Acorda Presents Data on Inhaled Levodopa Therapy CVT-301 at International Congress of Parkinson’s Disease and Movement Disorders

June 16,2015

Acorda Presents Data without ceasing Inhaled Levodopa Therapy CVT-301 at International Congress of Parkinson’s Disease and Movement Disorders

Acorda Therapeutics, Inc. (Nasdaq:ACOR) today presented given conditions from a Phase 2b clinical action of CVT-301, an inhaled levodopa (L-dopa) subject to development for the episodic treatment of OFF episodes associated with Parkinson’s disease (PD). OFF episodes are characterized through a re-emergence of PD motor symptoms, like as impaired ability to move, muscle austerity and tremor. The trial showed that patients experiencing some OFF episode, treated with CVT-301, showed significantly greater improvements in motor value derived than patients treated with inhaled placebo; the dissimilitude in improvement was already apparent 10 minutes in relation to dosing and was durable for at minutest an hour, the longest time period at which patients were measured. These facts were presented at the 19th International Congress of Parkinson’s Disease and Movement Disorders (MDS) in San Diego, CA.

“Oral levodopa, or L-dopa, is the current gold streamer of care for Parkinson’s malady. However, as the disease progresses, the full age of people will experience OFF episodes, even while on L-dopa therapy,” reported Enrique Carrazana, M.D., Chief Medical Officer of Acorda. “Based ~ward the successful results of this study, we be obliged initiated a Phase 3 clinical and a extended-term safety trial to further assess the in posse of CVT-301 to reduce the duration of OFF episodes in people seizure oral L-dopa. We believe that grant that successful, these results, together with the existing Phase 2b given conditions, will enable Acorda to file a New Drug Application through the FDA.”

The Phase 2b heartache was a randomized, double blind, placebo-controlled, multicenter study in 86 the million with PD for the treatment of OFF episodes. Participants were randomized to self-administer CVT-301 or placebo to the degree that an adjunct to oral PD medications. Participants believed 35mg of CVT-301 or placebo delivered to the lung in weeks 1 and 2, and 50mg of deaden with narcotics or placebo delivered to the lung in weeks 3 and 4. In-corporation assessments of the Unified Parkinson’s Disease Rating Scale Part 3 (UPDRS III) were performed at weeks 1, 2 and 4. The pristine endpoint was defined as the rascally change from baseline in UPDRS III sake (10-60 minutes post dose) hind 4 weeks of treatment. UPDRS III is ~y established scale to monitor PD motor impairment, and is considered a model in the field.

In this study, participants receiving CVT-301 showed a statistically signifying and clinically important reduction in medial sum UPDRS III motor score compared to placebo (p<0.01) and over all measured time points beginning at 10 and up to 60 minutes defame-administration (p < 0.05). Both doses of CVT-301 were well tolerated, with no increase relative to placebo in irksome or non-troublesome dyskinesias during ON periods. There were ~t one serious adverse events reported in the mix with ~s group, and the incidence of unsalable article-related adverse events was similar between treatment groups. The most common adverse events were dizziness, headache and cough; in that place were no adverse events on cardiovascular or lung occupation. PD patients were able to self-administer usage while in an OFF state.

“OFF episodes consider a major negative impact on the lives of lower classes with Parkinson’s disease, as well considered in the state of on their loved ones and care partners. Effective treatment options are desperately needed,” declared Robert Hauser, M.D., Professor of Neurology, Molecular Pharmacology and Physiology at the University of South Florida and individual of the authors of the poster. “The study results reported today mark that patients treated with CVT-301 had hasty, clinically meaningful improvements in motor occupation. This suggests CVT-301 has the in posse to be an exciting new therapy to behave to OFF episodes in people with Parkinson’s. I am looking early to the results of the ongoing clinical studies, which are designed to provide confirmatory intelligence about the safety and efficacy of CVT-301 in treating OFF episodes.”

The poster was chosen by the MDS Congress Scientific Program Chairs for a Guided Poster Tour Presentation. The poster is also under consideration for inclusion in the Blue Ribbon Highlights sitting, which will provide a critical overview of the most wise presentations highlighting the relevance, novelty and disposition of both clinical and basic investigation.

Data from this study were presented at the 2014 American Academy of Neurology Annual Meeting and the 18th International Congress of Parkinson’s Disease and Movement Disorders.

About CVT-301 Phase 3 Program

Based without ceasing the results of the Phase 2b dolor, Acorda has initiated a Phase 3 clinical grief that is expected to enroll near 345 participants across three arms: 50mg, 35mg, or placebo. These are the identical doses used in the Phase 2b study. The elementary outcome measure is improvement on the UPDRS III later than administration of CVT-301.

More minor circumstances about the study, including enrollment criteria, be able to be found at www.acorda.com or http://clinicaltrials.gov/ct2/grant/NCT02240030?term=CVT-301&fetid=2

About Acorda Therapeutics

Founded in 1995, Acorda Therapeutics is a biotechnology troop focused on developing therapies that replace function and improve the lives of the vulgar with neurological disorders.

Acorda markets three FDA-approved therapies, including AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. The Company has one of the leading pipelines in the habitual devotion to labor of novel neurological therapies. Acorda is commonly developing a number of clinical and preclinical stage-coach therapies. This pipeline addresses a set in a row of disorders including post-stroke walking deficits, Parkinson’s ailment, epilepsy, neuropathic pain, heart failure, MS and spinal line injury.

For more information, please call upon the Company’s website at: www.acorda.com.

Forward Looking Statements

This com~ release includes forward-looking statements in the reach the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, respecting management’s expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could undertaking actual results to differ materially, including the energy to realize the benefits anticipated from the Civitas transaction and to successfully integrate Civitas’ operations into our operations; our efficiency to successfully market and sell Ampyra in the U.S.; third party payers (including governmental agencies) may not refund for the use of Ampyra or our other products at grateful rates or at all and may prescribe restrictive prior authorization requirements that obstruction or block prescriptions; the risk of discouraging results from future studies of Ampyra or from our other study and development programs, including CVT-301, Plumiaz, or a single one other acquired or in-licensed programs; we may not have ~ing able to complete development of, obtain regulatory approval for, or successfully emporium CVT-301, Plumiaz, or any other products when exposed to development; we may need to put in action additional funds to finance our expanded operations and may not have existence able to do so on pleasant terms; the occurrence of adverse security events with our products; delays in obtaining or failure to earn regulatory approval of or to favorably market Fampyra outside of the U.S. and our trust on our collaboration partner Biogen in alliance therewith; competition; failure to protect our mental property, to defend against the pertaining property claims of others or to acquire third party intellectual property licenses needed concerning the commercialization of our products; and, failure to comply with regulatory requirements could result in unfavorable action by regulatory agencies.

These and other risks are described in greater describe in Acorda Therapeutics’ filings with the Securities and Exchange Commission. Acorda may not indeed achieve the goals or plans described in its encourage-looking statements, and investors should not grade undue reliance on these statements. Forward-looking statements made in this give up are made only as of the time hereof, and Acorda disclaims any end or obligation to update any help on-looking statements as a result of developments occurring about the date of this release.

View beginning version on businesswire.com: http://www.businesswire.com/news/home/20150616005425/en/

Acorda Therapeutics
Jeff Macdonald, 914-326-5232
jmacdonald@acorda.com

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