Gilead Sciences, Inc. (GILD) recently filed a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its pipeline candidate idelalisib (formerly GS-1101) for treating patients suffering from indolent non-Hodgkin’s lymphoma (iNHL).
The NDA was filed on the basis of data from a phase II study (101-09: n=125) on idelalisib in iNHL patients. We remind investors that in Jun 2013, Gilead had presented interim data from the study. The iNHL patients in the study had not responded to treatments by Roche’s (RHHBY) Rituxan (rituximab) and alkylating-agent-containing chemotherapy.
Interim data from the study revealed an overall response rate (ORR) of 53.6%. ORR for the study refers to the proportion of patients achieving a confirmed complete or partial response following treatment with idelalisib. 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.
Gilead stated in its press release that updated data from the study was included in the NDA. Gilead intends to present the updated data at an upcoming medical conference. European approval of idelalisib for treating iNHL patients is expected to be sought by year end.
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.
Although pleased with the progress on idelalisib, we believe that investor focus will remain on sofosbuvir, which is being developed for treating patients suffering from chronic hepatitis C virus (HCV). The HCV candidate is under priority review in the U.S. (target date: Dec 8, 2013). We note that the U.S. 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. Gilead is also seeking approval for the candidate in other countries such as Canada, Switzerland, Turkey and Australia.
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 carries a Zacks Rank #1 (Strong Buy). Companies like Actelion Ltd. (ALIOF) and Biogen Idec Inc. (BIIB) also appear to be attractive. Both companies carry a Zacks Rank #1.
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