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Recent Pfizer Press Releases

4/18/19 5:05pm EDT
Pfizer and Lilly Announce Top-Line Results From Long-Term Phase 3 Study of Tanezumab in Patients With Osteoarthritis

NEW YORK & INDIANAPOLIS--(BUSINESS WIRE)-- Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced top-line results from a Phase 3 study evaluating tanezumab 2.5 mg and 5 mg. The objective of the study was to compare the long-term joint safety and 16-week efficacy of tanezumab relative to nonsteroidal anti-inflammatory drugs (NSAIDs) in patients with moderate-to-severe osteoarthritis (OA) of the hip or knee. The tanezumab 5 mg treatment arm met two of the three co-primary efficacy endpoints, demonstrating a statistically significant improvement in pain and physical function compared to NSAIDs at the 16-week analysis, while patients’ overall assessment of their OA was not statistically different than NSAIDs. Patients who received tanezumab 2.5 mg did not experience a statistically significant improvement in pain, physical function or patients’ overall assessment of their OA at 16 weeks compared to NSAIDs. In the safety analysis, there was a higher rate of joint safety events in the tanezumab arms compared to NSAIDs at 80 weeks; the difference was statistically significant. Joint safety was a composite measure consisting of adjudicated outcomes of rapidly progressive osteoarthritis (RPOA) type 1 or type 2, subchondral insufficiency fracture, osteonecrosis or pathological fracture. Tanezumab is a monoclonal antibody that is part of an investigational class of non-opioid chronic pain medications known as nerve growth factor (NGF) inhibitors.

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4/18/19 2:00pm EDT
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.

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4/13/19 4:00am EDT
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

The U.S. FDA awarded Breakthrough Therapy Designation for this potential indication based on these Phase 2 data - - - The Biologics License Application is expected to be submitted to the U.S. FDA by the end of 2020, subject to the successful completion of Phase 3 studies

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).

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4/4/19 2:57pm EDT
U.S. FDA Approves IBRANCE® (palbociclib) for the Treatment of Men with HR+, HER2- Metastatic Breast Cancer

Approval of expanded indication based predominately on real-world data

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.

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4/3/19 9:42am EDT
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.

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4/2/19 7:00am EDT
Sangamo and Pfizer Announce Phase 1/2 Interim Data for Investigational Hemophilia A Gene Therapy

Eight patients treated with SB-525 gene therapy showed dose-dependent increases in FVIII activity, with the two patients treated with the 3e13 vg/kg dose reaching normal FVIII levels Safety Monitoring Committee recommended expansion of the 3e13 vg/kg dose cohort

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.

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3/20/19 6:45am EDT
Pfizer Secures Exclusive Option to Acquire Gene Therapy Company Vivet Therapeutics

Pfizer and Vivet to collaborate on development of potential breakthrough therapy for Wilson disease Pfizer acquires 15% ownership stake in Vivet

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.

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3/19/19 6:39pm EST
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-naïve 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.

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3/19/19 10:00am EDT
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.

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3/17/19 11:45am EDT
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

AUGUSTUS is the largest trial in this high-risk patient population requiring both anticoagulant and antiplatelet therapies

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.

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3/11/19 7:37pm EDT
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

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3/8/19 7:00am EST
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.

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3/5/19 10:00am EST
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.

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3/4/19 8:57pm EST
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:

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3/1/19 8:35am EST
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.

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2/28/19 8:00am EST
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

Company also provides update on upcoming presentation from a Phase 2 proof-of-concept study and Phase 3 pivotal trial status

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).

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2/19/19 10:30am EST
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.

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2/19/19 9:32am EST
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

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2/19/19 6:45am EST
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.

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2/16/19 5:10pm EST
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).

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