Bristol-Myers Squibb Company (BMY - Free Report) 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.
The phase III international study evaluated Sprycel’s efficacy and safety with that of Novartis’ (NVS - Free Report) 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 AstraZeneca (AZN - Free Report) 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 Actelion Ltd. which carries a Zacks Rank #1 (Strong Buy).