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MediciNova Receives a Notice of Allowance for a New Patent Covering MN-166 (ibudilast) for the Treatment of Macular Injury in Japan

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MediciNova, Inc. receives a Notice of Allowance from the Japan Patent Office for a pending patent application covering MN-166 (ibudilast) for the treatment of macular injury associated with progressive multiple sclerosis. The patent is expected to expire no earlier than October 2039 and covers a wide range of doses, dosing frequencies, and treatment periods. Chief Medical Officer, Kazuko Matsuda, highlights the potential value of MN-166 in ophthalmic neurodegenerative diseases based on positive data from previous studies.
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The receipt of a Notice of Allowance from the Japan Patent Office for MediciNova's MN-166 (ibudilast) represents a strategic milestone in the company's intellectual property portfolio. This allowance not only extends the exclusivity of MN-166's use in treating macular injury associated with progressive multiple sclerosis until at least 2039 but also underscores the drug's versatility in oral dosage forms. The breadth of the claims, encompassing a variety of dosages, frequencies and treatment durations, offers MediciNova a robust defense against generic competition in the Japanese market.

MediciNova's ability to secure similar patents in other major markets such as the U.S., Europe and China suggests a coordinated effort to build a global moat around MN-166. This strategic positioning could enhance the company's negotiating power in potential licensing deals or partnerships, especially given the positive data from preclinical studies and Phase 2b trials. However, it is essential to monitor how this patent will affect market access and pricing strategies in Japan, considering the country's stringent health economics assessment for new therapies.

The announcement by MediciNova regarding the patent allowance for MN-166 in Japan is likely to have a positive impact on investor sentiment, given the extended market protection and the potential for MN-166 to address an unmet medical need in progressive multiple sclerosis. The reference to positive data from animal model studies and the SPRINT-MS Phase 2b trial adds credence to the drug's efficacy profile. For investors, the patent news serves as a tangible progress indicator in MediciNova's pipeline development.

However, it is critical to assess the size of the target population for MN-166 and the competitive landscape. While the patent secures long-term prospects, the immediate impact on the stock market will depend on the drug's progress through clinical trials, regulatory approval and subsequent commercialization. Investors should weigh the potential revenue against the costs of ongoing development and the time required to bring MN-166 to market.

The clinical implications of MN-166 for progressive multiple sclerosis patients are significant, particularly for those suffering from macular injury. Optical Coherence Tomography (OCT) results indicating less retinal tissue loss with MN-166 compared to placebo suggest that the drug could offer a novel therapeutic approach for preserving vision in this patient population. The specificity of the patent claims to both primary and secondary progressive multiple sclerosis broadens the potential impact of MN-166, as it addresses two distinct forms of the disease.

While the patent is a positive development, it is important to consider the remaining clinical and regulatory hurdles that MN-166 must clear. The drug's efficacy and safety profile will need to be consistently demonstrated in larger, more diverse patient populations. Additionally, the treatment's long-term benefits and its position within the existing treatment paradigm will be closely scrutinized by both regulators and the medical community.

LA JOLLA, Calif., March 26, 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 it has received a Notice of Allowance from the Japan Patent Office for a pending patent application which covers MN-166 (ibudilast) for the treatment of macular injury associated with progressive multiple sclerosis.

Once issued, this patent is expected to expire no earlier than October 2039.  The allowed claims cover the use of MN-166 (ibudilast) for treating macular injury associated with progressive multiple sclerosis and for decreasing macular volume loss associated with progressive multiple sclerosis. The allowed claims specifically cover both primary progressive multiple sclerosis and secondary progressive multiple sclerosis. The allowed claims cover oral administration including tablets, capsules, granules, microbead dosage forms, and liquid dosage forms. The allowed claims cover a wide range of doses of MN-166 (ibudilast), 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, “We are very pleased to receive a notice of this new patent allowance in Japan and we believe it could increase the potential value of MN-166.   The potential of MN-166 in ophthalmic neurodegenerative diseases has been demonstrated previously by positive data from a glaucoma animal model study and a retinal damage animal model study. Previously, we reported positive Optical Coherence Tomography (OCT) results from the SPRINT-MS Phase 2b trial of MN-166 in progressive multiple sclerosis. All OCT measures showed less loss of retinal tissue for MN-166 compared to placebo. Similar patents have been granted in the U.S., Europe, and China.”

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, 2022 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:

Geoff O'Brien
Vice President
MediciNova, Inc.
info@medicinova.com


FAQ

What is the patent application about for MediciNova, Inc.?

The patent application covers MN-166 (ibudilast) for the treatment of macular injury associated with progressive multiple sclerosis.

When is the patent expected to expire?

The patent is expected to expire no earlier than October 2039.

Which types of multiple sclerosis are covered by the patent claims?

The patent claims cover both primary progressive multiple sclerosis and secondary progressive multiple sclerosis.

What forms of administration are included in the allowed claims?

The allowed claims cover oral administration including tablets, capsules, granules, microbead dosage forms, and liquid dosage forms.

What positive results were reported from previous studies regarding MN-166?

Positive results were reported from a glaucoma animal model study and a retinal damage animal model study, as well as positive Optical Coherence Tomography (OCT) results from the SPRINT-MS Phase 2b trial.

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