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Recently, Bristol-Myers Squibb Company ( BMY - Analyst Report ) 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 - Snapshot Report ) 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.
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 - Analyst Report ) . The loss of exclusivity is likely to result in substantial revenue losses for Bristol-Myers. Companies such as Mylan Inc. ( MYL - Analyst Report ) and Dr. Reddy’s Laboratories ( RDY - Snapshot Report ) 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.
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