million, 2. 9 percent less than in
2015. In the first half 0f 2017,
sales were $458 million, 4 percent less than in first-half 2016.
Coming in at No. 9 in 2016
sales was Xeljanz, at $927 million compared with $523 million in 2015. Sales in the first
half of 2017 were $582 million,
42 percent more than in the first
half of last year.
Pfizer’s 10th best seller in
2016 was the smoking cessation
drug Chantix/Champix. The
drug generated $842 million,
25. 5 percent more than in the
previous year. Chantix sales in
the first half of 2017 were $487
million, 12 percent more than in
the first half of 2016.
Executives say sales were
spurred by the removal in 2016
by U.S. and EU regulators of
the boxed warning/black triangle from the product’s labeling.
These actions were based on
EAGLES, the largest smoking
cessation clinical trial of its kind.
“We expect this revision will help
many more individuals to discuss
quitting smoking with health care
providers,” management says.
No. 11 in 2016 sales was the nonsteroidal anti-inflammatory drug
Celebrex, which generated $733
million, 13. 2 percent less than in
2015. Sales in the first half of 2017
were $353 million, 1 percent less
than in the same period last year.
In 2016, a 10-year study of over
24,000 osteoarthritis or rheumatoid arthritis (RA) patients with
or at a high risk for cardiovascular
disease and who required daily
treatment with nonsteroidal anti-inflammatory drugs (NSAIDs),
did not experience a greater cardiovascular risk when treated with
Celebrex as compared to patients
receiving prescription doses of
ibuprofen and naproxen.
Coming in at No. 12 in Pfiz-
er’s 2016 sales was Pristiq.
The antidepressant posted $732
million, 2. 4 percent more than
in 2015. In first-half 2017, sales
were $161 million, 57 percent
less than in the same period last
year. Sales declined after the
drug lost patent protection in
the United States in March 2017.
Pfizer’s 13th best-selling product in 2016 was the hemophilia
drug BeneFIX, which generated $712 million, 5. 3 percent less
than in 2015. The Factor IX inhibitor posted sales of $302 million in first-half 2016, 18 percent
less than in first-half 2015.
No. 14 in 2016 sales was
Vfend. The antifungal posted
$590 million, 13. 3 percent less
than in 2015. In the first half of
2017, sales came in at $208 million, 35 percent less than in the
same period last year.
In 2016 the company’s 15th
best-selling prescription product was the growth hormone
Genotropin. The product had
sales of $579 million, 6. 2 percent
less than in 2015. First-half 2016
sales were $83 million, 11 percent
less than in the first half of 2016.
Ranking as the 16th best-selling pharma product for Pfizer
in 2017 was Xalkori with sales
of $561 million. Approved for
treating ALK-positive NSCLC
and ROS1-positive NSCLC,
the product during the first six
months of 2017 produced global
sales of $296 million, representing an 8 percent year-over-year
Pfizer’s No. 17 drug in 2016
sales was the ReFacto AF and
Xyntha franchise. The hemophilia products posted $554
million, 3. 9 percent more than
in 2015. During the first half of
2017, sales came to $141 million,
10 percent less than in the same
period last year.
Executives say business in
2016 was further strengthened
with the addition of new products, including Eucrisa for mild
to moderate atopic dermatitis
and Xtandi for men with metastatic castration-resistant prostate cancer.
Additionally, Pfizer Essential
Health established market-leading positions in sterile injectables
with more than 250 products,
biosimilars with three marketed products and the industry’s
largest anti-infectives portfolio
with 80 assets globally. The anti-infectives portfolio was further
bolstered through the acquisition
of AstraZeneca’s small molecule
anti-infectives portfolio primarily
outside of the U.S.
Eliquis, which is jointly promoted with Bristol-Myers Squibb
and sales of which Pfizer accounts
for as alliance revenue, became
cardiologists’ top prescribed oral
anticoagulant in 12 countries.
During 2016 and in the ;rst half
of 2017, Pfizer issued a steady
stream of news about products
in its pipeline.
In July 2017, Merck KGaA and
Pfizer announced that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA)
recommended the approval of
Bavencio as a monotherapy for
the treatment of adult patients
with metastatic Merkel cell carcinoma (mMCC), a rare and aggressive skin cancer.
Bavencio was previously granted accelerated approval in May
from the U.S. Food and Drug
Administration for the treatment
of adults and pediatric patients
12 years and older with mMCC
based on tumor response and
duration of response.
In September, the European
Commission granted marketing
authorization for Bavencio. The
drug will have marketing authorization in the 28 countries of
the European Union in addition
to Norway, Liechtenstein, and
Iceland. Bavencio is expected to
become commercially available
to patients in Europe by prescription within the coming months,
with initial launches in Germany
and the United Kingdom expected as early as October 2017.
“This European approval fur-
ther establishes our continued
momentum, building on the
accelerated approvals Bavencio
received in the United States
earlier this year,” says Liz Bar-
rett, global president, Pfizer
Oncology. “Importantly, we are
now one step closer to our goal
of making Bavencio available to
patients around the world.”
In June 2017, Pfizer an-
nounced that the EC approved
Besponsa as monotherapy for
the treatment of adults with re-
lapsed or refractory CD22-posi-
tive B-cell precursor acute lym-
phoblastic leukemia (ALL).
This indication includes treatment of adults with Philadelphia
chromosome positive (Ph+) as
well as Philadelphia chromosome negative (Ph-) relapsed or
refractory B-cell precursor ALL.
Adults with Ph+ relapsed or refractory CD22-positive B-cell
precursor ALL should have
failed treatment with at least
one tyrosine kinase inhibitor.
With this approval, Besponsa
became the first antibody drug
conjugate (ADC) available for
patients with this type of leukemia in the European Union.
In the United States, Besponsa received Breakthrough Therapy designation from the FDA
in October 2015 for ALL. A Biologics License Application (BLA)
for Besponsa for the treatment
of adult patients with relapsed
or refractory B-cell precursor
ALL was accepted for filing and
granted Priority Review by the
FDA in February 2017.
In August 2017, Pfizer received
FDA approval for Besponsa.
“The approval of BESPONSA is
an important step forward for
adult patients with relapsed or
refractory B-cell acute lympho-
blastic leukemia, a rare disease
that can be fatal within a matter
of months if left untreated,” Bar-
rett says. “Besponsa will help ad-
dress a significant need for new
treatment options in B-cell acute
lymphoblastic leukemia, and
may help more patients reach
stem cell transplant, which pro-
vides the best chance for long
In July 2017, Pfizer an-
nounced that the FDA’s Onco-
logic Drug Advisory Commit-
tee voted 6-1 that Mylotarg in
combination with chemother-
apy has a favorable risk-benefit
profile for patients with newly
diagnosed CD33-positive acute
myeloid leukemia (AML). FDA
approved the drug in Septem-
ber for adults with newly diag-
nosed CD33-positive AML, and
adults and children 2 years and
older with relapsed or refractory
CD33-positive AML. Mylotarg is
the first therapy with an indica-
tion that includes pediatric AML
and is also the only AML therapy
that targets CD33, an antigen ex-
pressed on AML cells in up to 90
percent of patients.
In June 2017, Pfizer announced that it received a Complete Response Letter (CRL)
from the FDA regarding the
company’s BLA for its proposed
epoetin alfa biosimilar. This
CRL relates to matters noted in
a Warning Letter issued in February 2017 following a routine
FDA inspection of Pfizer’s manufacturing facility in McPher-son, Kansas, in 2016. This facility was listed as the potential
manufacturing site in the BLA
for the proposed epoetin alfa
biosimilar. The issues noted in
the Warning Letter do not relate
specifically to the manufacture
of epoetin alfa. No additional
clinical data was requested in
An ODAC voted in May 2017
to recommend this proposed biosimilar for approval.
Also in May 2017, Pfizer announced that a supplemental
New Drug Application (sNDA)
for Sutent was accepted for filing by the FDA. If approved, the
sNDA would expand the approved use of Sutent to include
use as an adjuvant treatment
in adult patients at high risk of
recurrent renal cell carcinoma
(RCC) following nephrectomy
(surgical removal of the can-cer-containing kidney). In addition, the EMA has validated for
review a Type II Variation application for Sutent in the same
The PDUFA goal date for a