Pfizer 2011 Annual Report Download - page 30

Financial Review
Pfizer Inc. and Subsidiary Companies
Late-stage clinical trials for additional uses and dosage forms for in-line and in-registration products:
PRODUCT INDICATION
ELIQUIS (Apixaban) For the prevention and treatment of venous thromboembolism, which is being developed in
collaboration with BMS
Eraxis/Vfend Combination Aspergillosis fungal infections
INLYTA (Axitinib) Oral and selective inhibitor of vascular endothelial growth factor (VEGF) receptor 1, 2 & 3 for the
treatment of renal cell carcinoma in treatment-naïve patients
Lyrica Peripheral neuropathic pain; CR (once-a-day) dosing
Sutent Adjuvant renal cell carcinoma
Tofacitinib A JAK kinase inhibitor for the treatment of psoriasis
Torisel Renal cell carcinoma 2nd line
Xalkori (Crizotinib) An oral ALK and c-Met inhibitor for the treatment of ALK-positive 1st and 2nd line non-small cell lung
cancer
Xiapex Peyronie’s disease
Zithromax/chloroquine Malaria
In October 2011, an independent Data Monitoring Committee (DMC) for a Phase 3 efficacy and safety study of Lyrica as
monotherapy for epilepsy patients with partial onset seizures recommended that the study be stopped based on positive findings for
the primary efficacy endpoint. We have accepted the DMC’s recommendation and stopped the study. We intend to submit the
results of the study for publication in a medical journal. We do not intend to seek an indication for Lyrica as monotherapy for epilepsy
patients with partial onset seizures.
New drug candidates in late-stage development:
CANDIDATE INDICATION
ALO-02 A Mu-type opioid receptor agonist for the management of moderate-to-severe pain when a
continuous, around-the-clock opioid analgesic is needed for an extended period of time
Bapineuzumab(a) A beta amyloid inhibitor for the treatment of mild-to-moderate Alzheimer’s disease being developed in
collaboration with Janssen Alzheimer Immunotherapy Research & Development, LLC (Janssen AI),
a subsidiary of Johnson & Johnson
Bazedoxifene-conjugated
estrogens
A tissue-selective estrogen complex for the treatment of menopausal vasomotor symptoms
Dacomitinib A pan-HER tyrosine kinase inhibitor for the treatment of advanced non-small cell lung cancer
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
Tanezumab(b) An anti-nerve growth factor monoclonal antibody for the treatment of pain (on clinical hold)
(a) Our collaboration with Janssen AI on bapineuzumab, a potential treatment for mild-to-moderate Alzheimer’s disease, continues with four Phase 3
studies. In December 2010, Janssen AI confirmed that enrollment was complete for its two Phase 3 primarily North American studies (301 and 302),
including the biomarker sub-studies. The other two Phase 3 primarily international studies (3000 and 3001) continue to enroll. Johnson & Johnson
expects that the two Janssen AI primarily North American studies will be completed (last patient out) in mid-2012. We expect that the last patient will
have completed our two primarily international 18-month trials, including associated biomarker studies, in 2014.
(b) Following requests by the FDA in 2010, we suspended and subsequently terminated worldwide the osteoarthritis, chronic low back pain and painful
diabetic peripheral neuropathy studies of tanezumab. The FDA’s requests followed a small number of reports of osteoarthritis patients treated with
tanezumab who experienced the worsening of osteoarthritis leading to joint replacement and also reflected the FDA’s concerns regarding the
potential for such events in other patient populations. In December 2010, the FDA placed a clinical hold on all other anti-nerve growth factor
therapies under clinical investigation in the U.S. Studies of tanezumab in cancer pain were allowed to continue. We continue to work with the FDA to
reach an understanding about the appropriate scope of continued clinical investigation of tanezumab. In July 2011, we submitted our response to
the “clinical hold” letter from the FDA, and we anticipate that an FDA Arthritis Advisory Committee meeting will be held to discuss the anti-nerve
growth factor class of investigational drugs.
In March 2010, we and Medivation, Inc. announced that a Phase 3 trial of dimebon (latrepiridine) did not meet its co-primary or
secondary endpoints. Subsequently, we and Medivation, Inc. agreed to discontinue the CONSTELLATION and CONTACT Phase 3
trials in patients with moderate-to-severe Alzheimer’s disease. In April 2011, we and Medivation, Inc. announced that the Phase 3
HORIZON trial in patients with Huntington’s disease did not meet its co-primary endpoints and that, as a result, development of
dimebon in Huntington’s disease has been discontinued. In January 2012, we and Medivation, Inc. announced that the CONCERT
trial in patients with mild-to-moderate Alzheimer’s disease did not meet the primary efficacy endpoints and that the two companies
will discontinue development of dimebon for all indications, terminate the ongoing open label extension study in Alzheimer’s disease
and terminate their collaboration to co-develop and market dimebon.
Additional product-related programs are in various stages of discovery and development. Also, see the discussion in the “Our
Business Development Initiatives” section of this Financial Review.
2011 Financial Report 29