Bristol-Myers Squibb Company
) 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
) 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
). The loss of exclusivity is likely to result in substantial
revenue losses for Bristol-Myers. Companies such as
Dr. Reddy's Laboratories
) have already launched their respective generic versions of the
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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