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How Is Bristol-Myers Squibb’s Sprycel Positioned Now?

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Sprycel revenue trends

In 3Q17, Bristol-Myers Squibb’s (BMY) Sprycel generated revenues of $509 million, an 8% increase on a year-over-year (or YoY) basis and ~1% growth on a quarter-over-quarter basis. Sprycel earned revenues of $1.5 billion during the first nine months of 2017 compared to $1.3 billion in the corresponding period of 2016.

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Label expansion for Sprycel

In November 2017, the U.S. Food and Drug Administration (or FDA) approved the label expansion of Bristol-Myers Squibb’s Sprycel to include the treatment of children with Philadelphia chromosome-positive chronic myeloid leukemia (or CML) who are in the chronic phase. The U.S. FDA also granted an orphan drug designation to the indication.

Bristol-Myers Squibb evaluated the safety and efficacy of Sprycel in two pediatric studies consisting of 97 candidates with chronic-phase CML. In the study, 51 patients had newly diagnosed chronic-phase CML, while 46 patients were resistant or could not tolerate prior treatment with Novartis’s (NVS) Gleevec (imatinib).

After three months, 43.1%, 60.8%, and 7.8% of patients who had newly diagnosed chronic phase CML achieved cytogenetic response (or CCyR), major cytogenetic response (or MCyR), and major molecular response (or MMR), respectively. After three months, 45.1%, 60.9%, and 15.2% of the patients who had prior imatinib therapy achieved CCyR, MCyR, and MMR, respectively.

After 12 months, 96.1%, 98.0%, and 56.9% of patients having the newly diagnosed disease achieved CCyR, MCyR, and MMR, respectively. After 12 months, 78.6%, 89.1%, and 39.1% of patients with prior imatinib therapy achieved CCyR, MCyR, and MMR, respectively.

After 24 months, 96.1%, 98.0%, and 74.5% of patients having newly diagnosed disease achieved CCyR, MCyR, and MMR, respectively. After 24 months, 82.6%, 89.1%, and 52.2% of patients with prior imatinib therapy achieved CCyR, MCyR, and MMR, respectively.

Sprycel competes with Takeda Pharmaceuticals’ (TKPYY) Iclusig, Pfizer’s (PFE) Bosulif, and Novartis’s Tasigna. In 3Q17, Bosulif, Tasigna, and Gleevec reported revenues of $57 million, $482 million, and $445 million, respectively.

The label expansion of Sprycel and superior clinical trial data is expected to boost Sprycel’s commercialization potential. The revenue growth of Bristol-Myers Squibb’s Sprycel could boost the stock prices of the Vanguard S&P 500 ETF (VOO). Bristol-Myers Squibb makes up about ~0.46% of VOO’s total portfolio holding.

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