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

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MediciNova, Inc. has received a Notice of Grant from the Chinese Patent Office for a new patent covering MN-166 (ibudilast) for the treatment of macular injury associated with progressive multiple sclerosis. The patent is expected to expire no earlier than April 2040 and covers a wide range of doses, dosing frequencies, and treatment periods. The Chief Medical Officer commented on the potential of MN-166 in ophthalmic neurodegenerative diseases and the positive data from previous studies.
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The granting of a patent by the Chinese Patent Office for MediciNova's MN-166 (ibudilast) is a pivotal development in the company's intellectual property portfolio. The protection of MN-166's use for treating macular injury in progressive multiple sclerosis until at least April 2040 secures MediciNova's exclusivity in a substantial market like China. This exclusivity is vital for recouping research and development investments and can act as a deterrent against generic competition for an extended period.

Such patents are a cornerstone in the biopharmaceutical industry, ensuring a company can maintain market share and pricing power. It is also indicative of the drug's innovation, as patent offices generally require a novel and non-obvious contribution to the existing body of knowledge. This patent not only covers the therapeutic use but also the administration methods and dosage, which provides comprehensive protection against potential infringement.

From a medical perspective, the application of MN-166 (ibudilast) in progressive multiple sclerosis, specifically targeting macular injury, addresses a significant unmet need. Macular injury can lead to vision problems which are a common and debilitating symptom of progressive multiple sclerosis. The drug's ability to decrease macular volume loss is crucial as it directly relates to preserving eyesight in patients.

Positive data from the SPRINT-MS Phase 2b trial, including Optical Coherence Tomography (OCT) results, supports the therapeutic potential of MN-166. These findings are important as they suggest a slowing down of neurodegenerative processes in the eye, which can be extrapolated to infer a possible protective effect on neurons. This is significant because current treatments for multiple sclerosis are often limited in their ability to prevent neurodegeneration.

In terms of market implications, the extension of MediciNova's patent coverage to China is a strategic move, considering China's large population and growing pharmaceutical market. The prevalence of multiple sclerosis in China is lower compared to Western countries, but the absolute number of patients is still considerable due to the vast population. Moreover, the Chinese healthcare sector is experiencing rapid growth and increased investment, making it a lucrative market for innovative treatments like MN-166.

Investors may view this patent grant as a positive indicator of MediciNova's future revenue streams from MN-166, potentially influencing the company's stock performance. The patent in China, along with existing patents in the U.S. and Europe, positions MediciNova for a strong market presence across major global markets, potentially enhancing shareholder value in the long term.

LA JOLLA, Calif., Jan. 17, 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 Grant from the Chinese Patent Office for a new patent 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 April 2040. 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, "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. and Europe. We are very pleased to receive a notice of this new patent which covers China and we believe it could increase the potential value of MN-166.”

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 patent has MediciNova, Inc. received a Notice of Grant for?

MediciNova, Inc. has received a Notice of Grant for a new patent covering MN-166 (ibudilast) for the treatment of macular injury associated with progressive multiple sclerosis.

What is the expected expiration date of the new patent?

The new patent is expected to expire no earlier than April 2040.

What does the new patent cover?

The new patent covers a wide range of doses, dosing frequencies, and treatment periods for MN-166 (ibudilast) for the treatment of macular injury associated with progressive multiple sclerosis.

Who commented on the potential of MN-166 in ophthalmic neurodegenerative diseases?

Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of MediciNova, Inc., commented on the potential of MN-166 in ophthalmic neurodegenerative diseases.

What positive data was reported from previous studies?

Positive data 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 of MN-166 in progressive multiple sclerosis, were reported.

Where has similar patents been granted?

Similar patents have been granted in the U.S. and Europe.

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