Shares of Pfizer Inc. (PFE) gained significantly following positive top-line data from a phase II study (PALOMA-1 or study 1003) on its oncology candidate palbociclib. Shares of the company were up by as much as 4% on the news during early trading on Feb 3, 2014. However, most of the gains were eaten away during the course of the day and each share of Pfizer, one of the world's largest pharmaceutical companies, gained 0.7% at the end of the trading session to close at $30.60. However, Pfizer was the sole stock to gain among the Dow 30 companies on the day. All other U.S. equity markets too ended the day in the red.
Results from the PALOMA-1 study revealed that treatment with the combination of palbociclib and Novartis’ (NVS) Femara (letrozole) caused a statistically significant improvement in progression-free survival (PFS) versus Femara alone. The study evaluated post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or newly diagnosed metastatic breast cancer. Pfizer will present detailed efficacy and safety data from the study in April this year.
We note that the U.S. Food and Drug Administration (:FDA) granted Breakthrough Therapy Designation to palbociclib for breast cancer in Apr 2013 on the basis of interim data from the PALOMA-1 study. Pfizer intends to discuss the results of the study with regulatory authorities across the globe, including the FDA, to determine the way forward for the candidate.
Pfizer is currently enrolling patients to evaluate the combination of palbociclib and Femara in the above population in a global phase III trial (PALOMA-2 or study 1008). Another phase III study (PALOMA-3 or study 1023) evaluating palbociclib combined with AstraZeneca’s (AZN) Faslodex (fulvestrant) versus Faslodex plus placebo in women with HR+ and HER2- metastatic breast cancer is underway. The cancer has progressed after hormonal therapy in the PALOMA-3 study patients.
Palbociclib is one of the most interesting candidates in Pfizer’s pipeline. We believe Pfizer’s pipeline must deliver since sales of many of its key products are declining due to generic competition.
Pfizer, a large cap pharma company, currently carries a Zacks Rank #3 (Hold). Allergan Inc. (AGN) is an example of a better-ranked stock in the large cap pharma space. The company carries a Zacks Rank #2 (Buy).