Wednesday, June 27, 2012

Chugai Files for approval of Tarceva for 1st line NSCLC in Japan

Chugai has submitted an application for approval of Tarceva in first line NSCLC. The applciation is based on results from the Phase 3 trial (EURTAC) and a Phase 2 trial in domestic patients. The EURTAC trial was discontinued early because the study met its primary endpoint - PFS improvement - in lung cancer patients with EGFR (epidermal growth factor receptor) activating mutations.

In the EURTAC trial, the response rate to erlotinib was 54.5%, compared with 10.5% to chemotherapy,  Tarceva improved Progression Free Survival (PFS) by 63 % compared to chemotherapy (9.7 m vs 5.2 m). Interim analysis of EURTAC trial showed that Tarceva improved the overall survival by 4 m (22.9 m vs 18.8 m) compared to cisplatin chemotherapy.

Potential Opportunity
Tarceva currently generates about $100m or Yen 8b in annual sales from Japan. With approval in first line, not only the target patient population will expand, but the duration of treatment will significantly improve. We expect Tarceva sales to trible from current levels, to reach $300m in Japan by 2015.  Globally Tarceva sales should reach $1.8b by 2016.
Peak Sales Assumption
1) 90,000 lung cancer diagnosed patients in Japan
2) 85% are NSCLC
3) 30% have EGFR+ve status
4) $30,000 as annual cost of therapy

About 110,000 lung cancer patietns expected to be diagnosed in Japan in 2015, About 30% Asian patients with lung cancer have NSCLC with EGFR activating mutation.