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Recent Pfizer Press Releases

2/18/20 6:45am EST
European Commission Approves VYNDAQEL®, the First Treatment in the EU for Transthyretin Amyloid Cardiomyopathy (ATTR-CM)

—VYNDAQEL is the only EC-approved medicine proven to reduce mortality and frequency of cardiovascular-related hospitalizations in adults with wild-type or hereditary ATTR-CM— —VYNDAQEL is the first approved medicine in the EU to treat both ATTR-CM and stage 1 symptomatic transthyretin amyloid polyneuropathy (ATTR-PN)—

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.

2/11/20 7:50am EST
XTANDI® (enzalutamide) Demonstrates Significant Improvement in Overall Survival in Phase 3 PROSPER Trial of Patients with nmCRPC

TOKYO and NEW YORK, February 11, 2020 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pfizer Inc. (NYSE: PFE) announced today results of the final overall survival (OS) analysis from the Phase 3 PROSPER trial, which evaluated XTANDI® (enzalutamide) plus androgen deprivation therapy (ADT) versus placebo plus ADT in men with non-metastatic castration-resistant prostate cancer (nmCRPC).

1/31/20 9:00am EST
Pfizer Receives Positive CHMP Opinion for Oncology Biosimilar, RUXIENCE™ (rituximab)

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.

1/28/20 6:45am EST

PROVIDES 2020 FINANCIAL GUIDANCE  Full-Year 2019 Revenues of $51.8 Billion, Reflecting 1% Operational Decline; Excluding the Impact from Consumer Healthcare(1), Revenues Increased 2% Operationally – 8% Operational Growth from Biopharma, Primarily Driven by Ibrance, Eliquis, Xeljanz and Vyndaqel as well as 14% Operational Growth in Emerging Markets – 16% Operational Decline from Upjohn, Primarily Due to U.S. Loss of Exclusivity of Lyrica in 2019 Fourth-Quarter 2019 Revenues of $12.7 Billion, Reflecting 8% Operational Decline; Excluding the Impact from Consumer Healthcare(1), Revenues Declined 1% Operationally – 9% Operational Growth from Biopharma; 32% Operational Decline from Upjohn Full-Year 2019 Reported Diluted EPS(2) of $2.87, Adjusted Diluted EPS(3) of $2.95; Fourth-Quarter 2019 Reported LPS(2) of $0.06, Adjusted Diluted EPS(3) of $0.55 Provides Full-Year 2020 Financial Guidance for Total Company(4), New Pfizer(5) and Upjohn(6) – Total Company(4) Revenue Guidance of $48.5 to $50.5 Billion, Adjusted Diluted EPS(3) of $2.82 to $2.92 (Assumes Full-Year 2020 Contribution from Biopharma and Upjohn and No 2020 Share Repurchases) – Midpoint of New Pfizer(5) Revenue Guidance Range Implies 8% Operational Growth Compared to 2019  

Pfizer Inc. (NYSE: PFE) reported financial results for fourth-quarter and full-year 2019 and provided 2020 financial guidance.

1/23/20 10:00am EST
Pfizer Vaccines Launches Global Centers of Excellence Network to Conduct Real-World Research on Vaccine-Preventable Diseases Affecting Adults

University of Louisville Named First Center of Excellence

Pfizer Inc. (NYSE: PFE) announced today the launch of its Vaccines Division’s Centers of Excellence Network, a global program of collaborations with academic institutions to conduct real-world epidemiologic research to accurately identify and measure the burden of specific vaccine-preventable diseases and potentially evaluate vaccine effectiveness affecting adults. Pfizer Vaccines has designated the University of Louisville as its first Center of Excellence with a second global center anticipated in the first half of 2020.

1/23/20 6:45am EST
Pfizer’s Greenstone and Digital Men’s Health Clinic Roman Collaborate to Offer Patients Remote Access to the Only FDA-Approved Authorized Generic Version of Viagra® (sildenafil citrate)

Agreement provides Roman members with erectile dysfunction treatment backed by Pfizer’s quality manufacturing standards and supply chain excellence

PEAPACK, N.J. & NEW YORK--(BUSINESS WIRE)--Greenstone, Upjohn’s U.S.-based generics business and a wholly owned subsidiary of Pfizer Inc., and Roman, an innovative digital healthcare clinic for men, today announced a supply agreement to offer Roman members access to the only FDA-approved authorized generic version of Viagra (sildenafil citrate). A division of the direct-to-patient telehealth company Ro, Roman provides patients access to a nationwide digital doctor’s office and online pharmacy for certain men’s health conditions through an integrated platform to enhance the convenience and quality of healthcare delivery. Greenstone has been a leader in authorized generics for more than 25 years and manufactures sildenafil citrate, a prescription medicine used to treat erectile dysfunction (ED). The exclusive supply agreement with Roman represents Greenstone’s first collaboration with a direct-to-patient telehealth company.

1/7/20 10:00am EST
Pfizer Invites Public to Listen to Webcast of Pfizer Discussion at Healthcare Conference

Pfizer Inc. (NYSE: PFE) invites investors and the general public to listen to a webcast of a discussion with Albert Bourla, Chairman and Chief Executive Officer, at the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 at 3:30 p.m. Pacific Standard Time.

1/6/20 9:00am EST
BAVENCIO Significantly Improved Overall Survival in Patients With Locally Advanced or Metastatic Urothelial Carcinoma

Rockland, MA and New York, US, January 6, 2020 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced the Phase III JAVELIN Bladder 100 study met its primary endpoint of overall survival (OS) at the planned interim analysis. In this study, patients with previously untreated locally advanced or metastatic urothelial carcinoma (UC) whose disease did not progress on induction chemotherapy and who were randomized to receive first-line maintenance therapy with BAVENCIO® (avelumab)* and best supportive care (BSC) lived significantly longer than those who received BSC only. A statistically significant improvement in OS was demonstrated in the BAVENCIO arm in each of the co-primary populations: all randomized patients and patients with PD-L1–positive tumors. The safety profile for BAVENCIO in the trial was consistent with that in the JAVELIN monotherapy clinical development program. The results of the study will be submitted for presentation at an upcoming medical congress and shared with the US Food and Drug Administration (FDA) and other health authorities.