Pfizer 2010 Annual Report Download - page 33

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Financial Review
Pfizer Inc. and Subsidiary Companies
In December 2010, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive
opinion recommending that the European Commission approve Xiapex for the treatment of Dupuytren’s contracture in adult patients
with a palpable cord.
Late-stage clinical trials for additional uses and dosage forms for in-line products:
PRODUCT INDICATION
Eraxis/Vfend Combination Aspergillosis fungal infections
Lyrica Epilepsy monotherapy; central neuropathic pain due to spinal cord injury; peripheral neuropathic pain
Revatio Pediatric PAH
Sutent Adjuvant renal cell carcinoma
Torisel Renal cell carcinoma
Zithromax/chloroquine Malaria
Set forth below are developments in 2010 with respect to certain Phase 3 trials for Sutent :
•A Phase 3 trial for advanced castration-resistant prostate cancer was discontinued based on an interim analysis, whereby an
independent Data Monitoring Committee (DMC) found that the combination of Sutent with prednisone was unlikely to improve overall
survival compared to prednisone alone.
•A Phase 3 trial in combination with erlotinib for the treatment of advanced non-small-cell lung cancer was completed and did not meet
its primary endpoint.
•The Phase 3 trial for advanced liver cancer was discontinued based on a higher incidence of serious adverse events in the sunitinib
arm compared to the sorafenib arm and the fact that sunitinib did not meet the criteria to demonstrate that it was either superior or
non-inferior to sorafenib in the survival of patients with advanced liver cancer.
•Two Phase 3 trials for first-line and second-line treatment of metastatic breast cancer were completed and did not meet their primary
endpoints.
New drug candidates in late-stage development in the U.S.:
CANDIDATE INDICATION
Apixaban For the prevention and treatment of venous thromboembolism and prevention of stroke in patients
with atrial fibrillation, which is being developed in collaboration with Bristol-Myers Squibb
Company (BMS)
Aprela (Bazedoxifene-
conjugated estrogens)
A tissue-selective estrogen complex for the treatment of menopausal vasomotor symptoms
Axitinib Oral and selective inhibitor of vascular endothelial growth factor (VEGF) receptor 1, 2, & 3 for the
treatment of advanced renal cell carcinoma
Bapineuzumab A beta amyloid inhibitor for the treatment of Alzheimer’s disease being developed in collaboration
with Janssen Alzheimer Immunotherapy Research & Development, LLC (Janssen AI), a
subsidiary of Johnson & Johnson
Bosutinib An Abl and src kinase inhibitor for the treatment of chronic myelogenous leukemia
Crizotinib (PF-02341066) An oral ALK and c-Met inhibitor for the treatment of advanced non-small-cell lung cancer
Dimebon (latrepirdine) A novel mitochondrial protectant and enhancer being developed in collaboration with Medivation,
Inc., for the treatment of Alzheimer’s disease and Huntington’s disease
Inotuzumab ozogamicin An antibody drug conjugate, consisting of an anti-CD22 monotherapy antibody linked to a cytotoxic
agent, calicheamycin, for the treatment of aggressive Non-Hodgkin’s Lymphoma
Moxidectin Treatment of onchocerciasis (river blindness)
Neratinib A pan-HER inhibitor for the treatment of breast cancer
PF-0299804 A pan-HER tyrosine kinase inhibitor for the treatment of advanced non-small-cell lung cancer
Tanezumab An anti-nerve growth factor monoclonal antibody for the treatment of pain (on clinical hold)
Tofacitinib (formerly
Tasocitinib (CP-690,550)
A JAK kinase inhibitor for the treatment of rheumatoid arthritis and psoriasis
The atrial fibrillation (AF) program of the investigational drug apixaban consists of two trials. First, the data from the Phase 3
AVERROES trial demonstrated that apixaban significantly reduced the relative risk of a composite stroke or systematic embolism by
55% without a significant increase in major bleeding, fatal bleeding or intracranial bleeding compared with aspirin in patients who
were expected or demonstrated to be unsuitable for warfarin treatment. Minor bleeding, however, was increased, compared to
aspirin. Second, the Phase 3 ARISTOTLE trial is investigating apixaban compared with warfarin for the prevention of stroke in
approximately 18,000 patients with AF. Based upon discussions with the FDA and in agreement with us, our alliance partner, BMS,
2010 Financial Report 31