PFE Pfizer Inc.

33.46
-0.29  -1%
Previous Close 33.75
Open 33.73
52 Week Low 27.88
52 Week High 43.56
Market Cap $185,864,737,409
Shares 5,554,833,754
Float 5,552,768,685
Enterprise Value $229,430,639,197
Volume 19,317,553
Av. Daily Volume 29,485,739
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Upcoming Catalysts

Drug Stage Catalyst Date
BNT162
Coronavirus COVID-19
Phase 2
Phase 2
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GMI-1070 (rivipansel)
Vaso-occlusive crisis of sickle cell disease
Phase 3
Phase 3
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Tanezumab
Osteoarthritis
PDUFA
PDUFA
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PF-06700841
Atopic Dermatitis
Phase 2
Phase 2
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Encorafenib, Binimetinib and Cetuximab (ANCHOR-CRC)
BRAF V600E-mutant Metastatic Colorectal Cancer
Phase 2
Phase 2
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Tofacitinib - Xeljanz
Ankylosing spondylitis
Phase 3
Phase 3
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PF-06826647
Psoriatic Arthritis
Phase 2
Phase 2
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Tanezumab
Cancer pain
Phase 3
Phase 3
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PF-06700841
Psoriasis
Phase 2
Phase 2
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XTANDI (EMBARK)
Non-metastatic high risk hormone-sensitive prostate cancer
Phase 3
Phase 3
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PF-06482077
Pneumococcal Disease
NDA Filing
NDA Filing
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PF-06700841
Psoriatic Arthritis
Phase 2
Phase 2
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IBRANCE (palbociclib) - PENELOPE-B
Early stage breast cancer
Phase 3
Phase 3
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PF-06425090
C. difficile Infection
Phase 3
Phase 3
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PF-06651600 - JAK3
Alopecia areata
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Pneumococcal polysaccharide conjugate vaccine
Pneumococcal Disease
Phase 3
Phase 3
Phase 3 initiation announced June 22, 2020.
Fostemsavir
HIV
Approved
Approved
FDA Approval announced July 2, 2020.
Bavencio (Avelumab) - JAVELIN Bladder 100
Bladder cancer
Approved
Approved
FDA approval announced June 30, 2020.
MenABCWY
Meningococcal vaccine
Phase 3
Phase 3
Phase 3 trial initiation announced June 22, 2020
RSVpreF
Respiratory syncytial virus (RSV) vaccine
Phase 3
Phase 3
Phase 3 trial initiation announced June 22, 2020.
NYVEPRIA
Biosimilar to Neulasta (pegfilgrastim)
Approved
Approved
FDA Approval announced June 11, 2020.
Abrocitinib - JADE Compare
Atopic dermatitis
Phase 3
Phase 3
Phase 3 trial met primary endpoints - June 10, 2020.
ARRY 797
LMNA A/C-related dilated cardiomyopathy (DCM)
Phase 3
Phase 3
Phase 3 trial enrolling - November 2018.
IBRANCE (palbociclib) - PALLAS
Early stage breast cancer
Phase 3
Phase 3
Phase 3 trial unlikely to show a statistically significant improvement in the primary endpoint following futility analysis - May 29, 2020.
PF-06928316
Respiratory syncytial virus
Phase 3
Phase 3
Phase 3 trial planned.
PF-06939926
Duchenne muscular dystrophy (DMD)
Phase 3
Phase 3
Phase 3 trial to be initiated 2H 2020.
FIX Replacement therapy
Hemophilia B
Phase 3
Phase 3
Phase 3 lead-in trial initiation announced July 16, 2018.
Protease inhibitor against SARS-CoV-2
COVID-19 Coronavirus
Phase 1
Phase 1
Clinical trials to commence 3Q 2020.
Encorafenib and cetuximab - BEACON CRC
BRAF-Mutant Colorectal Cancer
Approved
Approved
FDA Approval announced April 8, 2020.
Lorlatinib
ALK+ NSCLC
Approved
Approved
FDA approval announced November 2, 2018.
Abrocitinib - JADE Compare
Atopic Dermatitis
Phase 3
Phase 3
Phase 3 trial met primary endpoints - March 18, 2020.
Avelumab (JAVELIN Head and Neck100)
Head and Neck Cancer
Phase 3
Phase 3
Phase 3 trial terminated - unlikely to show a statistically significant improvement in the primary endpoint of progression-free survival (PFS).
Tanezumab
Chronic low back pain
Phase 3
Phase 3
Phase 3 data released February 19, 2019. 10mg dose met primary endpoint. 5mg dose did not meet endpoint.
Dolutegravir + rilpivirine
HIV
CRL
CRL
Complete Response Letter issued December 21, 2019.
XTANDI (ARCHES)
Metastatic hormone sensitive prostate cancer
Approved
Approved
FDA Approval announced December 16, 2019.
ABRILADA (adalimumab-afzb)
Bosimilar to Humira (adalimumab)
Approved
Approved
FDA Approval announced November 18, 2019.
Tofacitinib
Juvenile idiopathic arthritis (JIA)
Phase 3
Phase 3
Phase 3 trial met primary endpoint.
Avelumab - JAVELIN Gastric 100
Gastric cancer
Phase 3
Phase 3
Phase 3 endpoint not met - November 8, 2019.
Marstacimab (PF-06741086)
Hemophilia A or B
Phase 3
Phase 3
Phase 3 trial to commence in 2020.
Abrocitinib
Atopic Dermatitis
Phase 3
Phase 3
Phase 3 trial met primary and secondary endpoints - September 27, 2019.
Binimetinib - COLUMBUS
BRAF mutant melanoma cancer
Approved
Approved
Approval announced June 27, 2018.
Ruxience (Biosimilar to Rituxan)
CD20-positive, low tumor burden, follicular lymphoma.
Approved
Approved
FDA approval announced July 23, 2019.
Sildenafil and inhaled nitric oxide (iNO)
Persistent Pulmonary Hypertension (PPHN)
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - June 28, 2019.
PF-06439535
Biosimilar bevacizumab
Approved
Approved
FDA Approval announced June 28, 2019.
PF-04965842 - abrocitinib
Moderate-to-severe atopic dermatitis (AD)
Phase 3
Phase 3
Phase 3 data released May 15, 2019 met primary endpoints.
KEYTRUDA and Inlyta - KEYNOTE-426
Renal cell carcinoma
PDUFA priority review
PDUFA priority review
FDA approval announced April 22, 2019.
LYRICA (pregabalin)
Primary generalized tonic-clonic (PGTC) seizures - epilepsy
Phase 3
Phase 3
Phase 3 data released May 24, 2019 did not meet primary endpoint.
BAVENCIO (avelumab) and INLYTA (axitinib)
Renal cell carcinoma (RCC)
Approved
Approved
FDA Approval announced May 14, 2019.
Tafamidis (tafamidis free acid form)
Transthyretin amyloid cardiomyopathy (ATTR-CM)
Approved
Approved
FDA Approval announced May 6, 2019.
Tafamidis
Transthyretin amyloid cardiomyopathy (ATTR-CM)
Approved
Approved
FDA approval announced May 6, 2019.
IBRANCE (palbociclib)
HR+/HER2- advanced breast cancer in men
Approved
Approved
FDA approval of sNDA announced April 4, 2019.
PF-05280014 TRAZIMERA
Herceptin biosimilar
Approved
Approved
FDA Approval March 11, 2019.
Avelumab - JAVELIN Ovarian 100
Ovarian cancer
Phase 3
Phase 3
Phase 3 trial to be terminated due to lack of efficacy.
Glasdegib
Acute myeloid leukemia (AML)
Approved
Approved
FDA approval announced November 21, 2018.
Talazoparib
BRCA-mutated breast cancer
Approved
Approved
FDA Approval announced October 16, 2018.
Dacomitinib
Non-small cell lung cancer (NSCLC)
Approved
Approved
FDA Approval announced September 27, 2018.
Inotuzumab Ozogamicin
Relapsed or Refractory Acute Lymphoblastic Leukemia in Adults
Approved
Approved
Approval announced August 17, 2017.
Domagrozumab
Duchenne muscular dystrophy (DMD)
Phase 2
Phase 2
Phase 2 development terminated due to lack of efficacy.
XTANDI (PROSPER)
Non-metastatic high risk hormone-sensitive prostate cancer
Approved
Approved
FDA approval announced July 13, 2018.
IBRANCE - PALOMA-3
Breast cancer
Phase 3
Phase 3
Phase 3 overall survival secondary endpoint not met - June 25, 2018. PFS primary endpoint met (announced previously).
IBRANCE (palbociclib)
Head and neck squamous cell carcinoma
Phase 3
Phase 3
Phase 3 presentation at ASCO June 2018.
Xeljanz
Ulcerative colitis
Approved
Approved
Approval announced May 30, 2018.
Avelumab
Urothelial Carcinoma
Approved
Approved
Approval announced May 9, 2017.
INLYTA (axitinib)
Recurrent renal cell carcinoma (RCC)
Phase 3
Phase 3
Phase 3 trial discontinued due to futility.
XTANDI
Cancer - mCRPC who have not received chemotherapy
Approved
Approved
Approved Sept 10 2014
IBRANCE (palbociclib)
HR+, HER2- Metastatic Breast Cancer
Approved
Approved
sNDA acceptance announced December 21, 2016. Approval announced March 31, 2017.
Avelumab
Metastatic Merkel cell carcinoma
Approved
Approved
Priority review announced November 29, 2016. Approval announced March 23, 2017.
BOSULIF (BOSUTINIB)
First-Line Treatment of Philadelphia Chromosome Positive Chronic Myeloid Leukemia
Approved
Approved
Approval announced December 19, 2017.
Ertugliflozin
Type 2 diabetes
Approved
Approved
Approval announced December 20, 2017.
Xeljanz
Psoriatic arthritis
Phase 3
Phase 3
Approval announced December 14, 2017.
XTANDI (ENDEAR)
Triple negative breast cancer
Phase 3
Phase 3
Phase 3 trial terminated - noted May 17, 2017.
Sutent (Sunitinib)
Renal cell carcinoma (RCC)
Approved
Approved
Approval announced 16 November, 2017.
LYRICA (pregabalin)
Pediatric Epilepsy
Phase 3
Phase 3
Phase 3 trial met primary endpoint - December 2016.
Epoetin alfa biosimilar
CRL
CRL
CRL issued June 22, 2017.
Mylotarg (gemtuzumab ozogamicin)
Acute myeloid leukemia (AML)
Approved
Approved
Approval announced September 1, 2017.
XALKORI (crizotinib)
ALK-positive advanced non-small cell lung cancer(NSCLC)
Phase 3
Phase 3
Phase 3 data presented at ESMO 2017 - Overall survial HR=0.760 (p=0.09)
Staphylococcus aureus vaccine
PDUFA
PDUFA
Advisory Committee Meeting held November 7, 2017. No votes cast.
LYRICA (pregabalin)
Postherpetic neuralgia (PHN)
Approved
Approved
Approval announced October 12, 2017.
Avelumab
Gastric cancer
Phase 3
Phase 3
Phase 3 data released November 28, 2017 - primary endpoint not met.
IXIFI
Remicade (infliximab) biosimilar
Approved
Approved
Approval announced December 13, 2017.
Yescarta (Axicabtagene Ciloleucel) and Utomilumab (PF-05082566)
Large B-Cell Lymphoma
Phase 1/2
Phase 1/2
Phase 1/2 trial to be initiated in 2018.

Latest News

    • Funding to Support Development of New Antibiotics as Part of Broader Industry Effort
    • New Partnership with More than 20 Other Companies Will Focus on Medicines that Address Most Resistant Bacteria and Life-Threatening Infections
    • Builds on Pfizer's longstanding work to address the global burden of infectious diseases

    Pfizer Inc. (NYSE:PFE) announced today it has pledged $100 million to the new Antimicrobial Resistance (AMR) Action Fund, which launched today, to help address the significant global public health need for new antibiotics due to the rapid rise of antibiotic-resistant infections.

    The AMR Action Fund is a ground-breaking collaboration among more than 20 biopharmaceutical companies that aims to bring 2-4 new antibiotics to patients…

    • Funding to Support Development of New Antibiotics as Part of Broader Industry Effort
    • New Partnership with More than 20 Other Companies Will Focus on Medicines that Address Most Resistant Bacteria and Life-Threatening Infections
    • Builds on Pfizer's longstanding work to address the global burden of infectious diseases

    Pfizer Inc. (NYSE:PFE) announced today it has pledged $100 million to the new Antimicrobial Resistance (AMR) Action Fund, which launched today, to help address the significant global public health need for new antibiotics due to the rapid rise of antibiotic-resistant infections.

    The AMR Action Fund is a ground-breaking collaboration among more than 20 biopharmaceutical companies that aims to bring 2-4 new antibiotics to patients by 2030 through collaboration between pharmaceutical companies, philanthropies, development banks, and multilateral organizations to re-invigorate and accelerate antibiotic development.

    "As the COVID-19 pandemic has shown, we must invest in the development of medicines now so that we are prepared to help prevent the next public health crisis," said Pfizer Chairman and Chief Executive Albert Bourla. "We strongly believe the world cannot tackle the growing threat of AMR without collaboration – and that it will take a combination of prevention measures, responsible stewardship and innovative thinking to overcome existing obstacles. The new AMR Action Fund gives us the vehicle to do that by investing in and stimulating a potentially stronger pipeline for antimicrobial medicines."

    Each year 700,000 people die from AMR. By 2050, it is estimated that AMR could claim as many as 10 million lives per year. To combat AMR, antibiotics should only be used when necessary to preserve their effectiveness.

    While antibiotics revolutionized medicine in the 20th century and, together with vaccination, have led to the near eradication of many diseases in the developed world, over time, bacteria change and adapt to the use of antibiotics, rendering them ineffective. This makes it more difficult to treat common infections such as pneumonia, tuberculosis and salmonellosis, leading to longer hospital stays, higher medical costs and increased mortality.

    Pfizer takes a multi-pronged approach to tackling AMR. We are a leading developer of vaccines that help prevent infections in the first place, reducing the need for antibiotics that may result in resistant strains. We are also one of the few large research-based pharmaceutical companies still active in research and development for anti-infectives, and work with partners to close critical prevention and treatment gaps in infectious disease around the globe. In addition, we are committed to responsible antibiotic stewardship, and are proud to offer one of the largest and most accessible AMR surveillance programs in the world, called ATLAS – the only platform that provides public access to both antifungal and antibacterial resistance data through a single resource. ATLAS is accessible freely to anyone, anywhere via the Web or the ATLAS mobile application.

    Pfizer's commitment to the AMR Action Fund builds on our long-standing work fighting infectious diseases and reducing health disparities for patients in the United States and globally. In partnership with organizations around the world, Pfizer is redefining the way we fight infectious diseases by creating meaningful and sustainable solutions that address today's biggest health challenges and protect the world's most vulnerable people.

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    DISCLOSURE NOTICE: The information contained in this release is as of July 9, 2020. The Company assumes no obligation to update forward-looking statements contained in this release as a result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's pledge to the new Antimicrobial Resistance (AMR) Action Fund to help address the significant global public health need for new antibiotics due to the rapid rise of antibiotic-resistant infections, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties related to the effectiveness of the AMR Action Fund, the uncertainties inherent in research and development; the uncertainties inherent in business and financial planning, including, without limitation, risks related to Pfizer's business and prospects, adverse developments in Pfizer's markets, or adverse developments in the U.S. or global capital markets, credit markets, regulatory environment or economies generally; the impact of COVID-19 on our business, operations and financial results; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results," as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    View Full Article Hide Full Article
  1. Final data analysis from HPTN 083 study at AIDS 2020 shows investigational, long-acting injectable cabotegravir administered every two months is 66% more effective than daily pills in preventing HIV-1 acquisition

    ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that data presented from the HIV Prevention Trials Network (HPTN) 083 study demonstrated the superior efficacy of investigational, long-acting, injectable cabotegravir administered every two months when compared to daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF) tablets for HIV prevention.

    HPTN 083 is a Phase IIb/III randomised, multicentre, double-blind…

    Final data analysis from HPTN 083 study at AIDS 2020 shows investigational, long-acting injectable cabotegravir administered every two months is 66% more effective than daily pills in preventing HIV-1 acquisition

    ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that data presented from the HIV Prevention Trials Network (HPTN) 083 study demonstrated the superior efficacy of investigational, long-acting, injectable cabotegravir administered every two months when compared to daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg (FTC/TDF) tablets for HIV prevention.

    HPTN 083 is a Phase IIb/III randomised, multicentre, double-blind, clinical trial that is evaluating the safety and efficacy of long-acting, injectable cabotegravir for HIV pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) and transgender women who have sex with men. The blinded phase of the study was stopped early in May 2020 following a pre-planned independent Data and Safety Monitoring Board review, which showed that long-acting cabotegravir was highly effective at preventing HIV in the study population. Final analysis has since confirmed the superiority of long-acting cabotegravir, which was 66% more effective at preventing HIV when compared to daily oral FTC/TDF tablets. Study results were announced today at a press conference at the virtual 23rd International AIDS Conference (AIDS 2020) and will be presented at the conference on 8 July.

    Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: "These data are truly ground-breaking, demonstrating that long-acting injectable cabotegravir dosed every two months is superior to daily oral FTC/TDF at preventing HIV in at-risk men and transgender women who have sex with men. This advancement has the potential to be a game-changer for HIV prevention, offering an option with very high rates of effectiveness and the convenience of reduced dosing from daily to just six times per year. We are thrilled with the results not only because of the high effectiveness of cabotegravir but also because this study adequately represents some of the populations most disproportionately impacted by HIV -- black MSM in the US, young MSM globally and transgender women."

    In the final data analysis, 52 documented cases of HIV were observed in the HPTN 083 trial, with 13 cases occurring in the long-acting cabotegravir arm and 39 cases occurring in the daily, oral FTC/TDF arm. This translated to an HIV incidence rate of 0.41% in the cabotegravir group (95% confidence interval [CI] 0.22%-0.69%) and 1.22% in the FTC/TDF group (95% CI 0.87%-1.67%). Preliminary assessment of adherence to oral FTC/TDF was high, based on a random subset of 372 FTC/TDF participants that measured any detectable (> 0.31 ng/ml) tenofovir in 87% of participants and concentrations consistent with daily dosing levels (> 40 ng/ml) in 75% of all samples tested. Despite this high level of adherence to oral therapy, long-acting cabotegravir demonstrated superiority in the primary efficacy endpoint of documented HIV incident infections, and was 66% (95% CI 38%-82%) more effective than FTC/TDF in preventing HIV acquisition in the study population.

    Long-acting cabotegravir and FTC/TDF tablets were both well tolerated throughout the study, with most adverse events being mild or moderate in nature and balanced between both treatment arms. Injection site reactions, pyrexia, and hypertension were more common in the cabotegravir arm while nausea was more common in the FTC/TDF arm. Most participants in the cabotegravir group (80%) reported pain or tenderness at the injection site, compared to 31% of those in the FTC/TDF arm, who received placebo injections. Discontinuation due to injection site reactions or injection intolerance in the cabotegravir arm of the study was 2.2% and there were no discontinuations due to ISRs in the FTC/TDF arm.

    The HPTN 083 study enrolled HIV-negative men and transgender women who have sex with men, participants considered at increased risk for HIV acquisition. Two-thirds of study participants were under 30 years of age (median age of 26 years), and 12% were transgender women (n=567). Half of the participants in the United States identified as Black or African American (n=844).

    Myron S. Cohen, M.D., Co-Principal Investigator of the HPTN and the Yeargan-Bate Distinguished Professor of Medicine, Microbiology and Immunology and Epidemiology at the University of North Carolina (UNC) at Chapel Hill, said: "Medicines that help prevent new HIV incidence are essential to our ongoing global fight to end the HIV epidemic. It's exciting to discover that with injectable, long-acting cabotegravir, we now have compelling clinical evidence of another effective PrEP option that could play a critical role in helping to reduce HIV transmission that will ultimately save lives."

    HPTN 083 was jointly funded by the U.S. NIAID, part of the NIH, and ViiV Healthcare, and was conducted by the HPTN. Study product was provided by ViiV Healthcare and Gilead Sciences.

    In addition to the findings of HPTN 083, an additional study evaluating the safety and efficacy of long-acting cabotegravir for HIV prevention is being conducted in sexually active women (HPTN 084). To date, more than 3,000 sexually active women in seven African countries have enrolled in HPTN 084, which is co-funded by NIAID, ViiV Healthcare and the Bill & Melinda Gates Foundation.

    ViiV Healthcare plans to use the data from HPTN 083 for future regulatory submissions. Cabotegravir has not yet been approved for the treatment or prevention of HIV as a single agent by regulatory authorities anywhere in the world.

    About HPTN 083 (NCT02720094)

    The HPTN 083 study is a phase IIb/III double-blind study designed to evaluate the safety and efficacy of long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg). Each participant was to receive a maximum of three years of blinded study medication. The study opened to enrolment in November 2016. HPTN 083 was conducted in approximately 4,566 men who have sex with men and transgender women who have sex with men at research centres in Argentina, Brazil, Peru, United States, South Africa, Thailand and Vietnam.

    For further information on HPTN 083 please visit https://clinicaltrials.gov/ct2/show/NCT02720094.

    About HIV Prevention Trials Network (HPTN)

    The HIV Prevention Trials Network (HPTN) is a worldwide collaborative clinical trials network that brings together investigators, ethicists, community members and other partners to develop and test the safety and efficacy of interventions designed to prevent the acquisition and transmission of HIV. The National Institutes of Health (NIH), the National Institute of Mental Health (NIMH) and the National Institute on Drug Abuse (NIDA) co-fund the HPTN. The HPTN has collaborated with more than 85 clinical research sites in 19 countries to evaluate new HIV prevention interventions and strategies in populations that bear a disproportionate burden of infection. The HPTN research agenda – more than 50 trials ongoing or completed with over 161,000 participants enrolled and evaluated – is focused primarily on the use of antiretroviral drugs (antiretroviral therapy and pre-exposure prophylaxis); and integrated strategies including interventions for substance abuse, particularly injection drug use; behavioural risk reduction interventions and structural interventions. For more information, visit hptn.org.

    About ViiV Healthcare

    ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE:PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV.

    For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.

    About GSK

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us.

    Cautionary statement regarding forward-looking statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and any impacts of the COVID-19 pandemic.

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  2. Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), today announced that it has raised $15m (£12m) in equity investment. The round was led by existing investor Pfizer Ventures, the venture capital arm of Pfizer Inc. ("Pfizer")(NYSE:PFE).

    Mission and Pfizer Inc. have also expanded their relationship by entering into an evaluation and option agreement for DUB target validation.

    Fund raising

    Pfizer Ventures has been an investor in Mission Therapeutics since 2013. Today it made a further equity investment into the Company, contributing a super pro rata amount. All other existing investors within Mission joined the round on a pro rata basis. No further…

    Mission Therapeutics ("Mission"), a drug discovery and development company focused on selectively inhibiting deubiquitylating enzymes (DUBs), today announced that it has raised $15m (£12m) in equity investment. The round was led by existing investor Pfizer Ventures, the venture capital arm of Pfizer Inc. ("Pfizer")(NYSE:PFE).

    Mission and Pfizer Inc. have also expanded their relationship by entering into an evaluation and option agreement for DUB target validation.

    Fund raising

    Pfizer Ventures has been an investor in Mission Therapeutics since 2013. Today it made a further equity investment into the Company, contributing a super pro rata amount. All other existing investors within Mission joined the round on a pro rata basis. No further financial details have been disclosed.

    The new capital will support development of Mission's world-leading DUB platform, as well as growth of its pipeline of DUB inhibitor programmes.

    Expansion of Pfizer collaboration

    DUBs have attracted significant interest as potential drug targets. Playing an integral role in protein homeostasis, this large family of enzymes is involved in diverse cellular processes and many disease pathologies.

    Under the terms of the evaluation and option agreement, Pfizer will access specific DUB inhibitors from Mission's platform and test these compounds in phenotypic screens to validate promising drug targets. Pfizer will then have the option to negotiate target exclusivity for each of the DUBs of interest.

    The agreement does not include any of Mission's own lead DUB programs, such as USP30.

    Commenting on the agreement, Dr. Denis Patrick, Managing Partner of Pfizer Ventures and Member of Mission's Board of Directors, said:

    "Since our initial investment in Mission seven years ago, the company has grown tremendously and the depth of its scientific expertise and capability has grown alongside it. We are proud to expand our relationship with the company and our scientists are looking forward to a successful collaboration in this important area of research."

    Dr. Anker Lundemose, CEO of Mission Therapeutics added:

    "We are pleased to expand our relationship with Pfizer, one of the world's premier biopharmaceutical companies. We have benefitted from the valuable contributions of Dr. Denis Patrick as a member of our Board of Directors and we look forward to working with the wider Pfizer team."

    - ENDS -

    NOTES TO EDITORS:

    About Mission Therapeutics

    Mission Therapeutics is an early-stage drug development company targeting the ubiquitin pathway for the treatment of kidney disease, neurodegenerative disease, rare mitochondrial diseases and fibrosis. The Company has built a leading platform for the discovery and development of first-in-class, small molecule drugs that selectively target deubiquitylating enzymes (DUBs) – an emerging drug class that is attracting significant commercial interest in the area of protein homeostasis.

    Mission has strong links with key academic and research centers, including Prof. Steve Jackson's Cancer Research UK Laboratories at the University of Cambridge Gurdon Institute, and leading UK centres in neurodegenerative diseases. The Company also has secured major industry partnerships, including its collaboration with AbbVie in November 2018, for the research and preclinical development of specified DUB inhibitors for the treatment of Alzheimer's Disease and Parkinson's Disease. The Company is managed by a team with broad international, commercial and clinical-science experience.

    To date the Company has received £73 million / $101 million in funding. Its investors comprise blue chip institutional and corporate investors including: Pfizer Ventures, Sofinnova Partners, Roche Venture Fund, SR One, IP Group and Schroders Adveq. Mission Therapeutics was founded in 2011 and is based at the Babraham Research Campus, Cambridge, UK.

    For more information, please visit our website, www.missiontherapeutics.com, or follow us on Twitter or LinkedIn.

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  3. In a phase III study, a majority (60%) of heavily treatment-experienced adults randomized to receive Rukobia with an optimized background therapy achieved and maintained viral suppression through 96 weeks, addressing a critical unmet need

    ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, who are failing…

    In a phase III study, a majority (60%) of heavily treatment-experienced adults randomized to receive Rukobia with an optimized background therapy achieved and maintained viral suppression through 96 weeks, addressing a critical unmet need

    ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) has approved Rukobia (fostemsavir), 600 mg extended-release tablets. Rukobia is a novel attachment inhibitor for the treatment of HIV-1 infection indicated for use in combination with other antiretroviral (ARV) therapies in heavily treatment-experienced (HTE) adults with multidrug-resistant HIV-1 infection, who are failing their current ARV regimen due to resistance, intolerance or safety considerations.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200702005580/en/

    Rukobia Product Shot (Photo: Business Wire)

    Rukobia Product Shot (Photo: Business Wire)

    Significant advances over the past few decades have dramatically improved HIV treatment and for many, HIV is considered a manageable life-long condition. However, HTE adults – which account for approximately 6% of adults living with HIV who are on treatment – have little to no options left due to resistance, tolerability or safety considerations.1 HTE adults are at risk of progressing to AIDS and death and in great need of additional therapies.

    Deborah Waterhouse, CEO of ViiV Healthcare, said: "There is a small group of heavily treatment-experienced adults living with HIV who are not able to maintain viral suppression with currently available medication and, without effective new options, are at great risk of progressing to AIDS. The approval of Rukobia is a culmination of incredibly complex research, development, and manufacturing efforts to ensure we leave no person living with HIV behind."

    The approval was supported by data from the phase III BRIGHTE study, which evaluated the safety and efficacy of Rukobia in combination with optimized background therapy (OBT) in HTE adults living with multidrug-resistant HIV, many of whom had advanced HIV disease at study entry. In the randomized cohort, 60% (n=163/272) of individuals who received Rukobia in addition to an investigator-selected OBT achieved undetectable HIV viral load and clinically meaningful improvements to CD4+ T-cell count through Week 96.

    The proportion of participants who discontinued treatment with Rukobia due to an adverse event was 7% at Week 96 (randomized: 5% and nonrandomized: 12%). The most common adverse reactions (all grades) observed in ≥5% of randomized and nonrandomized participants were nausea, fatigue and diarrhea. The most common adverse events leading to discontinuation were related to infections (3%). Serious drug reactions occurred in 3% of people taking Rukobia and included three cases of severe immune reconstitution inflammatory syndrome.2

    Jacob P. Lalezari, M.D., Chief Executive Officer and Director of Quest Clinical Research, said: "As a novel HIV attachment inhibitor, fostemsavir targets the first step of the viral lifecycle offering a new mechanism of action to treat people living with HIV. In the BRIGHTE study, fostemsavir in combination with other ARVs effectively achieved and maintained long-term viral suppression and demonstrated clinically meaningful rise in CD4+ T-cell count even among heavily immunocompromised patients. These are exciting advances for the HTE population and an advancement the HIV community has long been waiting for. As an activist as well as researcher, I am very grateful to ViiV Healthcare for their commitment to heavily-treatment experienced people living with HIV."

    Rukobia was reviewed and approved under the FDA's Fast Track and Breakthrough Therapy Designations which are intended to facilitate and expedite the development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition.

    Gabriel Maldonado, Founder and CEO, TruEvolution, Inc., said: "Some members of the HIV community face very challenging treatment journeys and do not respond to available therapies for a variety of reasons. The approval of fostemsavir provides a sense of renewed hope for these adults who have few or no viable treatment options left and have been awaiting alternative medicines to control the virus."

    Fostemsavir is currently under review by the European Medicines Agency and additional submissions to regulatory authorities around the world are planned throughout 2020 and 2021.

    About BRIGHTE

    The BRIGHTE trial is an international, phase III, partially-randomized, double-blind, placebo-controlled study conducted in 371 HTE adults living with HIV-1 infection with multidrug resistance. All trial participants were required to have a viral load ≥400 copies/mL and ≤2 classes of antiretroviral medications remaining at baseline due to resistance, intolerability, contraindication, or other safety considerations. Trial participants were enrolled in either a randomized or nonrandomized cohort defined as follows:

    • Within the randomized cohort (n = 272), participants had 1, but no more than 2, fully active and available antiretroviral agent(s) at screening which could be combined as part of an efficacious background regimen. Randomized participants received either blinded fostemsavir 600 mg twice daily (n = 203) or placebo (n = 69) in addition to their current failing regimen for 8 days of functional monotherapy. Beyond Day 8, randomized participants received open-label fostemsavir 600 mg twice daily plus an investigator-selected optimized background therapy (OBT).
    • Within the nonrandomized cohort (n = 99), participants had no fully active and approved antiretroviral agent(s) available at screening. Nonrandomized participants were treated with open-label fostemsavir 600 mg twice daily plus OBT from Day 1 onward. The use of an investigational drug(s) as a component of the optimised background therapy was permitted in the nonrandomized cohort.

    The primary endpoint analysis, based on the adjusted mean decline in HIV-1 RNA from Day 1 at Day 8 in the randomized cohort, demonstrated superiority of fostemsavir to placebo (0.79 vs. 0.17 log10 copies/mL decline, respectively; P<0.0001, Intent-to-Treat-Exposed [ITT-E] population). In the randomized cohort, HIV-1 RNA <40 copies/mL was achieved in 53% and 60% of subjects at Weeks 24 and 96, respectively (ITT-E, Snapshot algorithm). Mean changes in CD4+ cell count from baseline continued to increase over time (i.e., 90 cells/mm3 at Week 24 and 205 cells/mm3 at Week 96). The most common adverse reaction (all grades) observed in ≥5% of participants were nausea. The proportion of participants who discontinued treatment with fostemsavir due to an adverse event was 7% at Week 96 (randomized: 5% and nonrandomized: 12%). In the nonrandomized cohort, HIV-1 RNA <40 copies/mL was achieved in 37% of subjects at Weeks 24 and 96. At these timepoints, the proportion of subjects with HIV-1 RNA <200 copies/mL was 42% and 39%, respectively (ITT-E, Snapshot algorithm). Mean changes in CD4+ cell count from baseline increased over time: 41 cells/mm3 at Week 24 and 119 cells/mm3 at Week 96. The most common adverse reactions reported in nonrandomized subjects were fatigue (7%), nausea (6%), and diarrhea (6%).

    About Rukobia

    The active ingredient in Rukobia is fostemsavir. Fostemsavir is a first-in-class HIV-1 attachment inhibitor. After oral administration, fostemsavir is converted to temsavir, which is then absorbed and exerts antiviral activity by attaching directly to the glycoprotein 120 (gp120) subunit on the surface of the virus, thereby blocking HIV from attaching to host immune system CD4+ T-cells and preventing the virus from infecting those cells and multiplying. As Rukobia is the first antiretroviral therapy to target this step of the viral cycle, there is no demonstrated resistance to other classes of antiretrovirals, which may help patients who have become resistant to most other medicines.

    Important Safety Information (ISI)

    The following ISI is based on the Highlights section of the Prescribing Information for RUKOBIA. Please consult the full Prescribing Information for all the labeled safety information for RUKOBIA.

    INDICATIONS AND USAGE

    • RUKOBIA, a human immunodeficiency virus type 1 (HIV-1) gp120-directed attachment inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.

    DOSAGE AND ADMINISTRATION

    • One tablet taken twice daily with or without food.

    DOSAGE FORMS AND STRENGTHS

    • Extended-release tablets: 600 mg

    CONTRAINDICATIONS

    • Hypersensitivity to fostemsavir or any of the components of the formulation.
    • Coadministration with strong cytochrome P450 (CYP)3A inducers as significant decreases in temsavir plasma concentrations may occur, which may result in loss of virologic response.

    WARNINGS AND PRECAUTIONS

    • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapies.
    • QTc prolongation: Use RUKOBIA with caution in patients with a history of QTc prolongation or with relevant pre-existing cardiac disease or who are taking drugs with a known risk of Torsade de Pointes.
    • Elevations in hepatic transaminases in patients with hepatitis B or C virus co-infection: Elevations in hepatic transaminases were observed in a greater proportion of subjects with HBV and/or HCV co-infection compared with those with HIV mono-infection.
    • Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions: The concomitant use of RUKOBIA and certain other drugs may result in known or potentially significant drug interactions, some of which may lead to 1) Loss of therapeutic effect of RUKOBIA and possible development of resistance due to reduced exposure of temsavir 2) Possible prolongation of QTc interval from increased exposure to temsavir.

    ADVERSE REACTIONS

    • The most common adverse reactions (all grades) observed in ≥5% of randomized and non-randomized participants were nausea, fatigue and diarrhea.

    DRUG INTERACTIONS

    • See full prescribing information for complete list of significant drug interactions.
    • Doses of oral contraceptives should not contain more than 30 mcg of ethinyl estradiol per day.

    USE IN SPECIFIC POPULATIONS

    • Lactation: Breastfeeding is not recommended due to the potential for HIV-1 transmission.

    About ViiV Healthcare

    ViiV Healthcare is a global specialist HIV company established in November 2009 by GlaxoSmithKline (LSE: GSK) and Pfizer (NYSE:PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of becoming infected with HIV. Shionogi joined in October 2012. The company's aim is to take a deeper and broader interest in HIV/AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline and commitment, please visit www.viivhealthcare.com.

    About ViiV Healthcare's Patient Support Program

    ViiV Healthcare is committed to providing assistance to eligible people living with HIV who need our medicines. ViiV Healthcare's centralised service, ViiV Connect, provides comprehensive information on access and coverage to help patients get their prescribed ViiV Healthcare medicines whether they are insured, underinsured or uninsured. ViiV Connect provides one-on-one support from dedicated access coordinators, as well as having an integrated website, one site with many resources, including a portal. For more information on ViiV Connect, visit www.viivconnect.com.

    About GSK

    GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com/about-us/.

    Cautionary statement regarding forward-looking statements

    GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D "Risk Factors" in the company's Annual Report on Form 20-F for 2019 and any impacts of the COVID19 pandemic.

    _________________________

    1 Hsu R, et al. Identifying Heavily Treatment-Experienced Patients in the OPERA Cohort. 22nd International AIDS Conference; July 23–27, 2018; Amsterdam, the Netherlands. Poster THPEB044.

    2 Rukobia (fostemsavir) Prescribing Information. US Approval 2020.

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    • In an ongoing U.S. Phase 1/2 placebo-controlled, observer-blinded clinical trial, nucleoside-modified messenger RNA vaccine candidate (BNT162b1) expressing the SARS-CoV-2 receptor binding domain (RBD) is being evaluated in 45 subjects
    • At day 28 (7 days after dose 2), all subjects who received 10 or 30 mg of BNT162b1 had significantly elevated RBD-binding IgG antibodies with geometric mean concentrations (GMCs) of 4,813 and 27,872 units/ml which are 8- and 46.3-times, respectively, the GMC of 602 units/ml in a panel of 38 sera of convalescent patients who had contracted SARS-CoV-2
    • At day 28 (7 days after dose 2), all subjects who received 10 or 30 mg of BNT162b1 had SARS-CoV-2 neutralizing antibodies with geometric mean titers (GMTs) of
    • In an ongoing U.S. Phase 1/2 placebo-controlled, observer-blinded clinical trial, nucleoside-modified messenger RNA vaccine candidate (BNT162b1) expressing the SARS-CoV-2 receptor binding domain (RBD) is being evaluated in 45 subjects
    • At day 28 (7 days after dose 2), all subjects who received 10 or 30 mg of BNT162b1 had significantly elevated RBD-binding IgG antibodies with geometric mean concentrations (GMCs) of 4,813 and 27,872 units/ml which are 8- and 46.3-times, respectively, the GMC of 602 units/ml in a panel of 38 sera of convalescent patients who had contracted SARS-CoV-2
    • At day 28 (7 days after dose 2), all subjects who received 10 or 30 mg of BNT162b1 had SARS-CoV-2 neutralizing antibodies with geometric mean titers (GMTs) of 168 and 267, which are 1.8- and 2.8-times, respectively, the GMT of the convalescent serum panel
    • Local reactions and systemic events after immunization with 10 µg and 30 µg of BNT162b1 were dose-dependent, generally mild to moderate, and transient. No serious adverse events were reported
    • Further data from the ongoing Phase 1/2 clinical trial of four vaccine candidates will enable selection of a lead candidate and dose level for a large, global Phase 2b/3 safety and efficacy study that may begin as early as July 2020
    • Efforts to manufacture the leading candidates, at risk, are gearing up. In case the safety and efficacy study is successful, and the vaccine receives regulatory approval, the companies are expecting to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021

    Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) today announced preliminary data from the most advanced of four investigational vaccine candidates from their BNT162 mRNA-based vaccine program, Project Lightspeed, against SARS-CoV-2, the virus causing the current global pandemic. The BNT162 program is evaluating at least four experimental vaccines, each of which represents a unique combination of mRNA format and target antigen. The manuscript describing the preliminary clinical data for the nucleoside-modified messenger RNA (modRNA) candidate, BNT162b1, which encodes an optimized SARS-CoV-2 receptor binding domain (RBD) antigen, is available on an online preprint server at https://www.medrxiv.org/content/10.1101/2020.06.30.20142570v1 and is concurrently undergoing scientific peer-review for potential publication. Overall, the preliminary data demonstrated that BNT162b1 could be administered in a dose that was well tolerated and generated dose dependent immunogenicity, as measured by RBD-binding IgG concentrations and SARS-CoV-2 neutralizing antibody titers.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200701005576/en/

    "We are encouraged by the clinical data of BNT162b1, one of four mRNA constructs we are evaluating clinically, and for which we have positive, preliminary, topline findings," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. "We are dedicated to develop potentially groundbreaking vaccines and medicines, and in the face of this global health crisis, we approach this goal with the utmost urgency. We look forward to publishing our clinical data in a peer-reviewed journal as quickly as possible."

    "These preliminary data are encouraging in that they provide an initial signal that BNT162b1 targeting the RBD SARS-CoV-2 is able to produce neutralizing antibody responses in humans at or above the levels observed in convalescent sera – and that it does so at relatively low dose levels. We look forward to providing further data updates on BNT162b1," said Ugur Sahin, M.D., CEO and Co-founder of BioNTech.

    The ongoing U.S. Phase 1/2 randomized, placebo-controlled, observer-blinded study is evaluating the safety, tolerability, and immunogenicity of escalating dose levels of BNT162b1. The initial part of the study included 45 healthy adults 18 to 55 years of age. Preliminary data for BNT162b1 was evaluated for 24 subjects who received two injections of 10 µg and 30 µg, 12 subjects who received a single injection of 100 µg, and 9 subjects who received 2 doses of placebo control.

    The participants received two doses, 21 days apart, of placebo, 10 µg or 30 µg of BNT162b1, or received a single dose of 100 µg of the vaccine candidate. Because of a strong vaccine booster effect, the highest neutralizing titers were observed seven days after the second dose of 10 µg or 30 µg on day 28 after vaccination. The neutralizing GMTs were 168 and 267 for the 10 µg and 30 µg dose levels, respectively, corresponding to 1.8- and 2.8-times the neutralizing GMT of 94 observed in a panel of 38 sera from subjects who had contracted SARS-CoV-2.

    In all 24 subjects who received 2 vaccinations at 10 µg and 30 µg dose levels of BNT162b1, elevation of RBD-binding IgG concentrations was observed after the second injection with respective GMCs of 4,813 and 27,872 units/ml at day 28, seven days after immunization. These concentrations are 8- and 46.3-times the GMC of 602 units/ml in a panel of 38 sera from subjects who had contracted SARS-CoV-2.

    At day 21 after a single injection, the 12 subjects who received 100 µg of BNT162b1 had an RBD-binding IgG GMC of 1,778 units/ml and a SARS-CoV neutralizing GMT of 33, which are 3-times and 0.35-times, respectively, the GMC and GMT of the convalescent serum panel.

    At the 10 µg or 30 µg dose levels, adverse reactions, including low grade fever, were more common after the second dose than the first dose. Following dose 2, 8.3% of participants who received 10 µg and 75.0% of participants who received 30 µg BNT162b1 reported fever ≥ 38.0 °C. Local reactions and systemic events after injection with 10 µg and 30 µg of BNT162b1 were dose-dependent, generally mild to moderate, and transient. The most commonly reported local reaction was injection site pain, which was mild to moderate, except in one of 12 subjects who received a 100 µg dose, which was severe. No serious adverse events were reported. Given higher numbers of subjects experiencing local reactions and systemic events after a single 100 µg dose with no significant increases in immunogenicity compared to the 30 µg dose level, the 12 participants in the 100 µg group were not administered a second dose.

    These preliminary data, together with additional preclinical and clinical data being generated, will be used by the two companies to determine a dose level and select among multiple vaccine candidates to seek to progress to a large, global Phase 2b/3 safety and efficacy trial. That trial may involve up to 30,000 healthy participants and is anticipated to begin in late July 2020, if regulatory approval to proceed is received. The preliminary clinical data from this ongoing study have been submitted for potential publication in a peer-reviewed journal and is available on an online preprint manuscript server.

    The BNT162b1 candidate remains under clinical study and is not currently approved for distribution anywhere in the world. If the ongoing studies are successful and the vaccine candidate receives regulatory approval, the companies expect to manufacture up to 100 million doses by the end of 2020 and potentially more than 1.2 billion doses by the end of 2021. In that event, BioNTech and Pfizer would work jointly to distribute the potential COVID-19 vaccine worldwide (excluding China, where BioNTech has a collaboration with Fosun Pharma for BNT162 for both clinical development and commercialization). The development of the vaccine is also supported by partners like Acuitas Therapeutics. The Canadian company provides lipid nanoparticles (LNP) for the formulation of various mRNA vaccines.

    Pfizer Conference Call and Webcast Information

    Pfizer Inc. invites investors and the general public to view and listen to a webcast of a conference call with investment analysts at 2 p.m. EDT today, Wednesday, July 1, 2020.

    To view and listen to the webcast, visit our web site at www.pfizer.com/investors. Participants are advised to pre-register in advance of the conference call.

    You can also listen to the conference call by dialing either (866) 669-8582 in the United States and Canada or (702) 495-1304 outside of the United States and Canada. The password is "PFIZER 2020".

    BioNTech Conference Call and Webcast Information

    BioNTech SE will host a conference call and webcast today at 11:00 a.m. EDT (5:00 p.m. CET) to review the Phase 1/2 clinical results for BNT162.

    To participate in the conference call, please dial the following numbers 10-15 minutes prior to the start of the call and provide the Conference ID: 7176269.

    United States international:

    +1 646 741 3167

    United States domestic (toll-free):

    +1 877 870 9135

    Germany:

    +49 692 2222 625

    Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company's website at https://biontech.de/. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call.

    About Pfizer: Breakthroughs That Change Patients' Lives

    At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

    Pfizer Disclosure Notice

    The information contained in this release is as of July 1, 2020. Pfizer assumes no obligation to update information or forward-looking statements contained in this release as the result of new information or future events or developments.

    This release contains forward-looking information about Pfizer's efforts to combat COVID-19, the BNT162 mRNA vaccine program, and a collaboration between BioNTech and Pfizer to develop a potential COVID-19 vaccine, including their potential benefits, and anticipated publication of data, manufacturing and distribution and the expected timing of clinical trials, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new preclinical or clinical trial data and further analyses of existing preclinical or clinical trial data; risks associated with preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether the scientific journal publications referenced above will occur and, if so, when and with what modifications; whether regulatory authorities will be satisfied with the design of and results from these and future preclinical and clinical studies; whether and when any biologics license applications may be filed in any jurisdictions for any potential vaccine candidates under the collaboration; whether and when any such applications may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such vaccine candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of any such vaccine candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; including whether the estimated numbers of doses can be manufactured within the projected time periods indicated; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities regarding any such vaccine candidates and uncertainties regarding the commercial impact of any such recommendations; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results," as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

    About BioNTech

    Biopharmaceutical New Technologies is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor T cells, bi-specific checkpoint immuno-modulators, targeted cancer antibodies and small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Genmab, Sanofi, Bayer Animal Health, Genentech, a member of the Roche Group, Genevant, Fosun Pharma, and Pfizer. For more information, please visit www.BioNTech.de.

    BioNTech Forward-looking statements

    This press release contains "forward-looking statements" of BioNTech within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, but may not be limited to, statements concerning: BioNTech's efforts to combat COVID-19; the timing to initiate clinical trials of BNT162 and anticipated publication of data from these clinical trials; collaborations between BioNTech and Pfizer, and BioNTech and Fosun Pharma, to develop a potential COVID-19 vaccine; and the ability of BioNTech to supply the quantities of BNT162 to support clinical development and, if approved, market demand. Any forward-looking statements in this press release are based on BioNTech current expectations and beliefs of future events, and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: competition to create a vaccine for Covid-19 and potential difficulties. For a discussion of these and other risks and uncertainties, see BioNTech's Annual Report on Form 20-F filed with the SEC on March 31, 2020, which is available on the SEC's website at www.sec.gov. All information in this press release is as of the date of the release, and BioNTech undertakes no duty to update this information unless required by law.

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