BN 11/17 07:56 *PFIZER CUTS FY REPORTED EPS VIEW TO $1.40-$1.49 VS $1.50-$1.59
BFW 11/17 07:54 *PFIZER CUTS EPS GUIDANCE RANGE TO $1.40-$1.49 FROM $1.50-$1.59
BN 11/17 07:54 *PFIZER MAINTAINING OTHER ELEMENTS OF '14 FINL GUIDANCE
BN 11/17 07:53 *PFIZER UPDATING '14 REPORTED EPS GUIDANCE RANGE TO $1.40-$1.49
BN 11/17 07:53 *PFIZER UPDATES '14 REPORTED EPS RANGE
BN 11/17 07:53 *PFIZER FORMS GLOBAL ALLIANCE W/ MERCK KGAA, GERMANY, TO JOINTLY
BFW 11/17 07:54 *PFIZER CUTS EPS GUIDANCE RANGE TO $1.40-$1.49 FROM $1.50-$1.59
BN 11/17 07:54 *PFIZER MAINTAINING OTHER ELEMENTS OF '14 FINL GUIDANCE
BN 11/17 07:53 *PFIZER UPDATING '14 REPORTED EPS GUIDANCE RANGE TO $1.40-$1.49
BN 11/17 07:53 *PFIZER UPDATES '14 REPORTED EPS RANGE
BN 11/17 07:53 *PFIZER FORMS GLOBAL ALLIANCE W/ MERCK KGAA, GERMANY, TO JOINTLY
Pfizer Forms Global Strategic Alliance with Merck KGaA, Germany, to Jointly Develop and Commercialize Anti-PD-L1 to Accelerate
2014-11-17 07:53:00.152 GMT
Pfizer Forms Global Strategic Alliance with Merck KGaA, Germany, to Jointly
Develop and Commercialize Anti-PD-L1 to Accelerate Presence in
Immuno-Oncology
PD-L1 Antibody Clinical Results Consistent with Class; Interim Data
Demonstrated A Complete and Partial Responses in Ovarian Cancer and NSCLC
Up to 20 High Priority Immuno-Oncology Clinical Development Programs,
Including Up to 6 Registration Trials, Expected to Commence in 2015
Updates 2014 Reported Diluted EPS Range Solely to Reflect the Transaction
Analyst Call Scheduled for 10 a.m. EST on Monday, November 17, 2014
Business Wire
NEW YORK -- November 17, 2014
Pfizer Inc. (NYSE:PFE) announced today that it has entered into an agreement
with Merck KGaA, Darmstadt, Germany, to jointly develop and commercialize
MSB0010718C, an investigational anti-PD-L1 antibody currently in development
by Merck KGaA as a potential treatment for multiple types of cancer. Pfizer
and Merck KGaA will explore the therapeutic potential of this novel anti-PD-L1
antibody as a single agent as well as in various combinations with Pfizer’s
and Merck KGaA’s broad portfolio of approved and investigational oncology
therapies.
Building on the ongoing Phase 1 program that has treated more than 550
patients, both companies will collaborate on up to 20 high priority
immuno-oncology clinical development programs expected to commence in 2015.
These clinical development programs include up to six trials (Phase 2 or 3)
that could be pivotal for potential product registrations.
“This global alliance enables Pfizer and Merck KGaA to join forces and combine
complementary strengths with the goal of meeting the needs of patients with
multiple types of cancer,” said Albert Bourla, group president Vaccines,
Oncology and Consumer Healthcare Businesses, Pfizer. “Immuno-oncology is a top
priority for Pfizer. Combining this promising anti-PD-L1 antibody with
Pfizer’s extensive portfolio of small molecules and antibodies, provides an
opportunity to potentially broaden the use of immunotherapy for patients with
cancer and rapidly expand our oncology business. In addition, this alliance
enables us to significantly accelerate the timeframe of our development
programs and move into the first wave of potential immuno-oncology based
treatment regimens.”
“Collaborating globally with Pfizer will allow us to benefit from the
strengths and capabilities of both companies in immuno-oncology, further
accelerating this promising asset in the race to address the needs of cancer
patients across multiple tumor types. Up to 20 high priority immuno-oncology
clinical development programs are expected to commence in 2015, including
pivotal registration studies,” continued Belén Garijo, president and chief
executive officer of Merck’s biopharmaceutical division Merck Serono and
Executive Board Member Elect. “On top of that, the global alliance will enable
Merck to gain an early entry into the US oncology market as well as to
strengthen our existing oncology business in several other important global
markets.”
There are currently two clinical development programs underway evaluating
Merck KGaA’s anti-PD-L1 antibody. In a Phase 1 trial, more than 550 patients
have been treated with MSB0010718C across multiple types of cancers. As part
of the Analyst and Investor Day hosted by Merck KGaA on September 18, 2014,
interim data were presented from an ongoing Phase 1 study demonstrating a
complete response and partial responses in patients with non-small cell lung
cancer and ovarian cancer. Additional data are expected to be presented at
medical congresses in 2015. There is also an ongoing Phase 2 trial evaluating
this antibody in patients with metastatic Merkel cell carcinoma, a rare form
of skin cancer. For more information, please visit www.clinicaltrials.gov.
“Early results for Merck KGaA’s PD-L1 in patient trials are impressive and
consistent with the results seen with the class of PD-1 and PD-L1 antibodies,”
said Mikael Dolsten, M.D., Ph.D., president of Pfizer Worldwide Research and
Development (WRD) and executive vice president, Pfizer. “This promising
foundation of research will form the basis of multiple registration trials.”
Separate from the PD-L1 programs, Pfizer and Merck KGaA will also combine
resources and expertise to advance Pfizer’s anti-PD-1 antibody into Phase 1
trials. The parties have also agreed to co-promote Pfizer’s XALKORI in the
United States and several other key markets.
Under the terms of the agreement, Merck KGaA will receive an upfront payment
of $850 million and is eligible to receive regulatory and commercial milestone
payments up to approximately $2 billion. Both companies will jointly fund all
development and commercialization costs and all revenues obtained from selling
any anti-PD-L1 or anti-PD-1 products generated from this collaboration will be
shared equally.
As a result of this transaction, Pfizer will recognize this upfront payment as
a certain significant item which will impact Reported Diluted earnings per
share or EPS.(*) Pfizer is updating its previous 2014 Reported Diluted EPS
guidance range from $1.50 - $1.59 to $1.40 - $1.49, while maintaining the
other elements of its 2014 financial guidance.(**)
Our updated 2014 financial guidance does not reflect the additional impact of
the exchange of future profits of Xalkori which will be measured at fair value
and will reduce our 2014 reported financial results as the fair value is
currently being determined. Our current expectation is that it may be between
$250-$400 million on a pre-tax basis as we have not concluded our analysis of
this component as of this date.
Pfizer Inc. invites investors and the general public to view and listen to a
webcast of a live conference call with investment analysts at 10 a.m. EST on
Monday, November 17, 2014.
To view and listen to the webcast visit our web site at www.pfizer.com and
click on the “Pfizer Immuno-Oncology Strategic Alliance Announcement” link in
the For Investors section located on the lower right-hand corner of that page.
Information on accessing and pre-registering for the webcast will be available
at www.pfizer.com beginning today. Participants are advised to pre-register in
advance of the conference call.
You can also listen to the conference call by dialing either 866-246-2545 in
the United States and Canada or 706-634-2365 outside of the United States and
Canada. The password is “Investors”. Please join the call five minutes prior
to the start time to avoid operator hold times.
Immuno-Oncology and Pfizer
Pfizer is working to advance the science in immuno-oncology and actively
exploring a variety of novel agents, including checkpoint modulating
antibodies, CAR-T therapies, bi-functional monoclonal antibodies and
vaccine-based immunotherapy regimens. Pfizer’s 4-1BB agonist antibody is
currently in Phase 1, with several other immunotherapeutic agents expected to
commence clinical testing in 2015, including a monoclonal antibody against
receptor OX40 (CD134), a PD-1 monoclonal antibody, and a vaccine-based regimen
for prostate cancer. Pfizer is exploring the full potential of combining
immunotherapies with its broad oncology portfolio through the company’s own
development efforts as well as in collaboration with other partners, working
together to improve outcomes for patients with cancer.
About XALKORI^® (crizotinib)
XALKORI is a kinase inhibitor indicated in the U.S. for the treatment of
patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are
anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
The U.S. indication is not limited to any specific line of therapy. In the EU,
XALKORI is indicated for the treatment of adults with previously treated
ALK-positive advanced NSCLC. XALKORI has received approval in more than 75
countries^1 including Australia, Canada, China, Japan, South Korea and the
European Union.
XALKORI^® Important Safety Information
Hepatotoxicity: Across three main clinical trials fatal hepatotoxicity
occurred in 0.2% of patients. Monitor with periodic liver testing. Temporarily
suspend, dose reduce, or permanently discontinue XALKORI.
Pneumonitis: Across three main clinical trials interstitial lung disease
(ILD)/pneumonitis occurred in 2% of patients. Permanently discontinue in
patients with ILD/pneumonitis.
QT Interval Prolongation: Across three main clinical trials QT interval
prolongation occurred in 2.7% of patients. Monitor with electrocardiograms and
electrolytes in patients who have a history of or predisposition for QTc
prolongation, or who are taking medications that prolong QT. Temporarily
suspend, dose reduce, or permanently discontinue XALKORI.
Bradycardia: XALKORI can cause bradycardia. Across three main clinical trials
11% of patients experienced a heart rate of less than 50 beats per minute.
Monitor heart rate and blood pressure regularly. Temporarily suspend, dose
reduce, or permanently discontinue XALKORI.
Embryofetal Toxicity: XALKORI can cause fetal harm when administered to a
pregnant woman. Women of childbearing potential should be advised to avoid
becoming pregnant while receiving XALKORI.
Adverse Reactions: Across three main clinical trials the most common adverse
reactions (≥25%) were vision disorders, nausea, diarrhea, vomiting,
constipation, edema, elevated transaminases, and fatigue.
In a phase 3 study in patients with ALK-positive metastatic NSCLC randomized
to XALKORI (n=172) or chemotherapy (n=171), serious adverse reactions were
reported in 37.2% of patients treated with XALKORI. The most frequent serious
adverse reactions reported in patients treated with XALKORI were pneumonia
(4.1%), pulmonary embolism (3.5%), dyspnea (2.3%), and ILD (2.9%). Fatal
adverse reactions in XALKORI-treated patients occurred in 9 (5%) patients,
consisting of: acute respiratory distress syndrome, arrhythmia, dyspnea, ILD,
pneumonia, pneumonitis, pulmonary embolism, respiratory failure, and sepsis.
Grade 3 or 4 events occurring at a higher incidence with XALKORI than with
chemotherapy and at greater than 2%, were syncope (3%), QT prolongation (3%),
and pulmonary embolism (5%). Elevation of ALT of any grade occurred in 76% of
patients and grade 3 or 4 in 17% of patients. Neutropenia of any grade
occurred in 49% of patients and grade 3 or 4 in 12% of patients. Lymphopenia
of any grade occurred in 51% of patients and grade 3 or 4 in 9% of patients.
Renal cysts occurred in 4% and neuropathy occurred in 19% of patients treated
with XALKORI.
Drug Interactions: Exercise caution with concomitant use of moderate CYP3A
inhibitors. Avoid grapefruit or grapefruit juice which may increase plasma
concentrations of crizotinib. Avoid concomitant use of strong CYP3A inducers
and inhibitors. Dose reduction may be needed for co-administered drugs that
are predominantly metabolized by CYP3A.
Nursing Mothers: Given the potential for serious adverse reactions in nursing
infants, consider whether to discontinue nursing or discontinue XALKORI.
Hepatic Impairment: XALKORI has not been studied in patients with hepatic
impairment. As crizotinib is extensively metabolized in the liver, hepatic
impairment is likely to increase plasma crizotinib concentrations. Use caution
in patients with hepatic impairment.
Renal Impairment: Administer XALKORI at a starting dose of 250 mg taken orally
once daily in patients with severe renal impairment (CLcr<30 mL/min) not
requiring dialysis. No starting dose adjustment is needed for patients with
mild and moderate renal impairment.
For more information and full prescribing information, please visit
www.XALKORI.com.
Pfizer Inc.: Working together for a healthier world^®
At Pfizer, we apply science and our global resources to bring therapies to
people that extend and significantly improve their lives. We strive to set the
standard for quality, safety and value in the discovery, development and
manufacture of healthcare products. Our global portfolio includes medicines
and vaccines as well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and emerging
markets to advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our responsibility as
one of the world's premier innovative biopharmaceutical companies, we
collaborate with health care providers, governments and local communities to
support and expand access to reliable, affordable health care around the
world. For more than 150 years, Pfizer has worked to make a difference for all
who rely on us. To learn more, please visit us at www.pfizer.com
DISCLOSURE NOTICE: The information contained in this release is as of November
17, 2014. 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 about an agreement between
Pfizer and Merck KGaA regarding an immuno-oncology alliance involving
anti-PD-L1 and anti-PD-1 therapies and Pfizer’s updated financial guidance for
2014 that involves substantial risks and uncertainties that could cause actual
results to differ materially from those expressed or implied by such
statements. Forward-looking statements include, among other things, those
regarding MSB0010718C and the agreement to jointly develop and commercialize
MSB0010718C, including plans to explore MSB0010718C as a single agent as well
as in various combinations with Pfizer’s and Merck KGaA’s oncology portfolios,
plans to advance Pfizer’s anti-PD-1 antibody into Phase 1 clinical trials,
development plans for additional clinical trials and plans to jointly
commercialize Xalkori in certain markets, and those regarding Pfizer’s
immuno-oncology portfolio, including their potential benefits, as well as
statements regarding the timing of potential commencement of clinical
development programs and testing and regarding Pfizer’s updated financial
guidance for 2014 and the expected impact of the exchange of future profits of
Xalkori. Risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including the ability to
meet anticipated clinical study commencement and completion dates as well as
the possibility of unfavorable study results; risks associated with interim
data, including the risk that the final results of the Phase 1 study for
MSB0010718C and/or additional clinical trials may be different from (including
less favorable than) the interim data results and may not support further
clinical development; the risk that clinical trial data are subject to
differing interpretations, and, even when we view data as sufficient to
support the safety and/or effectiveness of a product candidate, regulatory
authorities may not share our views and may require additional data or may
deny approval altogether; whether and when drug applications may be filed in
any jurisdictions for any potential product candidates or combination
therapies; whether and when any such applications may be approved by
regulatory authorities, which will depend on the assessment by such regulatory
authorities of the benefit-risk profile suggested by the totality of the
efficacy and safety information submitted; decisions by regulatory authorities
regarding labeling and other matters that could affect the availability or
commercial potential of any of such product candidates or combination
therapies; competitive developments; and regarding Pfizer’s updated financial
guidance for 2014, the uncertainties and variables inherent in business,
financial and operating performance, including among other things, general
economic, political, business, industry, regulatory and market conditions.
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, 2013 and in
its subsequent reports on Form 10-Q, including in the sections thereof
captioned “Risk Factors” and “Forward-Looking Information That May Affect
Future Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the SEC and available at www.sec.gov and www.pfizer.com.
(*) “Reported Diluted EPS” is defined as reported diluted EPS attributable to
Pfizer Inc. common shareholders in accordance with U.S. GAAP.
(**)
* Except for the Merck KGaA transaction referenced in this press release,
does not assume the completion of any business development transactions
not completed as of September 28, 2014 including any one-time upfront
payments associated with such transactions.
* Excludes the potential effects of the resolution of litigation-related
matters not substantially resolved as of September 28, 2014.
* Exchange rates assumed are a blend of the actual exchange rates in effect
through September 28, 2014 and the mid-October 2014 exchange rates for the
remainder of the year. Does not include the impact of a potential
devaluation of the Venezuelan bolivar or any other currency.
* Guidance for the effective tax rate on adjusted income does not assume
renewal of the U.S. research and development (R&D) tax credit. The renewal
of the R&D tax credit is not anticipated to have a material impact on the
effective tax rate on adjusted income.
* Assumes diluted weighted-average shares outstanding of approximately 6.4
billion shares.
* Revenues and cost of sales from the transitional manufacturing and supply
agreements with Zoetis have been excluded from the applicable Adjusted
components of the financial guidance.
^1 Pfizer data on file.
Contact:
Pfizer Europe Media:
Lisa O’Neill, +44.7929.339560
lisa.o'neill@pfizer.com
or
Pfizer U.S. Media:
Sally Beatty, 347-330-7867
Sally.Beatty@pfizer.com
or
Pfizer Investor:
Charles Triano, 212-733-3901
Charles.Triano@pfizer.com
-0- Nov/17/2014 07:53 GMT
2014-11-17 07:53:00.152 GMT
Pfizer Forms Global Strategic Alliance with Merck KGaA, Germany, to Jointly
Develop and Commercialize Anti-PD-L1 to Accelerate Presence in
Immuno-Oncology
PD-L1 Antibody Clinical Results Consistent with Class; Interim Data
Demonstrated A Complete and Partial Responses in Ovarian Cancer and NSCLC
Up to 20 High Priority Immuno-Oncology Clinical Development Programs,
Including Up to 6 Registration Trials, Expected to Commence in 2015
Updates 2014 Reported Diluted EPS Range Solely to Reflect the Transaction
Analyst Call Scheduled for 10 a.m. EST on Monday, November 17, 2014
Business Wire
NEW YORK -- November 17, 2014
Pfizer Inc. (NYSE:PFE) announced today that it has entered into an agreement
with Merck KGaA, Darmstadt, Germany, to jointly develop and commercialize
MSB0010718C, an investigational anti-PD-L1 antibody currently in development
by Merck KGaA as a potential treatment for multiple types of cancer. Pfizer
and Merck KGaA will explore the therapeutic potential of this novel anti-PD-L1
antibody as a single agent as well as in various combinations with Pfizer’s
and Merck KGaA’s broad portfolio of approved and investigational oncology
therapies.
Building on the ongoing Phase 1 program that has treated more than 550
patients, both companies will collaborate on up to 20 high priority
immuno-oncology clinical development programs expected to commence in 2015.
These clinical development programs include up to six trials (Phase 2 or 3)
that could be pivotal for potential product registrations.
“This global alliance enables Pfizer and Merck KGaA to join forces and combine
complementary strengths with the goal of meeting the needs of patients with
multiple types of cancer,” said Albert Bourla, group president Vaccines,
Oncology and Consumer Healthcare Businesses, Pfizer. “Immuno-oncology is a top
priority for Pfizer. Combining this promising anti-PD-L1 antibody with
Pfizer’s extensive portfolio of small molecules and antibodies, provides an
opportunity to potentially broaden the use of immunotherapy for patients with
cancer and rapidly expand our oncology business. In addition, this alliance
enables us to significantly accelerate the timeframe of our development
programs and move into the first wave of potential immuno-oncology based
treatment regimens.”
“Collaborating globally with Pfizer will allow us to benefit from the
strengths and capabilities of both companies in immuno-oncology, further
accelerating this promising asset in the race to address the needs of cancer
patients across multiple tumor types. Up to 20 high priority immuno-oncology
clinical development programs are expected to commence in 2015, including
pivotal registration studies,” continued Belén Garijo, president and chief
executive officer of Merck’s biopharmaceutical division Merck Serono and
Executive Board Member Elect. “On top of that, the global alliance will enable
Merck to gain an early entry into the US oncology market as well as to
strengthen our existing oncology business in several other important global
markets.”
There are currently two clinical development programs underway evaluating
Merck KGaA’s anti-PD-L1 antibody. In a Phase 1 trial, more than 550 patients
have been treated with MSB0010718C across multiple types of cancers. As part
of the Analyst and Investor Day hosted by Merck KGaA on September 18, 2014,
interim data were presented from an ongoing Phase 1 study demonstrating a
complete response and partial responses in patients with non-small cell lung
cancer and ovarian cancer. Additional data are expected to be presented at
medical congresses in 2015. There is also an ongoing Phase 2 trial evaluating
this antibody in patients with metastatic Merkel cell carcinoma, a rare form
of skin cancer. For more information, please visit www.clinicaltrials.gov.
“Early results for Merck KGaA’s PD-L1 in patient trials are impressive and
consistent with the results seen with the class of PD-1 and PD-L1 antibodies,”
said Mikael Dolsten, M.D., Ph.D., president of Pfizer Worldwide Research and
Development (WRD) and executive vice president, Pfizer. “This promising
foundation of research will form the basis of multiple registration trials.”
Separate from the PD-L1 programs, Pfizer and Merck KGaA will also combine
resources and expertise to advance Pfizer’s anti-PD-1 antibody into Phase 1
trials. The parties have also agreed to co-promote Pfizer’s XALKORI in the
United States and several other key markets.
Under the terms of the agreement, Merck KGaA will receive an upfront payment
of $850 million and is eligible to receive regulatory and commercial milestone
payments up to approximately $2 billion. Both companies will jointly fund all
development and commercialization costs and all revenues obtained from selling
any anti-PD-L1 or anti-PD-1 products generated from this collaboration will be
shared equally.
As a result of this transaction, Pfizer will recognize this upfront payment as
a certain significant item which will impact Reported Diluted earnings per
share or EPS.(*) Pfizer is updating its previous 2014 Reported Diluted EPS
guidance range from $1.50 - $1.59 to $1.40 - $1.49, while maintaining the
other elements of its 2014 financial guidance.(**)
Our updated 2014 financial guidance does not reflect the additional impact of
the exchange of future profits of Xalkori which will be measured at fair value
and will reduce our 2014 reported financial results as the fair value is
currently being determined. Our current expectation is that it may be between
$250-$400 million on a pre-tax basis as we have not concluded our analysis of
this component as of this date.
Pfizer Inc. invites investors and the general public to view and listen to a
webcast of a live conference call with investment analysts at 10 a.m. EST on
Monday, November 17, 2014.
To view and listen to the webcast visit our web site at www.pfizer.com and
click on the “Pfizer Immuno-Oncology Strategic Alliance Announcement” link in
the For Investors section located on the lower right-hand corner of that page.
Information on accessing and pre-registering for the webcast will be available
at www.pfizer.com beginning today. Participants are advised to pre-register in
advance of the conference call.
You can also listen to the conference call by dialing either 866-246-2545 in
the United States and Canada or 706-634-2365 outside of the United States and
Canada. The password is “Investors”. Please join the call five minutes prior
to the start time to avoid operator hold times.
Immuno-Oncology and Pfizer
Pfizer is working to advance the science in immuno-oncology and actively
exploring a variety of novel agents, including checkpoint modulating
antibodies, CAR-T therapies, bi-functional monoclonal antibodies and
vaccine-based immunotherapy regimens. Pfizer’s 4-1BB agonist antibody is
currently in Phase 1, with several other immunotherapeutic agents expected to
commence clinical testing in 2015, including a monoclonal antibody against
receptor OX40 (CD134), a PD-1 monoclonal antibody, and a vaccine-based regimen
for prostate cancer. Pfizer is exploring the full potential of combining
immunotherapies with its broad oncology portfolio through the company’s own
development efforts as well as in collaboration with other partners, working
together to improve outcomes for patients with cancer.
About XALKORI^® (crizotinib)
XALKORI is a kinase inhibitor indicated in the U.S. for the treatment of
patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are
anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.
The U.S. indication is not limited to any specific line of therapy. In the EU,
XALKORI is indicated for the treatment of adults with previously treated
ALK-positive advanced NSCLC. XALKORI has received approval in more than 75
countries^1 including Australia, Canada, China, Japan, South Korea and the
European Union.
XALKORI^® Important Safety Information
Hepatotoxicity: Across three main clinical trials fatal hepatotoxicity
occurred in 0.2% of patients. Monitor with periodic liver testing. Temporarily
suspend, dose reduce, or permanently discontinue XALKORI.
Pneumonitis: Across three main clinical trials interstitial lung disease
(ILD)/pneumonitis occurred in 2% of patients. Permanently discontinue in
patients with ILD/pneumonitis.
QT Interval Prolongation: Across three main clinical trials QT interval
prolongation occurred in 2.7% of patients. Monitor with electrocardiograms and
electrolytes in patients who have a history of or predisposition for QTc
prolongation, or who are taking medications that prolong QT. Temporarily
suspend, dose reduce, or permanently discontinue XALKORI.
Bradycardia: XALKORI can cause bradycardia. Across three main clinical trials
11% of patients experienced a heart rate of less than 50 beats per minute.
Monitor heart rate and blood pressure regularly. Temporarily suspend, dose
reduce, or permanently discontinue XALKORI.
Embryofetal Toxicity: XALKORI can cause fetal harm when administered to a
pregnant woman. Women of childbearing potential should be advised to avoid
becoming pregnant while receiving XALKORI.
Adverse Reactions: Across three main clinical trials the most common adverse
reactions (≥25%) were vision disorders, nausea, diarrhea, vomiting,
constipation, edema, elevated transaminases, and fatigue.
In a phase 3 study in patients with ALK-positive metastatic NSCLC randomized
to XALKORI (n=172) or chemotherapy (n=171), serious adverse reactions were
reported in 37.2% of patients treated with XALKORI. The most frequent serious
adverse reactions reported in patients treated with XALKORI were pneumonia
(4.1%), pulmonary embolism (3.5%), dyspnea (2.3%), and ILD (2.9%). Fatal
adverse reactions in XALKORI-treated patients occurred in 9 (5%) patients,
consisting of: acute respiratory distress syndrome, arrhythmia, dyspnea, ILD,
pneumonia, pneumonitis, pulmonary embolism, respiratory failure, and sepsis.
Grade 3 or 4 events occurring at a higher incidence with XALKORI than with
chemotherapy and at greater than 2%, were syncope (3%), QT prolongation (3%),
and pulmonary embolism (5%). Elevation of ALT of any grade occurred in 76% of
patients and grade 3 or 4 in 17% of patients. Neutropenia of any grade
occurred in 49% of patients and grade 3 or 4 in 12% of patients. Lymphopenia
of any grade occurred in 51% of patients and grade 3 or 4 in 9% of patients.
Renal cysts occurred in 4% and neuropathy occurred in 19% of patients treated
with XALKORI.
Drug Interactions: Exercise caution with concomitant use of moderate CYP3A
inhibitors. Avoid grapefruit or grapefruit juice which may increase plasma
concentrations of crizotinib. Avoid concomitant use of strong CYP3A inducers
and inhibitors. Dose reduction may be needed for co-administered drugs that
are predominantly metabolized by CYP3A.
Nursing Mothers: Given the potential for serious adverse reactions in nursing
infants, consider whether to discontinue nursing or discontinue XALKORI.
Hepatic Impairment: XALKORI has not been studied in patients with hepatic
impairment. As crizotinib is extensively metabolized in the liver, hepatic
impairment is likely to increase plasma crizotinib concentrations. Use caution
in patients with hepatic impairment.
Renal Impairment: Administer XALKORI at a starting dose of 250 mg taken orally
once daily in patients with severe renal impairment (CLcr<30 mL/min) not
requiring dialysis. No starting dose adjustment is needed for patients with
mild and moderate renal impairment.
For more information and full prescribing information, please visit
www.XALKORI.com.
Pfizer Inc.: Working together for a healthier world^®
At Pfizer, we apply science and our global resources to bring therapies to
people that extend and significantly improve their lives. We strive to set the
standard for quality, safety and value in the discovery, development and
manufacture of healthcare products. Our global portfolio includes medicines
and vaccines as well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and emerging
markets to advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our responsibility as
one of the world's premier innovative biopharmaceutical companies, we
collaborate with health care providers, governments and local communities to
support and expand access to reliable, affordable health care around the
world. For more than 150 years, Pfizer has worked to make a difference for all
who rely on us. To learn more, please visit us at www.pfizer.com
DISCLOSURE NOTICE: The information contained in this release is as of November
17, 2014. 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 about an agreement between
Pfizer and Merck KGaA regarding an immuno-oncology alliance involving
anti-PD-L1 and anti-PD-1 therapies and Pfizer’s updated financial guidance for
2014 that involves substantial risks and uncertainties that could cause actual
results to differ materially from those expressed or implied by such
statements. Forward-looking statements include, among other things, those
regarding MSB0010718C and the agreement to jointly develop and commercialize
MSB0010718C, including plans to explore MSB0010718C as a single agent as well
as in various combinations with Pfizer’s and Merck KGaA’s oncology portfolios,
plans to advance Pfizer’s anti-PD-1 antibody into Phase 1 clinical trials,
development plans for additional clinical trials and plans to jointly
commercialize Xalkori in certain markets, and those regarding Pfizer’s
immuno-oncology portfolio, including their potential benefits, as well as
statements regarding the timing of potential commencement of clinical
development programs and testing and regarding Pfizer’s updated financial
guidance for 2014 and the expected impact of the exchange of future profits of
Xalkori. Risks and uncertainties include, among other things, the
uncertainties inherent in research and development, including the ability to
meet anticipated clinical study commencement and completion dates as well as
the possibility of unfavorable study results; risks associated with interim
data, including the risk that the final results of the Phase 1 study for
MSB0010718C and/or additional clinical trials may be different from (including
less favorable than) the interim data results and may not support further
clinical development; the risk that clinical trial data are subject to
differing interpretations, and, even when we view data as sufficient to
support the safety and/or effectiveness of a product candidate, regulatory
authorities may not share our views and may require additional data or may
deny approval altogether; whether and when drug applications may be filed in
any jurisdictions for any potential product candidates or combination
therapies; whether and when any such applications may be approved by
regulatory authorities, which will depend on the assessment by such regulatory
authorities of the benefit-risk profile suggested by the totality of the
efficacy and safety information submitted; decisions by regulatory authorities
regarding labeling and other matters that could affect the availability or
commercial potential of any of such product candidates or combination
therapies; competitive developments; and regarding Pfizer’s updated financial
guidance for 2014, the uncertainties and variables inherent in business,
financial and operating performance, including among other things, general
economic, political, business, industry, regulatory and market conditions.
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, 2013 and in
its subsequent reports on Form 10-Q, including in the sections thereof
captioned “Risk Factors” and “Forward-Looking Information That May Affect
Future Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the SEC and available at www.sec.gov and www.pfizer.com.
(*) “Reported Diluted EPS” is defined as reported diluted EPS attributable to
Pfizer Inc. common shareholders in accordance with U.S. GAAP.
(**)
* Except for the Merck KGaA transaction referenced in this press release,
does not assume the completion of any business development transactions
not completed as of September 28, 2014 including any one-time upfront
payments associated with such transactions.
* Excludes the potential effects of the resolution of litigation-related
matters not substantially resolved as of September 28, 2014.
* Exchange rates assumed are a blend of the actual exchange rates in effect
through September 28, 2014 and the mid-October 2014 exchange rates for the
remainder of the year. Does not include the impact of a potential
devaluation of the Venezuelan bolivar or any other currency.
* Guidance for the effective tax rate on adjusted income does not assume
renewal of the U.S. research and development (R&D) tax credit. The renewal
of the R&D tax credit is not anticipated to have a material impact on the
effective tax rate on adjusted income.
* Assumes diluted weighted-average shares outstanding of approximately 6.4
billion shares.
* Revenues and cost of sales from the transitional manufacturing and supply
agreements with Zoetis have been excluded from the applicable Adjusted
components of the financial guidance.
^1 Pfizer data on file.
Contact:
Pfizer Europe Media:
Lisa O’Neill, +44.7929.339560
lisa.o'neill@pfizer.com
or
Pfizer U.S. Media:
Sally Beatty, 347-330-7867
Sally.Beatty@pfizer.com
or
Pfizer Investor:
Charles Triano, 212-733-3901
Charles.Triano@pfizer.com
-0- Nov/17/2014 07:53 GMT