Pfizer’s Bosutinib Receives Positive Opinion For Conditional Marketing Authorization From The Committee For Medicinal

  Pfizer’sBosutinib Receives Positive Opinion For Conditional Marketing
  Authorization From The Committee For Medicinal Products For Human Use For
  The Treatment Of Ph+ Chronic Myelogenous Leukemia With Resistance Or
  Intolerance To Prior Therapy In Europe

Business Wire

NEW YORK -- January 18, 2013

Pfizer Inc. announced today that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive
opinion regarding the conditional marketing authorization of bosutinib in the
European Union (EU) for the treatment of adult patients with chronic phase
(CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome
positive chronic myelogenous leukemia (Ph+ CML) previously treated with one or
more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and
dasatinib are not considered appropriate treatment options.

The positive opinion for bosutinib was based on data from Study 200, a global,
single-arm, open-label, multi-cohort, Phase 1/2 study of bosutinib in more
than 500 patients with Ph+ CML with separate cohorts for chronic, accelerated
and blast phase disease previously treated with one or more prior TKIs.

Conditional approvals in the EU are granted to medicinal products with a
positive benefit/risk assessmentthat address unmet medical needs and whose
availability would result in a significant public health benefit.

CML accounts for 15 percent of all leukemia cases.^1 Despite the availability
of existing treatments for CML, there remains a need for additional treatment
options. During the course of initial treatment some patients may never
respond, may develop drug-resistant disease or may not be able to tolerate
their therapy.^2,3

“We are very pleased with this positive recommendation on bosutinib by the
CHMP. We believe that bosutinib, if approved by the European Commission, would
represent an important option for patients with CML who have progressed on
prior treatment and are not candidates for alternative treatments. The
development of bosutinib is evidence of our commitment to bringing meaningful
new medicines to patients with hematologic cancers,” said Mace Rothenberg, MD,
senior vice president of Clinical Development and Medical Affairs, Pfizer
Oncology Business Unit. “We believe many doctors and CML patients will find
this treatment, if approved, to be a welcome addition, offering a distinct
adverse event profile and a convenient once-daily dosing regimen.”

The CHMP’s positive opinion will be reviewed by the European Commission, which
has the authority to approve medicines for the EU. Pfizer anticipates a
decision from the Commission in the coming months.

About Bosutinib

Bosutinib is an oral, once-daily, kinase inhibitor, which limits cancer cell
growth by inhibiting the Abl and Src signaling pathways.^4 Bosutinib was first
approved as BOSULIF^® in the United States (U.S.) in September 2012 for the
treatment of adult patients with chronic, accelerated, or blast phase Ph+ CML
with resistance, or intolerance to prior therapy. Bosutinib is an
investigational agent under review in other markets.

Bosutinib (BOSULIF^®) U.S. Important Safety Information

Contraindication: Hypersensitivity to BOSULIF. Anaphylactic shock occurred in
less than 0.2% of treated patients.

Gastrointestinal Toxicity: Diarrhea, nausea, vomiting, and abdominal pain can
occur. In the clinical trial, median time to onset for diarrhea was 2 days,
median duration was 1 day, and median number of episodes per patient was 3
(range 1-221). Monitor and manage patients using standards of care, including
antidiarrheals, antiemetics, and/or fluid replacement. Withhold, dose reduce,
or discontinue BOSULIF as necessary.

Myelosuppression: Thrombocytopenia, anemia, and neutropenia can occur. A
complete blood count should be performed weekly for the first month and then
monthly or as clinically indicated. Withhold, dose reduce, or discontinue
BOSULIF as necessary.

Hepatic Toxicity: Twenty percent of patients experienced an increase in either
alanine aminotransferase (ALT) or aspartate aminotransferase (AST). Liver
enzyme elevation usually occurs early in treatment. Perform monthly hepatic
enzyme tests for the first 3 months and as clinically indicated. In patients
with transaminase elevations, monitor liver enzymes more frequently.
Drug-induced liver injury has occurred. Withhold, dose reduce, or discontinue
BOSULIF as necessary.

Fluid Retention: Fluid retention can occur and may cause pericardial effusion,
pleural effusion, pulmonary edema, and/or peripheral edema. Monitor and manage
patients using standards of care. Interrupt, dose reduce, or discontinue
BOSULIF as necessary.

Embryofetal Toxicity: BOSULIF may cause fetal harm when administered to a
pregnant woman. Women of childbearing potential should be advised of potential
hazard to the fetus and to avoid becoming pregnant while receiving BOSULIF.

Adverse Reactions: The most common adverse reactions observed in greater than
20% of patients in the Phase 1/2 safety population (N=546) were diarrhea,
nausea, thrombocytopenia, vomiting, abdominal pain, rash, anemia, pyrexia, and

The most common Grade 3/4 adverse reactions and laboratory abnormalities
observed in greater than 10% of patients were thrombocytopenia, anemia, and

Drug Interactions: Avoid concurrent use with strong or moderate CYP3A
inhibitors or inducers.

Proton Pump Inhibitors (PPIs): Consider using short-acting antacids or H2
blockers instead of PPIs. Separate antacid or H2 blocker dosing and BOSULIF
dosing by more than 2 hours.

Substrates of P-glycoprotein: BOSULIF may increase the plasma concentrations
of drugs that are P-gp substrates, such as digoxin.

Nursing Mothers: Given the potential for serious adverse reactions in nursing
infants, a decision should be made whether to discontinue nursing or BOSULIF.

Hepatic Impairment: Treat with a dose of 200 mg daily in patients with any
baseline hepatic impairment.

For more information and full prescribing information, please visit

About Pfizer Oncology

Pfizer Oncology is committed to the discovery, investigation and development
of innovative treatment options to improve the outlook for cancer patients

Hematologic cancers are a complex group of diseases, with over 70 different
types of lymphomas, leukemias or myelomas. While there have been significant
advancements in the treatment of some hematologic cancers, there continues to
be a need for additional therapeutic options. Pfizer Oncology is committed to
improving outcomes for patients living with hematologic malignancies like CML.
Pfizer Oncology has a robust hematology pipeline, with biologics and small
molecules in clinical development across a number of hematologic malignancies.
We are advancing technologies as well as working to identify new and
innovative options that address specific hematologic cancers, molecular
subtypes, gene over-expression and mechanisms of resistance.

For more information, please visit

DISCLOSURE NOTICE: The information contained in this release is as of January
18, 2013. Pfizer assumes no obligation to update forward-looking statements
contained in this release as the result of new information or future events or
developments. This release contains forward-looking information that involves
substantial risks and uncertainties about an oncology product candidate,
bosutinib, including its potential benefits, that is under review by
regulatory authorities in the EU and various other jurisdictions. Such risks
and uncertainties include, among other things, whether and when the European
Commission and regulatory authorities in such other jurisdictions will approve
drug applications that have been or may be filed for bosutinib as well as
their decisions regarding labeling and other matters that could affect its
availability or commercial potential; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2011 and in
its reports on Form 10-Q and Form 8-K.

^1 Jabbour E et al. Targeted Therapy in Chronic Myeloid Leukemia. Expert
Review of Anticancer Therapy. 2008; 8: 99-110.

^2 Steegman J.L et al. Off-target effects of BCR-ABL1 inhibitors and their
potential long-term implications in patients with chronic myeloid leukemia.
Leukemia & Lymphoma. 2012; Early Online: 1-11.

^3 Cortes J, Kantarjian H. Resistance in Chronic Myeloid Leukemia: Still an
Issue? American Society of Clinical Oncology. 2011; 270-274.

^4 Konig H. Effects of Dasatinib on Src Kinase Activity and Downstream
Intracellular Signaling in Primitive Chronic Myelogenous Leukemia
Hematopoietic Cells. Cancer Research. 2008; 68: 9624-9633.


Pfizer Inc.
Victoria Davis, (+1) 347-558-3455
Jennifer Davis, (+1) 212-733-0717
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