(Adds analyst comment, background; updates shares)
By Bill Berkrot
May 16 Pfizer Inc, which is in the
process of trying to acquire British rival AstraZeneca
for more than $100 billion, on Friday said it planned to file
for U.S. approval for palbociclib, its experimental drug for
advanced breast cancer, in the third quarter.
The largest U.S. drugmaker said it made the decision to
submit its application to the Food and Drug Administration
following discussions with the regulatory agency about the
results of a midstage clinical trial.
Morningstar analyst Damien Conover said he believed Pfizer
may be looking to strengthen its position in negotiations with
AstraZeneca by showcasing its own cancer drugs, although he had
considered an FDA filing based on the Phase II data a strong
The strength of AstraZeneca's portfolio of experimental
cancer medicines has been cited as one of the reasons Pfizer
wants to acquire the company, and has been a centerpiece of the
case Astra has made in seeking a significantly higher offer.
AstraZeneca has rejected a $106 billion approach from its
larger U.S. rival. Pfizer is widely expected to raise its cash
and stock bid for Astra ahead of a May 26 deadline under UK law.
Palbociclib had received the FDA's new breakthrough
designation given to help speed up the approval process for
potentially important new medicines.
Pfizer presented data from the trial at a cancer meeting
last month. Patients in the study who took the experimental
Pfizer medicine plus the hormone drug letrozole went 20.2 months
on average before their cancer began to worsen, compared with
10.2 months for those that received only letrozole.
Palbociclib is considered to be one of the most important
medicines in Pfizer's developmental pipeline. A rival drug is
also being developed by Eli Lilly and Co, which several
analysts have said appears promising.
Morningstar's Conover forecast peak sales of more than $2
billion for palbociclib and gives the drug a 70 percent chance
of approval based on the current data.
He also noted that potential rival drugs from Lilly and
Swiss drugmaker Novartis lag behind Pfizer in the
"Pfizer will have the first mover advantage, which is pretty
significant, especially in cancer," Conover said.
Pfizer shares were up 0.5 percent at $29.19 in afternoon
trading on the New York Stock Exchange.
(Reporting by Bill Berkrot, editing by G Crosse)