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 U.S. Patent and Trademark
Office for a pending patent application which covers the
combination of MN-166 (ibudilast) and riluzole for the treatment of
amyotrophic lateral sclerosis (ALS) and other neurodegenerative
diseases.
Once issued, the patent maturing from this allowed patent
application is expected to expire no earlier than November 2035.
The allowed claims cover a method of treating a patient diagnosed
with ALS, as well as a wide range of other neurodegenerative
diseases, with the combination of MN-166 (ibudilast) and
riluzole. Other neurodegenerative diseases covered by this
patent include Alzheimer’s disease, Parkinson’s disease, multiple
sclerosis, Huntington’s disease, Lewy body disease, motor neuron
disease, spinal muscular atrophy, myelopathy, traumatic brain
injury, spinal cord injury, and many others.
MediciNova was previously granted a U.S. patent which covers the
use of MN-166 (ibudilast) as monotherapy for the treatment of
amyotrophic lateral sclerosis (ALS) and it expires no earlier than
January 2029. MediciNova was previously granted three U.S.
patents which cover the use of MN-166 (ibudilast) as monotherapy
for the treatment of progressive multiple sclerosis including both
primary progressive multiple sclerosis and secondary progressive
multiple sclerosis. The first one of these patents expires no
earlier than November 2029 and patent term restoration would add 5
years once MN-166 (ibudilast) is approved for progressive multiple
sclerosis, extending the patent expiration to November 2034.
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 it could
extend the patent life for the ALS indication by almost 7 years
compared to our first ALS patent. In addition, the patent
covers a wide range of other neurodegenerative diseases which
expands the opportunities for clinical development of MN-166."
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 6,000 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. It 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 progressive multiple sclerosis (MS) and
other neurological diseases such as amyotrophic lateral sclerosis
(ALS), substance abuse/addiction and glioblastoma (GBM). MediciNova
is developing MN-166 for progressive MS and other neurological
conditions such as ALS, substance abuse/addiction,
chemotherapy-induced neuropathy, and glioblastoma. MediciNova has a
portfolio of patents which cover the use of MN-166 (ibudilast) to
treat various diseases including progressive MS, ALS, 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 MN-166 (ibudilast) for neurological disorders such
as progressive multiple sclerosis (MS), amyotrophic lateral
sclerosis (ALS), substance dependence (e.g., alcohol use disorder,
methamphetamine dependence, opioid dependence) and glioblastoma
(GBM), 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 MN-166, MN-221, MN-001, 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-221, MN-001, 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, 2017 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
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