LA JOLLA, Calif., Oct. 11, 2016 (GLOBE NEWSWIRE) -- 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 Sclerosis
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 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 Designation
Drugs 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 MediciNova
MediciNova, 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. [email protected]
