MediciNova Announces FDA Grants Orphan Drug Designation to MN-166 (ibudilast) for Glioblastoma
October 04 2018 - 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) as adjunctive therapy to
temozolomide for the treatment of glioblastoma
(GBM).
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of
MediciNova, Inc., commented, "We are very pleased that the FDA has
granted orphan-drug designation for MN-166 as adjunctive therapy to
temozolomide for the treatment of GBM, a rare cancer with a high
recurrence rate and poor prognosis."
About GlioblastomaAccording to the American
Association of Neurological Surgeons, glioblastoma (GBM) is a
devastating brain cancer that typically results in death in the
first 15 months after diagnosis. An aggressive, extremely lethal
form of brain malignancy, GBM develops from glial cells (astrocytes
and oligodendrocytes) and rapidly grows and commonly spreads into
nearby brain tissue. GBM is classified as Grade IV, the highest
grade, in the World Health Organization (WHO) brain tumor grading
system. GBM has an incidence of 2-3 per 100,000 adults per year.
The American Brain Tumor Association reports that GBM represents
15% of all brain tumors and 56% of all gliomas and has the highest
number of cases of all malignant tumors, with an estimated 12,760
new cases predicted for 2018. Despite decades of advancements in
neuroimaging, neurosurgery, chemotherapy, and radiation therapy,
only modest improvements have been achieved and the prognosis has
not improved for individuals diagnosed with GBM. Median
survival is 14.6 months and two-year survival is 30%. Only
approximately 5% of GBM patients survive longer than 36 months.
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 multiple sclerosis (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 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 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, 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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