FDA Grants Fast Track Designation for MediciNova's MN-166 (ibudilast) for the Treatment of Methamphetamine Dependence

FDA Grants Fast Track Designation for MediciNova's MN-166 (ibudilast) for the
Treatment of Methamphetamine Dependence

SAN DIEGO, Feb. 25, 2013 (GLOBE NEWSWIRE) -- MediciNova, Inc., a
biopharmaceutical company that is publicly traded on the NASDAQ Global Market
(Nasdaq:MNOV) and the Jasdaq Market of the Osaka Securities Exchange (Code
Number: 4875), today announced that it has received Fast Track designation
from the U.S. Food and Drug Administration (FDA) for MN-166 (ibudilast) for
the treatment of methamphetamine dependence. Fast Track is a process designed
to facilitate the development and expedite the review of drugs that are
intended to treat serious diseases and have the potential to fill an unmet
medical need. An important feature of the FDA's Fast Track program is that it
emphasizes early and frequent communication between the FDA and the sponsor
throughout the entire drug development and review process to improve the
efficiency of product development.Accordingly, Fast Track status can
potentially lead to a shortened timeline to ultimate drug approval.

According to the Substance Abuse and Mental Health Services Administration's
(SAMHSA) 2011 National Survey on Drug Use and Health, there are approximately
439,000 methamphetamine abusers in the U.S. An independent study conducted by
the Rand Corporation estimated the economic burden of methamphetamine use in
the U.S. at $23.4 billion in 2005.There are no medications currently approved
by the FDA for the treatment of methamphetamine dependence. Herbert D. Kleber
M.D., founder and Director of the Division on Substance Abuse, New York State
Psychiatric Institute, and Professor of Psychiatry at Columbia University
Medical Center, and a prior Deputy Director at the White House Office of
National Drug Control Policy noted that "there truly is an unmet need for
pharmacotherapy treatment of methamphetamine dependence and the recognition of
such need by the FDA is positive for the field."

"We are very pleased that MN-166 has received Fast Track designation and
believe this validates its potential to address unmet medical needs in this
devastating and life-threatening disease," Dr. Yuichi Iwaki, President and CEO
of MediciNova commented."We look forward to initiating the NIDA-funded Phase
2 outpatient clinical trial of MN-166 for the treatment of methamphetamine
addiction with UCLA investigators."

About Fast Track Designation

According to the FDA, in order to be granted Fast Track designation, a drug
must (1) be intended for the treatment of a serious or life-threatening
condition; and (2) demonstrate the potential to address unmet medical needs
for the condition.

A drug that receives Fast Track designation is eligible for some or all of the

  oMore frequent meetings with the FDA to discuss the drug's development plan
    and ensure collection of appropriate data needed to support drug approval;
  oMore frequent written correspondence from the FDA about such things as the
    design of the proposed clinical trials;
  oAccelerated Approval, i.e., approval based on an effect on a surrogate, or
    substitute endpoint reasonably likely to predict clinical benefit;
  oRolling Review, which means that a sponsor can submit completed sections
    of its New Drug Application (NDA) for review by the FDA, rather than
    waiting until every section of the application is completed before the
    entire application can be reviewed; and
  oPriority Review, with an FDA goal for completing review within eight
    months of submission.

About MN-166 Clinical Development in Addiction

Clinical development of MN-166 is ongoing in both methamphetamine addiction
and opioid addiction.These clinical trials are conducted by some of the
country's leading experts in opioid and methamphetamine addiction.A Phase 1b
clinical trial of MN-166 in methamphetamine dependence is near completion at
UCLA. A Phase 2 outpatient clinical trial of MN-166 in methamphetamine
dependence, led by investigators at UCLA, has been funded by NIDA. In opioid
addiction, a Phase 1b clinical trial of MN-166 in heroin-dependent volunteers
was completed at Columbia University/New York State Psychiatric Institute. A
NIDA-funded Phase 2a clinical trial of MN-166 in opioid dependence is
currently ongoing and led by investigators at Columbia University and the New
York State Psychiatric Institute.

About Methamphetamine Addiction

Methamphetamine is a very addictive stimulant that is closely related to
amphetamine. It is long lasting and toxic to dopamine nerve terminals in the
central nervous system. It is a white, odorless, bitter-tasting powder taken
orally or by snorting or injecting, or a rock "crystal" that is heated and

Methamphetamine increases wakefulness and physical activity, produces rapid
heart rate, irregular heartbeat, and increased blood pressure and body
temperature. Long-term use can lead to memory loss, aggression, psychotic
behavior, heart damage, malnutrition and severe dental problems. All users,
but particularly those who inject the drug, risk infectious diseases such as
HIV/AIDS and hepatitis.

About MN-166 (ibudilast)

MN-166 has been marketed in Japan and Korea since 1989 to treat
cerebrovascular disorders, including post-stroke complications, and bronchial
asthma. MediciNova licensed MN-166 (ibudilast), from Kyorin Pharmaceutical in
October 2004 for potential utility in relapsing remitting multiple sclerosis.
MediciNova scientists and collaborators independently established evidence of
ibudilast utility in opioid and methamphetamine addiction as well as chronic
neuropathic pain.

MN-166 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
including IL-1ß, TNF-a, and IL-6, and may upregulate the anti-inflammatory
cytokine IL-10 and neurotrophic factors. It has additionally been shown to be
a toll-like receptor 4 (TLR4) functional antagonist that may contribute to its
therapeutic action.

MediciNova's development efforts in progressive MS and chronic neuropathic
pain is also founded upon both preclinical and clinical data indicating
anti-neuroinflammatory and neuroprotective actions, which may be beneficial in
those conditions.

MediciNova's method-of-use patent for MN-166 for the treatment of addiction
expires no earlier than 2030 in the U.S.In the approved and pending
grant-funded MN-166 trials, one of MediciNova's commitments is to provide
delayed-release ibudilast final product.A drug supply collaboration with
Taisho Pharmaceutical Industries, Ltd., owned by Teva Pharmaceuticals, has
expanded to include development of higher dosage strength ibudilast capsules.

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 need with a commercial focus on the U.S.
market.MediciNova's current strategy is to focus on its two prioritized
product candidates, MN-166 (ibudilast) for neurological disorders, and MN-221
for the treatment of acute exacerbations of asthma. MN-166 is being
developed in Phase 1 and Phase 2 clinical trials for drug dependence and pain,
largely through investigator sponsored trials and outside funding.Proceeding
with proof-of-concept Phase 2b trial(s) in Progressive MS is dependent on
receipt of funding, which we are pursuing. MediciNova is engaged in strategic
partnering and consortium funding discussions to support further development
of both the MN-221 and ibudilast/MN-166 programs.For more information on
MediciNova, Inc., please visit www.medicinova.com.

The MediciNova, Inc. logo is available at

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 our clinical
development strategies, including future development, statements regarding the
progress of clinical trials, statements regarding expectations for the
ibudilast/MN-166 program, including development of ibudilast/MN-166 for
certain indications and expectations on future progress in the development of
our drug candidates, expected timing of clinical trial results and any
implication as to the results of our development, partnering and funding
efforts, theimplication of patent terms and potential product exclusivity and
the implication that the company will have the ability to execute on its
priorities. 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," 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-221 and MN-166 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 obtained 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, 2011 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.

         Mike Coffee
         Chief Business Officer
         MediciNova, Inc.
         (858) 736-7180
         Stephanie Ashe
         Continuum Health Communications
         (650) 245-0425

MediciNova, Inc. Logo
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