Sprycel revenue trends
In 2016, Bristol-Myer Squibb’s (BMY) Sprycel reported revenues of ~$1.8 billion, which represents a ~13% YoY (year-over-year) rise. In 2016, the US accounted for ~53% of Sprycel’s total revenues.
In 1Q17, Sprycel generated revenues of ~$463 million, which represents a ~14% YoY rise and a 6% sequential fall.
Sprycel (dasatinib) is indicated for the treatment of adult patients with newly diagnosed Philadelphia CML (chromosome-positive chronic myeloid leukemia), chronic myeloid, or lymphoid blast phase-positive CML who had intolerance or resistance to prior therapies. The drug is also indicated in Philadelphia chromosome-positive ALL (acute lymphoblastic leukemia) patients who proved resistance or intolerance to prior therapies.
In May 2017, the company announced the validation of its application by the EMA (European Medical Agency) for Sprycel in children with chronic myelogenous leukemia. This validation signifies completion of the submission process and the start of the centralized review process by the EMA. The approval of label expansion in Europe could boost the drug’s revenues.
In June 2017, BMY presented the data of its phase-2 CA180-226 trial. The phase-2 CA180-226 trial was conducted to evaluate Sprycel in imatinib-resistant or intolerant and newly diagnosed pediatric patients in the chronic phase of chronic myeloid leukemia.
Sprycel achieved the primary endpoint by demonstrating a CCyR (cumulative major cytogenetic response) rate of ~55.2% after three months of treatment, which surpassed the defined threshold of clinical interest, or 30%. Success in the clinical trial could help in the drug’s label expansion.
BMY Sprycel faces tough competition from Novartis’ (NVS) Gleevec and Tasigna, Pfizer’s (PFE) Bosutinib, Ariad Pharmaceuticals’ (ARIA) Iclusig. The iShares Core S&P 500 ETF (IVV) has ~0.45% of its total portfolio holdings in BMY.