaches the market.

It’s important to note the patent's coverage on pharmaceutical formulation and manufacturing methods, which adds another layer of protection. This comprehensive approach limits the ability of competitors to create similar products, thereby enhancing MindMed’s competitive positioning. Additionally, the company’s strategy to utilize Catalent’s Zydis® ODT technology indicates a commitment to leveraging cutting-edge solutions to improve patient outcomes, which is likely to resonate well with stakeholders.

From an investor’s perspective, the long-term IP protection and the potential for a unique clinical profile could translate into a substantial revenue stream, assuming successful clinical trials and eventual regulatory approval. However, it’s important to keep an eye on the ongoing clinical development and regulatory milestones, as these will be key drivers of market performance in the short to medium term.

Financial Analyst

The issuance of a patent that extends the protection of MM120 ODT to 2041 is a positive development for MindMed’s financial outlook. The extended patent life allows for a longer period to recoup the substantial investment in R&D and to generate sustained revenue streams from the product. Given that the patent also covers methods of manufacturing and treatment, it could significantly lower the risk of generic competition, thereby protecting profit margins.

MindMed’s collaboration with Catalent to use the Zydis® ODT technology adds financial value by potentially speeding up the drug’s market entry and improving patient adherence through its enhanced pharmacological profile. Faster absorption and improved bioavailability could lead to quicker therapeutic effects, making MM120 an attractive option compared to existing treatments. This could result in a higher market penetration rate and thus higher revenue.

For retail investors, this patent strengthens the investment case for MindMed by offering a longer time horizon for revenue generation from MM120 ODT. However, investors should remain cautious and monitor the progress of clinical trials and any regulatory hurdles that may arise. The success of Phase 3 trials and eventual market approval are critical to realizing the financial benefits of this patent issuance.

- New patent covers MM120 ODT formulation and extends patent term to 2041-

- Claims include pharmaceutical formulation, methods of manufacturing and methods of treatment for MM120 ODT-

NEW YORK--(BUSINESS WIRE)-- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat mental health disorders, today announced the issuance of a new patent by the United States Patent and Trademark Office (USPTO) covering MM120 (lysergide). MM120 is currently in clinical development for adults with generalized anxiety disorder (GAD) and presents opportunities for treating a range of additional brain health disorders.

The newly issued patent (USPN 12,036,220) includes claims covering the pharmaceutical formulation, methods of manufacturing and method of treatment for MM120 ODT, MindMed’s proprietary and pharmaceutically optimized form of lysergide (LSD). The pharmaceutical formulation patent is the first US patent issued on the MM120 ODT formulation and extends the Company’s intellectual property protection for MM120 through 2041.

This advanced formulation incorporates Catalent’s Zydis® ODT fast-dissolve technology, which the Company believes will deliver substantial pharmacological advantages for MM120 and a unique clinical profile with more rapid absorption, improved bioavailability and reduced gastrointestinal side effects. MindMed holds exclusive rights to the Zydis technology for all salt and polymorphic forms of lysergide for pharmaceutical usage for the treatment of human disease and disorders in the United States, the United Kingdom, the European Union, Switzerland, Israel, and Canada.

“We have adopted an effective, multi-pronged strategy to protect MM120 and its potential uses across a number of large therapeutic indications like GAD and other brain health disorders,” said Rob Barrow, Chief Executive Officer of MindMed. “The issuance of this patent extends our IP protection for MM120 to at least 2041 and, more importantly, covers the unique properties of our MM120 ODT formulation. These clinical features underscore our dedication to creating treatments that are effective and optimize the patient's experience. Our PK bridging study reported earlier this year demonstrated these advantageous properties and support this formulation’s use in our Phase 3 clinical trials, and, if ultimately approved, for clinical use.”

About MM120

MM120 (LSD or lysergide D-tartrate) is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM120, the tartrate salt form of lysergide, for GAD and is exploring its potential applications in other serious brain health disorders. Based on the significant unmet medical need in the treatment of GAD – especially in patients who do not respond to or tolerate currently available medications – along with the initial clinical data from Phase 2b and other research conducted by MindMed, the U.S. Food & Drug Administration (FDA) has designated MM120 for GAD as a breakthrough therapy. MM120 is entering Phase 3 clinical trials in the second half of 2024 in GAD with additional clinical indications under exploration.

About Generalized Anxiety Disorder (GAD)

GAD is a common condition associated with significant impairment that adversely affects millions of people. GAD results in fear, persistent anxiety, and a constant feeling of being overwhelmed. It is characterized by excessive, persistent, and unrealistic worry about everyday things. Approximately 10% of U.S. adults, representing around 20 million people, currently suffer from GAD. This underdiagnosed and underserved indication is associated with significant impairment, less accomplishment at work and reduced labor force participation. Despite the significant personal and societal burden of GAD, there has been little innovation in the treatment of GAD in the past several decades, with the last new drug approval occurring in 2007.

About MindMed

MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders. MindMed trades on NASDAQ under the symbol MNMD.

Forward-Looking Statements

Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding timing of the initiation of a potential Phase 3 clinical trial of MM120, the potential benefits of the Zydis ODT fast-dissolve technology and the potential benefits of the Company’s product candidates. There can be no guarantees regarding the timing or results of the potential Phase 3 clinical trials for MM120 for the treatment of GAD or that, following any such trials, MM120 will receive the necessary regulatory approvals. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including its history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, under headings such as “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR+ at www.sedarplus.ca and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240717521621/en/

For Media: media@mindmed.co

For Investors: ir@mindmed.co

Source: Mind Medicine Inc.

FAQ

What is the new patent MindMed (MNMD) received for MM120?

MindMed received a new patent (USPN 12,036,220) from the USPTO covering the pharmaceutical formulation, manufacturing methods, and treatment applications for MM120 orally disintegrating tablet (ODT), extending protection until 2041.

What technology does MindMed's MM120 ODT formulation use?

MindMed's MM120 ODT formulation incorporates Catalent's Zydis® ODT fast-dissolve technology, which is expected to provide pharmacological advantages such as faster absorption, improved bioavailability, and reduced gastrointestinal side effects.

What condition is MindMed's MM120 (MNMD) currently being developed to treat?

MM120 is currently in clinical development for the treatment of generalized anxiety disorder (GAD) in adults, with potential applications for other brain health disorders.

In which markets does MindMed (MNMD) hold exclusive rights for the Zydis technology used in MM120?

MindMed holds exclusive rights to the Zydis technology for lysergide in the United States, the United Kingdom, the European Union, Switzerland, Israel, and Canada.