Recently, Bristol-Myers Squibb Company (BMY) and partner Otsuka Pharmaceutical Europe Ltd. presented six-year follow-up data on their leukemia drug, Sprycel (dasatinib) at the 17th Congress of the European Hematology Association.
The companies presented data from a randomized, open-label, dose-optimization phase III study (CA180-034: n=670) which evaluated the safety and efficacy of Sprycel in adults suffering from Philadelphia chromosome-positive (Ph+) chronic-phase chronic myeloid leukaemia (CP-CML). The patients were either resistant or intolerant to Novartis’ (NVS) Glivec. The study evaluated Sprycel at 100 mg once daily, 50 mg twice daily, 140 mg once daily and 70 mg twice daily dosages.
Data from the study revealed that 49.3% patients treated with Sprycel (100 mg: n=167) experienced progression-free survival (i.e. survival without the disease worsening) and 71% experienced overall survival. The long-term data further revealed that Sprycel (100 mg) was safe and well-tolerated.
We note that Sprycel is already available in the US, EU and multiple other markets for treating adults in all phases (chronic, accelerated, or myeloid or lymphoid blast phase) of Ph+ CML either resistant or intolerant to prior treatments. Moreover, the drug is also approved as a first-line therapy for treating adults suffering from Ph+ CML in the chronic phase.
Our Recommendation
We currently have a Neutral recommendation on Bristol-Myers. The stock carries a Zacks #3 Rank (Hold rating) in the short run. We believe that investor focus will remain on how Bristol-Myers fares following the US loss of exclusivity of its blockbuster blood thinner Plavix on May 17, 2012.
Bristol-Myers has co-developed Plavix with Sanofi (SNY). The loss of exclusivity is likely to result in substantial revenue losses for Bristol-Myers. Companies such as Mylan Inc. (MYL) and Dr. Reddy’s Laboratories (RDY) have already launched their respective generic versions of the drug.
Bristol-Myers is looking to combat the generic threat through partnering deals and acquisitions. Apart from acquisitions and partnership deals, Bristol-Myers is looking to introduce new products to augment its product portfolio to combat the generic threat. Bristol-Myers has met with a fair amount of success towards achieving this objective. Many new products were launched/ approved in 2011. We expect Bristol-Myers to continue introducing new products throughout 2012.
BRISTOL-MYERS (BMY): Free Stock Analysis Report
MYLAN INC (MYL): Free Stock Analysis Report
NOVARTIS AG-ADR (NVS): Free Stock Analysis Report
DOCTOR REDDYS (RDY): Free Stock Analysis Report
SANOFI-AVENTIS (SNY): Free Stock Analysis Report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment