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Recent Pfizer Press Releases

7/29/19 6:50am EDT
Pfizer Inc. Reschedules Second-Quarter 2019 Earnings Conference Call to July 29, 2019 at 10:30 a.m. EDT

 

Due to today’s announcement of a proposed transaction between Pfizer and Mylan, Pfizer’s second-quarter 2019 earnings conference call with investment analysts has been rescheduled for today, July 29, 2019, at 10:30 a.m. EDT. This call was previously scheduled for Tuesday, July 30, 2019 at 10 a.m. EDT.

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7/29/19 6:46am EDT
PFIZER REPORTS SECOND-QUARTER 2019 RESULTS 

Second-Quarter 2019 Revenues of $13.3 Billion, Reflecting 2% Operational Growth Driven by 6% Operational Growth from Pfizer Biopharmaceuticals Group Second-Quarter 2019 Reported Diluted EPS(1) of $0.89, Adjusted Diluted EPS(2) of $0.80 Updated 2019 Financial Guidance Primarily to Reflect the Anticipated August 1, 2019 Formation of the Consumer Healthcare Joint Venture with GlaxoSmithKline plc(3) and the Anticipated Near-Term Completion of the Array BioPharma Inc. Acquisition Announces Reverse Morris Trust Transaction to Combine Upjohn and Mylan, Creating a New Global Pharmaceutical Company  

Pfizer Inc. (NYSE: PFE) reported financial results for second-quarter 2019 and updated certain components of its 2019 financial guidance.

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7/29/19 6:45am EDT
Mylan and Upjohn, a Division of Pfizer, to Combine, Creating a New Champion for Global Health Uniquely Positioned to Fulfill the World’s Need for Medicine

Delivers enhanced global scale and geographic reach, including leading positions in China and other emerging markets Combines Mylan’s sustainable, diverse and differentiated portfolio of medicines with Upjohn’s trusted, iconic brands Creates powerful platform comprising Mylan’s pipeline engine and supply chain and Upjohn’s commercial and medical infrastructure and expertise Focused on driving returns through consistent cash flow growth, an attractive dividend and shareholder-focused capital policies Commitment to solid investment grade ratings Domiciled in the U.S. and governed by Delaware law Robert J. Coury named Executive Chairman of the new company; Michael Goettler named CEO and Rajiv Malik named President Concludes work of Mylan’s Strategic Review Committee Mylan and Pfizer will host Investor Conference Call, Monday, July 29, 2019 at 8:30 AM Eastern Daylight Time

HERTFORDSHIRE, England & PITTSBURGH & Mylan N.V. (Nasdaq: MYL) and Pfizer Inc. (NYSE: PFE) today announced a definitive agreement to combine Mylan with Upjohn, Pfizer’s off-patent branded and generic established medicines business, creating a new global pharmaceutical company. Under the terms of the agreement, which is structured as an all-stock, Reverse Morris Trust transaction, each Mylan share would be converted into one share of the new company. Pfizer shareholders would own 57% of the combined new company, and Mylan shareholders would own 43%. The Boards of Directors of both Mylan and Pfizer have unanimously approved the transaction.

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7/23/19 1:48pm EDT
FDA Approves Pfizer’s Biosimilar, RUXIENCE™ (rituximab-pvvr), for Certain Cancers and Autoimmune Conditions

Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved RUXIENCE™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab),1 for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).2

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7/5/19 11:15pm EDT
Sangamo and Pfizer Announce Updated Phase 1/2 Results for SB-525 Investigational Hemophilia A Gene Therapy Showing Sustained Increased Factor VIII Levels

Sangamo Therapeutics, Inc. (NASDAQ: SGMO), a genomic medicine company, and Pfizer, Inc. (NYSE: PFE) today announced updated results from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy for severe hemophilia A.

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7/1/19 10:00am EDT
Pfizer Completes Acquisition of Therachon

Early clinical development program for achondroplasia augments Pfizer’s Rare Disease portfolio

Pfizer Inc. (NYSE: PFE) today announced the successful completion of its acquisition of the privately held clinical-stage biotechnology company Therachon Holding AG. Under the terms of the transaction, Pfizer acquired Therachon for $340 million with an additional $470 million in additional payments contingent on the achievement of key milestones in the development and commercialization of TA-46. TA-46 is an investigational medicine for the treatment of achondroplasia, a genetic condition and the most common form of short-limb dwarfism. There are currently no approved treatment options for achondroplasia.

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7/1/19 8:00am EDT
Pfizer Announces Positive Top-Line Results from Phase 4 Study of Crisaborole Ointment, 2%, in Children Aged 3 Months to Less Than 24 Months with Mild to Moderate Atopic Dermatitis

Data show crisaborole ointment, 2%, a steroid-free topical treatment, was well-tolerated over 4-week treatment period Safety profile consistent with previous clinical trial experience

Pfizer Inc. (NYSE:PFE) today announced top-line results from a Phase 4 study (CrisADe CARE 1) which showed that crisaborole ointment, 2%, was well-tolerated in children aged 3 months to less than 24 months with mild to moderate atopic dermatitis (AD), also known as eczema. The data from the trial are supportive of the primary study objective to examine the safety of crisaborole ointment, 2%, in this patient population, and are consistent with previous clinical trial experience.1 Crisaborole ointment, 2%, is currently approved in select countries for mild to moderate AD in patients two years of age and older.2,3,4,5

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6/28/19 4:05pm EDT
Pfizer Announces Results from Phase 3 Trial of Revatio® (Sildenafil Citrate) in Newborns with Persistent Pulmonary Hypertension

Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 study to assess the efficacy and safety of intravenous (IV) sildenafil when added to inhaled nitric oxide (iNO) for the treatment of newborns with Persistent Pulmonary Hypertension (PPHN) did not meet its primary efficacy endpoint. Treatment with IV sildenafil when added to iNO did not result in a statistically significant reduction in treatment failure rate or time on iNO compared to treatment with iNO alone. Sildenafil is not indicated for the treatment of PPHN. The study was part of an EU Pediatric Investigational Plan (PIP).

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6/28/19 10:15am EDT
Pfizer Presents Initial Clinical Data on Phase 1b Gene Therapy Study for Duchenne Muscular Dystrophy (DMD)

Pfizer Inc. (NYSE:PFE) will present initial Phase 1b clinical data on PF-06939926, an investigational gene therapy to potentially treat Duchenne muscular dystrophy (DMD) at the 25th Annual Parent Project Muscular Dystrophy (PPMD) Connect Conference in Orlando, FL. These are preliminary data drawn from a small number of participants in an ongoing study.

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6/28/19 7:33am EDT
Pfizer Receives U.S. FDA Approval for Its Oncology Biosimilar, ZIRABEV™ (bevacizumab-bvzr)

Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration(FDA) has approved ZIRABEV™ (bevacizumab-bvzr), a biosimilar to Avastin® (bevacizumab),1 for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (NSCLC); recurrent glioblastoma; metastatic renal cell carcinoma (RCC); and persistent, recurrent or metastatic cervical cancer.2

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6/27/19 4:17pm EDT
Scott Gottlieb Elected to Pfizer’s Board of Directors

Pfizer Inc. (NYSE:PFE) today announced the election of Dr. Scott Gottlieb to its Board of Directors, effective immediately. Dr. Gottlieb, age 47, was also appointed to the Regulatory and Compliance Committee and the Science and Technology Committee of Pfizer’s Board.

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6/27/19 4:15pm EDT
Pfizer Declares Third-Quarter 2019 Dividend

Board of Directors approves quarterly cash dividend to $0.36 per share

The Board of Directors of Pfizer Inc. today declared a 36-cent third-quarter 2019 dividend on the company’s common stock, payable September 3, 2019, to holders of the Common Stock of record at the close of business on August 2, 2019. Pfizer maintained the dividend from the second-quarter at 36 cents per share. The third-quarter 2019 cash dividend will be the 323rd consecutive quarterly dividend paid by Pfizer.

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6/21/19 10:45am EDT
European Commission Approves TALZENNA® (talazoparib) for Patients with Inherited (Germline) BRCA-Mutated Locally Advanced or Metastatic Breast Cancer

Only once-daily PARP inhibitor approved in Europe for hereditary breast cancer

Pfizer Inc. (NYSE:PFE) today announced that the European Commission approved TALZENNA® (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth factor receptor 2-negative (HER2-) locally advanced (LA) or metastatic breast cancer (MBC). Patients should have been previously treated with an anthracycline and/or a taxane in the (neo)adjuvant, locally advanced or metastatic setting unless patients were not suitable for these treatments. Patients with hormone receptor-positive (HR+) breast cancer should have been treated with a prior endocrine-based therapy, or be considered unsuitable for endocrine-based therapy.1 This approval follows the medicine’s approval by the U.S. Food and Drug Administration (FDA) in October 2018.

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6/18/19 10:00am EDT
Pfizer Invites Public to View and Listen to Webcast of July 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, July 30, 2019. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Second Quarter 2019 Performance Report, to be issued that morning.

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6/17/19 6:45am EDT
Pfizer to Acquire Array BioPharma

—Proposed acquisition strengthens Pfizer’s innovative biopharmaceutical business and is expected to accelerate its growth trajectory particularly in the long term —Opportunity to strengthen category leadership in Oncology with the addition of a breakthrough combination of BRAF/MEK inhibitors under investigation for a potential first-in-class therapy for patients with BRAF-mutant metastatic colorectal cancer —Expands Pfizer’s pipeline with multiple high-potential targeted investigational cancer therapies and adds a large portfolio of royalty-generating out-licensed medicines —Plans to maintain highly productive research unit in Boulder to complement Pfizer’s research hubs —Transaction valued at $48 per Array share in cash, for a total enterprise value of approximately $11.4 billion

NEW YORK & BOULDER, Colo.--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) and Array BioPharma Inc. (NASDAQ: ARRY) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Array, a commercial stage biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need. Pfizer has agreed to acquire Array for $48 per share in cash, for a total enterprise value of approximately $11.4 billion. The Boards of Directors of both companies have approved the merger.

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6/12/19 8:00am EDT
Pfizer Announces Results from XELJANZ® XR (tofacitinib) ORAL Shift Study, The First Phase 3b/4 Study to Evaluate Methotrexate Withdrawal with a JAK Inhibitor

Results to be Presented During a Late-Breaking Oral Session at the Annual European Congress of Rheumatology (EULAR 2019)

Pfizer Inc. (NYSE:PFE) announced today positive results from ORAL Shift, a Phase 3b/4 study in adult patients with moderately to severely active rheumatoid arthritis (RA). Patients who achieved low disease activity (LDA) with XELJANZ® (tofacitinib) extended release (XR) 11 mg once daily (QD) plus methotrexate (MTX) after a 24-week open-label run-in period, were randomized to evaluate the efficacy and safety of XELJANZ XR 11 mg QD as monotherapy after MTX withdrawal compared with XELJANZ XR with continued MTX. The study demonstrated non-inferiority of MTX withdrawal with XELJANZ XR 11 mg QD compared to XELJANZ XR 11 mg QD plus MTX at week 48 as measured by the primary endpoint, the change in the Disease Activity Score (DAS28-4[ESR]) from randomization at week 24 to the end of the double-blind MTX withdrawal phase at week 48. The study results will be presented during a late-breaking oral session at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain (15 June).

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6/5/19 1:30pm EDT
Jeff Settleman, Ph.D., Joins Pfizer to Lead Oncology Research & Development

Pfizer Inc. (NYSE: PFE) announced today that Jeff Settleman, Ph.D., will join the company as Senior Vice President and Group Head of Oncology Research & Development, leading all early oncology research, from discovery to proof of concept clinical studies. Dr. Settleman, a leader in molecularly targeted cancer therapeutics, the epigenetics of cancer drug resistance, and personalized cancer medicine, will report directly to Mikael Dolsten, M.D., Ph.D., Chief Scientific Officer and President of Worldwide Research, Development and Medical at Pfizer, and will be based in La Jolla, California.

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5/24/19 4:00pm EDT
Pfizer Announces Top-Line Results from Phase 3 Trial of LYRICA® (pregabalin) in Primary Generalized Tonic-Clonic Seizures

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today that a Phase 3 study to assess the use of LYRICA® (pregabalin) as adjunctive therapy for epilepsy patients 5 to 65 years of age with primary generalized tonic-clonic (PGTC) seizures did not meet its primary endpoint. Treatment with LYRICA did not result in a statistically significant reduction in seizure frequency versus placebo. Lyrica is not indicated in any population for the treatment of PGTC seizures. The study was a post-marketing commitment to the U.S. Food and Drug Administration (FDA).

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5/15/19 5:01pm EDT
Pfizer Oncology to Showcase New Data from Innovative Science That Address Patient Needs at ASCO 2019 Annual Meeting

Data spans 10 therapies across 10 types of cancer

Pfizer Inc. (NYSE:PFE) will present data across its industry-leading oncology portfolio, covering multiple tumor types and mechanisms of action at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago from May 31-June 4, 2019. Data will highlight Pfizer’s cutting-edge approach, expertise in precision medicine and work in immunotherapy combinations, including company-sponsored and collaborative research studies.

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5/15/19 6:45am EDT
Pfizer Announces Positive Top-Line Results from Phase 3 Study of Investigational Oral JAK1 Candidate, Abrocitinib (PF-04965842), in Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis

Study achieves all co-primary and secondary endpoints

Pfizer Inc. (NYSE: PFE) announced today positive top-line results from a Phase 3 pivotal study (B7451012) evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib (PF-04965842), in patients aged 12 and older with moderate to severe atopic dermatitis (AD).

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