MediciNova Receives Notice of Allowance for New Patent Covering the Combination of MN-166 (ibudilast) and Riluzole for the T...
January 18 2021 - 6:00PM
MediciNova, Inc., a biopharmaceutical company traded on the NASDAQ
Global Market (NASDAQ:MNOV) and the JASDAQ Market of the Tokyo
Stock Exchange (Code Number: 4875), today announced that it has
received a Notice of Allowance from the Japan Patent
Office for a pending patent application which covers the
combination of MN-166 (ibudilast) and riluzole for the treatment of
amyotrophic lateral sclerosis (ALS).
Once issued, the patent maturing from this allowed patent
application is expected to expire no earlier than November
2035. The allowed claims cover the combination of MN-166
(ibudilast) and riluzole for alleviating the negative effects of
ALS, treating a patient diagnosed with ALS, and slowing progression
of disease in a patient diagnosed with ALS. The allowed
claims cover a wide range of doses and dosing regimens for both
MN-166 (ibudilast) and riluzole.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer
of MediciNova, Inc., commented, "We are very pleased to
receive notice that this new patent will be granted. We believe it
could substantially increase the potential value of MN-166 as
patients are using the combination of MN-166 and riluzole in our
ongoing Phase 3 clinical trial in ALS. Previously, a similar
patent was granted in the U.S., the U.S. FDA granted both
orphan-drug designation and fast-track designation to MN-166 for
the treatment of ALS, and the European Commission granted
Orphan Medicinal Product Designation to MN-166 for the treatment of
ALS."
About ALS
Amyotrophic lateral sclerosis (ALS), also known
as Lou Gehrig's disease, is a progressive
neurodegenerative disease that affects nerve cells in the brain and
the spinal cord. The nerves lose the ability to trigger specific
muscles, which causes the muscles to become weak. As a result, ALS
affects voluntary movement and patients in the later stages of the
disease may become completely paralyzed. Life expectancy of an ALS
patient is usually 2-5 years. According to the ALS
Association, there are approximately 20,000 ALS patients in the
U.S. and approximately 5,000 people in the U.S. are diagnosed with
ALS each year.
About MN-166 (ibudilast)
MN-166 (ibudilast) is a first-in-class, orally
bioavailable, small molecule macrophage migration inhibitory factor
(MIF) inhibitor and phosphodiesterase (PDE) -4 and -10 inhibitor
that suppresses pro-inflammatory cytokines and promotes
neurotrophic factors. Our earlier human studies demonstrated
significant reductions of serum MIF level after treatment with
MN-166 (ibudilast). It also attenuates activated glial cells, which
play a major role in certain neurological conditions. MN-166
(ibudilast)'s anti-neuroinflammatory and neuroprotective actions
have been demonstrated in preclinical and clinical studies, which
provide the rationale for treatment of amyotrophic lateral
sclerosis (ALS), progressive multiple sclerosis (MS) and other
neurological diseases such as glioblastoma (GBM), and substance
abuse/addiction. MediciNova is developing MN-166 for ALS,
progressive MS and other neurological conditions such as
degenerative cervical myelopathy (DCM), glioblastoma, substance
abuse/addiction, and chemotherapy-induced peripheral neuropathy, as
well as prevention of acute respiratory distress syndrome (ARDS)
caused by COVID-19. MediciNova has a portfolio of patents which
covers the use of MN-166 (ibudilast) to treat various diseases
including ALS, progressive MS, and drug addiction.
About
MediciNova
MediciNova, Inc. is a publicly-traded
biopharmaceutical company founded upon developing novel,
small-molecule therapeutics for the treatment of diseases with
unmet medical needs with a primary commercial focus on the U.S.
market. MediciNova's current strategy is to focus on BC-PIV
SARS-COV-2 vaccine for COVID-19, MN-166 (ibudilast) for
neurological disorders such as progressive multiple sclerosis (MS),
amyotrophic lateral sclerosis (ALS), degenerative cervical
myelopathy (DCM), substance dependence (e.g., alcohol use disorder,
methamphetamine dependence, opioid dependence) and glioblastoma
(GBM), as well as prevention of acute respiratory distress syndrome
(ARDS) caused by COVID-19, and MN-001 (tipelukast) for fibrotic
diseases such as nonalcoholic steatohepatitis (NASH) and idiopathic
pulmonary fibrosis (IPF). MediciNova’s pipeline also includes
MN-221 (bedoradrine) and MN-029 (denibulin). For more information
on MediciNova, Inc., please visit www.medicinova.com.
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 BC-PIV SARS-COV-2 vaccine, 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 BC-PIV SARS-COV-2 vaccine, 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, 2019 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'BrienVice PresidentMediciNova,
Inc.info@medicinova.com
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