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