Bristol-Myers Squibb Company
) and partner Otsuka America Pharmaceutical, Inc. presented
four-year follow-up data from a phase III study (DASISION: n=519)
on their leukemia drug Sprycel (dasatinib: 100 mg, once daily) at
the annual meeting of the American Society of Hematology.
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The phase III international study evaluated Sprycel's efficacy
and safety with that of
) Glivec (imatinib) as a first-line therapy in adults suffering
from Philadelphia chromosome-positive (Ph+) chronic phase chronic
myeloid leukemia (CP-CML).
Data revealed that 76% patients in the Sprycel arm achieved a
major molecular response as opposed to 63% patients treated with
Novartis' cancer treatment. Moreover, 84% patients in the Sprycel
arm achieved an optimal molecular response at three months,
compared to 64% in the Glivec arm. Moreover, the safety profile
of Sprycel in the follow up study was found to be consistent with
that observed earlier in Ph+ CP-CML patients.
Sprycel is one of the key drugs in Bristol-Myers' product
portfolio. The drug performed impressively in the third quarter
of 2013 with sales climbing 20% to $316 million. Apart from the
long-term data on Sprycel, Bristol-Myers was in the news when the
U.S. Food and Drug Administration (FDA) released the briefing
documents ahead of the review by its Endocrinologic and Metabolic
Drugs Advisory Committee (EMDAC) of the company's candidate
metreleptin (proposed trade name: Myalept) on Dec 11,2013.
Bristol-Myers, which has an agreement with
) on the candidate, is looking to get it approved for treating
metabolic disorders associated with lipodystrophy in pediatrics
and adults suffering from the disease (not HIV related).
Metreleptin has been granted priority review and a response from
the FDA is expected by Feb 24, 2014. The content of the briefing
documents highlighted that the candidate appeared to be
beneficial only for a subgroup of patients. The candidate was not
free from safety concerns as per the document. We believe
investor focus will remain on updates regarding the candidate.
Bristol-Myers, a biopharmaceutical company, carries a Zacks Rank
#3 (Hold). A better-ranked stock in the biopharma space is
) which carries a Zacks Rank #1 (Strong Buy).