Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) and Pfizer Inc. (NYSE:PFE), today announced that the companies have entered into a worldwide exclusive licensing agreement for AKCEA-ANGPTL3-LRx, an investigational antisense therapy being developed to treat patients with certain cardiovascular and metabolic diseases.
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Pfizer Inc. (NYSE: PFE) today announced detailed results from the interim analysis of the Phase 3 BEACON CRC trial evaluating the combination of BRAFTOVI? (encorafenib), MEKTOVI? (binimetinib), and cetuximab (BRAFTOVI Triplet), in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy. The results show significant improvements in overall survival (OS) and objective response rates (ORR) for the BRAFTOVI Triplet and BRAFTOVI Doublet combination (BRAFTOVI and cetuximab), compared to cetuximab plus irinotecan-containing regimens (Control), and provide analysis of the efficacy and safety of the BRAFTOVI Triplet compared to the BRAFTOVI Doublet. These data will be presented today during a late-breaking oral session at the 2019 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, and simultaneously published online in The New England Journal of Medicine (NEJM). Pfizer intends to submit the results of the BEACON CRC trial for marketing approval in the U.S. in the fourth quarter of 2019. The use of BRAFTOVI, MEKTOVI and cetuximab for the treatment of patients with BRAFV600E-mutant mCRC is investigational and not approved by the FDA.
Following its regularly scheduled meeting, the Board of Directors of Pfizer Inc. (NYSE:PFE) today announced that Executive Chairman of the Board Ian C. Read has chosen to retire on December 31, 2019, and that it has unanimously elected Pfizer’s Chief Executive Officer (CEO), Dr. Albert Bourla, to succeed him as Chairman of the Board of Directors effective January 1, 2020. Bourla will also retain the CEO role.
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today positive top-line results from a second Phase 3 pivotal study evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients aged 12 and older with moderate to severe atopic dermatitis (AD). This is the second monotherapy trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program (B7451013, or JADE MONO-2). Pfizer announced positive top-line results from the first trial in the JADE program (B7451012, or JADE MONO-1) on May 15, 2019. Complete results from JADE MONO-1 will be presented as a late-breaking abstract at a major upcoming European scientific meeting in Madrid in October 2019.
• Analyses from the Phase III JAVELIN Renal 101 study support efficacy of BAVENCIO plus axitinib across multiple subgroups of patients with advanced renal cell carcinoma (RCC)
• Abstracts highlight data on BAVENCIO as a monotherapy and in combination in multiple advanced cancers
The Board of Directors of Pfizer Inc. today declared a 36-cent fourth-quarter 2019 dividend on the company’s common stock, payable December 2, 2019, to holders of the Common Stock of record at the close of business on November 8, 2019. Pfizer maintained the dividend from the third-quarter at 36 cents per share. The fourth-quarter 2019 cash dividend will be the 324th consecutive quarterly dividend paid by Pfizer.
Pfizer Inc. (NYSE: PFE) today announced the presentation of four IBRANCE? (palbociclib) real-world analyses. The studies support the effectiveness of IBRANCE combination therapy in everyday clinical practice and provide additional insights on its use in certain patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). The posters will be presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain on Sunday, September 29.
Pfizer Inc. (NYSE: PFE) and Flatiron Health today announced an expanded strategic collaboration to further integrate and increase the use of real-world data in Pfizer’s development of innovative targeted cancer medicines.
Rockland, MA and New York, US, September 20, 2019 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of BAVENCIO® (avelumab) in combination with axitinib for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) is presenting data across its industry-leading oncology portfolio, including company-sponsored and collaborative research studies, spanning 11 therapies in 22 types of cancer, at the European Society for Medical Oncology (ESMO) Congress to be held in Barcelona, Spain, September 27 - October 1, 2019. Data from nearly 50 abstracts involving Pfizer cancer medicines will illustrate the diversity of the portfolio and the company’s cutting-edge scientific approach. For the first time, this will include data presentations on compounds from the acquisition of Array Biopharma Inc.
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, October 29, 2019. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s Third Quarter 2019 Performance Report, to be issued that morning.
Pfizer Inc. (NYSE: PFE) announced today positive preliminary results following administration of three doses in a four-dose series for a Proof-of-Concept Phase 2 study (B7471003) to assess safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and otitis media caused by Streptococcus pneumoniae serotypes contained in the vaccine in healthy infants. Pfizer’s 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) plus seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).
Pfizer Inc. invites investors and the general public to listen to a webcast of a discussion with Frank D’Amelio, Chief Financial Officer and Executive Vice President, Global Supply and Business Operations, at the Morgan Stanley 17th Annual Global Healthcare Conference on Monday, September 9, 2019 at 3:40 p.m. Eastern Daylight Time.
TOKYO & Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the filing of a supplemental New Drug Application (sNDA) for XTANDI? (enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC). The application has also been granted Priority Review, a designation given to those applications for drugs that, if approved, may offer significant improvements in the safety or effectiveness of the treatment, diagnosis or prevention of serious conditions when compared to standard applications. XTANDI is currently indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC).
Pfizer announced today an additional half billion dollar investment for the construction of its state-of-the-art gene therapy manufacturing facility in Sanford, North Carolina. This facility is anticipated to support Pfizer’s continuing investment in gene therapy research and development, similar to Pfizer’s Chapel Hill and Kit Creek, North Carolina research and development sites. This facility would expand the company’s presence in North Carolina, where there are currently more than 3,600 Pfizer colleagues, including 650 in Sanford. The expanded facility is projected to add approximately 300 new jobs.
Globally, infectious diseases are responsible for an estimated 8.4 million deaths annually and are a leading cause of death worldwide, particularly among young children and marginalized populations in underserved communities,1 often perpetuating the cycle of poverty. It is estimated that the rise of AMR, which occurs when pathogens evolve to withstand the effect of even the most effective medicines, now accounts for approximately 700,000 of these deaths.2 Without action, this number could reach ten million deaths per year by 2050,2 and could cost the world an estimated US $100 trillion in lost productivity in the same amount of time.3 The World Health Organization (WHO) included AMR in its list of ten threats to global health in 2019.4
Pfizer Inc. (NYSE:PFE) announced today that the Phase 3 Rivipansel (GMI-1070): Evaluating Safety, Efficacy and Time to Discharge (RESET) pivotal study did not meet its primary or key secondary efficacy endpoints. The objective of the trial was to evaluate the efficacy and safety of rivipansel in patients aged six and older with sickle cell disease (SCD) who were hospitalized for a vaso-occlusive crisis (VOC) and required treatment with intravenous (IV) opioids. The primary endpoint was time to readiness-for-discharge and the key secondary efficacy endpoints were time-to-discharge, cumulative IV opioid consumption, and time to discontinuation of IV opioids.
Pfizer Inc. (NYSE: PFE) today announced the closing of its joint venture with GlaxoSmithKline plc (NYSE: GSK) to combine the parties’ respective consumer healthcare businesses to create the world’s largest over-the-counter (OTC) business with robust iconic brands. As previously announced, under the terms of the transaction, Pfizer owns a 32% equity stake in the joint venture and GSK owns 68%. The combined business, which will operate globally as GSK Consumer Healthcare, will be led by CEO Brian McNamara.
Pfizer Inc. (NYSE:PFE) today announced the successful completion of its acquisition of Array BioPharma Inc., advancing breakthrough science for the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need.
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.
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.