The Company announced today that it began the launch of Esbriet in Canada on January 2. As communicated earlier, up to six months are needed to secure coverage for new medicines from the major private insurance companies in Canada and, on average, about 18 months are needed to secure reimbursement from all ten provincial governments that reimburse the majority of medicines in Canada.
Guidance for 2013 Revenue and Operating Expenses
The Company provided its forward-looking financial guidance for Esbriet revenue and operating expenses in 2013:
- Esbriet revenue: currently projected to be in a range of $40 to $70 million. This includes projected revenue in a range of $40 to $55 million in countries where Esbriet is currently launched ( Germany, France, Canada and seven mid-sized European countries), and projected revenue in a range of $0 to $15 million in countries where Esbriet pricing and reimbursement approval and launch is not yet concluded but is currently anticipated during 2013 ( Italy, UK, Spain and three mid-sized European countries). The guidance also accounts for the projected time needed to address regional and provincial reimbursement procedures in Italy, Spain and Canada before meaningful Esbriet revenues can be achieved in all regions or provinces in these countries.
- R&D expense: currently anticipated to be in a range of $100 to $120 million.
- SG&A expense: currently anticipated to be in a range of $145 to $165 million.
- Total Operating Expenses (R&D and SG&A): currently anticipated to be in a range of $245 to $285 million.
ASCEND is a multinational, randomized, double-blind, placebo controlled Phase 3 trial designed to evaluate the safety and efficacy of Esbriet® (pirfenidone) in IPF patients with mild to moderate impairment in lung function. Patients
are randomly assigned 1:1 to receive oral pirfenidone (2403 mg/day) or placebo. The primary endpoint is change in percent predicted forced vital capacity (FVC), with the primary outcome analysis a Rank ANCOVA at Week 52. The magnitude of effect will also be presented on a categorical basis as the proportion of patients with decrements of less than 0% or greater than 10% at pre-specified study time points. The study was conservatively powered by estimating the treatment effect size of pirfenidone based on the results of the intent-to-treat analysis of the pooled results of the two CAPACITY Phase 3 studies.
Key secondary endpoints include change in six-minute walk test (6MWT) distance and progression-free survival, which will be based on the earliest of time to death, FVC decrement of 10% or greater, or decrement in 6MWT distance of 50 meters or more. Additional secondary endpoints in ASCEND include all-cause mortality and on-treatment IPF-related deaths (both evaluated independently in ASCEND as well as pooled with the previous CAPACITY data), and dyspnea. Based on the relatively low mortality rate in this patient population, ASCEND is not powered for the mortality endpoint, even after pooling with CAPACITY data.