MediciNova Receives Notice of Allowance from United States Patent and Trademark Office for New Patent Covering MN-166 (ibudilast) for the Post-COVID Condition
MediciNova (NASDAQ:MNOV) has received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering MN-166 (ibudilast) for post-COVID conditions. The Method of Use patent covers administering ibudilast to alleviate various post-COVID symptoms, including anxiety, fatigue, depression, and shortness of breath. The patent allows for multiple administration methods and dosing regimens, either alone or in combination with other active agents.
The patent is expected to expire no earlier than November 2042, providing extended exclusivity for MediciNova. The company is currently conducting a Phase 2/3 clinical trial in Long COVID in collaboration with University Health Network in Canada. MediciNova plans to initiate discussions with Health Canada for a New Drug Application if the RECLAIM study shows positive results.
MediciNova (NASDAQ:MNOV) ha ricevuto un Avviso di Concessione da parte dell'Ufficio Brevetti e Marchi degli Stati Uniti per un nuovo brevetto riguardante MN-166 (ibudilast) per le condizioni post-COVID. Il brevetto sul Metodo di Utilizzo copre la somministrazione di ibudilast per alleviare vari sintomi post-COVID, inclusi ansia, affaticamento, depressione e mancanza di respiro. Il brevetto prevede metodi di somministrazione multipli e schemi di dosaggio, sia singolarmente che in combinazione con altri agenti attivi.
Il brevetto dovrebbe scadere non prima di novembre 2042, offrendo una lunga esclusività per MediciNova. L'azienda sta attualmente conducendo uno studio clinico di fase 2/3 sul Long COVID in collaborazione con il Network Sanitario Universitario in Canada. MediciNova prevede di avviare discussioni con Health Canada per un'Applicazione per Nuovo Farmaco se lo studio RECLAIM mostra risultati positivi.
MediciNova (NASDAQ:MNOV) ha recibido un Aviso de Concesión de la Oficina de Patentes y Marcas de EE. UU. para una nueva patente que cubre MN-166 (ibudilast) para las condiciones post-COVID. La patente de Método de Uso cubre la administración de ibudilast para aliviar varios síntomas post-COVID, incluidos la ansiedad, la fatiga, la depresión y la falta de aliento. La patente permite métodos de administración múltiples y regímenes de dosificación, ya sea solos o en combinación con otros agentes activos.
Se espera que la patente expire no antes de noviembre de 2042, proporcionando exclusividad prolongada para MediciNova. La empresa está llevando a cabo actualmente un ensayo clínico de fase 2/3 en Long COVID en colaboración con la Red de Salud Universitaria en Canadá. MediciNova planea iniciar conversaciones con Health Canada para una Nueva Solicitud de Medicamento si el estudio RECLAIM muestra resultados positivos.
메디치노바 (NASDAQ:MNOV)는 미국 특허 상표청으로부터 MN-166 (이부딜라스트)의 포스트 COVID 조건을 위한 새로운 특허에 대한 허가 통지를 받았습니다. 사용방법 특허는 불안, 피로, 우울증 및 호흡 곤란을 포함한 다양한 포스트 COVID 증상을 완화하기 위해 이부딜라스트를 투여하는 것을 다룹니다. 이 특허는 다양한 투여 방법 및 투약 요법을 허용하며, 단독으로 또는 다른 활성 물질과 혼합하여 사용할 수 있습니다.
이 특허는 2042년 11월 이전에 만료되지 않을 것으로 예상되며, 메디치노바에 대한 독점성을 연장합니다. 이 회사는 현재 캐나다의 대학 건강 네트워크와 협력하여 롱 COVID에 대한 2/3상 임상 시험을 진행하고 있습니다. 메디치노바는 RECLAIM 연구가 긍정적인 결과를 보여줄 경우 Health Canada와 새로운 약물 신청을 위한 논의를 시작할 계획입니다.
MediciNova (NASDAQ:MNOV) a reçu un Avis de Concession de l'Office des brevets et des marques des États-Unis pour un nouveau brevet couvrant MN-166 (ibudilast) pour les conditions post-COVID. Le brevet sur la Méthode d'Utilisation couvre l'administration d'ibudilast pour atténuer divers symptômes post-COVID, notamment l'anxiété, la fatigue, la dépression et l'essoufflement. Le brevet permet plusieurs méthodes d'administration et régimes posologiques, soit seul, soit en combinaison avec d'autres agents actifs.
Le brevet devrait expirer au plus tôt en novembre 2042, offrant une exclusivité prolongée à MediciNova. L'entreprise mène actuellement un essai clinique de phase 2/3 sur le Long COVID en collaboration avec le Réseau de santé universitaire au Canada. MediciNova prévoit d'engager des discussions avec Santé Canada pour une demande de nouveau médicament si l'étude RECLAIM montre des résultats positifs.
MediciNova (NASDAQ:MNOV) hat von dem US-Patent- und Markenamt eine Zulassungsankündigung für ein neues Patent erhalten, das MN-166 (Ibudilast) für Post-COVID-Bedingungen abdeckt. Das Verwendungsmuster-Patent deckt die Verabreichung von Ibudilast zur Linderung verschiedener Post-COVID-Symptome wie Angst, Müdigkeit, Depression und Atemnot ab. Das Patent erlaubt mehrere Verabreichungsmethoden und Dosierungsregime, entweder einzeln oder in Kombination mit anderen aktiven Wirkstoffen.
Es wird erwartet, dass das Patent nicht vor November 2042 abläuft, wodurch MediciNova eine verlängerte Exklusivität erhält. Das Unternehmen führt derzeit eine Phase 2/3 klinische Studie zu Long COVID in Zusammenarbeit mit dem University Health Network in Kanada durch. MediciNova plant, Gespräche mit Health Canada über einen Antrag auf Neuzulassung von Arzneimitteln aufzunehmen, wenn die RECLAIM-Studie positive Ergebnisse zeigt.
- Received Notice of Allowance for new patent covering MN-166 (ibudilast) for post-COVID conditions
- Patent expected to expire no earlier than November 2042, providing extended market exclusivity
- Patent covers multiple administration methods and dosing regimens, enhancing flexibility in treatment options
- Ongoing Phase 2/3 clinical trial for Long COVID in collaboration with University Health Network in Canada
- None.
Insights
The USPTO's Notice of Allowance for MediciNova's patent application covering MN-166 (ibudilast) for post-COVID conditions is a significant development. This patent, expected to expire no earlier than November 2042, provides long-term market exclusivity for MediciNova's potential treatment of various post-COVID symptoms. The broad claims covering different administration routes, dosages and combinations with other drugs offer flexibility in future drug development.
The ongoing Phase 2/3 clinical trial for Long COVID, in collaboration with University Health Network in Canada, positions MediciNova to potentially address an unmet medical need. If successful, this could lead to a New Drug Application, opening up a substantial market opportunity given the prevalence of post-COVID conditions globally. However, investors should note that clinical trial success is not guaranteed and regulatory approval processes can be lengthy and complex.
This patent allowance strengthens MediciNova's intellectual property portfolio, potentially enhancing the company's long-term value proposition. The extended patent protection until 2042 could translate into a sustained revenue stream if MN-166 proves effective and gains regulatory approval for post-COVID conditions.
Investors should consider the market potential for Long COVID treatments, given the global impact of the pandemic. However, it's important to balance this against the costs of clinical trials and potential regulatory hurdles. MediciNova's commitment to pursuing a New Drug Application upon positive study results indicates confidence but also implies significant future R&D expenses. The company's financial position and burn rate should be closely monitored as it progresses through clinical development.
LA JOLLA, Calif., Aug. 29, 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), announces 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 post-COVID conditions. The Method of Use patent covers administering a therapeutically effective doses of ibudilast (or a pharmaceutically acceptable salt thereof) to alleviate a range of post-COVID conditions including anxiety, fatigue, depression, shortness of breath, post-traumatic stress disorder, chest tightness, palpitations, smell or taste dysfunction, sleep difficulties, hair loss, and rash.
The claim method allows for MN-166 (ibudilast) to be administered alone or in combination with other active agents, including corticosteroids, NSAIDs, SSRIs, and more. The allowed claims cover oral administration, intravenous administration, subcutaneous injection, intramuscular injection, and inhalation administration. The allowed claims cover a wide range of doses, a range of different dosing frequencies, and a range of different treatment periods. Once issued, this patent is expected to expire no earlier than November 2042.
Kazuko Matsuda, M.D., Ph.D., M.P.H., MediciNova’s Chief Medical Officer commented, “This additional patent for ibudilast provides additional opportunities for us to maintain exclusivity in areas where research is underway. We remain dedicated to addressing the complex and persistent health challenges posed by COVID-19 through key partnerships, such as our current collaboration with University Health Network in Canada, where a Phase 2/3 clinical trial in Long COVID is ongoing. We believe that ibudilast may offer hope to millions of patients suffering from post-COVID conditions, providing a versatile and effective therapeutic option. Since we have committed to move forward to apply New Drug Application when the study shows positive outcome, we plan to initiate the discussion with Health Canada when the RECLAIM study shows the positive data.”
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 is the new patent MediciNova (MNOV) received for MN-166 (ibudilast)?
When is the expected expiration date for MediciNova's (MNOV) new patent on MN-166 (ibudilast)?
What clinical trial is MediciNova (MNOV) currently conducting for MN-166 (ibudilast) in Long COVID?
What are MediciNova's (MNOV) plans if the RECLAIM study for MN-166 (ibudilast) shows positive results?
