European Launch of Esbriet
The Company has launched Esbriet in nine of its Top 15 targeted European countries and anticipates that in 2013, Esbriet will be marketed in all 15 of its targeted EU markets, assuming acceptable pricing and reimbursement for Esbriet is negotiated in each remaining country:
- The Company currently expects to conclude pricing and reimbursement discussions regarding Esbriet in Italy in Q1 2013 and Spain by mid-2013 and to launch Esbriet in those countries as soon as possible after pricing and reimbursement is concluded. In both of these countries, several quarters are needed after national reimbursement is secured to address regional reimbursement procedures before complete patient access to Esbriet is achieved.
- The review of Esbriet by the National Institute for Clinical Excellence (NICE) in the UK is expected to conclude in March 2013. In November of 2012, the preliminary assessment of Esbriet completed by NICE was unsupportive of Esbriet reimbursement and the Company is in the process of addressing various outstanding issues in the NICE preliminary assessment. If NICE decides in March to support the reimbursement of Esbriet, the Company currently expects to launch the product as soon as possible with a target to complete the launch in the second quarter of 2013.
- The Company anticipates launches of Esbriet by mid-2013 in several so-called mid-sized countries – Belgium, Netherlands, Finland and Ireland. The first of these, Belgium, began its full launch on January 2.
- InterMune currently has 118 employees in Europe and plans to expand its European commercial infrastructure to support expected launches in the remaining six targeted European countries. The Company currently expects to have between 200 and 220 employees in Europe by the end of 2013, assuming that all country launches of Esbriet occur as currently planned and the company expands its distribution beyond the Top 15 countries.
North America: ASCEND, U.S. Pre-Launch Preparations and Canadian Launch
InterMune today announced that the full-enrollment target of 500 randomized patients for ASCEND was achieved in December 2012. ASCEND is the Company's Phase 3 clinical trial to further evaluate pirfenidone as a treatment for patients with idiopathic pulmonary fibrosis (IPF), and to support regulatory approval in the United States. InterMune noted there has been strong interest from investigators and a large number of patients entered screening in the last two months; these patients will be allowed to continue the screening process in ASCEND and the last patient is expected to be randomized on or before January 9, 2013. The ASCEND trial design includes a 52-week treatment period, followed by a five-week safety follow-up. Top-line results from ASCEND currently are expected in the second quarter of 2014. (See "About ASCEND" section for details of the study)In 2013, InterMune currently plans to begin building its U.S. commercial infrastructure and begin pre-launch preparations for Esbriet.