LETTER FROM THE CEO

Dear Members of the Acorda Community:

We aim to grow Acorda into the preeminent biopharmaceutical company delivering innovative therapies for people with neurological disorders, and are building on three pillars to drive long-term value creation:

• Advancing our diversified clinical pipeline to approval and commercialization;
• Acquiring assets that leverage our core competencies in neurology; and
• Continuing to grow sales in multiple sclerosis of AMPYRA^® (dalfampridine) Extended Release Tablets, 10 mg.

We have made progress in all three areas since our last annual report. We:

• Announced the acquisition of Biotie Therapies in January 2016. Key to this transaction are global rights to two clinical-stage Parkinson’s disease (PD) programs, which would complement our late-stage PD program CVT-301.
• Continued to advance our leading innovative neurology pipeline. Pending the close of the Biotie transaction, we will have eight clinical-stage assets – including four in Phase 3, two in Phase 2 and two in Phase 1. With positive clinical trial data, we potentially will be able to submit New Drug Applications for three of our pipeline therapies – Plumiaz^TM (diazepam) Nasal Spray, CVT-301 and tozadenant – by the end of 2018. We project these products, if approved, could have combined U.S. peak sales of over $1 billion.
• Successfully completed our first early-stage clinical study for CVT-427 in migraine and continued to enroll participants in our second Phase 1 study for rHIgM22 in MS.
• Achieved AMPYRA net revenue of $437 million in 2015, a 19% increase over 2014. We are projecting continued growth in 2016, guiding to net sales of $475-$485 million.

Transforming Our Pipeline

Acorda’s early history was defined by our efforts to develop and commercialize AMPYRA, which has become a standard of care for people with multiple sclerosis (MS) who experience MS-related walking difficulty. Over the past 24 months, we have dramatically enhanced our company’s profile.

Our acquisition of Civitas Therapeutics in late 2014 added CVT-301, a highly promising therapy currently in Phase 3 development for treating OFF periods in people with Parkinson’s disease. In addition, this transaction brought to Acorda the novel ARCUS^® inhaled dry powder technology platform, and a commercial-scale manufacturing facility for ARCUS-based products. ARCUS has shown the ability to deliver medication rapidly into the bloodstream, in much larger doses than other inhalation technologies. The ARCUS platform already has yielded a second pipeline product, CVT-427, an inhaled zolmitriptan formulation aimed at acute treatment of migraine, and has the potential to deliver others. We plan to initiate additional CVT-427 studies later this year.

Our acquisition of Biotie Therapies, which we expect to complete in the second half of 2016, adds two Parkinson’s disease therapies to our pipeline that are complementary to CVT-301. One of these, tozadenant, is in Phase 3 clinical development. Additional information about the acquisition can be found here.

Late-Stage Pipeline: Multiple Near-Term Milestones

We anticipate milestones in the next 6-12 months for three of our late-stage programs:

• CVT-301: We expect to achieve the “last patient out” milestone in the pivotal Phase 3 clinical trial by the end of 2016. If successful, we plan to file a New Drug Application (NDA) in the first quarter of 2017.
• PLUMIAZ: We are advancing the clinical work necessary to refile an NDA for PLUMIAZ and anticipate submitting the NDA in Q1 2017.
• Dalfampridine for Post-Stroke Walking Difficulty (PSWD):
  • At the end of Q1 2016, we announced the completion of our single-dose pharmacokinetic (PK) studies of three different once-daily (QD) formulations of dalfampridine. Results for at least one of these formulations met our criteria. The multi-dose phase of PK testing will begin in the second quarter of 2016.
  • Given our progress in the development of a QD formulation, we made the decision to stop enrollment of the Phase 3 clinical trial and conduct an unblinded analysis of the data, having reached 50% of its target enrollment in the study, or 270 subjects. Data are expected by the fourth quarter of 2016 and will be used to inform the design of planned Phase 3 trials.

Earlier-Stage Program Updates

• rHIgM22: We began a second Phase 1 clinical trial for remyelination in MS, following successful completion of a Phase 1 trial in 2014. We presented the results of the first Phase 1 trial at the 2015 American Academy of Neurology (AAN) and European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) annual meetings.
• CVT-427: This program uses the ARCUS technology to deliver doses of zolmitriptan from the lungs directly to the bloodstream. Results of our Phase 1 PK trial met our specifications, and we plan to continue clinical development of CVT-427.
• Cimaglermin alfa: The program for heart failure was put on clinical hold following a safety report of hepatotoxicity in our second Phase 1 clinical trial. There was a similar report in the first cimaglermin trial. We are working with outside experts to better understand this liver effect and to assess next steps for this program.

AMPYRA Intellectual Property

As expected, generics companies have challenged our AMPYRA patents. We have five Orange Book-listed patents on AMPYRA that extend through 2027. Our outstanding in-house Legal team, together with experienced outside counsel, are vigorously defending our intellectual property. We have settled with four of the ten entities that submitted Abbreviated New Drug Applications (ANDA) for AMPYRA, granting them the right to launch generic dalfampridine tablets on a designated date in 2027, or potentially earlier under certain circumstances. A patent infringement litigation hearing with the remaining ANDA filers is scheduled to begin in federal district court in September.

Our legal team achieved a significant victory in a case against Mylan Laboratories, which had sought to litigate our patent case in its home state of West Virginia. The Federal Circuit Court of Appeals upheld the lower court’s verdict permitting the case to proceed in the District Court of Delaware, along with the other ANDA cases. Mylan has petitioned the Federal Circuit for a rehearing en banc, which we are now opposing.

Four of our Orange Book patents are also being challenged in a separate, relatively new U.S. Patent and Trademark Office process called Inter Partes Review (IPR). In 2015, the Patent Trial and Appeal Board (PTAB) rejected IPR filings by a hedge fund against two of our AMPYRA patents. In March 2016, the PTAB instituted four IPRs that were filed subsequently by the same hedge fund. We will litigate vigorously before the PTAB to defend our patents and anticipate a ruling on these IPR petitions by March 2017.

Looking Ahead

Our top priorities for 2016-2017 are 1) execution of our late-stage CVT-301 and PLUMIAZ clinical trials, and the subsequent preparation and filing of regulatory submissions; 2) planning for commercialization of these therapies; 3) conducting an unblinded analysis of the BID dalfampridine post-stroke walking difficulty trial and completion of ongoing QD formulation development for use in future planned studies; 4) completion of the Biotie acquisition, integration of Biotie employees and execution of ongoing clinical programs; and 5) defending our intellectual property rights for AMPYRA.

Over the past two years, with the acquisitions of Civitas and Biotie, we have evolved Acorda into a company that is poised to make major contributions to the treatment of people with neurological disorders and deliver significant shareholder value. Diversification has been a key pillar of our growth strategy. All biopharma companies face repeated challenges and risks in their clinical, regulatory and intellectual property endeavors. Success ultimately depends on having enough high-quality “shots on goal,” in addition to outstanding personnel and supportive shareholders who are willing to take the long view. On behalf of our Management Team, Board of Directors and our passionate team of more than 500 Acordans, thank you, our shareholders, for your support in helping us build a great enterprise at Acorda.

I look forward to updating you on our progress.

Ron Cohen, M.D.
President and CEO