MediciNova Announces FDA Granted Orphan Drug Designation to MN-166 (ibudilast) for Amyotrophic Lateral Sclerosis
October 11 2016 - 7:00PM
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 the U.S.
Food and Drug Administration (FDA) has granted orphan-drug
designation to MN-166 (ibudilast) for treatment of Amyotrophic
Lateral Sclerosis (ALS).
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of
MediciNova, Inc., commented, "We are very pleased to receive
orphan-drug designation for MN-166 for ALS, a rare disease for
which riluzole is the only currently approved treatment option.
Currently we have two ongoing clinical trials to evaluate MN-166 in
ALS in collaboration with researchers at Carolinas HealthCare
System's (CHS) Neuromuscular/ALS-MDA Center and Massachusetts
General Hospital. MN-166 demonstrated positive trends in the
interim efficacy data from the mid-study analysis of the CHS
Neuromuscular/ALS-MDA Center study. This interim data was
submitted to FDA to address the scientific rationale for
orphan-drug designation to establish the medical basis for the use
of MN-166 (ibudilast) for ALS."
About Amyotrophic Lateral
SclerosisAmyotrophic 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
totally paralyzed. Life expectancy of an ALS patient is usually 2-5
years. According to the ALS Association, there are approximately
30,000 ALS patients in the U.S. and approximately 5,600 people in
the U.S. are diagnosed with ALS each year. Riluzole is the only
pharmaceutical treatment approved for ALS, but it has limited
efficacy.
About Orphan Drug DesignationDrugs that receive
orphan-drug designation from FDA are entitled to seven years of
marketing exclusivity if they are approved by the FDA for the same
rare disease. The Orphan Drug Designation program provides orphan
status to drugs and biologics which are defined as those intended
for the safe and effective treatment, diagnosis or prevention of
rare diseases or disorders that affect fewer than 200,000 people in
the U.S., or that affect more than 200,000 persons but are not
expected to recover the costs of developing and marketing a
treatment drug.
About MN-166 (ibudilast)MN-166 (ibudilast) has
been marketed in Japan and Korea since 1989 to treat post-stroke
complications and bronchial asthma. MediciNova is developing MN-166
for progressive MS and other neurological conditions such as ALS
and substance abuse/addiction. MN-166 (ibudilast) is a
first-in-class, orally bioavailable, small molecule
phosphodiesterase (PDE) -4 and -10 inhibitor and a macrophage
migration inhibitory factor (MIF) inhibitor that suppresses
pro-inflammatory cytokines and promotes neurotrophic factors. It
attenuates activated glia cells, which play a major role in certain
neurological conditions. Ibudilast's anti-neuroinflammatory and
neuroprotective actions have been demonstrated in preclinical and
clinical study results and provide the rationale for its
therapeutic utility in neurodegenerative diseases (e.g.,
progressive MS and ALS), substance abuse/addiction and chronic
neuropathic pain. 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 MediciNovaMediciNova,
Inc. is a publicly-traded biopharmaceutical company founded upon
acquiring and developing novel, small-molecule therapeutics for the
treatment of diseases with unmet medical needs with a commercial
focus on the U.S. market. MediciNova's current strategy is to focus
on MN-166 (ibudilast) for neurological disorders such as
progressive MS, ALS and substance dependence (e.g., alcohol use
disorder, methamphetamine dependence, opioid dependence) 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) for the treatment of acute exacerbations of asthma
and MN-029 (denibulin) for solid tumor cancers. MediciNova is
engaged in strategic partnering and other potential funding
discussions to support further development of its programs. 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, 2015 and its subsequent periodic reports on
Forms 10-Q and 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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