Zohydro (hydrocodone bitartrate) extended release capsules

Our lead product candidate, Zohydro, is a novel, oral, single-entity extended-release formulation of hydrocodone currently in Phase 3 clinical trials for the treatment of moderate to severe chronic pain in patients requiring around-the-clock opioid therapy. Zohydro utilizes Elan Pharma International Limited’s proprietary Spheroidal Oral Drug Absorption System, or SODAS^® Technology, which serves to enhance the release profile of hydrocodone to provide consistent 12-hour pain relief relative to existing immediate-release combination formulations. Most marketed hydrocodone products contain the analgesic combination ingredient acetaminophen, which if taken in high quantities over time can cause liver toxicity. Zohydro, if approved, may represent the first available extended-release version of hydrocodone and also the first hydrocodone product that is not combined with another analgesic. As a result, we believe Zohydro could generate sales from both patients who are using immediate-release opioid products on a chronic basis and patients already using extended-release opioids. We initiated the Phase 3 clinical development program for Zohydro in March 2010.

We believe that Zohydro, if approved, may provide patients and physicians with the following benefits when compared to existing opioid pain medications:

• Single-entity hydrocodone
• Twice daily dosing provides true around-the-clock relief
• Easier adherence/greater patient convenience
• Another opioid option for chronic medication rotation