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Pfizer's Orphan Drug Approved

Zacks Equity Research

Pfizer Inc. (PFE) received approval for another oncology candidate recently. Bosulif (bosutinib) gained US Food and Drug Administration (:FDA) approval for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (:CML) in adult patients who are resistant or intolerant to prior therapy.

Bosulif enjoys orphan drug status in the US. According to the American Cancer Society, more than 5,000 new cases of chronic myelogenous leukemia, which is one of the four most common types of leukemia, are diagnosed annually in the US.

Treatments approved for different kinds of chronic myelogenous leukemia include Novartis’ (NVS) Gleevec and Tasigna and Bristol-Myers Squibb’s (BMY) Sprycel.

Pfizer has been making significant progress with its oncology pipeline. Bosulif is the third candidate in Pfizer’s oncology pipeline to gain US approval in the last thirteen months.

Meanwhile, Pfizer also gained European Commission (EC) approval for its renal cell cancer drug, Inlyta (axitinib). Inlyta gained approval from the EC for use in treatment-failed patients (prior treatment with Sutent (sunitinib or a cytokine) with advanced renal cell carcinoma (:RCC).

Approval was largely expected as earlier this year the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (:EMA) had issued a positive opinion regarding Inlyta. The EU approval of Inlyta will provide advanced renal cell carcinoma patients, especially previously-treated patients, with an additional treatment option. We note that Inlyta gained approval earlier this year in the US. Other countries where Inlyta is already approved include Switzerland, Japan, Canada, Australia, and Korea. Pfizer is currently conducting a phase III study with Inlyta in treatment-naïve patients suffering from renal cell carcinoma. Besides Inlyta, Pfizer has two drugs approved for kidney cancer – Sutent and Torisel.

We currently have a Neutral recommendation on Pfizer, which carries a Zacks #3 Rank (short-term Hold rating). While near-term earnings will be driven by cost cutting efforts and share repurchases, longer-term growth will depend on the success of drug development.


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