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Pfizer (PFE) Gains on Label Expansion Efforts for Ibrance

Pfizer Inc. PFE shares were up 3.5% after the company along with the Alliance Foundation Trials and the Austrian Breast & Colorectal Cancer Study Group announced the commencement of a global phase III study (PALLAS – Palbociclib Collaborative Adjuvant Study) on its breast cancer drug, Ibrance. Overall, the company’s shares are up 5.8% since the announcement.

The two-arm, international, multicenter, randomized, open-label study (n~4,600) is being conducted with the goal of determining whether Ibrance when added to standard therapy improves disease-free survival rate and prevents the disease from recurring in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) early-stage (stage II or stage III) breast cancer. The study is being conducted in concurrence with the Breast International Group, German Breast Group, National Surgical Adjuvant Breast and Bowel Project and PrECOG.

We remind investors that Ibrance received accelerated approval from the FDA in Feb 2015. The drug was approved in combination with Novartis AG’s NVS Femara (letrozole) for the treatment of postmenopausal women with estrogen receptor-positive, HER2- advanced breast cancer as an initial endocrine-based therapy for their metastatic disease.

Pfizer is also looking to get the drug approved in combination with endocrine therapy for the treatment of HR+/HER2- advanced or metastatic breast cancer in the EU.

We are encouraged by Pfizer’s efforts to expand Ibrance’s label by targeting different segments of breast cancer patients. According to the press release issued by Pfizer, cancers that are HR+/HER2- account for approximately 60–65% of all breast cancer cases in the U.S.

Ibrance is already off to an encouraging start and has registered sales of $178 million in the first half of 2015 since its launch in Feb 2015. Label expansion will boost the drug’s sales further.

We expect investor focus to remain on the commercialization and sales ramp up of Ibrance.

Pfizer currently carries a Zacks Rank #3 (Hold). Gilead Sciences Inc. GILD and Regeneron Pharmaceuticals, Inc. REGN are better-ranked stocks in the health care sector, each carrying a Zacks Rank #1 (Strong Buy).

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