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Press Release Archive

 
- Pfizer Invites Public to Listen to Webcast of April 25 Annual Meeting of Shareholders

Pfizer Inc. invites investors and the general public to listen to an audio webcast of the Annual Meeting of Shareholders at 9:00 a.m. Eastern Daylight Time on Thursday, April 25, 2019. To pre-register and access the live audio webcast, visit https://investors.pfizer.com/proxy and click on the “Meeting Webcast” button. Pre-registration begins today.

 
- Pfizer Announces Presentation of Data from a Phase 2 Study of its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older

Pfizer Inc. (NYSE: PFE) announced today the presentation of data from a Phase 2 study of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes contained in the vaccine in adults aged 18 years and older. The presentation was delivered at the 29th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Amsterdam, Netherlands. Pfizer’s 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 plus seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).

 
- U.S. FDA Approves IBRANCE? (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer

Pfizer (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to expand the indications for IBRANCE? (palbociclib) in combination with an aromatase inhibitor or fulvestrant to include men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. The approval is based on data from electronic health records and postmarketing reports of the real-world use of IBRANCE in male patients sourced from three databases: IQVIA Insurance database, Flatiron Health Breast Cancer database and the Pfizer global safety database.

 
- VIZIMPRO? (dacomitinib) Receives Marketing Authorization in European Union (EU) for the First-Line Treatment of Adult Patients with EGFR-Mutated Non-Small Cell Lung Cancer

Pfizer Inc. (NYSE: PFE) today announced that the European Commission has approved VIZIMPRO? (dacomitinib), a tyrosine kinase inhibitor (TKI), as monotherapy for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)-activating mutations.

 
- Sangamo and Pfizer Announce Phase 1/2 Interim Data for Investigational Hemophilia A Gene Therapy

BRISBANE, Calif. & Sangamo Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine company, and Pfizer, Inc. (NYSE: PFE) today announced interim data from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy for severe hemophilia A. Data indicate that SB-525 was generally well-tolerated and demonstrated a dose-dependent increase in Factor VIII (FVIII) levels across the four dosage cohorts. Eight patients total were dosed. Based on these results, the Safety Monitoring Committee (SMC) recommended cohort expansion at the 3e13 vg/kg dose. Further details will be disclosed during Sangamo’s conference call and webcast scheduled for 8:00 a.m. ET today, which can be accessed on the Sangamo website.

 
- Pfizer Secures Exclusive Option to Acquire Gene Therapy Company Vivet Therapeutics

PARIS &? Vivet Therapeutics (“Vivet”), a privately held gene therapy biotech company dedicated to developing gene therapy treatments for inherited liver disorders with high unmet medical need, and Pfizer Inc. (NYSE: PFE) announced today that Pfizer has acquired a 15% equity interest in Vivet and secured an exclusive option to acquire all outstanding shares. Pfizer and Vivet will collaborate on the development of VTX-801, Vivet’s proprietary treatment for Wilson disease.

 
- Merck KGaA, Darmstadt, Germany, and Pfizer Announce Discontinuation of Phase III JAVELIN Ovarian PARP 100 Trial in Previously Untreated Advanced Ovarian Cancer

Darmstadt, Germany and New York, US, March 19, 2019 – Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced the discontinuation of the ongoing Phase III JAVELIN Ovarian PARP 100 study evaluating the efficacy and safety of avelumab in combination with chemotherapy followed by maintenance therapy of avelumab in combination with talazoparib,* a poly (ADP-ribose) polymerase (PARP) inhibitor, versus an active comparator in treatment-na?ve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). The alliance has notified health authorities and trial investigators of the decision to discontinue the trial.

 
- Pfizer Invites Public to View and Listen to Webcast of April 30 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 Tuesday, April 30, 2019. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s First Quarter 2019 Performance Report, to be issued that morning.

 
- AUGUSTUS Demonstrates Favorable Safety Results of Eliquis? Versus Vitamin K Antagonists in Non-Valvular Atrial Fibrillation Patients with Acute Coronary Syndrome and/or Undergoing Percutaneous Coronary Intervention

PRINCETON, N.J. & The Bristol-Myers Squibb-Pfizer Alliance today announced results from the Phase 4 AUGUSTUS trial evaluating Eliquis? (apixaban) versus vitamin K antagonists (VKAs) in patients with non-valvular atrial fibrillation (NVAF) and recent acute coronary syndrome (ACS) and/or undergoing percutaneous coronary intervention (PCI). Results show that in patients receiving a P2Y12 inhibitor with or without aspirin (antiplatelet therapies), the proportion of patients with major or clinically relevant non-major (CRNM) bleeding at six months was significantly lower for those treated with Eliquis compared to those treated with a VKA (10.5% vs. 14.7%, respectively; hazard ratio [HR]: 0.69, 95% confidence interval [CI]: 0.58-0.81; p-superiorityNew England Journal of Medicine.

 
- U.S. FDA Approves Pfizer’s Oncology Biosimilar TRAZIMERA? (trastuzumab-qyyp), a Biosimilar to Herceptin?1

Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA? (trastuzumab-qyyp), a biosimilar to Herceptin? (trastuzumab),1 for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.2

 
- European Medicines Agency Validates Application for BAVENCIO? (avelumab) Plus INLYTA? (axitinib) for the Treatment of Advanced Renal Cell Carcinoma

Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the European Medicines Agency (EMA) has validated for review the Type II variation application for BAVENCIO??(avelumab) in combination with INLYTA? (axitinib)* for the treatment of patients with advanced renal cell carcinoma (RCC). With this validation, the application is complete, and the EMA will now begin the review procedure.

 
- Pfizer Invites Public to View and Listen to Webcast of Pfizer Presentation at Healthcare Conference

Pfizer Inc. invites investors and the general public to view and listen to a webcast of a presentation by Andy Schmeltz, Global President, Oncology, and Chris Boshoff, Chief Development Officer, Oncology, at the Cowen and Company 39th Annual Healthcare Conference on Tuesday, March 12, 2019 at 9:20 a.m. Eastern Daylight Time.

 
- Pfizer Prices $5,000,000,000 Debt Offering

Pfizer Inc. (NYSE: PFE) today announced the pricing of a debt offering consisting of five tranches of notes:

 
- Pfizer Receives Positive CHMP Opinion for LORVIQUA? (lorlatinib) for Certain Adult Patients with Previously-Treated ALK-Positive Advanced Non-Small Cell Lung Cancer

Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for LORVIQUA? (lorlatinib, approved in the U.S., Canada, and Japan under the brand name LORBRENA?), an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI). The CHMP has adopted a positive opinion recommending conditional marketing authorization for LORVIQUA as monotherapy for the treatment of adult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK TKI therapy, or crizotinib and at least one other ALK TKI. Conversion to normal approval will be contingent on provisions of comprehensive data confirming that the benefit-risk balance is positive. The CHMP’s opinion will now be reviewed by the European Commission (EC), with a decision expected in the coming months.

 
- Pfizer Announces Serotypes Included in 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older

Pfizer Inc. (NYSE: PFE) announced today the new serotypes included in its 20-Valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes covered in the vaccine in adults aged 18 years and older. Pfizer’s 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) plus 7 additional serotypes (8, 10A, 11A, 12F, 15BC, 22F and 33F).

 
- Ochsner Health System and Pfizer Partner to Develop Innovative Models for Clinical Trials

NEW ORLEANS & Ochsner Health System, Louisiana’s largest non-profit academic healthcare system, and Pfizer Inc (NYSE:PFE) have entered into a multi-year strategic alliance to develop innovative models for clinical trials. Through this partnership, Pfizer and Ochsner — through its innovation lab, innovationOchsner (iO), in partnership with Ochsner Research — will explore ways to enhance the clinical trial experience and ease participation in clinical research for both patients and healthcare professionals.

 
- Pfizer Receives European Approval for ZIRABEV? (bevacizumab), a Biosimilar to Avastin?*

Pfizer Inc. (NYSE: PFE) today announced the European Commission (EC) has approved ZIRABEV? for the treatment of metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer (NSCLC), advanced and/or metastatic renal cell cancer and persistent, recurrent or metastatic carcinoma of the cervix.1,2

 
- Pfizer and Lilly Announce Top-line Results From Phase 3 Study of Tanezumab in Chronic Low Back Pain

Pfizer Inc. (NYSE: PFE) and Eli Lilly and Company (NYSE: LLY) today announced positive top-line results from a Phase 3 study evaluating tanezumab in patients with moderate-to-severe chronic low back pain (CLBP). In the study, treatment with tanezumab 10 mg met the primary endpoint, demonstrating a statistically significant improvement in pain at 16 weeks compared to placebo. The tanezumab 5 mg arm demonstrated a numerical improvement in pain, but did not reach statistical significance compared to placebo at the week 16 analysis. Full results from this study will be submitted for future scientific publication and presentation. Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid pain medications known as nerve growth factor (NGF) inhibitors.

 
- Pivotal Phase III Data for BAVENCIO? (avelumab) Plus INLYTA? (axitinib) in Advanced Renal Cell Carcinoma Published in The New England Journal of Medicine

Darmstadt, Germany and New York, NY, February 16, 2019 – Merck KGaA, Darmstadt, Germany, which operates its biopharmaceutical business as EMD Serono in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced the publication of results from an interim analysis of the pivotal JAVELIN Renal 101 trial online in the New England Journal of Medicine.1 The combination of BAVENCIO? (avelumab) and INLYTA? (axitinib)* significantly extended median progression-free survival (PFS) by more than five months compared with SUTENT? (sunitinib) as a first-line treatment for patients with advanced renal cell carcinoma (RCC), irrespective of PD-L1 expression (HR: 0.69 [95% CI: 0.56–0.84]; BAVENCIO+INLYTA: 13.8 months [95% CI: 11.1-NE]; SUTENT: 8.4 months [95% CI: 6.9-11.1]; p<0.001). Further, the objective response rate (ORR) was doubled with BAVENCIO+INLYTA versus SUTENT in this population (51.4% [95% CI: 46.6-56.1] vs. 25.7% [95% CI: 21.7-30.0]). The study is continuing for the other primary endpoint of overall survival (OS).

 
- FDA Accepts sBLA and Grants Priority Review for BAVENCIO? (avelumab) Plus INLYTA? (axitinib) for the Treatment of Advanced Renal Cell Carcinoma

Rockland, MA and New York, NY, – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for BAVENCIO? (avelumab) in combination with INLYTA? (axitinib)* for patients with advanced renal cell carcinoma (RCC). The application has been given a target action date in June 2019.

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Note: These press releases were issued in the United States and are intended as reference information for U.S. investors and journalists. The information contained in each press release was accurate at the time of issuance, and Pfizer assumes no responsibility for updating the information to reflect subsequent developments.

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