MediciNova Announces European Medicines Agency Recommends Orphan Medicinal Product Designation for MN-166 (ibudilast) for Amy...
November 10 2016 - 6:00AM
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
European Medicines Agency’s (EMA) Committee for Orphan Medicinal
Products (COMP) has issued a positive opinion recommending orphan
medicinal product (orphan-drug) designation for MN-166 (ibudilast)
for the treatment of amyotrophic lateral sclerosis (ALS).
Orphan-drug designation offers potential benefits including
protocol assistance, fee waivers, and 10-year market exclusivity
once the medicine is on the market in Europe.
This is the first orphan medicinal product
designation that MediciNova has received from the EMA. The
process required a thorough scientific evaluation including
establishing “sufficient justification” under the EMA’s COMP
criteria and that MN-166 (ibudilast) “will be of significant
benefit to those affected by the condition…”
Yuichi Iwaki, MD, PhD, President and Chief
Executive Officer of MediciNova, Inc., commented, "We are very
pleased to receive a positive opinion recommending orphan-drug
designation for MN-166 for ALS in the European Union, a
recommendation that complements our recently granted orphan-drug
designation in the U.S. This is an important milestone for
the development of a promising new therapeutic treatment for ALS, a
life-threatening, rare disease for which riluzole is the only
currently-approved treatment option in the EU and U.S.
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 (ibudilast)
demonstrated positive trends in the interim efficacy data from the
mid-study analysis of the CHS Neuromuscular/ALS-MDA Center
study. This interim data, along with previously reported
positive ALS preclinical study data, was submitted to EMA COMP to
address the scientific rationale for orphan medicinal product
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
20,000 ALS patients in the U.S. and approximately 6,000 people in
the U.S. are diagnosed with ALS each year. Publications
estimate that there are approximately 29,000 ALS patients in the
EU. Riluzole is the only pharmaceutical treatment approved for ALS
in the U.S. and EU, but it has limited efficacy.
About Orphan Medicinal Product
DesignationOrphan medicinal product designation in the EU
refers to pharmaceuticals that have been developed for the
treatment of life-threatening or chronically debilitating rare
diseases with reported prevalence of fewer than 5 patients per
10,000 population. Orphan medicinal product designation
allows a more straightforward clinical development path for the
drug and allows the sponsor to receive significant potential
economic, scientific, and regulatory benefits, including reduced
fees and taxes, access to free protocol assistance and scientific
advice by the EMA, and a 10-year period of marketing
exclusivity.
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 ALS and other neurological conditions such as
progressive MS and drug use disorders. 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., ALS and
progressive MS), drug use disorders and chronic neuropathic
pain. MediciNova has a portfolio of patents which cover the
use of MN-166 (ibudilast) to treat various diseases including ALS,
progressive MS, and drug use disorders.
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. and European markets. MediciNova's current
strategy is to focus on MN-166 (ibudilast) for neurological
disorders such as ALS, progressive MS and drug use disorders (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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