Dear Shareholder:
In 2014, we began charting a course for the next stage of Acorda’s growth, seeking to identify and acquire promising late-stage therapeutic candidates outside the company to bolster our internal development activities. These actions were important to accelerate the pursuit of our mission while improving the opportunity to generate long-term value for our shareholders.
As a result of this new strategy, Acorda successfully acquired two companies with late-stage programs in Parkinson’s disease: Civitas Therapeutics in the fall of 2014 and Biotie Therapies in early 2016. If successful, the key programs from these acquisitions, CVT-301 and tozadenant, will serve as the foundation for Acorda’s future value and position the Company as a leader in the treatment of Parkinson’s disease. Parkinson’s affects more than one million Americans and between 7 million and 10 million people around the world. We are excited by the potential for CVT-301 and tozadenant to address unmet needs in the Parkinson’s community.
In 2016, we focused on advancing these newly acquired late-stage Parkinson’s disease programs. Our acquisition strategy has begun to deliver results, most recently with the positive efficacy and safety data from Phase 3 pivotal and long-term safety trials of CVT-301 that will support our upcoming New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA). If approved, we believe CVT-301 likely will become a key therapeutic option for people with Parkinson’s experiencing highly disruptive and sometimes unexpected OFF periods in their daily lives.
As we evolve toward Acorda’s future in Parkinson’s disease, we acknowledge the challenges we are experiencing: the failures of two of our development programs (PLUMIAZ and dalfampridine-SR for post-stroke walking difficulties) and a significant setback for AMPYRA, which has enabled the Company’s historical growth. A U.S. District Court invalidated four patents that would have preserved market exclusivity for AMPYRA into the next decade. While we strongly disagree with the Court’s ruling and will appeal the decision, we are prepared should we ultimately lose market exclusivity for AMPYRA in July 2018. We already have acted decisively to reduce expenses, downsizing the Company within days of the Court’s ruling. Restructuring was painful, yet a necessary step to ensure that we focus resources on bringing our Parkinson’s disease candidates to the marketplace.
We anticipate the following milestones in the next 12 months:
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CVT-301: We plan to submit an NDA to the FDA in the second quarter of 2017. We believe CVT-301 has the potential to achieve at least $500 million in annual net sales in the U.S. We also plan to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) by year-end.
- Tozadenant: An oral adenosine A2a antagonist, tozadenant represents a potential first-in-class treatment for Parkinson’s disease in the U.S. Phase 2b data showed its potential to lower average daily OFF time by more than an hour relative to placebo, in people already being treated with multiple other medications. We expect results from our pivotal Phase 3 clinical trial in Q1 2018. As part of the Phase 3 program, we also initiated an open-label, long-term safety study in the second quarter of 2017. We believe that tozadenant, if approved, represents a commercial opportunity that could exceed that for CVT-301.
Our top priorities are:
1) submitting an NDA for CVT-301 in Q2 2017;
2) submitting an MAA to the EMA for CVT-301 the end of 2017;
3) planning for commercialization and launch of CVT-301 in the U.S.; and
4) executing the ongoing tozadenant clinical program, with pivotal efficacy data expected in Q1 2018.
On behalf of our Management Team, Board of Directors and our associates: thank you, our shareholders, for your continued support. Our focus to deliver both promising therapies and shareholder value has only sharpened over the past few months and we look forward to sharing with you the significant opportunities that lie ahead.
Ron Cohen, M.D.
President and CEO