As part of our acquisition of Civitas Therapeutics in 2014, we obtained global rights to the investigational ARCUS® pulmonary delivery system. The ARCUS technology platform allows for delivery of medication through inhalation. It has been used in clinical trials across a broad spectrum of applications: local and systemic disease targets, large and small molecules, and a wide range of doses. As an example, ARCUS-based therapies targeting the central nervous system are designed to enter the body through the lungs to reach the brain, bypassing the digestive system. This differs from oral and some intra-nasally administered medications for which onset of action is dependent upon some or all of the medicine being absorbed through the digestive tract before reaching the brain.

We currently have one FDA-approved therapy and one clinical-stage programs that use the ARCUS technology: INBRIJA™ (levodopa inhalation powder) and CVT-427 (acute treatment of migraine).

The types of medications that can be taken by inhalation have historically been limited, because only a small quantity of medicine is delivered through standard inhalation devices. The ARCUS technology changes the size and shape of the medicine so that a greater amount of drug is able to be carried by the breath into the lungs.

The ARCUS inhaler is passive and breath-actuated. To use the ARCUS inhaler, the user simply breathes in. There is no need to coordinate inhalation with a pump or other actuation. The ARCUS technology has been used to successfully deliver more than one million doses to patients in clinical trials of various products.

Many Acorda associates have been working with the ARCUS technology for over twenty years. Research on ARCUS-based products, along with commercial-scale manufacturing, is conducted at our facility in Chelsea, MA. We are excited about INBRIJA and the potential for CVT-427, and are also exploring the application of the ARCUS technology in a broad range of therapies.