MediciNova Receives Issue Notification for New Patent Covering Extended-Release Formulations of MN-166 (ibudilast)
07 Mai 2024 - 12:00PM
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 an issue notification from the U.S. Patent and
Trademark Office for a new patent which covers extended-release
oral formulations of MN-166 (ibudilast). This new patent is
expected to expire no earlier than September 2040. The allowed
claims cover a formulation in the form of a tablet or capsule and
cover a range of doses of MN-166 (ibudilast).
Kazuko Matsuda, MD, PhD, MPH, Chief Medical Officer of
MediciNova, Inc., commented, "We are very pleased to receive the
issue notification for this new patent and we believe it could
increase the potential value of MN-166. New extended-release
formulations are more convenient for patients which may lead to
improve compliance with the dosing schedule and to reduce
undesirable side effect.”
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
Medicinova (NASDAQ:MNOV)
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