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Market Overview

Acorda Therapeutics Announces FDA Approval of INBRIJA™ (levodopa inhalation powder)

  • First and Only FDA-Approved Inhaled Levodopa for Intermittent
    Treatment of OFF Episodes in People with Parkinson's Taking
  • Expected to be Available by Prescription in First Quarter 2019
  • Based on Innovative ARCUS® Technology Platform for Inhaled
    Drug Delivery
  • Conference Call on Monday, December 24, 2018 at 8:30am Eastern Time

Acorda Therapeutics, Inc. (NASDAQ:ACOR) today announced that the U.S.
Food and Drug Administration approved INBRIJA™ for intermittent
treatment of OFF episodes in people with Parkinson's disease treated
with carbidopa/levodopa. OFF episodes, also known as OFF periods, are
defined as the return of Parkinson's symptoms that result from low
levels of dopamine between doses of oral carbidopa/levodopa, the
standard oral baseline Parkinson's treatment.

"Today's approval of INBRIJA marks a major milestone for both Acorda and
the Parkinson's community, for whom we are gratified to have developed
this much needed therapy," said Ron Cohen, M.D., Acorda President and
CEO. "This milestone resulted from over two decades of research and
development, beginning in the laboratory of Dr. Robert Langer at
Massachusetts Institute of Technology, through years of enormous
perseverance and ingenuity by the entire Acorda team."

"Despite being on treatment, patients may experience OFF periods as
Parkinson's progresses, which can be disruptive," said Todd Sherer,
Ph.D., CEO, The Michael J. Fox Foundation. "The Foundation provided
funding for the early clinical development of INBRIJA because patients
told us that OFF periods were one of their most serious issues. We knew
we had to help address this unmet need, and this approval is a
significant step forward for the community as it provides a new option
to manage these gaps in symptom control."

"In the clinical study program, INBRIJA established its safety profile
and demonstrated clinically meaningful improvements in motor function,
as measured by the UPDRS Part III," said Robert A. Hauser, M.D., MBA,
Professor of Neurology and Director of the Parkinson's Disease and
Movement Disorders Center at the University of South Florida. "INBRIJA
helps address a significant unmet need for people with Parkinson's, and
we look forward to adding this new treatment option to our

FDA approval of INBRIJA was based on a clinical program that included
approximately 900 people with Parkinson's on a carbidopa/levodopa
regimen experiencing OFF periods. INBRIJA is not to be used by patients
who take or have taken a nonselective monoamine oxidase inhibitor such
as phenelzine or tranylcypromine within the last two weeks.

"I'm delighted that INBRIJA has been approved and may be added to
patients' existing Parkinson's medications for on-demand use, based on
individual patient need," said Burkhard Blank, M.D., Chief Medical
Officer of Acorda. "We thank the FDA for a constructive dialogue
throughout the development program and their partnership during the
review cycle. We especially thank all those who volunteered for the
INBRIJA clinical trials, without whose commitment new medications could
not be developed. And we are grateful for the people living with
Parkinson's, their care partners, researchers, clinicians and advocacy
groups, who have all collaborated with us to help achieve this

About the INBRIJA (levodopa inhalation powder) Clinical Development

The Phase 3 pivotal efficacy trial – SPANSM-PD – was a
12-week, randomized, placebo controlled, double blind study evaluating
the effectiveness of INBRIJA in patients with mild to moderate
Parkinson's experiencing OFF periods.

The SPAN-PD trial met its primary endpoint, with patients showing a
statistically significant improvement in motor function at the Week 12
visit, as measured by a reduction in Unified Parkinson's Disease Rating
Scale (UPDRS) Part III score for INBRIJA 84 mg (n=114) compared to
placebo (n=112) at 30 minutes post-dose (-9.83 points and -5.91 points
respectively; p=0.009). Onset of action was seen as early as 10 minutes.

The most common adverse reactions with INBRIJA (at least 5% and greater
than placebo) in the pivotal trial were cough (15% vs. 2%), upper
respiratory tract infection (6% vs. 3%), nausea (5% vs. 3%) and sputum
discolored (5% vs. 0%).

INBRIJA was also studied in a Phase 3 long-term, active-controlled,
randomized, open-label study (N=398) assessing safety and tolerability
over one year. This study showed the average reduction in FEV1 (forced
expiratory volume in 1 second) from baseline was the same (-0.1 L) for
the INBRIJA and observational cohorts. Patients with chronic obstructive
pulmonary disease (COPD), asthma, or other chronic respiratory disease
within the last five years were excluded from this study.

INBRIJA is expected to be commercially available by prescription in the
U.S. in the first quarter of 2019 and will be distributed through a
network of specialty pharmacies.

Additional Important Safety Information

Before using INBRIJA, patients should tell their healthcare provider
about all their medical conditions, including:

  • asthma, chronic obstructive pulmonary disease (COPD), or any chronic
    lung disease
  • daytime sleepiness from a sleep disorder or if they get drowsy/sleepy
    without warning or take a medicine that increases sleepiness such as
    sleep medicines, antidepressants, or antipsychotics
  • feel dizzy, nausea, sweaty, or faint when standing from sitting/lying
  • history of abnormal movement (dyskinesia)
  • mental health problem such as hallucinations or psychosis
  • uncontrollable urges (for example, gambling, increased sexual urges,
    intense urges to spend money, or binge eating)
  • glaucoma
  • pregnancy or plans to become pregnant. It is not known if INBRIJA will
    harm an unborn baby.
  • breastfeeding or plans to breastfeed. Levodopa (the medicine in
    INBRIJA) can pass into breastmilk and it is unknown if it can harm the

Patients should tell their healthcare provider if they take:

  • MAO-B inhibitors
  • dopamine D2 receptor antagonists (including phenothiazines,
    butyrophenones, risperidone, metoclopramide), or isoniazid
  • iron salts or multivitamins that contain iron salts

No more than 1 dose (2 capsules) should be taken for any OFF period. No
more than 5 doses (10 capsules) of INBRIJA should be taken in a day.

INBRIJA is for oral inhalation only. INBRIJA capsules are not
to be swallowed or opened.

Patients are not to drive, operate machinery, or do other activities
until they know how INBRIJA affects them. Sleepiness and falling asleep
suddenly can happen as late as a year after treatment is started.

INBRIJA (levodopa inhalation powder) can cause serious side effects
including the following. Patients should tell their healthcare provider
if they experience them:

  • falling asleep during normal daily activities (such as driving,
    doing physical tasks, using hazardous machinery, talking, or eating)
    and can be without warning. If patients become drowsy while using
    INBRIJA, they should not drive or do activities where they need to be
    alert. Chances of falling asleep during normal activities increases if
    patients take medicines that cause sleepiness.
  • withdrawal-emergent hyperpyrexia and confusion (symptoms
    including fever, confusion, stiff muscles, and changes in breathing
    and heartbeat) in patients who suddenly lower or change their dose or
    stop using INBRIJA or carbidopa/levodopa medicines.
  • low blood pressure with or without dizziness, fainting, nausea,
    and sweating. Patients should get up slowly after sitting or lying
  • hallucinations and other psychosis – INBRIJA may cause or
    worsen psychotic symptoms including hallucinations (seeing/hearing
    things that are not real); confusion, disorientation, or disorganized
    thinking; trouble sleeping; dreaming a lot; being overly suspicious or
    feeling people want to harm them; believing things that are not real,
    acting aggressive, and feeling agitated/restless.
  • unusual uncontrollable urges such as gambling, binge eating,
    shopping, and sexual urges has occurred in some people using medicines
    like INBRIJA.
  • uncontrolled, sudden body movements (dyskinesia) may be caused
    or worsened by INBRIJA. INBRIJA may need to be stopped or other
    Parkinson's medicines may need to be changed.
  • bronchospasm – people with asthma, COPD, or other lung diseases
    may wheeze or have difficulty breathing after inhaling INBRIJA. If
    patients have these symptoms, they should stop taking INBRIJA and call
    their healthcare provider or go to the nearest hospital emergency room
    right away.
  • increased eye pressure in patients with glaucoma. Healthcare
    providers should monitor this.
  • changes in certain lab values including liver tests.

The most common side effects of INBRIJA include cough, upper respiratory
tract infection, nausea, and change in the color of saliva or spit.

Please see the accompanying Full Prescribing Information available at

Webcast and Conference Call

The company will host a conference call on Monday, December 24, 2018 at
8:30 a.m. ET. To participate in the conference call, please dial (833)
236-2756 (domestic) or (647) 689-4181 (international) and reference the
access code 4049817. The presentation will also be available on the
Investors section of
A replay of the call will be available from 11:30 a.m. ET on December
24, 2018. To access the replay, please dial (800) 585-8367 (domestic) or
(416) 621-4642 (international); reference code 4049817. The archived
webcast will be available in the Investor Relations section of the
Acorda website at

About INBRIJATM (levodopa inhalation powder)

INBRIJA is the first and only inhaled levodopa for intermittent
treatment of OFF episodes in patients with Parkinson's disease treated
with carbidopa/levodopa. INBRIJA utilizes Acorda's innovative
ARCUS® platform for inhaled therapeutics. A Marketing
Authorization Application (MAA) for INBRIJA was submitted to the
European Medicines Agency (EMA) in March 2018 and was formally validated
in May 2018.

About Parkinson's and OFF Periods

Parkinson's is a progressive neurodegenerative disorder resulting from
the gradual loss of certain neurons in the brain. These neurons are
responsible for producing dopamine and that loss causes a range of
symptoms including impaired movement, muscle stiffness and tremors. As
Parkinson's progresses, people are likely to experience OFF periods,
which are characterized by the return of Parkinson's symptoms, which can
occur despite underlying baseline therapy. Approximately one million
people in the U.S. and 1.2 million Europeans are diagnosed with
Parkinson's; it is estimated that approximately 40 percent of people
with Parkinson's in the U.S. experience OFF periods.

About ARCUS® Technology Platform

The ARCUS Technology Platform allows systemic delivery of medication
through inhalation, by transforming molecules into a light, porous dry
powder. This allows delivery of substantially higher doses of medication
than can be delivered via conventional dry powder technologies. ARCUS
has the potential to be used in the development of a variety of inhaled
medicines. Acorda acquired the ARCUS technology platform as part of the
acquisition of Civitas Therapeutics in 2014.

About Acorda Therapeutics

Acorda Therapeutics develops therapies to restore function and improve
the lives of people with neurological disorders. INBRIJA™ (levodopa
inhalation powder) is approved for intermittent treatment of OFF
episodes in patients with Parkinson's disease treated with
carbidopa/levodopa. INBRIJA utilizes Acorda's innovative ARCUS®
pulmonary delivery system, a technology platform designed to deliver
medication through inhalation. Acorda also markets the branded AMPYRA®
(dalfampridine) Extended Release Tablets, 10 mg.

Forward-Looking Statement

This press release includes forward-looking statements. All statements,
other than statements of historical facts, regarding management's
expectations, beliefs, goals, plans or prospects should be considered
forward-looking. These statements are subject to risks and uncertainties
that could cause actual results to differ materially, including: we may
not be able to successfully market Inbrija or any other products under
development; risks associated with complex, regulated manufacturing
processes for pharmaceuticals, which could affect whether we have
sufficient commercial supply of Inbrija to meet market demand; third
party payers (including governmental agencies) may not reimburse for the
use of Inbrija or our other products at acceptable rates or at all and
may impose restrictive prior authorization requirements that limit or
block prescriptions; competition for Inbrija, Ampyra and other products
we may develop and market in the future, including increasing
competition and accompanying loss of revenues in the U.S. from generic
versions of Ampyra (dalfampridine) following our loss of patent
exclusivity; the ability to realize the benefits anticipated from
acquisitions, among other reasons because acquired development programs
are generally subject to all the risks inherent in the drug development
process and our knowledge of the risks specifically relevant to acquired
programs generally improves over time; we may need to raise additional
funds to finance our operations and may not be able to do so on
acceptable terms; the risk of unfavorable results from future studies of
Inbrija (levodopa inhalation powder) or from our other research and
development programs, or any other acquired or in-licensed programs; the
occurrence of adverse safety events with our products; the outcome (by
judgment or settlement) and costs of legal, administrative or regulatory
proceedings, investigations or inspections, including, without
limitation, collective, representative or class action litigation;
failure to protect our intellectual property, to defend against the
intellectual property claims of others or to obtain third party
intellectual property licenses needed for the commercialization of our
products; and failure to comply with regulatory requirements could
result in adverse action by regulatory agencies.

These and other risks are described in greater detail in our filings
with the Securities and Exchange Commission. We may not actually achieve
the goals or plans described in our forward-looking statements, and
investors should not place undue reliance on these statements.
Forward-looking statements made in this press release are made only as
of the date hereof, and we disclaim any intent or obligation to update
any forward-looking statements as a result of developments occurring
after the date of this press release.

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