MediciNova Receives Notice of Allowance for New Patent Covering MN-001 and MN-002 for the Treatment of Fibrosis in Japan
January 07 2019 - 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 MN-001 (tipelukast) and MN-002 (a major metabolite of
MN-001) for the treatment of “fibrosis” which includes a
broad range of fibrosis / fibrotic disease in different organs due
to different causes.
Once issued, the patent maturing from this
allowed patent application is expected to expire no earlier
than June 2035. The allowed claims cover a composition for
inhibiting or treating fibrosis using MN-001 or MN-002. The allowed
claims cover oral administration including liquid and solid dosage
forms.
Yuichi Iwaki, MD, PhD, President and CEO
of MediciNova, Inc. commented, "We are very pleased to
receive notice that this new patent will be granted as the claims
are broad enough to cover MN-001 for the treatment of many forms of
fibrosis and fibrotic disease. A similar patent that extensively
covers the treatment of various forms of fibrosis / fibrotic
disease has already been approved by the U.S. Patent Office in
2016. We believe this patent could substantially increase the
potential value of MN-001 as MN-001’s broad anti-fibrotic activity
enables us to pursue clinical development in various types of
fibrosis.”
About MN-001
MN-001 (tipelukast) is a novel, orally
bioavailable small molecule compound thought to exert its effects
through several mechanisms to produce its anti-inflammatory and
anti-fibrotic activity in preclinical models, including leukotriene
(LT) receptor antagonism, inhibition of phosphodiesterases (PDE)
(mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO). The
5-LO/LT pathway has been postulated as a pathogenic factor in
fibrosis development, and MN-001's inhibitory effect on 5-LO and
the 5-LO/LT pathway is considered to be a novel approach to treat
fibrosis. MN-001 has been shown to down-regulate expression of
genes that promote fibrosis including LOXL2, Collagen Type 1 and
TIMP-1. MN-001 has also been shown to down-regulate expression of
genes that promote inflammation including CCR2 and MCP-1. In
addition, histopathological data shows that MN-001 reduces fibrosis
in multiple animal models.
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'BrienVice
PresidentMediciNova, Inc.info@medicinova.com
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