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MediciNova Receives Notice of Allowance for New Patent Covering MN-166 (ibudilast) for the Prevention of Metastasis of Eye Cancer

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MediciNova, a biopharmaceutical company listed on NASDAQ and Tokyo Stock Exchange, announced it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent covering MN-166 (ibudilast) for preventing metastasis in eye cancer. The patent, expected to expire by July 2042, covers the use of MN-166 for uveal melanoma, detailing various doses, frequencies, and treatment periods. MN-166 impedes uveal melanoma migration by inhibiting the macrophage migration inhibitory factor and reducing immune suppressive cells, enhancing CD8 T cell activity. The company views this patent as enhancing the potential value of MN-166 in oncology.

Positive
  • Received a Notice of Allowance for a new patent from the U.S. Patent and Trademark Office.
  • Patent covers MN-166 (ibudilast) for preventing metastasis in eye cancer, specifically uveal melanoma.
  • Patent expected to expire no earlier than July 2042, providing long-term protection.
  • MN-166 demonstrates efficacy in preventing cancer metastasis through multiple mechanisms.
  • Enhanced CD8 T cell activity and lowered immune suppressive myeloid-derived suppressor cells (MDSCs).
  • Potentially enhances the commercial value of MN-166 in the oncology field.
Negative
  • Does not include any immediate or forthcoming financial revenue data from the issuance of the patent.
  • Long-term commercial success of MN-166 still dependent on further clinical trials and regulatory approvals.
  • Patent allowance does not immediately impact the cash flow or profitability.

Receiving a Notice of Allowance for a patent is a significant step forward for MediciNova, especially considering the potential of MN-166 (ibudilast) in treating uveal melanoma, a rare and aggressive form of eye cancer. This patent grant essentially provides MediciNova with exclusivity until at least July 2042, which is a considerable duration in the biopharmaceutical industry. By securing this patent, MediciNova can potentially prevent competitors from developing similar treatments, giving the company a competitive edge in the oncology sector.

MN-166 has shown promising preclinical results, particularly in inhibiting the metastasis of uveal melanoma through mechanisms such as inhibition of macrophage migration inhibitory factor (MIF) and modulation of the tumor microenvironment to enhance immune response. This aligns with current trends and needs in cancer treatment, where therapies are increasingly focusing on the immune system's role in combating cancer.

Investors should note that while these preclinical results are encouraging, the drug still needs to undergo clinical trials to confirm its efficacy and safety in humans. Clinical trials are expensive and time-consuming and there's always a risk of failure. However, if successful, the long-term benefits could be substantial, especially given the unmet need in uveal melanoma treatment.

From a financial perspective, the patent allowance for MN-166 creates a valuable asset for MediciNova. The exclusivity period until 2042 means potential revenue streams extending over the next two decades, assuming the successful commercialization of the drug. This would be particularly impactful in a niche market like uveal melanoma, where treatment options are limited and there is a high unmet need.

Further, this patent strengthens MediciNova's intellectual property portfolio, which can enhance the company's valuation and improve its negotiating position in any potential partnerships, licensing deals, or even acquisition discussions. However, it's important to keep in mind that drug development is a high-risk venture and the costs associated with clinical trials can significantly impact the company's finances in the short term.

Overall, this development can be seen as a positive step for MediciNova, but investors should remain cautious and monitor the progress of clinical trials and subsequent regulatory approvals.

The market potential for MN-166 in the treatment of uveal melanoma is noteworthy. Uveal melanoma, though rare, is an aggressive cancer with limited treatment options, making new therapies highly desirable. The approval of this patent could position MediciNova as a key player in this niche market.

By addressing a specific unmet medical need, MN-166 could command premium pricing and capture substantial market share upon successful commercialization. Furthermore, the anti-metastasis properties of MN-166 could open up potential off-label uses for other cancers, thereby expanding its market potential beyond uveal melanoma.

However, it's essential to consider the competitive landscape. While MN-166 offers a unique mechanism of action, other biopharmaceutical companies are also exploring advanced treatments for metastatic cancers. MediciNova's ability to differentiate MN-166, through both efficacy and safety profiles, will be critical in securing a strong market position.

LA JOLLA, Calif., May 20, 2024 (GLOBE NEWSWIRE) -- MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ Global Market (NASDAQ:MNOV) and the Standard Market of the Tokyo Stock Exchange (Code Number: 4875), today announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for a pending patent application which covers MN-166 (ibudilast) for the prevention of metastasis of eye cancer.

Once issued, this patent is expected to expire no earlier than July 2042. The allowed claims cover the use of MN-166 (ibudilast) for preventing, ameliorating, or minimizing metastasis of eye cancer. The allowed claims specifically cover the use of MN-166 (ibudilast) for preventing, ameliorating, or minimizing metastasis of uveal melanoma. The allowed claims cover oral administration, a wide range of doses, a range of different dosing frequencies, and a range of different treatment periods.

Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented, “Our research efforts demonstrated the efficacy of MN-166 (ibudilast) in preventing cancer metastasis in an orthotopic uveal melanoma metastasis model (1,2). MN-166 (ibudilast) significantly impeded uveal melanoma migration through the inhibition of macrophage migration inhibitory factor (MIF), a proinflammatory cytokine, to suppress exosomal cell migration activity. Also, we previously reported that MN-166 (ibudilast) reduced levels of immune suppressive myeloid-derived suppressor cells (MDSCs) and enhanced CD8 T cell activity in the tumor microenvironment (3). We are gratified that this new patent will enhance potential value of MN-166 (ibudilast) in the oncology field.”

1: MediciNova Announces New Data regarding MN-166 (ibudilast) in Uveal Melanoma Presented at the CURE OM Global Science Meeting”
https://investors.medicinova.com/news-releases/news-release-details/medicinova-announces-new-data-regarding-mn-166-ibudilast-uvea
2: MediciNova Announces Publication of MN-166 (ibudilast) Data regarding Prevention of Metastasis in Uveal Melanoma in Molecular Cancer Research
https://investors.medicinova.com/news-releases/news-release-details/medicinova-announces-publication-mn-166-ibudilast-data-regarding
3: MediciNova Announces Positive Preclinical Results Regarding MN-166 (ibudilast) in Glioblastoma (GBM) Published in Frontiers in Immunology
https://investors.medicinova.com/news-releases/news-release-details/medicinova-announces-positive-preclinical-results-regarding-mn

About MN-166 (ibudilast)

MN-166 (ibudilast) is a small molecule compound that inhibits phosphodiesterase type-4 (PDE4) and inflammatory cytokines, including macrophage migration inhibitory factor (MIF). It is in late-stage clinical development for the treatment of neurodegenerative diseases such as ALS (amyotrophic lateral sclerosis), progressive MS (multiple sclerosis), and DCM (degenerative cervical myelopathy); and is also in development for glioblastoma, Long COVID, CIPN (chemotherapy-induced peripheral neuropathy), and substance use disorder. In addition, MN-166 (ibudilast) was evaluated in patients that are at risk for developing acute respiratory distress syndrome (ARDS).

About MediciNova

MediciNova, Inc. is a clinical-stage biopharmaceutical company developing a broad late-stage pipeline of novel small molecule therapies for inflammatory, fibrotic, and neurodegenerative diseases. Based on two compounds, MN-166 (ibudilast) and MN-001 (tipelukast), with multiple mechanisms of action and strong safety profiles, MediciNova has 11 programs in clinical development. MediciNova’s lead asset, MN-166 (ibudilast), is currently in Phase 3 for amyotrophic lateral sclerosis (ALS) and degenerative cervical myelopathy (DCM) and is Phase 3-ready for progressive multiple sclerosis (MS). MN-166 (ibudilast) is also being evaluated in Phase 2 trials in Long COVID and substance dependence. MN-001 (tipelukast) was evaluated in a Phase 2 trial in idiopathic pulmonary fibrosis (IPF) and a second Phase 2 trial in non-alcoholic fatty liver disease (NAFLD) is ongoing. MediciNova has a strong track record of securing investigator-sponsored clinical trials funded through government grants.

Statements in this press release that are not historical in nature constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, statements regarding the future development and efficacy of MN-166, MN-001, MN-221, and MN-029. These forward-looking statements may be preceded by, followed by, or otherwise include the words "believes," "expects," "anticipates," "intends," "estimates," "projects," "can," "could," "may," "will," "would," “considering,” “planning” or similar expressions. These forward-looking statements involve a number of risks and uncertainties that may cause actual results or events to differ materially from those expressed or implied by such forward-looking statements. Factors that may cause actual results or events to differ materially from those expressed or implied by these forward-looking statements include, but are not limited to, risks of obtaining future partner or grant funding for development of MN-166, MN-001, MN-221, and MN-029 and risks of raising sufficient capital when needed to fund MediciNova's operations and contribution to clinical development, risks and uncertainties inherent in clinical trials, including the potential cost, expected timing and risks associated with clinical trials designed to meet FDA guidance and the viability of further development considering these factors, product development and commercialization risks, the uncertainty of whether the results of clinical trials will be predictive of results in later stages of product development, the risk of delays or failure to obtain or maintain regulatory approval, risks associated with the reliance on third parties to sponsor and fund clinical trials, risks regarding intellectual property rights in product candidates and the ability to defend and enforce such intellectual property rights, the risk of failure of the third parties upon whom MediciNova relies to conduct its clinical trials and manufacture its product candidates to perform as expected, the risk of increased cost and delays due to delays in the commencement, enrollment, completion or analysis of clinical trials or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, and the timing of expected filings with the regulatory authorities, MediciNova's collaborations with third parties, the availability of funds to complete product development plans and MediciNova's ability to obtain third party funding for programs and raise sufficient capital when needed, and the other risks and uncertainties described in MediciNova's filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2023 and its subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Undue reliance should not be placed on these forward-looking statements, which speak only as of the date hereof. MediciNova disclaims any intent or obligation to revise or update these forward-looking statements.

INVESTOR CONTACT:

David H. Crean, Ph.D.
Chief Business Officer
MediciNova, Inc
info@medicinova.com


FAQ

What new patent did MediciNova receive for MN-166?

MediciNova received a Notice of Allowance for a patent covering MN-166 (ibudilast) for the prevention of metastasis in eye cancer.

When does the new patent for MN-166 expire?

The new patent for MN-166 is expected to expire no earlier than July 2042.

What type of cancer is MN-166 used for?

MN-166 is used for preventing metastasis of uveal melanoma, a type of eye cancer.

How does MN-166 work in preventing cancer metastasis?

MN-166 works by inhibiting macrophage migration inhibitory factor (MIF), reducing immune suppressive cells, and enhancing CD8 T cell activity.

What markets is MediciNova listed on?

MediciNova is listed on the NASDAQ Global Market under the symbol MNOV and the Standard Market of the Tokyo Stock Exchange.

What impact does the new patent have on MN-166's value?

The new patent enhances the potential value of MN-166 in the oncology field.

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