Gilead Sciences, Inc. (GILD - Analyst Report) recently presented interim data from a phase II study (101-09: n=125) on its pipeline candidate idelalisib (formerly GS-1101). The study is evaluating idelalisib in patients suffering from indolent non-Hodgkin’s lymphoma (iNHL). The patients have not responded to treatments by Roche Holding AG’s (RHHBY - Analyst Report) Rituxan (rituximab) and alkylating-agent-containing chemotherapy. The company intends to present detailed data from the study shortly.
Overall response rate (ORR) is the primary end point of the study. ORR for the study refers to the proportion of patients achieving a confirmed complete or partial response following treatment with idelalisib. ORR of 53.6% was observed in the study. Interim data also revealed that the ORR was consistent across the cohorts analyzed for the study.
Data also revealed that the median progression-free survival was 11.4 months and the size of the tumor diminished in 89% patients following idelalisib therapy.
Apart from iNHL, idelalisib is also being evaluated in other oncology indications, such as chronic lymphocytic leukemia. Successful development and commercialization of idelalisib for the oncology indication would boost Gilead’s top line further. In May 2013, Gilead presented encouraging data on idelalisib from a phase II study for the CLL indication.
Although pleased with the progress on idelalisib, we believe that investor focus will remain on sofosbuvir being developed for treating patients suffering from chronic hepatitis C virus (HCV). The HCV candidate is under priority review in the US (target date: Dec 8, 2013). We note that the US Food and Drug Administration generally reviews those drugs, which offer major advances in treating diseases over existing therapies, on a priority basis. Sofosbuvir is also under review in the EU.
Approval of sofosbuvir would not only boost Gilead’s top line but also strengthen its position in the lucrative HCV market. A sizeable population suffers from HCV globally. However, the treated population is much lower. This leaves the field open for new treatments.
Gilead, a biopharmaceutical company, carries a Zacks Rank #4 (Sell). Cubist Pharmaceuticals Inc. and Alexion Pharmaceuticals, Inc. (ALXN - Analyst Report) appear to be more attractive in the biopharma space with a Zacks Rank #2 (Buy) each.