Gilead Sciences, Inc.
) 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
) 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
Gilead, a biopharmaceutical company, carries a Zacks Rank #4
Cubist Pharmaceuticals Inc.
Alexion Pharmaceuticals, Inc.
) appear to be more attractive in the biopharma space with a
Zacks Rank #2 (Buy) each.
ALEXION PHARMA (ALXN): Free Stock Analysis
CUBIST PHARM (CBST): Free Stock Analysis
GILEAD SCIENCES (GILD): Free Stock Analysis
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