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Recent Pfizer Press Releases

12/7/19 4:00pm EST
Findings Released from Real-World Data Analysis of Eliquis (apixaban) for the Treatment of Venous Thromboembolism in Patients with Active Cancer

Results highlighted in two oral presentations at the American Society of Hematology Annual Meeting

PRINCETON, N.J. & The Bristol-Myers Squibb-Pfizer Alliance today announced results from retrospective real-world data analyses reporting outcomes on the safety and effectiveness of Eliquis® (apixaban) compared to low molecular weight heparin (LMWH) or warfarin for the treatment of venous thromboembolism (VTE) in patients with active cancer (n=14,086). The real-world data analyses were highlighted during oral presentations at the American Society of Hematology (ASH) Annual Meeting in Orlando, Florida. Results from the primary analysis showed that Eliquis use was associated with lower rates of major bleeding (MB) (hazard ratio [HR]: 0.63, 95% confidence interval [CI]: 0.47-0.86, p=0.003), clinically-relevant non-major (CRNM) bleeding (HR: 0.81, 95% CI: 0.70-0.94, p=0.006) and recurrent VTE (HR: 0.61, 95% CI: 0.47-0.81, p=0.001) compared to LMWH. Eliquis was also associated with a lower rate of recurrent VTE (HR: 0.68, 95% CI: 0.52-0.90, p=0.007) and similar rates of major bleeding (HR: 0.73, 95% CI: 0.53-1.0, p=0.051) and CRNM bleeding (HR: 0.89, 95% CI: 0.77-1.04, p=0.145) compared to warfarin. Outcomes were defined based on diagnosis codes and setting of care.

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12/7/19 9:00am EST
Sangamo and Pfizer Announce Updated Phase 1/2 Results Showing Sustained Increased Factor VIII Activity Through 44 Weeks Following SB-525 Gene Therapy Treatment

- The first two patients treated with the 3e13 vg/kg dose achieved stable Factor VIII (FVIII) levels demonstrating durability in the normal range through 44 and 37 weeks, respectively - All five patients in the 3e13 vg/kg dose cohort achieved normal range FVIII levels within 5-7 weeks following treatment, with no bleeding events with up to 44 weeks of follow-up - Lower-dose cohorts indicated durable FVIII activity with up to 52 weeks of follow-up - The Companies have progressed SB-525 into a Phase III registrational program led by Pfizer

BRISBANE, Calif. & Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, and Pfizer, Inc. (NYSE: PFE), today announced updated follow-up results from the Phase 1/2 Alta study evaluating investigational SB-525 gene therapy in patients with severe hemophilia A. The data showed that SB-525 was generally well tolerated and demonstrated sustained increased Factor VIII (FVIII) levels following treatment with SB-525 through to 44 weeks, the extent of follow-up for the longest treated patient in the 3e13 vg/kg dose cohort. Data from 11 patients treated with SB-525 will be featured in a poster presentation today, December 7, 2019, at the 61st Annual Meeting of the American Society of Hematology (ASH) in Orlando, FL. The SB-525 ASH poster, which includes the full set of data, is available on Sangamo’s website in the Investors and Media section under Events and Presentations.

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11/27/19 10:00am EST
Pfizer Invites Public to Listen to Webcast of Pfizer Discussion at Healthcare Conference

Pfizer Inc. invites investors and the general public to listen to a webcast of a discussion with Mikael Dolsten, Chief Scientific Officer and President, Worldwide Research, Development and Medical, and Michael Vincent, Senior Vice President and Chief Scientific Officer, Inflammation and Immunology, at the Evercore ISI 2nd Annual HealthCONx Conference on Wednesday, December 4, 2019 at 10:15 a.m. Eastern Standard Time.

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11/18/19 6:45am EST
FDA Approves Pfizer’s Biosimilar, ABRILADA™ (adalimumab-afzb) for Multiple Inflammatory Conditions

Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved ABRILADA™ (adalimumab-afzb), as a biosimilar to Humira® (adalimumab),1 for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis and plaque psoriasis.2 For full details of indications please see the approved label.

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11/15/19 9:00am EST
Bristol-Myers Squibb and Pfizer Announce Randomized, Controlled Trial to Evaluate the Effect of Atrial Fibrillation Screening on Health Outcomes in Older Individuals

PRINCETON, N.J. & The Bristol-Myers Squibb-Pfizer Alliance today announced the initiation of a new randomized, controlled study, GUARD-AF (ReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals). The study seeks to determine if earlier detection of atrial fibrillation (AFib) through screening in previously undiagnosed men and women at least 70 years of age in the U.S. ultimately impacts the rate of stroke, compared to usual standard medical care. This study will also assess potential bleeding leading to hospitalization, and therefore provide an evaluation of net clinical benefit or harm. AFib is the most common type of significant irregular heart rhythm, and it is estimated that 8 million people in the U.S. will be affected by AFib in 2019.i,ii AFib is a significant risk factor for stroke; stroke risk is up to five times higher in people with AFib than in those without it.iii,iv AFib can often go undetected, as it can be asymptomatic,i and some studies suggest that more than 25 percent of people who have an AFib-related stroke find out they have AFib after a stroke.v

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11/12/19 12:15pm EST
Mylan and Pfizer Announce Viatris as the New Company Name in the Planned Mylan-Upjohn Combination

HERTFORDSHIRE, England & PITTSBURGH & Mylan N.V. (NASDAQ: MYL) and Pfizer Inc. (NYSE: PFE) today announced that the name of the new company to be formed by the planned combination of Mylan and Upjohn, a division of Pfizer, will be Viatris (pronounced ‘viǝ-trīs).

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11/12/19 6:45am EST
Pfizer Announces Results of Phase 3 Study for XELJANZ® (tofacitinib) in Juvenile Idiopathic Arthritis Ahead of Presentation at 2019 American College of Rheumatology/Association of Rheumatology Professionals Annual Meeting

Pfizer Inc. (NYSE: PFE) announced today that positive results from a Phase 3 investigational study of tofacitinib in children and adolescents aged two to less than 18 with juvenile idiopathic arthritis (JIA) will be presented for the first time during a late-breaking oral presentation at the American College of Rheumatology (ACR)/Association of Rheumatology Professionals (ARP) Annual Meeting (November 8-13, Atlanta, GA). The study of tofacitinib in JIA is investigative and JIA is not an FDA-approved indication for XELJANZ. Pfizer has plans to file for the indication in 2020.

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11/8/19 8:30am EST
EMD Serono and Pfizer Provide Update on Phase III JAVELIN Gastric 100 Trial

Not intended for UK-based media

Rockland, MA and New York, US, November 8, 2019 – EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced topline results of the Phase III JAVELIN Gastric 100 study evaluating avelumab as first-line maintenance therapy following induction chemotherapy in patients with unresectable, locally advanced or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) cancer versus continuation of chemotherapy or best supportive care. While the study showed clinical activity for avelumab in this setting, it did not meet the primary endpoints of superior overall survival compared with the standard of care in the overall intent-to-treat population (n=499; HR: 0.91; 95% CI: 0.74, 1.11) or the PD-L1–positive population (n=54; HR: 1.13; 95% CI: 0.57, 2.23).

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10/29/19 6:45am EDT
PFIZER REPORTS THIRD-QUARTER 2019 RESULTS

Third-Quarter 2019 Revenues of $12.7 Billion, Reflecting 3% Operational Decline; Excluding the Impact from Consumer Healthcare(1), Third-Quarter 2019 Revenues were Flat Operationally – 9% Operational Growth from Biopharma (Pfizer RemainCo), Primarily Driven by Ibrance, Xeljanz, Eliquis, Vyndaqel and Inlyta as well as 15% Operational Growth in Emerging Markets – 26% Operational Decline from Upjohn, Primarily Due to U.S. Loss of Exclusivity of Lyrica in July 2019 – Partial Quarter Revenue Contribution for Consumer Healthcare in Third-Quarter 2019, Reflecting the July 31, 2019 Completion of the Consumer Healthcare Joint Venture (JV) Transaction with GlaxoSmithKline plc (GSK)(1) Third-Quarter 2019 Reported Diluted EPS(2) of $1.36, Primarily Driven by a Gain Associated with the Completion of the Consumer Healthcare JV Transaction with GSK(1); Adjusted Diluted EPS(3) of $0.75 Updated Certain 2019 Financial Guidance Ranges – Raised Midpoint of Guidance Range for Revenues by $0.2 Billion Driven by a $0.4 Billion Operational Improvement, Partially Offset by a $0.2 Billion Unfavorable Impact from Recent Changes in Foreign Exchange (FX) Rates – Raised Midpoint of Adjusted Diluted EPS(3) Guidance Range by $0.16, Reflecting an $0.18 Operational Improvement, Partially Offset by a $0.02 Unfavorable Impact from Recent Changes in FX Rates  

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

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10/28/19 4:00pm EST
European Commission Approves BAVENCIO® (avelumab) Plus Axitinib Combination for First-Line Treatment of Patients With Advanced Renal Cell Carcinoma

Not intended for UK-based media

  • EU approval based on JAVELIN Renal 101 trial results demonstrating significant improvement in progression-free survival with BAVENCIO in combination with axitinib compared with sunitinib
  • Combination regimen approved across all IMDC prognostic risk groups and irrespective of PD-L1 expression
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10/21/19 8:00am EST
OPKO and Pfizer Announce Positive Phase 3 Top-Line Results for Somatrogon, an Investigational Long-Acting Human Growth Hormone to Treat Children with Growth Hormone Deficiency

— Results demonstrated potential to reduce current dosing frequency from once-daily to a single weekly injection —

MIAMI and NEW YORK, October 21, 2019 – OPKO Health Inc. (NASDAQ: OPK) and Pfizer Inc. (NYSE: PFE) announced today that the global Phase 3 trial evaluating somatrogon dosed once-weekly in pre-pubertal children with growth hormone deficiency (GHD) met its primary endpoint of non-inferiority to daily GENOTROPIN® (somatropin) for injection, as measured by annual height velocity at 12 months.

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10/17/19 9:00am EST
The Bristol-Myers Squibb-Pfizer Alliance and Fitbit Collaborate to Address Gaps in Atrial Fibrillation Detection with the Aim of Accelerating Diagnosis

Leaders in atrial fibrillation and wearable technology to develop educational content around atrial fibrillation to help identify and support those at increased risk of stroke

PRINCETON, N.J., NEW YORK, N.Y. and SAN FRANCISCO, C.A., October 17, 2019 – The Bristol-Myers Squibb-Pfizer Alliance and Fitbit today announced at the TIME 100 Health Summit in New York

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10/12/19 4:45am EDT
Pfizer Presents Positive Phase 3 Data at the 28th Congress of the European Academy of Dermatology and Venereology for Abrocitinib in Moderate to Severe Atopic Dermatitis

–Abrocitinib met all co-primary and secondary endpoints in JADE MONO-1 study– –Findings follow recent positive top-line results for second abrocitinib Phase 3 pivotal study, JADE MONO-2–

Pfizer Inc. (NYSE: PFE) announced today complete results from a Phase 3, 12-week, pivotal study (JADE MONO-1) in patients aged 12 and older with moderate to severe atopic dermatitis (AD). Abrocitinib, an investigational oral Janus kinase 1 (JAK1) inhibitor, met all the co-primary and key secondary endpoints, which were related to skin clearance and itch relief compared to placebo. Safety data showed that both evaluated doses of abrocitinib (200mg and 100mg) were well tolerated and were consistent with a companion study (JADE MONO-2) from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. The results were shared as a Late-Breaking presentation at the 28th Congress of the European Academy of Dermatology and Venereology (EADV) taking place October 9-13, 2019 in Madrid, Spain.

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10/7/19 6:50am EDT
Akcea and Pfizer Inc. Announce Licensing Agreement for investigative antisense therapy AKCEA-ANGPTL3-LRx

Akcea Therapeutics, Inc. (NASDAQ: AKCA), a majority-owned affiliate of Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) and Pfizer Inc. (NYSE:PFE), today announced that the companies have entered into a worldwide exclusive licensing agreement for AKCEA-ANGPTL3-LRx, an investigational antisense therapy being developed to treat patients with certain cardiovascular and metabolic diseases.

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9/30/19 2:30am EDT
Pfizer Presents Interim Analysis Results from Phase 3 BEACON CRC Trial of BRAFTOVI® (Encorafenib), MEKTOVI® (Binimetinib) and Cetuximab for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer

- Results to be presented during a late-breaking oral session at the 2019 ESMO Congress and simultaneously published in The New England Journal of Medicine – - As previously announced, BRAFTOVI combinations showed statistically significant improvements in OS and ORR versus control –

Pfizer Inc. (NYSE: PFE) today announced detailed results from the interim analysis of the Phase 3 BEACON CRC trial evaluating the combination of BRAFTOVI® (encorafenib), MEKTOVI® (binimetinib), and cetuximab (BRAFTOVI Triplet), in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy. The results show significant improvements in overall survival (OS) and objective response rates (ORR) for the BRAFTOVI Triplet and BRAFTOVI Doublet combination (BRAFTOVI and cetuximab), compared to cetuximab plus irinotecan-containing regimens (Control), and provide analysis of the efficacy and safety of the BRAFTOVI Triplet compared to the BRAFTOVI Doublet. These data will be presented today during a late-breaking oral session at the 2019 European Society for Medical Oncology (ESMO) Congress in Barcelona, Spain, and simultaneously published online in The New England Journal of Medicine (NEJM). Pfizer intends to submit the results of the BEACON CRC trial for marketing approval in the U.S. in the fourth quarter of 2019. The use of BRAFTOVI, MEKTOVI and cetuximab for the treatment of patients with BRAFV600E-mutant mCRC is investigational and not approved by the FDA.

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9/27/19 8:00am EDT
Ian Read to Retire as Executive Chairman of Pfizer’s Board of Directors; Chief Executive Officer Dr. Albert Bourla Named Chairman

Following its regularly scheduled meeting, the Board of Directors of Pfizer Inc. (NYSE:PFE) today announced that Executive Chairman of the Board Ian C. Read has chosen to retire on December 31, 2019, and that it has unanimously elected Pfizer’s Chief Executive Officer (CEO), Dr. Albert Bourla, to succeed him as Chairman of the Board of Directors effective January 1, 2020. Bourla will also retain the CEO role.

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9/27/19 6:45am EDT
Pfizer Announces Positive Top-Line Results from Second Pivotal Phase 3 Study of Investigational Oral JAK1 Candidate, Abrocitinib, in Patients Aged 12 and Older with Moderate to Severe Atopic Dermatitis

–Study achieves all co-primary and key secondary endpoints– –Safety results show both doses of abrocitinib consistent with prior clinical trial experiences–

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) announced today positive top-line results from a second Phase 3 pivotal study evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients aged 12 and older with moderate to severe atopic dermatitis (AD). This is the second monotherapy trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program (B7451013, or JADE MONO-2). Pfizer announced positive top-line results from the first trial in the JADE program (B7451012, or JADE MONO-1) on May 15, 2019. Complete results from JADE MONO-1 will be presented as a late-breaking abstract at a major upcoming European scientific meeting in Madrid in October 2019.

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9/27/19 5:00am EST
New Data for BAVENCIO® (avelumab) for Advanced Cancers to Be Presented at ESMO 2019

Not intended for UK-based media

• Analyses from the Phase III JAVELIN Renal 101 study support efficacy of BAVENCIO plus axitinib across multiple subgroups of patients with advanced renal cell carcinoma (RCC)
• Abstracts highlight data on BAVENCIO as a monotherapy and in combination in multiple advanced cancers

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9/24/19 10:19am EDT
Pfizer Declares Fourth-Quarter 2019 Dividend

Board of Directors approves quarterly cash dividend to $0.36 per share

The Board of Directors of Pfizer Inc. today declared a 36-cent fourth-quarter 2019 dividend on the company’s common stock, payable December 2, 2019, to holders of the Common Stock of record at the close of business on November 8, 2019. Pfizer maintained the dividend from the third-quarter at 36 cents per share. The fourth-quarter 2019 cash dividend will be the 324th consecutive quarterly dividend paid by Pfizer.

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9/24/19 8:00am EDT
Pfizer Presents New Evidence of IBRANCE® (palbociclib) Effectiveness in HR+, HER2- Metastatic Breast Cancer Patients in Four Real-World Studies at ESMO Congress 2019

First-of-its-kind comparative analysis of real-world data in the CDK 4/6 inhibitor class supports benefits of IBRANCE combination therapy initially shown in clinical trials

Pfizer Inc. (NYSE: PFE) today announced the presentation of four IBRANCE® (palbociclib) real-world analyses. The studies support the effectiveness of IBRANCE combination therapy in everyday clinical practice and provide additional insights on its use in certain patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC). The posters will be presented at the European Society for Medical Oncology (ESMO) Congress 2019 in Barcelona, Spain on Sunday, September 29.

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