Pfizer 2008 Annual Report Download - page 26

Financial Review
Pfizer Inc and Subsidiary Companies
•Zyrtec/Zyrtec D allergy medicines experienced a 92% decline in worldwide revenues in 2008 compared to 2007, following the loss of
U.S. exclusivity 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 19. 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, 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, and we have taken important steps to prioritize our research and
development portfolio to maximize value. After a review of all our therapeutic areas, in 2008, we announced our decision to exit
certain disease areas—anemia, atherosclerosis/hyperlipidemia, bone health/frailty, gastrointestinal, heart failure, liver fibrosis,
muscle, obesity, osteoarthritis (disease modifying concepts only) and peripheral arterial disease—and give higher priority to the
following disease areas: Alzheimer's disease, diabetes, inflammation/immunology, oncology, pain and psychoses (schizophrenia).
We also will continue to work in many other disease areas, such as asthma, chronic obstructive pulmonary disorder, genitourinary,
infectious diseases, ophthalmology, smoking cessation, thrombosis and transplant, among others. These decisions did not affect our
portfolio of marketed products, the development of compounds currently in Phase 3 or any launches planned over the next three
years. Notwithstanding our efforts, 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
Toviaz (fesoterodine) Treatment of overactive bladder October 2008
Zmax Community-acquired pneumonia–Pediatric filing October 2008
Pending U.S. new drug applications (NDAs) and supplemental filings:
PRODUCT INDICATION DATE SUBMITTED
Selzentry (maraviroc) HIV in treatment-naïve patients December 2008
Geodon Maintenance treatment of bipolar mania December 2008
Geodon Treatment of bipolar disorders–Pediatric filing October 2008
Fablyn (lasofoxifene) Treatment of osteoporosis December 2007
Spiriva Respimat device for chronic obstructive pulmonary disease November 2007
Zmax Treatment of bacterial infections–sustained release–acute otitis media (AOM) and
sinusitis–Pediatric filing
November 2006
Vfend Treatment of fungal infections–Pediatric filing June 2005
Thelin Treatment of pulmonary arterial hypertension (PAH) May 2005
We received “not-approvable” letters from the FDA for Fablyn (lasofoxifene) for the prevention of post-menopausal osteoporosis in
September 2005 and for the treatment of vaginal atrophy in January 2006. We submitted a new NDA for the treatment of
osteoporosis in post-menopausal women in December 2007, including the three-year interim data from the Postmenopausal
Evaluation And Risk-reduction with Lasofoxifene (PEARL) study in support of the new NDA. In September 2008, nine of the 13
members of an FDA advisory committee concluded that there is a population of women with post-menopausal osteoporosis for
which the benefit of treatment with Fablyn is likely to outweigh the risks. In January 2009, we received a “complete response” letter
from the FDA for the Fablyn submission. The FDA is seeking additional data and we are working with the FDA to determine the
appropriate next steps regarding our application.
In September 2008, we received a “complete response” letter from the FDA for the Spiriva Respimat submission. The FDA is
seeking additional data and we are working with the FDA to provide the additional information.
24 2008 Financial Report