) recently announced that its oncology drug, Abraxane, has
performed well in a phase III study (MPACT: n=861). The study
evaluated the combination of Abraxane and
) Gemzar as a first-line therapy in patients suffering from
advanced pancreatic cancer.
Data from the study revealed that there was significant
improvement in overall survival in patients treated with Abraxane
and Gemzar compared with those treated with Gemzar alone. Data
also revealed a 31% decline in the risk of disease progression or
death of patients treated with the combination of Abraxane and
Gemzar as opposed to those in the Gemzar arm. Moreover, median
progression-free survival of 5.5 months was observed in the
Abraxane plus Gemzar arm compared with 3.7 months for patients in
the Gemzar arm.
Based on encouraging data from the MPACT study, Celgene
intends to seek approval of Abraxane for the new indication in
the US and EU in the first half of 2013. Approval in other
markets is expected to be sought in the second half of 2013.
We note that Abraxane is already available in the US as a
second-line therapy for metastatic breast cancer. The label of
the drug was expanded in Oct 2012 when the US Food and Drug
Administration (FDA) approved Abraxane as a first-line
combination therapy for treating patients suffering from locally
advanced or metastatic non-small cell lung cancer. Curative
surgery or radiation therapy is not applicable for those
patients. The FDA approval of Abraxane for the additional
indication was based on positive results from a phase III study
If Celgene is successful in expanding Abraxane's label into
the advanced pancreatic cancer indication, the drug's sales
potential would be boosted further. Celgene boasts of a strong
pipeline. The company has multiple pipeline events lined up in
the coming quarters. Positive pipeline related news would boost
Celgene carries a Zacks Rank #2 (Buy) in the short run. Pharma
stocks, which appear to be more favorably placed, include
). Both the companies carry a Zacks Rank #1 (Strong Buy).
CELGENE CORP (CELG): Free Stock Analysis
LILLY ELI & CO (LLY): Free Stock Analysis
MEDIVATION INC (MDVN): Free Stock Analysis
VALEANT PHARMA (VRX): Free Stock Analysis
To read this article on Zacks.com click here.