) 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.
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Results from the PALOMA-1 study revealed that treatment with the
combination of palbociclib and
) 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
) 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
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
Pfizer, a large cap pharma company, currently carries a Zacks
Rank #3 (Hold).
) is an example of a better-ranked stock in the large cap pharma
space. The company carries a Zacks Rank #2 (Buy).