Pfizer Inc. reports developments across its global biopharmaceutical business, including prescription medicines, vaccines, biosimilars, sterile injectables, and oncology therapies. Recurring news covers financial results and guidance, commercial portfolio changes within Biopharma, dividend declarations, capital allocation priorities, and product access initiatives for established medicines such as Eliquis.
Company updates also address clinical and regulatory activity across Pfizer's pipeline and marketed products. Recent themes include oncology data presentations, Phase 3 results for ELREXFIO in relapsed or refractory multiple myeloma, PADCEV combination regulatory activity in bladder cancer, VYNDAMAX patent litigation settlements, and shareholder meeting communications.
The CARISEL study revealed that the long-acting regimen of cabotegravir and rilpivirine was successfully implemented across various European healthcare settings. Conducted by ViiV Healthcare, the study showed high acceptability, appropriateness, and feasibility among clinical staff and people living with HIV. At 12 months, 87% of participants maintained viral suppression while 81% felt the regimen was less stigmatizing than daily treatments. Staff identified and overcame initial implementation barriers, further endorsing this innovative treatment approach.
Pfizer Inc. (NYSE: PFE) is set to present diverse data from its infectious disease portfolio at IDWeek 2022, focusing on the efficacy and safety of its bivalent RSVpreF vaccine for older adults, alongside findings on PAXLOVID™ for COVID-19 treatment. A late-breaking presentation will detail results from the Phase 3 clinical trial of RSVpreF on October 20, 2022. The company aims to demonstrate its commitment to addressing critical health challenges posed by infectious diseases. Presentations will span a range of topics, showcasing investigational vaccines and therapies.
Pfizer and BioNTech have announced encouraging early results from a Phase 2/3 clinical trial of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine. Following a 30-µg booster dose, participants exhibited a significant increase in neutralizing antibodies against the Omicron BA.4/BA.5 variants. Both younger and older adults demonstrated similar responses. Notably, the bivalent vaccine is expected to outperform the original vaccine in providing protection against these variants. The vaccine was well tolerated, with safety profiles resembling that of the original formulation. Additional data is forthcoming.
Pfizer and BioNTech announced that the FDA granted Emergency Use Authorization (EUA) for a 10-µg booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for children aged 5 to 11. The CDC's recommendation is pending before shipping. This booster aims to enhance protection as Omicron subvariants dominate U.S. cases. A clinical trial is underway for younger children. The companies have also applied for regulatory approvals in Europe and plan global submissions. Eligible residents will receive vaccines for free under U.S. government provisions.
Pfizer (NYSE: PFE) has successfully completed the acquisition of Global Blood Therapeutics (GBT) for $68.50 per share, totaling approximately $5.4 billion. This strategic move enhances Pfizer's commitment to addressing the needs of the sickle cell disease (SCD) community, with GBT's portfolio including the first-in-class drug Oxbryta® (voxelotor). Pfizer aims to innovate and expedite treatments for SCD, which affects millions globally, particularly among underserved populations. GBT's assets also include promising investigational therapies, with FDA designations in place.
Pfizer (NYSE: PFE) announced positive results from its Phase 3 TALAPRO-2 study of TALZENNA (talazoparib) combined with XTANDI (enzalutamide) for men with metastatic castration-resistant prostate cancer (mCRPC), achieving the primary endpoint of radiographic progression-free survival (rPFS) with a hazard ratio of 0.696. Consistent efficacy was noted irrespective of homologous recombination repair gene mutations. While a trend towards improved overall survival was observed, it needs further analysis. Safety profiles were generally consistent with known data, paving the way for potential regulatory discussions.
Pfizer has completed its acquisition of Biohaven Pharmaceutical for $11.6 billion, paying $148.50 per share. This acquisition adds the innovative migraine therapy NURTEC® ODT and a portfolio of CGRP receptor antagonists, including rimegepant and zavegepant, to Pfizer's pipeline. These drugs aim to serve over 1 billion migraine patients globally. The merger enhances Pfizer's Internal Medicine portfolio with strong growth potential through 2030 and beyond. Biohaven became a wholly-owned subsidiary, while Biohaven Ltd. retained non-CGRP assets and will continue trading under the ticker BHVN.
Pfizer (PFE) and BioNTech (BNTX) announced the submission of a request to the FDA for Emergency Use Authorization of a 10-µg booster dose of their bivalent COVID-19 vaccine targeting the Omicron BA.4/BA.5 variant for children aged 5-11. This request is backed by safety and immunogenicity data. Additionally, a Phase 1/2/3 study has been initiated to evaluate the vaccine's safety and immune response among children aged 6 months to 11 years. The companies also plan to submit a marketing authorization application to the EMA for the same age group.
Pfizer Inc. (NYSE: PFE) has declared a $0.40 cash dividend for Q4 2022, marking the 336th consecutive quarterly dividend payment. The dividend will be payable on December 5, 2022, to shareholders on record as of November 4, 2022. This announcement highlights the company's ongoing commitment to return value to its shareholders.
Pfizer (NYSE: PFE) has announced an agreement to supply up to six million treatment courses of its COVID-19 oral treatment, PAXLOVID™, to the Global Fund for low-and-middle-income countries. These treatment courses will be available for procurement in 132 eligible countries beginning in 2022, pending regulatory approval. The agreement is part of Pfizer's strategy for equitable access to COVID-19 treatments. Additionally, Pfizer has established tiered pricing for different income classifications and signed prior agreements with UNICEF and the Medicines Patent Pool to enhance global access.