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Acorda to Present New Data For INBRIJA™ (levodopa inhalation powder) at 70th American Academy of Neurology Annual Meeting
[April 16, 2018]

Acorda to Present New Data For INBRIJA™ (levodopa inhalation powder) at 70th American Academy of Neurology Annual Meeting


Acorda Therapeutics, Inc. (Nasdaq: ACOR) will present new data for INBRIJA during four oral platform presentations at the upcoming American Academy of Neurology Annual Meeting in Los Angeles, taking place April 21-27, 2018. INBRIJA is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson's disease taking a carbidopa/levodopa regimen.

"We are delighted to have the opportunity to present data from our Phase 3 clinical development program for INBRIJA, an investigational treatment for people with Parkinson's living with OFF periods, or the re-emergence of Parkinson's symptoms. To date, INBRIJA has been studied in more than 800 people with Parkinson's worldwide," said Burkhard Blank, M.D., Acorda's Chief Medical Officer. "OFF periods are one of the most disruptive aspects of Parkinson's and there is a tremendous unmet need for new treatment options to address them."

The INBRIJA data will be presented on Tuesday, April 24, 2018, during Session S26: Movement Disorders - Parkinson's Disease Clinical Trials from 3:30 PM - 5:30 PM PT. Details are as follows:





                         

PRESENTATION
TIME

      ABSTRACT #       TITLE       PRESENTER
4:06 PM PT       3102      

Inhaled Levodopa Administered With Oral
Carbidopa/Levodopa for Early Morning OFF
Symptoms in Patients with Parkinson's Disease:
Exploratory Efficacy Analysis

     

Stuart H.
Isaacson, MD

4:18 PM PT       3008      

Inhaled Levodopa Administered With Oral
Carbidopa/Levodopa for Early Morning OFF
Symptoms in Patients with Parkinson's Disease:
Safety Assessment

     

Robert A.
Hauser, MD

4:30 PM PT       1484      

Long-Term Pulmonary Safety of Inhaled Levodopa in
Parkinson's Disease Subjects with Motor Fluctuations:
a Phase 3 Open-Label Randomized Study

     

Charles Oh,
MD

4:54 PM PT

      1454      

Long-term Efficacy of Inhaled Levodopa in
Parkinson's Disease Subjects with Motor Fluctuations:
a Phase 3 Open-Label Randomized Study

 

   

Charles OH,
MD


A New Drug Application for INBRIJA was accepted for review by U.S. Food and Drug Administration in February 2018, and FDA has set a target PDUFA date of October 5, 2018.

Acorda will also present data from the Phase 3 tozadenant clinical trial on Monday, April 23, 2018, during Session P2: Movement Disorders, Poster Presentation #045 between 11:30 AM and 7 PM PT.

About Parkinson's and OFF periods

Parkinson's is a progressive neurodegenerative disorder resulting from the gradual loss of certain neurons responsible for producing dopamine. Approximately one million people in the U.S. and 1.2 million Europeans are diagnosed with Parkinson's; OFF periods are experienced by approximately 350,000 in the U.S. and 420,000 in Europe. It causes a range of symptoms including impaired movement, muscle stiffness and tremors. As Parkinson's progresses, people will experience OFF periods, which are characterized by the re-emergence of Parkinson's motor and non-motor symptoms. This re-emergence can occur even when an individual's treatment regimen has been optimized.

About INBRIJATM (levodopa inhalation powder) and ARCUS®

INBRIJA is a self-administered, orally inhaled levodopa (L-dopa) therapy in development for the treatment of symptoms of OFF periods in people with Parkinson's disease taking a carbidopa/levodopa regimen. INBRIJA utilizes Acorda's investigational ARCUS® platform for inhaled therapeutics. INBRIJA was designed to deliver a precise dose of a dry powder formulation of L-dopa through the lung. Oral medication can be associated with variable onset of action, as the medicine is absorbed through the gastrointestinal (digestive) tract before reaching the brain. Inhaled treatments enter the body through the lungs and reach the brain, bypassing the digestive system.

The proprietary name INBRIJA has been conditionally accepted by the U.S. Food and Drug Administration (FDA).

About Acorda Therapeutics

Founded in 1995, Acorda Therapeutics is a biopharmaceutical company focused on developing therapies that restore function and improve the lives of people with neurological disorders. Acorda has a pipeline of novel neurological therapies addressing a range of disorders, including Parkinson's disease and multiple sclerosis. Acorda markets two FDA-approved therapies, including 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: 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; our ability to successfully market and sell Ampyra (dalfampridine) Extended Release Tablets, 10 mg in the U.S., which will likely be materially adversely affected by the March 2017 court decision in our litigation against filers of Abbreviated New Drug Applications to market generic versions of Ampyra in the U.S.; 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; we may not be able to complete development of, obtain regulatory approval for, or successfully market Inbrija or any other products under development; third party payers (including governmental agencies) may not reimburse for the use of Ampyra, Inbrija or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; 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; competition; 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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