Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for EUCRISA^® (crisaborole) ointment, 2%, extending the lower age limit from 24 months down to 3 months in children with mild-to-moderate atopic dermatitis (AD), also known as eczema.¹ EUCRISA was previously approved for use in adults and children 2 years of age and older.² This supplemental approval makes EUCRISA the first and only steroid-free, topical prescription medication for mild-to-moderate AD patients as young as 3 months of age.

Pfizer Inc. (NYSE:PFE) today announced top-line results from one of its Phase 3 studies (NCT03760146), which evaluated the safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate in adults 18 years of age or older not previously vaccinated against pneumococcal disease. The primary immunogenicity objectives of non-inferiority for the 20 serotypes included in 20vPnC in adults 60 years of age and older at one month after vaccination were met for all serotypes in common with licensed Prevnar 13® (pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) and six of the seven additional serotypes when compared to a licensed pneumococcal polysaccharide vaccine (PPSV23); one of the new seven serotypes missed noninferiority criteria by a small margin.¹ Secondary immunogenicity objectives for adults 18-59 years old compared to those 60-64 years old met non-inferiority for all 20 serotypes. The safety objectives were met in adults 18 years of age or older demonstrating that the safety and tolerability of 20vPnC were comparable to licensed pneumococcal vaccines. Based on prior discussions with regulators, these data are expected to meet licensure criteria.

Pfizer Inc. (NYSE:PFE) 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, April 28, 2020. The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s First Quarter 2020 Performance Report, to be issued that morning.

Pfizer today issued a five-point plan calling on the biopharmaceutical industry to join the company in committing to unprecedented collaboration to combat COVID-19.

Pfizer Inc. (NYSE: PFE) today announced the election of Dr. Susan Hockfield to its Board of Directors, effective immediately. Dr. Hockfield, age 68, was also appointed to the Regulatory and Compliance Committee and the Science and Technology Committee of Pfizer’s Board.

Pfizer Inc. (NYSE: PFE) today announced the election of James Quincey to its Board of Directors, effective immediately. Mr. Quincey, age 55, was also appointed to the Compensation Committee and the Science and Technology Committee of Pfizer’s Board.

HERTFORDSHIRE, England, PITTSBURGH & Mylan N.V. (NASDAQ: MYL) and Pfizer Inc. (NYSE: PFE) today announced the remaining appointees to the inaugural 13-member Board of Directors for Viatris, the new company that will result from the combination of Mylan and Upjohn, a division of Pfizer, which is expected to occur in mid-2020, subject to receipt of regulatory approvals, Mylan shareholder approval, and the satisfaction of other customary closing conditions. In addition to the previously announced Pfizer-designated appointments of Ian Read and Jim Kilts, Pfizer has appointed current Pfizer board member W. Don Cornwell, who will resign from the Pfizer board to serve as a director of Viatris upon the close of the transaction. Additionally, Mylan has appointed eight of its own directors to serve on the Viatris Board of Directors, including JoEllen Lyons Dillon, Neil Dimick, Melina Higgins, Harry A. Korman, Rajiv Malik, Richard A. Mark, Mark W. Parrish and Pauline van der Meer Mohr. As previously announced, the Board of Directors of Viatris will also include Viatris Executive Chairman Robert J. Coury and Viatris CEO Michael Goettler.

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has approved VYNDAQEL^® (tafamidis), a once-daily 61 mg oral capsule, for the treatment of wild-type or hereditary transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). VYNDAQEL is the first and only treatment approved in the European Union (EU) for patients with ATTR-CM. Prior to this approval, treatment options for patients with ATTR-CM were restricted to symptom management, and, in rare cases, heart (or heart and liver) transplant.

Pfizer Inc. (NYSE: PFE) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending marketing authorization for RUXIENCE™ (rituximab),¹ a potential biosimilar to MabThera® (rituximab).^2,3 RUXIENCE is a monoclonal antibody (mAb) for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).¹ The CHMP’s opinion will now be reviewed by the European Commission, with a regulatory decision anticipated in the first half of 2020.