Pfizer 2007 Annual Report Download - page 22

20 2007 Financial Report
Financial Review
Pfizer Inc and Subsidiary Companies
•Camptosar is indicated as first-line therapy for metastatic colorectal
cancer in combination with 5-fluorouracil and leucovorin. It is also
indicated for patients in whom metastatic colorectal cancer has
recurred or progressed despite following initial fluorouracil-
based therapy. Camptosar is for intravenous use only. Worldwide
revenues in 2007 increased 7% to $969 million, compared to
2006. The National Comprehensive Cancer Network (NCCN), an
alliance of 21 of the world’s leading cancer centers, has issued
guidelines recommending Camptosar as an option across all lines
of treatment for advanced colorectal cancer. The U.S. basic patent
for Camptosar expired in February 2008.
•Sutent is an oral multi-kinase inhibitor that combines anti-
angiogenic and anti-tumor activity to inhibit the blood supply
to tumors and has direct anti-tumor effects. Sutent was
approved by the FDA and launched in the U.S. in January 2006
for advanced renal cell carcinoma, including metastatic renal
cell carcinoma, and gastrointestinal stromal tumors (GIST) after
disease progression on, or intolerance to, imatinib mesylate. In
the first quarter of 2007, the U.S. label was revised to include
new first-line advanced renal cell carcinoma data. In January
2007, Sutent received full marketing authorization and
extension of the indication to first-line treatment of advanced
and/or metastatic renal cell carcinoma (mRCC), as well as
approval as a second-line treatment for GIST, in the E.U. We
believe that future growth of Sutent will be fueled by emerging
new data in a range of potential new indications. Sutent
recorded $581 million in worldwide revenues in 2007.
•Xalatan/Xalacom, a prostaglandin analogue used to lower the
intraocular pressure associated with glaucoma and ocular
hypertension, is one of the world’s leading branded glaucoma
medicines. Clinical data showing its advantages in treating
intraocular pressure compared with beta blockers should
support the continued growth of this important medicine.
Xalacom, the only fixed combination prostaglandin (Xalatan)
and beta blocker, is available primarily in European markets.
Xalatan/Xalacom worldwide revenues grew 10% in 2007,
compared to 2006.
•Genotropin, for the treatment of short stature in children with
growth hormone deficiency, Prader-Willi Syndrome, Turner
Syndrome, Small for Gestational Age Syndrome and in adults
with growth hormone deficiency, is the world’s leading human
growth hormone. Genotropin revenues grew 6% worldwide,
driven by its broad platform of innovative injection delivery
devices.
•Zyrtec/Zyrtec D, allergy medicines, experienced a 2% decline
in worldwide revenues compared to 2006. We lost U.S.
exclusivity for Zyrtec/Zyrtec D in January 2008. Since we sold our
rights to market Zyrtec/Zyrtec D over-the-counter in connection
with the sale of our Consumer Healthcare business, we ceased
selling this product in late January 2008.
•Alliance revenues reflect revenues primarily associated with our
co-promotion of Aricept, Rebif and Spiriva.
—Aricept, discovered and developed by our alliance partner
Eisai Co., Ltd, is the world’s leading medicine to treat
symptoms of Alzheimer’s disease. See Notes to Consolidated
Financial Statements—Note 20. Legal Proceedings and
Contingencies for a discussion of certain patent litigation
relating to Aricept.
—Rebif, discovered and developed by EMD Serono, Inc. (Serono),
is used to treat symptoms of relapsing forms of multiple
sclerosis. Pfizer co-promotes Rebif with Serono in the U.S.
—Spiriva, discovered and developed by our alliance partner
Boehringer Ingelheim (BI), is used to treat chronic obstructive
pulmonary disease, a chronic respiratory disorder that includes
chronic bronchitis and emphysema.
Alliances allow us to co-promote or license these products for
sale in certain countries. Under the co-promotion agreements,
these products are marketed and promoted with our alliance
partners. We provide funding through cash, staff and other
resources to sell, market, promote and further develop these
products.
Product Developments
We continue to invest in R&D to provide future sources of revenues
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.
However, there are no assurances as to when, or if, we will receive
regulatory approval for additional indications for existing products
or any of our other products in development. Below are significant
regulatory actions by, and filings pending with, the FDA and
regulatory authorities in the E.U. and Japan.
Recent FDA approvals:
PRODUCT INDICATION DATE APPROVED
Selzentry Treatment of human immuno- August 2007
(maraviroc) deficiency virus/acquired immune
deficiency (HIV) in CCR5-tropic
treatment-experienced patients
Lyrica Treatment of fibromyalgia June 2007
Fragmin Prevention of blood clots in May 2007
patients with cancer
Lipitor Secondary prevention of March 2007
cardiovascular (CV) events in
patients with established
coronary heart disease
Pending U.S. new drug applications (NDAs) and
supplemental filings:
PRODUCT INDICATION DATE SUBMITTED
Fablyn Treatment of osteoporosis December 2007
(lasofoxifene)
Spiriva Respimat device for chronic November 2007
obstructive pulmonary disease
Zmax Treatment of bacterial infections— November 2006
sustained release—Pediatric acute
otitis media (AOM) filing
fesoterodine Treatment of overactive bladder March 2006
Vfend Treatment of fungal infections— June 2005
Pediatric filing
dalbavancin Treatment of complicated skin/skin December 2004
structure gram-positive bacterial
infections
On September 28, 2007, we received an “approvable” letter from
the FDA for Zmax that sets forth requirements to obtain approval
for the AOM indication based on pharmacokinetic data. We plan
to discuss these requirements with the FDA and seek an agreement
on actions to address the FDA’s comments.