MediciNova Receives Notice of Intention to Grant for New Patent Covering MN-001 for the Treatment of Idiopathic Pulmonary Fib...
January 27 2020 - 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 Intention to Grant
from the European Patent Office for a pending patent
application which covers MN-001 (tipelukast) for the treatment of
idiopathic pulmonary fibrosis (IPF).
Once issued, the patent maturing from this allowed patent
application is expected to expire no earlier than May 2035.
The allowed claims cover the use of MN-001 for treating a patient
diagnosed with idiopathic pulmonary fibrosis. The allowed claims
also cover the inhibition of pulmonary scarring, the reduction or
inhibition of elevated lung hydroxyproline levels, the reduction of
elevated lung density, and the reduction of elevated total cell
count in bronchoalveolar lavage fluid using MN-001. The allowed
claims cover oral administration, including tablets and capsules,
as well as liquid dosage forms.
Yuichi Iwaki, MD, PhD, President and CEO of MediciNova,
Inc., commented, "Previously, we were granted patents covering IPF
in Japan and China, and now we are very pleased to receive notice
that this new patent will be granted in Europe. We believe it could
substantially increase the potential value of MN-001 as we now have
patent or marketing exclusivity coverage for IPF in every major
pharmaceutical market in the world. Previously, the U.S.
FDA granted orphan-drug designation, which will
provide MediciNova with seven years of marketing
exclusivity, and fast-track designation to MN-001 for the treatment
of IPF. We currently have a Phase 2 clinical trial ongoing that is
evaluating the safety and tolerability and clinical effect of
MN-001 in IPF.”
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), degenerative cervical myelopathy (DCM), 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, 2018 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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