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Recent Pfizer Press Releases

4/22/14 8:00am EDT
Pfizer Announces Positive Top-Line Results From Two Phase 3 Trials Of Tofacitinib In Adults With Moderate-to-Severe Chronic Plaque Psoriasis

OPT Pivotal #1 and OPT Pivotal #2 Studies, Together with Three Other Phase 3 Trials, to Form Basis for Planned Psoriasis Indication Submission to Regulatory Authorities 

Pfizer Inc. (NYSE:PFE) announced today top-line results from two pivotal Phase 3 trials from the Oral treatment Psoriasis Trials (OPT) Program, OPT Pivotal #1 (A3921078) and OPT Pivotal #2 (A3921079), evaluating the efficacy and safety of tofacitinib, an oral Janus kinase (JAK) inhibitor, the first in a new class of medicines being investigated for the treatment of moderate-to-severe plaque psoriasis. The OPT Pivotal #1 and OPT Pivotal #2 studies showed that tofacitinib, as a 5 mg or a 10 mg dose taken as a pill twice-daily, met the primary efficacy endpoints of statistically significant superiority over placebo at Week 16 in the proportion of subjects achieving a Physician’s Global Assessment response of “clear” or “almost clear,” and the proportion of subjects achieving at least a 75% reduction in Psoriasis Area and Severity Index, two commonly used measures of efficacy in psoriasis.

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4/18/14 1:40pm EST
Pfizer Invites Public To Listen To Webcast Of April 24 Annual Meeting Of Shareholders

Pfizer Inc. invites investors and the general public to listen to a webcast of the Annual Meeting of Shareholders at 8:30 a.m. (Eastern Daylight Time) on Thursday, April 24.

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4/14/14 7:02am EDT
Advil® Relief in Action and Josh Duhamel Celebrate National Volunteer Week with Points of Light & Kick Off a Nationwide "Relief" Tour

Pfizer Consumer Healthcare, makers of Advil® and a unit of Pfizer Inc. (NYSE:PFE), is teaming up with actor and active volunteer Josh Duhamel for the Advil® Relief in Action campaign. Through the#ReliefinAction Pledge on Facebook and a Mobile Relief Center tour making approximately 100 stops throughout the country, Advil® will relieve the tough physical pain that can come with actively volunteering.

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4/6/14 10:30am EST
Pfizer’s Novel CDK 4/6 Inhibitor Palbociclib plus Letrozole Significantly Prolonged Progression-Free Survival in Patients with Advanced Breast Cancer

Pfizer Inc. today announced detailed results from the PALOMA-1 study, a randomized Phase 2 study of palbociclib (PD-0332991) in combination with letrozole.

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3/28/14 6:26pm EDT
Pfizer Statement on U.S. FDA Approval of Over-the-Counter Nexium® 24HR

Today the U.S. Food and Drug Administration (FDA) approved over-the-counter Nexium® 24HR (esomeprazole 20mg) marking a key step towards providing those who suffer from frequent heartburn broader access to a brand doctors and patients have trusted for years.

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3/27/14 8:14am EDT
In A Subanalysis, The Benefits Of Eliquis® (apixaban) Vs. Warfarin In Reducing The Risk Of Stroke In Patients With Nonvalvular Atrial Fibrillation Were Consistent, Regardless Of Blood Pressure Control 1

Blood Pressure Control Key Factor in Stroke Risk

Bristol-Myers Squibb Company (NYSE: BMY) andPfizer Inc. (NYSE: PFE) today announced the results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial that assessed the effect of blood pressure control on outcomes as well as the treatment effect of Eliquis (apixaban) compared to warfarin according to blood pressure control.1 The results showed that poor blood pressure control was associated with a substantially higher risk of stroke or systemic embolism, independent of Eliquis or warfarin treatment. However, this subanalysis found consistent results for Eliquisversus warfarin in reducing the risk of stroke, regardless of blood pressure control.1 These data will be presented Saturday, March 29, at the American College of Cardiology’s (ACC) 63rd Annual Scientific Session in Washington, D.C.

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3/27/14 8:00am EDT
Bococizumab (RN316) Significantly Reduced LDL Cholesterol In Statin-Treated Adults With High Cholesterol In A Phase 2b Study

 

Results Presented at the American College of Cardiology’s (ACC) 63rd Annual Scientific Session in Washington D.C.
 
Phase 3 Program Focused on CV Outcomes in Patient Populations at High Risk for Cardiovascular Events  
 

Pfizer Inc. (NYSE: PFE) today announced the Phase 2b results of a 24 week, randomized, placebo-controlled, dose-ranging study of investigational bococizumab, the proposed generic name for RN316. Statin treated patients with high cholesterol were randomized to various doses of either bococizumab twice or once monthly subcutaneous administration or placebo. The study met its primary endpoint across all doses, showing that bococizumab significantly reduced low density lipoprotein cholesterol (LDL-C) from baseline compared to placebo in adults with high cholesterol also taking statin therapy.1 The percentage of patients reporting adverse events or serious adverse events was similar across placebo- and bococizumab-treatment groups. The Phase 3 program for bococizumab was initiated in October 2013.

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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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