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Recent Pfizer Press Releases

3/26/14 8:00am EST
Pfizer Achieves Primary Endpoint With Phase 3B Top-Line Results Of GENOTROPIN® In Very Young Children Born Small For Gestational Age

Pfizer Inc. (NYSE:PFE) announced today the top-line results from a Phase 3B study evaluating the 24-month efficacy of GENOTROPIN® (somatropin) on the height in small-for-gestational-age (SGA) children 24-30 months old. The primary endpoint of the study was achieved: there was a statistically significant difference at 24 months in change from baseline height between patients treated with GENOTROPIN and those in the untreated control group, as measured by height standard deviation score (SDS).

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3/25/14 5:10pm EDT
Pfizer Invites Public To View And Listen To Webcast Of May 5 Conference Call With Analysts

Pfizer Inc. invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Monday, May 5, 2014. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s First Quarter 2014 Performance Report, to be issued that morning.

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3/25/14 8:30am EDT
Pfizer Reports Positive Phase 3 Study Outcome Of XALKORI® (crizotinib) Compared To Chemotherapy In Previously Untreated Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (NSCLC)

Crizotinib is the Only Agent That Demonstrated Superior PFS Over Chemotherapy in Two Global Randomized Studies in First- and Second-Line ALK-Positive Advanced NSCLC

Pfizer Inc. announced today that PROFILE 1014, a Phase 3 study of anaplastic lymphoma kinase (ALK) inhibitor XALKORI® (crizotinib), met its primary objective of significantly prolonging progression-free survival (PFS) in previously untreated patients with ALK-positive advanced non-squamous non-small cell lung cancer (NSCLC) when compared to standard platinum-based chemotherapy regimens. PROFILE 1014 is the second positive global Phase 3 study that evaluated XALKORI against chemotherapy, a standard of care for patients with advanced NSCLC.

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3/22/14 11:45am EDT
Pfizer Announces Detailed Results of OPT Compare Phase 3 Study of Tofacitinib 5 mg and 10 mg Twice Daily Compared to High-Dose ENBREL® in Adults with Moderate-to-Severe Chronic Plaque Psoriasis

Data from First of Five Phase 3 Studies in Psoriasis to be Presented Today During Oral Session at the 72nd Annual American Academy of Dermatology Meeting in Denver, CO

Pfizer Inc. (NYSE:PFE) announced today detailed results from OPT Compare (A3921080), a Phase 3 study of tofacitinib, the first in a new class of treatment, oral Janus kinase (JAK) inhibitors, the safety and efficacy of which are being investigated for the treatment of adults with moderate-to-severe chronic plaque psoriasis.

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3/20/14 8:30am EDT
Pfizer’s Investigational Vaccine Candidate Bivalent rLP2086 Receives U.S. Food and Drug Administration Breakthrough Therapy Designation for Potential Prevention of Meningococcal B Disease

Pfizer Intends to Submit Biologics License Application for Bivalent rLP2086 to U.S. Food and Drug Administration by Mid-2014

Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Pfizer’s vaccine candidate, bivalent rLP2086, currently under investigation for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in persons 10 – 25 years of age.

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3/18/14 10:00am EDT
Pfizer Launches 2013 Integrated Annual Review

Pfizer Inc. (NYSE:PFE) today announced the launch of its fourth integrated annual review (www.pfizer.com/annual), which summarizes the company’s 2013 financial, environmental and social responsibility performance.

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3/12/14 2:18pm EDT
Pfizer Will Appeal Court Decision Regarding Celebrex Reissue Patent

Pfizer Inc. confirmed today that the United States District Court for the Eastern District of Virginia granted summary judgment invalidating the reissue patent (U.S. Patent No. RE44,048), covering methods of treating osteoarthritis and other approved conditions with celecoxib, the active ingredient in Celebrex®. 

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3/12/14 10:00am EDT
Pfizer Announces Webcast Of April 6 Conference Call With Securities Analysts To Review Palbociclib Phase 2 Final Results Following Presentation At AACR Annual Meeting 2014

Pfizer Inc. invites investors and the general public to view and listen to a webcast of a presentation by Pfizer’s Oncology leadership on Sunday, April 6, 2014 at 1:30 p.m. Pacific Daylight Time, in connection with the presentation of the final results of the PALOMA-1 Phase 2 trial for palbociclib at the American Association for Cancer Research (AACR) Annual Meeting 2014. There will be a Q&A session following the presentation during the webcast.

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3/12/14 6:37am EDT
Pfizer Presents Detailed Results From Landmark Community-Acquired Pneumonia Immunization Trial In Adults (CAPiTA) Evaluating Efficacy Of Prevenar 13*

Study Findings, Presented at ISPPD, Demonstrate that Prevenar 13 Can Prevent Vaccine-Type Community-Acquired Pneumonia

Pfizer Inc. (NYSE:PFE) today presented detailed results of the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), the landmark study of approximately 85,000 subjects, demonstrating that Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) prevented a first episode of vaccine-type community-acquired pneumonia (CAP) in adults 65 years of age and older, the study’s primary objective. This trial is the first in adults to clearly demonstrate a significant reduction in vaccine-type pneumococcal CAP, and importantly, non-bacteremic/non-invasive vaccine-type pneumococcal CAP. Results were presented during the late-breaker session at the 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) in Hyderabad, India, on March 12, 2014.

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3/6/14 5:15pm EST
Pfizer Initiates Nationwide Voluntary Recall Of Two Lots Of Pfizer's Effexor XR® 150 mg Extended-Release Capsules And One Lot Of Greenstone's Venlafaxine HCI 150 mg Extended-Release Capsules Due To The Possible Presence Of Tikosyn® Capsule

 Pfizer Inc. is voluntarily recalling one lot of 30-count Effexor XR® (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules.

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2/24/14 11:45am EST
Pfizer Announces FDA Approval To Include Radiographic Data On Reduction Of Progression Of Structural Joint Damage For Adults With Moderately To Severely Active Rheumatoid Arthritis In Labeling For XELJANZ® (tofacitinib citrate)

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) to update the current label of XELJANZ® (tofacitinib citrate) 5 mg tablets to include radiographic data from two Phase 3 studies, ORAL Scan (A3921044) and ORAL Start (A3921069).  “XELJANZ is the first oral JAK inhibitor for moderately to severely active rheumatoid arthritis.  The reduction of radiographic progression seen in ORAL Scan and ORAL Start represents a clinically meaningful outcome for patients,” said Dr. Steven Romano, Global Medicines Development Lead for the Pfizer Global Innovative Pharmaceutical business.  

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2/24/14 7:00am EST
Pfizer Announces Positive Top-Line Results Of Landmark Community-Acquired Pneumonia Immunization Trial In Adults (CAPiTA) Evaluating Efficacy Of Prevenar 13*

Data to Be Presented at 9th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD) on March 12, 2014 

Pfizer Inc. (NYSE: PFE) today announced that the Community-Acquired Pneumonia Immunization Trial in Adults (CAPiTA), the landmark study of approximately 85,000 subjects evaluating the efficacy of Prevenar 13* (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) in adults 65 years of age and older, achieved its primary clinical objective and both secondary clinical objectives.  CAPiTA is the largest double-blind, randomized, placebo-controlled vaccine efficacy trial ever conducted in adults.

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2/21/14 11:06am EST
In a Subanalysis, Eliquis® (apixaban) Reduced the Risk of Stroke and Demonstrated Fewer Major Bleeding Events Versus Warfarin Consistently Across Age Groups, Including Older Patients with Nonvalvular Atrial Fibrillation[i]

Data from Phase 3 ARISTOTLE trial pre-specified subanalysis published in the European Heart Journal 

Bristol-Myers Squibb Company (NYSE: BMY) and Pfizer Inc. (NYSE: PFE) today announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial in relation to patient age. ARISTOTLE was designed to evaluate the efficacy and safety of Eliquis compared to warfarin for reducing the risk of stroke or systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). This subanalysis found consistent results across age groups for reducing the risk of stroke and systemic embolism and reducing the risk of all-cause death with fewer bleeding events. Owing to the higher risk at older age (age 75 and older), the absolute benefit to patients with NVAF was greater with Eliquis in the older population. These data were published today in the European Heart Journal.

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2/11/14 2:04pm EDT
Pfizer Statement on Today’s Joint Meeting of FDA Advisory Committees

Pfizer agrees with the recommendation of the joint meeting of the FDA Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee that the available data do not support a conclusion that naproxen has a lower risk of cardiovascular thrombotic events as compared to other non-steroidal anti-inflammatory drugs (NSAIDs). 

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2/5/14 6:45am EST
Pfizer And Merck To Collaborate On Innovative Anti-Cancer Combination Studies

Agreement to Combine Merck’s Investigational Anti-PD-1 and Key Pfizer Oncology Assets 

Pfizer Inc. (NYSE:PFE) announced today that it has agreed with Merck & Co., Inc., known as MSD outside the United States and Canada (“Merck”), through two Merck subsidiaries, to explore the therapeutic potential of Merck’s investigational anti-PD-1 therapy, MK-3475, in combination with two Pfizer oncology assets.  A Phase I/II clinical study will evaluate the safety and anti-cancer efficacy of MK-3475 combined with Pfizer’s axitinib (INLYTA®) in renal cell carcinoma (RCC).  A separate Phase I study will evaluate the safety and tolerability of the combination of MK-3475 and PF-05082566 (PF-2566), Pfizer’s investigational, fully humanized monoclonal antibody (mAb) that stimulates signaling through 4-1BB (CD-137), a protein involved in regulation of immune cell proliferation and survival. 

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2/3/14 7:00am EST
Pfizer Announces Positive Top-Line Results From PALOMA-1 Evaluating Palbociclib Plus Letrozole in Women with Advanced Breast Cancer

Clinical Benefit Demonstrated For Potential First-in-Class CDK 4 and 6 Inhibitor

Pfizer Inc. (NYSE: PFE) today announced that the randomized Phase 2 trial [PALOMA-1] of palbociclib achieved its primary endpoint by demonstrating a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for the combination of palbociclib and letrozole compared with letrozole alone in post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or newly diagnosed metastatic breast cancer.  

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1/28/14 7:00am EST
Pfizer Reports Fourth-Quarter and Full-Year 2013 Results; Provides 2014 Financial Guidance

Pfizer Inc. (NYSE: PFE) reported financial results for fourth-quarter and full-year 2013. As a result of the full disposition of Zoetis(3) on June 24, 2013, the financial results of the Animal Health business are reported as a discontinued operation in the consolidated statements of income for full-year 2013, and fourth-quarter and full-year 2012. Results and guidance are summarized below.

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1/27/14 7:00am EST
Pfizer Announces Top-Line Results From Two Phase 3 Trials Of Dacomitinib In Patients With Refractory Advanced Non-Small Cell Lung Cancer

An Ongoing, Third Phase 3 Trial is Evaluating Dacomitinib in First-Line in EGFR-Mutant NSCLC   

Pfizer Inc. (NYSE:PFE) today announced top-line results from two randomized Phase 3 studies of the irreversible pan-HER kinase inhibitor dacomitinib in patients with advanced non-small cell lung cancer (NSCLC).

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1/23/14 8:00am EST
Pfizer Reports Top-Line Results From ALO-02 Phase 3 Study

Pfizer Inc. (NYSE: PFE) announced today top-line results from a Phase 3 study of investigational agent ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate-to-severe chronic low back pain.  In this study, ALO-02 met the primary efficacy endpoint, demonstrating a statistically significant difference from placebo.

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