Pfizer 2005 Annual Report Download - page 19

18 2005 Financial Report
Financial Review
Pfizer Inc and Subsidiary Companies
The increase in Animal Health revenues in 2004, as compared to
2003, despite the impact on the cattle industry following the
discovery of BSE (bovine spongiform encephalopathy or mad
cow disease) in the U.S., was attributable to:
•in livestock, the launch of a new claim for Bovishield (protects
pregnant cows and fetal and nursing calves against viral
diseases) in the U.S. during the fourth quarter of 2003; the
launch of Draxxin in Europe during the first quarter of 2004;
and the third quarter of 2004 launch of Excede in the U.S.;
•in companion animal, Rimadyl (for relief of arthritis pain in dogs
and for post-operative treatment), Revolution and Clavamox
all grew at double-digit rates in 2004;
•the favorable impact of the weakening of the U.S. dollar
relative to many foreign currencies; and
•the inclusion of Pharmacia product revenues, which are
reflected in both product categories, for a full year in 2004.
Product Developments
We continue to invest in R&D to provide future sources of revenue
through the development of new products, as well as through
additional uses for existing in-line and alliance products. We have
a broad and deep pipeline of medicines in development. We have
10 new products (Lyrica, Macugen, Revatio, Zmax, Champix, Sutent,
Eraxis, Exubera, indiplon and Zeven) that recently have been
approved or are undergoing regulatory review in the U.S. and/or
the E.U. We launched, or intend to launch, these new products in
markets once regulatory approvals are received. However, there
are no assurances as to when, or if, we will receive regulatory
approval for these or any of our other products in development.
Significant regulatory actions by, and filings pending with, the FDA
and other regulatory authorities follow:
Recent FDA Approvals
PRODUCT INDICATION DATE APPROVED
Eraxis Treatment of candidemia and February 2006
invasive candidiasis
Treatment of esophageal February 2006
candidiasis
Exubera Inhaled form of insulin for January 2006
use in adults with type 1 and
type 2 diabetes
Sutent Treatment of metastatic renal January 2006
cell carcinoma (mRCC) and
malignant gastrointestinal
stromal tumors (GIST)
Aromasin Treatment of early breast October 2005
cancer in post-menopausal
women
Lipitor Reduce the risk of stroke and September 2005
myocardial infarction in
patients with type 2 diabetes
Norvasc For treatment of September 2005
angiographically
documented coronary
artery disease
Celebrex For the relief of the signs and July 2005
symptoms associated with
ankylosing spondylitis
Lyrica Add-on therapy for adult June 2005
epilepsy patients with partial
onset seizures
Revatio Oral treatment for adult PAH June 2005
Zmax Single dose version of June 2005
Zithromax for acute bacterial
sinusitis and community-
acquired pneumonia
Zyvox For the treatment of bacterial May 2005
infections in pediatric patients
Depo-SubQ Subcutaneous formulations to March 2005
Provera treat pain associated with
endometriosis
Ellence Adjuvant long-term cancer March 2005
treatment
Pending U.S. New Drug Applications (NDAs)
and Supplemental Filings
PRODUCT INDICATION DATE SUBMITTED
Champix Nicotine-receptor partial November 2005
agonist for smoking cessation
Aricept Treatment of severe August 2005
Alzheimer’s disease
Genotropin Treatment of short stature and June 2005
growth problems resulting
from Turner’s syndrome
Vfend Pediatric filing June 2005
Indiplon Modified-release tablets for May 2005
treatment of multiple
aspects of insomnia
Immediate-release capsules April 2005
for treatment of multiple
aspects of insomnia
Zeven Treatment of Gram-positive December 2004
bacterial infections
Norvasc Reduction of cardiovascular August 2004
risk, including risk of
coronary heart disease,
myocardial infarction,
cardiovascular procedures
and strokes
Fragmin Use in oncology patients to March 2004
reduce cardiac toxicity
associated with
chemotherapy
In September 2005, we received “not-approvable” letters from the
FDA for Oporia for the prevention of post-menopausal
osteoporosis, and Dynastat (parecoxib), an injectable prodrug for
valdecoxib for the treatment of acute pain. In January 2006, we
received a “not-approvable” letter from the FDA for Oporia for
the treatment of vaginal atrophy. Pfizer is currently in discussions
with the FDA regarding these “not-approvable” letters and we
continue to develop both of these compounds.
On September 14, 2005, Pfizer completed the acquisition of
Vicuron. Zeven (dalbavancin), one of the key product candidates
acquired in the Vicuron acquisition, is a new injectable antibiotic
to treat Gram-positive infections. The FDA has designated as
approvable the NDA for Zeven. We anticipate a rapid and
successful resolution of outstanding issues to allow final NDA
approval in the coming months. Eraxis (anidulafungin), also
acquired in the Vicuron acquisition, was approved by the FDA in
February 2006. The addition of these two medications will broaden
Pfizer’s existing portfolio of anti-infectives, where the Company
has a long history of providing patients and physicians with life-
saving medicines.
An NDA for Champix (varenicline), a nicotine-receptor partial
agonist for smoking cessation was submitted to the FDA in
November 2005. In December 2005, the FDA granted Champix
priority-review status.