Bristol-Myers Squibb Co.’s (BMY) product portfolio just got even better with the European Commission’s (EC) recent approval of the pharma-major’s drug Yervoy (ipilimumab), which is indicated for the treatment of adult patients with previously-treated advanced melanoma (skin cancer).
The approval was based on data from a late stage trial which demonstrated that patients treated with Yervoy experienced 1- and 2-year estimated survival rates of 46% and 24%, respectively, versus 25% and 14% in the comparator arm.
We note that Yervoy was approved by the US Food and Drug Administration (FDA) as a treatment for metastatic melanoma in late March 2011. The FDA’s approval was based on the results of a late-stage study, which showed that treatment with the drug extended overall survival of patients suffering from advanced skin cancer, while the current therapies for the indication did not prolong the lives of the patients.
In the US, the label of Yervoy includes a boxed warning for immune-mediated side effects. Bristol-Myers has developed a risk evaluation strategy (REMS) so that the drug can be used safely. The REMS also aims to inform patients about the risks associated with the usage of Yervoy.
Our Take
We have a Neutral recommendation on Bristol-Myers. The stock carries a Zacks #3 Rank (Hold rating) in the short run. We believe that the European approval of Yervoy is a major positive for the company and will bolster its top line, and help the company counter the loss of revenues resulting from the genericization of its key drugs, including the blockbuster blood-thinner Plavix. Bristol-Myers has a development agreement with Sanofi-Aventis (SNY) for Plavix. Further, Bristol-Myers is looking to combat the generic threat through deals and acquisitions and introducing new products.
BRISTOL-MYERS (BMY): Free Stock Analysis Report
SANOFI-AVENTIS (SNY): Free Stock Analysis Report
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment