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pfizer inc (PFE) Key Developments

Bristol-Myers Squibb Company and Pfizer Announce Positive Results from Anticoagulant Study

Bristol-Myers Squibb Company and Pfizer Inc. have announced results from a human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates, or PCCs, in healthy subjects. The study results demonstrated that both PCCs, Sanquin's Cofact (a heparin-free formulation) and CSL Behring's Beriplex P/N (a formulation containing heparin) reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential (ETP). Eliquis is a novel oral anticoagulant that specifically inhibits Factor Xa. This study evaluated the effect of two non-activated 4-factor PCCs, Cofact and Beriplex P/N, on Eliquis pharmacodynamics and pharmacokinetics in healthy subjects. Cofact and Beriplex P/N are used to stop severe bleeding in patients taking vitamin K antagonists, such as warfarin, or with a blood clotting factor deficiency. Currently there are no approved reversal agents for Eliquis or other direct Factor Xa inhibitors. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects (mean age 33+7 years). Within each period, subjects received Eliquis 10 mg twice daily. On day four (after steady-state was achieved), three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. The mean Eliquis pharmacokinetic profiles were consistent across all treatment groups and were not affected by PCC administration. Following completion of the 30-minute Cofact infusion, the effect of Eliquis on ETP was significantly reduced compared to placebo (p 0.05). Mean ETP was comparable to the day four Eliquis pre-dose value (steady-state trough Eliquis concentration) at the end of the Cofact infusion and 30 minutes after completing the Beriplex P/N infusion. Mean ETP was within the baseline value (Eliquis naive) within 5.5 hours after completing the infusion for both PCCs. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.

Pfizer Inc.(NYSE:PFE) dropped from S&P 500 Growth Index

Pfizer Inc.(NYSE:PFE) dropped from S&P 500 Growth Index

Pfizer Inc. Announces Presentation of Early- and Late-Stage Data from Clinical Studies

Pfizer Inc. announced the presentation of encouraging early- and late-stage data from clinical studies across several hematologic malignancies, including acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML). Among the highlights are results from several investigator-led, large, randomized studies evaluating the antibody-drug conjugate (ADC) MYLOTARG (gemtuzumab ozogamicin) in select adult AML populations. Oral and poster presentations focused on the efficacy of MYLOTARG in previously untreated patients with AML. Two oral presentations included: AML-19 (abstract #619 [1]): This investigator-led, randomized, Phase 3 study (N=237) found that MYLOTARG significantly improved overall survival (OS) in elderly patients with AML not considered fit for intensive chemotherapy, compared to best supportive care (BSC). The study was conducted by the European Organization for the Research and Treatment of Cancer (EORTC) and Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) leukemia groups.

Spark Therapeutics Announces Gene Therapy Collaboration in Hemophilia B with Pfizer Inc

Spark Therapeutics announced that it has entered into a global collaboration with Pfizer Inc. for the development and potential commercialization of SPK-FIX, a development program advancing proprietary, bio-engineered adeno-associated virus (AAV) vectors for the potential treatment of hemophilia B. The companies will work together on a worldwide basis with the aim of bringing an important investigational therapy to patients. Hemophilia B is a rare genetic blood disorder that affects approximately 4,000 males in the U.S. and 26,000 males worldwide. Current treatment requires recurrent intravenous infusions of either plasma-derived or recombinant Factor IX to control bleeding episodes. Spark's proprietary, bioengineered vectors are designed to deliver a high-activity Factor IX gene to patients, enabling endogenous production of Factor IX, with the potential to be effective for a number of years. This program leverages a long track record of hemophilia B gene therapy research and clinical development conducted by Spark and its founding scientific team over the past two decades. Under the terms of the agreement, Spark will receive an upfront payment of $20 million and will be eligible for additional development and commercialization milestone payments of up to $260 million for multiple hemophilia B product candidates that may be developed under the collaboration. Spark will be responsible for conducting all Phase 1/2 studies while Pfizer will assume responsibility for pivotal studies, any regulatory approvals and potential global commercialization of the product. Spark is entitled to receive double-digit royalties based on global product sales.

iTeos Therapeutics SA Announces License and Collaboration with Pfizer Inc. for Discovery and Development of Cancer Immunosuppression Targets

iTeos Therapeutics SA announced a strategic collaboration with Pfizer Inc. pursuant to which iTeos will license to Pfizer rights to iTeos' pre-clinical compounds targeting Indoleamine 2,3-dioxygenase (IDO1) and Tryptophan 2,3-dioxygenase (TDO2). Pfizer will be responsible for the development and commercialization of IDO1 and TDO2 drug candidates. Additionally, the parties will collaborate to discover and validate new targets that play key roles in the ability of tumors to evade immune responses. These new targets will be shared by iTeos and Pfizer for further independent or collaborative development. iTeos will receive from Pfizer an up-front payment of EUR 24 million, plus an equity investment, licensing fees and collaborative funding. Further, iTeos will be eligible to earn potential milestone payments from Pfizer based on the achievement of specific development, regulatory and commercial milestones across the IDO1 and TDO2 programs, in addition to royalties on sales. iTeos also has the opportunity to earn additional milestone and royalty payments for any of the new target programs that are advanced by Pfizer.


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