1. Pfizer Inc. (NYSE:PFE) and OPKO Health, Inc. (NASDAQ:OPK) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for somatrogon. Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Pfizer is evaluating the FDA's comments and will work with the agency to determine an appropriate path forward.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220121005474/en/

    "We remain confident in the potential treatment benefits that somatrogon has to offer patients around the world," said Brenda…

    Pfizer Inc. (NYSE:PFE) and OPKO Health, Inc. (NASDAQ:OPK) announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for somatrogon. Somatrogon is an investigational once-weekly long-acting recombinant human growth hormone for the treatment of growth hormone deficiency (GHD) in pediatric patients. Pfizer is evaluating the FDA's comments and will work with the agency to determine an appropriate path forward.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220121005474/en/

    "We remain confident in the potential treatment benefits that somatrogon has to offer patients around the world," said Brenda Cooperstone, MD, Chief Development Officer, Rare Disease, Pfizer Global Product Development. "We will work closely with the FDA to determine the best path forward to bring this important once-weekly treatment option to pediatric growth hormone deficiency patients and their families."

    Regulatory applications for somatrogon have been submitted to several countries around the world for review. Earlier this week, Japan's Ministry of Health, Labour and Welfare approved NGENLA® (somatrogon) Inj. 24 mg Pens and 60mg Pens, for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone. In 2021, Health Canada approved NGENLA® for the long-term treatment of pediatric patients who have GHD, and Australia's Therapeutic Goods Administration (TGA) approved NGENLA® for the long-term treatment of pediatric patients with growth disturbance due to insufficient secretion of growth hormone. Furthermore, in December 2021, the Committee for Medicinal Products for Human Use (CHMP) of EMA issued a positive opinion recommending somatrogon for marketing authorization in the EU, to treat children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone. A decision from the European Commission (EC) is expected in early 2022.

    In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product for GHD.

    About Growth Hormone Deficiency

    Growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland and affects one in approximately 4,000 to 10,000 children.1,2 In children, this disease can be caused by genetic mutations or acquired after birth.1,3 Because the patient's pituitary gland secretes inadequate levels of somatropin, the hormone that causes growth, a child's height may be affected and puberty may be delayed.1,3,4 Without treatment, affected children will have persistent growth attenuation and a very short height in adulthood.3,4 Children may also experience other problems with physical health and mental well-being.3,4

    Pfizer Rare Disease

    Rare disease includes some of the most serious of all illnesses and impacts millions of patients worldwide, representing an opportunity to apply our knowledge and expertise to help make a significant impact on addressing unmet medical needs. The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including rare hematologic, neurologic, cardiac and inherited metabolic disorders.

    Pfizer Rare Disease combines pioneering science and deep understanding of how diseases work with insights from innovative strategic collaborations with academic researchers, patients, and other companies to deliver transformative treatments and solutions. We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures.

    Click here to learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness.

    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 January 21, 2022. Pfizer and OPKO assume no obligation to update 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 an investigational growth hormone deficiency therapy, somatrogon, including a potential indication in the U.S. for once-weekly treatment of pediatric patients with growth hormone deficiency, 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, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; uncertainties regarding the company's ability to address the comments in the complete response letter to the satisfaction of the FDA; whether and when drug applications may be filed in any other jurisdictions for any potential indication for somatrogon; whether and when the BLA pending with the FDA for somatrogon for the treatment of pediatric patients with growth hormone deficiency may be approved and whether and when regulatory authorities in any jurisdictions may approve any such other applications that may be pending or filed (including the application filed in the EU), 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 somatrogon 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 somatrogon; uncertainties regarding the impact of COVID-19 on Pfizer's and OPKO's business, operations and financial results; and competitive developments.

    A further description of risks and uncertainties can be found in Pfizer's and OPKO's respective Annual Report on Form 10- K for the fiscal year ended December 31, 2020 and in their respective 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 their respective 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, www.pfizer.com, and www.opko.com.

    About OPKO Health, Inc.

    OPKO is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development, and commercialization expertise and novel and proprietary technologies. For more information, visit http://www.OPKO.com.


    1 National Organization for Rare Disorders. Growth Hormone Deficiency. https://rarediseases.org/rare-diseases/growth-hormone-deficiency/. Accessed August 24, 2021.

    2 Stanley T. Diagnosis of growth hormone deficiency in childhood. Curr Opin Endocrinol Diabetes Obes. 2012;19(1):47-52. doi:10.1097/MED.0b13e32834ec952.

    3 Cerbone M, Dattani MT. Progression from isolated growth hormone deficiency to combined pituitary hormone deficiency. Growth Horm IGF Res. 2017;37:19-25. doi:10.1016/j.ghir.2017.10.005.

    4 Ergun-Longmire B, Wajnrajch M. Growth and growth disorders. Feingold KR, Anawalt B, Boyce A, et al., editors. Endotext [Internet]. South Dartmouth (MA): MDText.com, Inc.; 2000. Available from: https://www.ncbi.nlm.nih.gov/books/NBK279142/

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    • Sugemalimab is the world's first PD-L1 monoclonal antibody that when administered along with chemotherapy improved overall survival of first-line metastatic squamous and non-squamous non-small cell lung cancer patients in a statistically significant and clinically meaningful manner
    • Survival benefits across all the subgroups including different tumor pathology type and PD-L1 expression levels
    • The National Medical Products Administration (NMPA) of China has approved sugemalimab in combination with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC
    • The updated data from the GEMSTONE-302 study, together with clinical data in other indications will be used to support new drug applications for sugemalimab…
    • Sugemalimab is the world's first PD-L1 monoclonal antibody that when administered along with chemotherapy improved overall survival of first-line metastatic squamous and non-squamous non-small cell lung cancer patients in a statistically significant and clinically meaningful manner
    • Survival benefits across all the subgroups including different tumor pathology type and PD-L1 expression levels
    • The National Medical Products Administration (NMPA) of China has approved sugemalimab in combination with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC
    • The updated data from the GEMSTONE-302 study, together with clinical data in other indications will be used to support new drug applications for sugemalimab in this indication in multiple countries and regions outside of Greater China

    SUZHOU, China, Jan. 18, 2022 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today announced that the GEMSTONE-302 registrational clinical study of sugemalimab for the first-line treatment of metastatic (stage IV) non-small cell lung cancer (NSCLC) met the overall survival (OS) endpoint. The results demonstrated that sugemalimab in combination with chemotherapy showed statistically significant and clinically meaningful OS improvement in patients. Based on the previously reported impressive progression-free survival (PFS) data, the National Medical Products Administration (NMPA) of China approved sugemalimab in combination with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC in December 2021. A detailed presentation of the OS analysis will be reported at an upcoming international academic conference.

    Professor Caicun Zhou, Principal Investigator of the GEMSTONE-302 registrational clinical study of sugemalimab and Director of the Department of Oncology, Shanghai Pulmonary Hospital, Tongji University, said, "Globally, the mortality of lung cancer ranks first among all malignant tumors. The goal of first-line treatment for advanced lung cancer is to maximally prolong survival benefits for patients and to delay disease progression. The prespecified OS analysis data further confirmed that sugemalimab in combination with chemotherapy provided durable survival benefits to patients. Sugemalimab has the potential to reshape the first-line treatment landscape of advanced NSCLC and could become the preferred immune-oncology therapy for the treatment of advanced NSCLC."

    Dr. Jason Yang, Chief Medical Officer of CStone, said, "We've had exciting news about sugemalimab successively in recent days. After being approved in China last month and with the first batch of prescriptions issued recently, now the OS analysis of the GEMSTONE-302 study demonstrated that sugemalimab in combination with chemotherapy brought significant improvement to the overall survival of patients even with high percentage of patients in the chemotherapy control group received subsequent PD-1/PD-L1 inhibitors, including crossover treatment based on the protocol design, after disease progression. As OS represents the gold standard efficacy endpoint in cancer clinical trials, the achievement of the OS endpoint further demonstrates the important value of sugemalimab in the first-line treatment of NSCLC. Sugemalimab is a PD-(L)1 monoclonal antibody addressing both stage III and stage IV NSCLC in all comer settings, and the new drug application of sugemalimab in stage III NSCLC is under regulatory review and a pivotal phase II trial just met its primary endpoint of overall response rate in patients with relapsed and refranctory natural killer/T-cell lymphoma. In addition, we are advancing the registrational studies of sugemalimab in gastric cancer, esophageal squamous cell carcinoma, and lymphoma, so as to enable sugemalimab to benefit a broader population of cancer patients."

    About Sugemalimab

    The anti-PD-L1 monoclonal antibody sugemalimab was discovered by CStone using OmniRat® transgenic animal platform, which allows creation of fully human antibodies in one step. Sugemalimab is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may allow a reduced the risk of immunogenicity and toxicity for patients, a unique advantage over similar drugs.

    Currently, the NMPA of China has approved sugemalimab (Cejemly®) in combination with pemetrexed and carboplatin as first-line treatment of patients with metastatic non-squamous NSCLC, lacking EGFR and ALK genomic tumor aberrations; and in combination with paclitaxel and carboplatin as first-line treatment of patients with metastatic squamous NSCLC. In addition, sugemalimab is being investigated in a number of ongoing clinical trials, including one Phase 2 registrational study for lymphoma and four Phase 3 registrational studies in stage IV NSCLC, stage III NSCLC, gastric cancer, and esophageal cancer, respectively.

    CStone formed a strategic collaboration agreement with Pfizer Inc. (NYSE:PFE) that includes the development and commercialization of sugemalimab in mainland China, and a framework to bring additional Oncology medicines to the Greater China market.

    About the GEMSTONE-302 study

    The GEMSTONE-302 study (ClinicalTrials.gov registration number: NCT03789604; drug clinical trial registration number: CTR20181452) is a randomized, double-blind Phase 3 study, designed to evaluate the efficacy and safety of sugemalimab in combination with chemotherapy as a first-line treatment patients with stage IV NSCLC as compared to placebo in combination with chemotherapy. The primary endpoint of the study was investigator-assessed PFS. Secondary endpoints included OS, BICR-assessed PFS and safety

    In August 2020, the GEMSTONE-302 study met its primary endpoint of significantly prolonged PFS, with the risk of disease progression or death reduced by 50% with sugemalimab combined with chemotherapy, as compared to placebo combined with chemotherapy, as assessed by the independent data monitoring committee (iDMC) at the planned interim analysis. PFS data were presented in a Proffered Paper Oral Presentation (Late-Breaking Abstract) at the ESMO Asia 2020.

    In July 2021, the final analysis of PFS from the GEMSTONE-302 study showed that sugemalimab in combination with chemotherapy demonstrated further improvement in PFS, with the risk of disease progression or death reduced by 52%, together with a trend toward improved OS. Data were presented in a Mini Oral Presentation (Late-Breaking Abstract) at the IASLC 2021 World Conference on Lung Cancer. The results of the GEMSTONE-302 study were published in The Lancet Oncology in January 2022.

    About CStone

    CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 15 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, CStone has received five drug approvals in Greater China, including three in Mainland China, one in Hong Kong, and one in Taiwan. CStone's vision is to become globally recognized as a world-renowned biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.

    For more information about CStone, please visit: www.cstonepharma.com.

    Forward-looking statement

    The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments.

    Cision View original content:https://www.prnewswire.com/news-releases/cstone-announces-the-gemstone-302-study-of-sugemalimab-met-the-endpoint-of-overall-survival-in-the-first-line-treatment-of-metastatic-non-small-cell-lung-cancer-patients-301462818.html

    SOURCE CStone Pharmaceuticals

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  2. CIBINQO is a once-daily oral treatment with proven efficacy to manage symptoms for adults who have not yet found relief with current options

    Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved CIBINQO® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

    CIBINQO is approved at the recommended doses of 100 mg and 200 mg, with the 200 mg dose being recommended for patients who are not responding to the 100 mg dose. Additionally…

    CIBINQO is a once-daily oral treatment with proven efficacy to manage symptoms for adults who have not yet found relief with current options

    Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) approved CIBINQO® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of adults living with refractory, moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

    CIBINQO is approved at the recommended doses of 100 mg and 200 mg, with the 200 mg dose being recommended for patients who are not responding to the 100 mg dose. Additionally, a 50 mg dose was approved to treat moderate-to-severe AD specifically in patients with moderate renal impairment (kidney failure), certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19, or patients who are known or suspected to be poor metabolizers of CYP2C19. For patients with moderate renal impairment who are not responding to 50 mg once daily, 100 mg once daily may also be prescribed.

    "The reality for patients living with chronic inflammatory skin disease such as moderate-to-severe atopic dermatitis is that many experience debilitating symptoms that are not managed by current treatment options. Today's approval of CIBINQO will provide an important new oral option that could help those who have yet to find relief," said Jonathan Silverberg, MD, PhD, MPH, Department of Dermatology, The George Washington University School of Medicine and Health Sciences. "In multiple large-scale clinical trials, CIBINQO demonstrated strong efficacy at clearing skin, improving itch, and managing the extent and severity of eczema, offering a benefit-risk profile that supports the use of this treatment in the FDA-approved patient population."

    The FDA approval was based on results of five clinical trials from a large-scale clinical trial program of more than 1,600 patients. The safety and efficacy of CIBINQO was evaluated in three randomized, placebo-controlled, Phase 3 trials. Additionally, safety was evaluated through a randomized, placebo-controlled, dose-ranging trial and an ongoing long-term open-label extension trial. Across the trials, CIBINQO demonstrated a consistent safety profile and profound improvements in skin clearance, extent of disease, and severity, as well as rapid improvement in itch after two weeks, for some people living with AD versus placebo. In addition, a higher proportion of subjects treated with CIBINQO in two monotherapy trials achieved improvement in itching at week 12 compared to placebo.

    "The FDA's approval offers hope to the millions of patients across the U.S. who are suffering daily with an immuno-inflammatory condition that can cause intense and persistent itching, pain, discomfort, and distress if left uncontrolled," said Mike Gladstone, Global President of Pfizer Inflammation & Immunology. "CIBINQO, an efficacious once-daily pill, is a medical breakthrough made possible by Pfizer researchers and the people living with moderate-to-severe atopic dermatitis who participated in our clinical trials."

    "Atopic dermatitis is so much more than just a rash, and it goes beyond the surface of the skin. It's a chronic condition that can both significantly disrupt patients' daily lives and negatively impact their emotional well-being," said Julie Block, President and CEO, National Eczema Association. "We appreciate Pfizer's commitment to this resilient patient community and eagerly await the positive impact CIBINQO could have on the treatment landscape for moderate-to-severe atopic dermatitis."

    The most common adverse events reported in ≥5% of patients with CIBINQO included nasopharyngitis (12.4% with CIBINQO 100 mg, 8.7% with CIBINQO 200 mg, and 7.9%, with placebo), nausea (6%, 14.5%, and 2.1%, respectively), and headache (6%, 7.8%, and 3.5%, respectively).

    The full prescribing information for CIBINQO can be found here. CIBINQO will be made available in the coming weeks.

    Additional Details on the CIBINQO Clinical Trial Program

    Five clinical trials in the CIBINQO JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program were included in the New Drug Application (NDA) to support the FDA approval.

    The safety and efficacy of CIBINQO was evaluated in three Phase 3, randomized, placebo-controlled clinical trials. The trials evaluated measures of improvements in skin clearance, itch, disease extent, and severity, including the Investigator Global Assessment (IGA), Eczema Area and Severity Index (EASI), and Peak Pruritus Numerical Ratings Scale (PP-NRS). In each of the trials, over 40% of patients had prior exposure to a systemic therapy:

    • JADE MONO-1 and JADE MONO-2: A pair of randomized, double-blind, placebo-controlled trials designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of CIBINQO monotherapy in 778 patients 12 years of age and older with moderate-to-severe AD. The trials assessed the co-primary endpoints of IGA and EASI-75 responses at Week 12.
    • JADE COMPARE: A randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of CIBINQO in 837 adult patients with moderate-to-severe AD on background topical medicated therapy. The trial also included an active control arm with dupilumab, a biologic treatment administered by subcutaneous injection, compared with placebo. The trial assessed the co-primary endpoints of IGA and EASI-75 responses at Week 12.

    Select findings for CIBINQO 100 mg, 200 mg, and placebo follow (*p<0.01 or **p<0.001):

    • JADE MONO-1:
      • IGA Response Rate (Week 12): 24%*, 44%**, and 8%, respectively
      • EASI-75 Response Rate (Week 12): 40%**, 62%**, and 12%, respectively
    • JADE MONO-2
      • IGA Response Rate (Week 12): 28%**, 38%**, and 9%, respectively
      • EASI-75 Response Rate (Week 12): 44%**, 61%**, and 10%, respectively
    • JADE COMPARE
      • IGA Response Rate (Week 12): 36%**, 47%**, and 14%, respectively
      • EASI-75 Response Rate (Week 12): 58%**, 68%**, and 27%, respectively

    Safety was additionally evaluated through a randomized dose-ranging trial and a long-term, open-label, extension trial (JADE EXTEND).

    U.S. IMPORTANT SAFETY INFORMATION

    WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS

    Serious Infections

    Patients treated with CIBINQO may be at increased risk for developing serious infections that may lead to hospitalization or death. The most frequent serious infections reported with CIBINQO were herpes simplex, herpes zoster, and pneumonia.

    If a serious or opportunistic infection develops, discontinue CIBINQO and control the infection.

    Reported infections from Janus kinase (JAK) inhibitors used to treat inflammatory conditions:

    • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.
    • Invasive fungal infections, including cryptococcosis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
    • Bacterial, viral (including herpes zoster), and other infections due to opportunistic pathogens.

    Avoid use of CIBINQO in patients with an active, serious infection, including localized infections. The risks and benefits of treatment with CIBINQO should be carefully considered prior to initiating therapy in patients with chronic or recurrent infections or those who have resided or traveled in areas of endemic tuberculosis or endemic mycoses.

    Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with CIBINQO, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

    Consider yearly screening for patients in highly endemic areas for TB. CIBINQO is not recommended for use in patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, or for patients with a negative test for latent TB but who are at high risk for TB infection, start preventive therapy for latent TB prior to initiation of CIBINQO.

    Viral reactivation, including herpes virus reactivation (eg, herpes zoster, herpes simplex), was reported in clinical studies with CIBINQO. If a patient develops herpes zoster, consider interrupting CIBINQO until the episode resolves. Hepatitis B virus reactivation has been reported in patients receiving JAK inhibitors. Perform viral hepatitis screening and monitoring for reactivation in accordance with clinical guidelines before starting therapy and during therapy with CIBINQO. CIBINQO is not recommended for use in patients with active hepatitis B or hepatitis C.

    Mortality

    In a large, randomized postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing another JAK inhibitor to TNF blocker treatment, a higher rate of all-cause mortality (including sudden cardiovascular death) was observed with the JAK inhibitor. CIBINQO is not approved for use in RA patients.

    Malignancies

    Malignancies, including non-melanoma skin cancer (NMSC), were reported in patients treated with CIBINQO. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. Perform periodic skin examination for patients who are at increased risk for skin cancer. Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen.

    In a large, randomized postmarketing safety study of another JAK inhibitor in RA patients, a higher rate of malignancies (excluding non-melanoma skin cancer [NMSC]) was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. CIBINQO is not approved for use in RA patients. A higher rate of lymphomas was observed in patients treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers. Patients who are current or past smokers are at additional increased risk.

    Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.

    Major Adverse Cardiovascular Events

    Major adverse cardiovascular events were reported in patients treated with CIBINQO. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of major adverse cardiovascular events (MACE) (defined as cardiovascular death, myocardial infarction, and stroke), was observed when compared with TNF blockers. CIBINQO is not approved for use in RA patients. Patients who are current or past smokers are at additional increased risk. Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke.

    Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur.

    Thrombosis

    Deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients treated with CIBINQO. Thrombosis, including PE, DVT, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions. Many of these adverse reactions were serious and some resulted in death. In RA patients 50 years of age and older with at least one cardiovascular risk factor treated with another JAK inhibitor, a higher rate of overall thrombosis, DVT, and PE were observed when compared with TNF blockers. CIBINQO is not approved for use in RA patients.

    Avoid CIBINQO in patients that may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue CIBINQO and treat patients appropriately.

    Contraindication

    CIBINQO is contraindicated in patients taking antiplatelet therapies, except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment.

    Laboratory Abnormalities

    Hematologic Abnormalities: Treatment with CIBINQO was associated with an increased incidence of thrombocytopenia and lymphopenia. Prior to CIBINQO initiation, perform a complete blood count (CBC). CBC evaluations are recommended at 4 weeks after initiation and 4 weeks after dose increase of CIBINQO. Discontinuation of CIBINQO therapy is required for certain laboratory abnormalities.

    Lipid Elevations: Dose-dependent increase in blood lipid parameters were reported in patients treated with CIBINQO. Lipid parameters should be assessed approximately 4 weeks following initiation of CIBINQO therapy, and thereafter patients should be managed according to clinical guidelines for hyperlipidemia. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.

    Immunizations

    Prior to initiating CIBINQO, complete all age-appropriate vaccinations as recommended by current immunization guidelines, including prophylactic herpes zoster vaccinations. Avoid vaccination with live vaccines immediately prior to, during, and immediately after CIBINQO therapy.

    Renal Impairment

    Avoid use in patients with severe renal impairment or end stage renal disease, including those on renal replacement therapy.

    Hepatic Impairment

    Avoid use in patients with severe hepatic impairment.

    Adverse Reactions

    Most common adverse reactions (≥1%) in subjects receiving 100 mg and 200 mg include: nasopharyngitis, nausea, headache, herpes simplex, increased blood creatinine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis.

    Most common adverse reactions (≥1%) in subjects receiving either 100 mg or 200 mg also include: impetigo, hypertension, contact dermatitis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia.

    Use in Pregnancy

    Available data from pregnancies reported in clinical trials with CIBINQO are not sufficient to establish a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Advise females of reproductive potential that CIBINQO may impair fertility.

    There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CIBINQO during pregnancy. Pregnant women exposed to CIBINQO and health care providers are encouraged to call 1-877-311-3770.

    Lactation

    Advise women not to breastfeed during treatment with CIBINQO and for one day after the last dose.

    Indication

    CIBINQO is indicated for the treatment of adults with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is inadvisable.

    Limitations of Use: CIBINQO is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

    About CIBINQO® (abrocitinib)

    CIBINQO is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).

    In addition to receiving regulatory approval in the U.S., CIBINQO has received marketing authorization in the European Union, Great Britain, Japan, Korea, the United Arab Emirates, Norway, Iceland, and Singapore.

    About Atopic Dermatitis

    AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects.i,ii Most people know AD is a skin condition. But many don't realize it can be caused in part by an abnormal immune response beneath the skin. This dysregulated immune response is thought to contribute to inflammation within the skin and the signs of AD on the surface. Lesions of AD are characterized by erythema (red/pink or discolored skin patches, depending on normal skin color), itching, lichenification (thick/leathery skin), induration (hardening)/papulation (formulation of papules), and oozing/crusting.i,ii

    AD is one of the most common inflammatory skin diseases, affecting approximately 5-10% of adults in the U.S.iii,iv Approximately 1 in 3 adults with AD have moderate-to-severe disease.v,vi

    About Pfizer Inflammation & Immunology

    At Pfizer Inflammation & Immunology, we strive to deliver breakthroughs that enable freedom from day-to-day suffering for people living with autoimmune and chronic inflammatory diseases, which can be debilitating, disfiguring and distressing, dramatically affecting what they can do. With a focus on immuno-inflammatory conditions in Rheumatology, Gastroenterology and Medical Dermatology, our current portfolio of approved medicines and investigational molecules spans multiple action and delivery mechanisms, from topicals to small molecules, biologics and biosimilars. The root cause of many immunological diseases is immuno-inflammation, which requires specifically designed agents. Our differentiated R&D approach resulted in one of the broadest pipelines in the industry, where we purposefully match molecules to diseases where we believe they can make the biggest difference. Building on our decades-long commitment and pioneering science, we continue to advance the standard of care for patients living with immuno-inflammatory diseases and are working hand-in-hand with patients, caregivers and the broader healthcare community on healthcare solutions for the many challenges of managing chronic inflammatory diseases, allowing patients to live their best lives.

    Pfizer Inc.: 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 170 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 January 14, 2022. Pfizer assumes no obligation to update 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 CIBINQO (abrocitinib), including its potential benefits, an approval in the U.S. and anticipated product availability, 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 our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when drug applications may be filed in any other jurisdictions for any potential indication for CIBINQO; whether and when any such other applications that may be pending or filed for CIBINQO 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 CIBINQO 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 CIBINQO; uncertainties regarding the commercial or other impact of the results of Janus kinase (JAK) inhibitor studies and data and actions by regulatory authorities based on analysis of such studies and data, which will depend, in part, on benefit-risk assessments and labeling determinations; uncertainties regarding 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, 2020 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.


    i Hanifin JM, Reed ML. A population-based survey of eczema in the United States. Dermatitis. 2007;18(2):82-91.

    ii Bieber T. Atopic dermatitis. Dermatology. 2012;1(3):203-217.

    iii Oszukowska M, Michalak I, Gutfreund K, et al. Role of primary and secondary prevention in atopic dermatitis. Postep Derm Alergol. 2015:32(6):409-420.

    iv Kim BE, Leung DYM. Significance of Skin Barrier Dysfunction in Atopic Dermatitis. Allergy Asthma Immunol Res. 2018;10(3):207-215. doi:10.4168/aair.2018.10.3.207.

    v Silverberg JI. Public health burden and epidemiology of atopic dermatitis. Dermatol Clin. 2017;35:283-289.

    vi Chiesa Fuxench ZC, Block JK, Boguniewicz M, et al. Atopic dermatitis in America study: a cross-sectional study examining the prevalence and disease burden of atopic dermatitis in the US adult population. J Invest Dermatol. 2019;139(3):583-590.

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    • Chinese National Medical Products Administration (NMPA) granted Drug Approval License to Basilea's license partner Pfizer
    • Second approved indication after invasive mucormycosis in December 2021

    Basel, Switzerland, January 13, 2022

    Basilea Pharmaceutica Ltd. (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with infectious diseases and cancer, announced today that its license partner, Pfizer Inc. (NYSE:PFE, "Pfizer"))), has received a Drug Approval License from the National Medical Products Administration (NMPA) in China, for the oral formulation of its antifungal Cresemba® (isavuconazole) for the treatment of adult patients with invasive aspergillosis.

    This is the second…

    • Chinese National Medical Products Administration (NMPA) granted Drug Approval License to Basilea's license partner Pfizer
    • Second approved indication after invasive mucormycosis in December 2021

    Basel, Switzerland, January 13, 2022

    Basilea Pharmaceutica Ltd. (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with infectious diseases and cancer, announced today that its license partner, Pfizer Inc. (NYSE:PFE, "Pfizer"))), has received a Drug Approval License from the National Medical Products Administration (NMPA) in China, for the oral formulation of its antifungal Cresemba® (isavuconazole) for the treatment of adult patients with invasive aspergillosis.

    This is the second approved indication for oral Cresemba in China, after the approval for the treatment of adult patients with invasive mucormycosis, which was received in December 2021. Pfizer submitted separate marketing authorization applications for the intravenous formulations of Cresemba for the treatment of invasive aspergillosis and mucormycosis and these are under regulatory review by the Center for Drug Evaluation at the NMPA.

    David Veitch, Basilea's CEO said: "Invasive aspergillosis is the more frequent infection than mucormycosis and we congratulate our partner Pfizer on this second approval of Cresemba in China, thus broadening the range of approved indications. Invasive fungal infections can pose a serious threat to patients. With this approval, patients in China who are suffering from invasive aspergillosis will now have access to a treatment that can help to address their unmet needs. China is a very important commercial market for Cresemba, accounting for approximately 20 percent of global sales for newer antifungals."

    The license agreement between Basilea and Pfizer covers Europe (excluding the Nordic countries), Russia, Turkey, Israel, as well as China (including Hong Kong and Macao) and sixteen countries in the Asia Pacific region. In addition to receiving mid-teen royalties on sales, Basilea remains eligible for further milestone payments of up to approximately USD 600 million under the agreement with Pfizer.

    Cresemba has been approved in more than 60 countries to date and is currently marketed in 56 countries, including the United States, most EU member states and additional countries inside and outside of Europe. In the twelve months between October 2020 and September 2021, total in-market sales of Cresemba amounted to more than USD 300 million, a 26.5 percent growth year-on-year.1

    About invasive aspergillosis and invasive mucormycosis

    Invasive aspergillosis and invasive mucormycosis are life-threatening mold infections that predominantly affect immunocompromised patients, such as patients with hematologic malignancies (blood cancer). Both infections are associated with high morbidity and mortality.

    About isavuconazole (Cresemba)

    Isavuconazole is an intravenous (i.v.) and oral azole antifungal, commercialized under the trade name Cresemba. Basilea has entered into several license and distribution agreements for isavuconazole covering the United States, Europe, China, Japan, Latin America, Asia-Pacific, the Middle East and North Africa region, Canada, Russia, Turkey and Israel. In the 27 European Union member states, as well as in Iceland, Liechtenstein, Norway and the U.K., isavuconazole is approved for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate.2 In China, the oral formulation is approved for the treatment of adult patients with invasive aspergillosis and invasive mucormycosis. Isavuconazole is also approved in the United States and several additional countries in Europe and beyond.3 It has orphan drug designation in the U.S., Europe and Australia for its approved indications.

    About Basilea

    Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with cancer and infectious diseases. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of severe bacterial infections. We are conducting clinical studies with two targeted drug candidates for the treatment of a range of cancers and have several preclinical assets in both cancer and infectious diseases in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.

    Disclaimer

    This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd. and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd. to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd. is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

    For further information, please contact:

    Peer Nils Schröder, PhD



    Head of Corporate Communications & Investor Relations
    Phone +41 61 606 1102
    E-mail

    This press release can be downloaded from www.basilea.com.

    References

    1. IQVIA, September 2021. In-market sales reported as moving annual total (MAT) in U.S. dollar.
    2. European Public Assessment Report (EPAR) Cresemba: http://www.ema.europa.eu [Accessed: January 12, 2022]
    3. The registration status and approved indications may vary from country to country.

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  3. Pfizer Inc. (NYSE:PFE) today announced positive top-line results from a Phase 3 study (B74710126) describing the safety and immunogenicity of PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) in 570 adults in the United States 65 years of age or older when administered at the same time as the Pfizer-BioNTech COVID-19 Vaccine or when each vaccine was given with placebo.

    Responses elicited by PREVNAR 20 for all 20 serotypes were similar whether given with a dose of the Pfizer-BioNTech COVID-19 Vaccine (n=190) or with placebo (n=191). Responses to a booster dose of the Pfizer-BioNTech COVID-19 Vaccine were also similar when given with PREVNAR 20 or given with placebo (n=189). The safety profile of co-administering PREVNAR 20 with a booster…

    Pfizer Inc. (NYSE:PFE) today announced positive top-line results from a Phase 3 study (B74710126) describing the safety and immunogenicity of PREVNAR 20™ (Pneumococcal 20-valent Conjugate Vaccine) in 570 adults in the United States 65 years of age or older when administered at the same time as the Pfizer-BioNTech COVID-19 Vaccine or when each vaccine was given with placebo.

    Responses elicited by PREVNAR 20 for all 20 serotypes were similar whether given with a dose of the Pfizer-BioNTech COVID-19 Vaccine (n=190) or with placebo (n=191). Responses to a booster dose of the Pfizer-BioNTech COVID-19 Vaccine were also similar when given with PREVNAR 20 or given with placebo (n=189). The safety profile of co-administering PREVNAR 20 with a booster dose of the Pfizer-BioNTech COVID-19 Vaccine generally reflected that observed with the Pfizer-BioNTech COVID-19 Vaccine booster dose.

    "Pfizer is steadfast in its commitment to address the burden of certain respiratory diseases while raising awareness of the importance of adult immunizations," said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer. "These new safety and immunogenicity data provide further evidence supporting the potential to administer PREVNAR 20 and the Pfizer-BioNTech COVID-19 Vaccine at the same time, thereby reducing the number of visits adults make to their doctor's office or pharmacy for recommended immunization. As the COVID-19 vaccines and booster doses continue to be administered, we believe that healthcare providers have an opportunity to talk to their adult patients about other recommended vaccines in line with CDC guidance."

    The initiation of the study exploring the coadministration of PREVNAR 20 along with a booster dose of the Pfizer-BioNTech COVID-19 Vaccine in older adults was announced in May 2021. The study recruited adults from the pivotal Phase 3 Pfizer-BioNTech COVID-19 Vaccine clinical trial and included adults who received their second dose of the vaccine at least six months prior to entering the coadministration study. Pfizer will seek to present and publish detailed outcomes from this clinical trial at a future date. At this time no coadministration data are included in the PREVNAR 20 or Pfizer-BioNTech COVID-19 Vaccine prescribing information.

    About PREVNAR 20

    PREVNAR 20 is Pfizer's next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) already included in PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD),1,2,3,4,5 and have been associated with high case-fatality rates,6,7,8,9 antibiotic resistance,10,11,12 and/or meningitis.13,14 PREVNAR 20 contains the broadest conjugate serotype coverage and helps protect against more strains of the bacteria that cause pneumococcal pneumonia than any other conjugate vaccine available.

    On June 8, 2021, Pfizer announced the U.S. Food and Drug Administration (FDA) approved PREVNAR 20, which is the U.S. trade name, for the prevention of invasive disease and pneumonia in adults age 18 years or older. On December 16, 2021, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion to recommend the granting of a marketing authorization for the 20-valent pneumococcal conjugate vaccine candidate for the prevention of invasive disease and pneumonia caused by 20 Streptococcus pneumoniae (pneumococcus) serotypes in adults ages 18 years and older in the 27 European Union (EU) member states plus Iceland, Lichtenstein and Norway. The EMA had previously accepted review of Pfizer's Marketing Authorization Application (MAA) for the 20-valent pneumococcal conjugate vaccine candidate on February 26, 2021.

    Pfizer has recently submitted to the FDA a supplemental Biologics License Application to include data in the PREVNAR 20 prescribing information for adults age 18 years or older regarding coadministration of PREVNAR 20 with a seasonal inactivated influenza vaccine.

    Pivotal Phase 3 studies of the 20-valent pneumococcal conjugate vaccine candidate in infants are expected to read out in the second half of 2022 and, if positive, form the basis of potential regulatory submissions to the FDA and EMA later this year.

    U.S. INDICATIONS FOR PREVNAR 20™

    • PREVNAR 20™ is a vaccine indicated for active immunization for the prevention of pneumonia and invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in adults 18 years of age and older
    • This indication for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA) assay. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

    U.S. IMPORTANT SAFETY INFORMATION

    • PREVNAR 20™ should not be given to anyone with a history of severe allergic reaction to any component of PREVNAR 20™ or any diphtheria toxoid–containing vaccine
    • Some adults with weakened immune systems may have a lower response to PREVNAR 20™. Safety data are not available for these groups. Your healthcare provider can tell you if PREVNAR 20™ is right for you
    • In adults 18 years of age and older, the most common side effects were pain at the injection site, muscle pain, fatigue, and headache
    • Ask your healthcare provider about the risks and benefits of PREVNAR 20™. Only a healthcare provider can decide if PREVNAR 20™ is right for you

    Please see full prescribing information for PREVNAR 20™.

    COMIRNATY® U.S. Indication & Authorized Use

    HOW IS THE VACCINE GIVEN?

    The vaccine will be given to you as an injection into the muscle.

    Primary Series:

    In individuals 5 years of age and older, the vaccine is administered as a 2-dose series, 3 weeks apart.

    In individuals 5 years of age and older, a third primary series dose may be administered at least 28 days after the second dose to individuals who are determined to have certain kinds of immunocompromise.

    Booster Dose:

    • A single booster dose of the vaccine may be administered at least 5 months after completion of a primary series of the Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals 12 years of age and older
    • A single booster dose of the vaccine may be administered to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. Individuals should check with their healthcare provider regarding timing of the booster dose

    WHAT IS THE INDICATION AND AUTHORIZED USE?

    The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide:

    • a 2-dose primary series to individuals 5 years of age and older
    • a third primary series dose to individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise
    • a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
    • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series

    COMIRNATY® (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech.

    • It is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older
    • It is also authorized under EUA to provide:
      • a 2-dose primary series to individuals 12 through 15 years of age
      • a third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
      • a single booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
      • a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series

    EUA Statement

    Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 5 years of age and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheets at www.cvdvaccine-us.com.

    IMPORTANT SAFETY INFORMATION

    Individuals should not get the vaccine if they:

    • had a severe allergicreaction after a previous dose of this vaccine
    • had a severe allergicreaction to any ingredient of this vaccine

    Individuals should tell the vaccination provider about all of their medical conditions, including if they:

    • have any allergies
    • have had myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the lining outside the heart)
    • have a fever
    • have a bleeding disorder or are on a blood thinner
    • are immunocompromised or are on a medicine that affects the immune system
    • are pregnant, plan to become pregnant, or are breastfeeding
    • have received another COVID-19 vaccine
    • have ever fainted in association with an injection

    The vaccine may not protect everyone.

    Side effects reported with the vaccine include:

    • There is a remote chance that the vaccine could cause a severe allergic reaction
      • A severe allergic reaction would usually occur within a few minutes to 1 hour after getting a dose of the vaccine. For this reason, vaccination providers may ask individuals to stay at the place where they received the vaccine for monitoring after vaccination
      • Signs of a severe allergic reaction can include difficulty breathing, swelling of the face and throat, a fast heartbeat, a bad rash all over the body, dizziness, and weakness
      • If an individual experiences a severe allergic reaction, they should call 9-1-1 or go to the nearest hospital
    • Myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have occurred in some people who have received the vaccine, more commonly in males under 40 years of age than among females and older males. In most of these people, symptoms began within a few days following receipt of the second dose of the vaccine. The chance of having this occur is very low. Individuals should seek medical attention right away if they have any of the following symptoms after receiving the vaccine:
      • chest pain
      • shortness of breath
      • feelings of having a fast-beating, fluttering, or pounding heart
    • Additional side effects that have been reported with the vaccine include:
      • severe allergic reactions; non-severe allergic reactions such as rash, itching, hives, or swelling of the face; myocarditis (inflammation of the heart muscle); pericarditis (inflammation of the lining outside the heart); injection site pain; tiredness; headache; muscle pain; chills; joint pain; fever; injection site swelling; injection site redness; nausea; feeling unwell; swollen lymph nodes (lymphadenopathy); decreased appetite; diarrhea; vomiting; arm pain; fainting in association with injection of the vaccine
    • These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. Call the vaccination provider or healthcare provider about bothersome side effects or side effects that do not go away

    Data on administration of this vaccine at the same time as other vaccines have not yet been submitted to FDA. Individuals considering receiving this vaccine with other vaccines, should discuss their options with their healthcare provider.

    Patients should always ask their healthcare providers for medical advice about adverse events. Individuals are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit https://www.vaers.hhs.gov or call 1-800-822-7967. In addition, side effects can be reported to Pfizer Inc. at http://www.pfizersafetyreporting.com or by calling 1-800-438-1985.

    Click for

    Fact Sheets and Prescribing Information for individuals 12 years of age and older

    Full Prescribing Information (16 years of age and older) DILUTE BEFORE USE, Purple Cap

    Full Prescribing Information (16 years of age and older) DO NOT DILUTE, Gray Cap

    EUA Fact Sheet for Vaccination Providers (12 years of age and older), Purple Cap

    EUA Fact Sheet for Vaccination Providers (12 years of age and older), Gray Cap

    Recipients and Caregivers Fact Sheet (12 years of age and older)

    Fact Sheets for individuals 5 through 11 years of age

    EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), Orange Cap

    Recipients and Caregivers Fact Sheet (5 through 11 years of age)

    When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older (purple cap and gray cap) can be used interchangeably without presenting any safety or effectiveness concerns.

    Individuals 5 through 11 years can only receive the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine formulation identifiable with an orange cap.

    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 170 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 January 12, 2022. Pfizer assumes no obligation to update 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 PREVNAR 20 (Pneumococcal 20-valent Conjugate Vaccine), Pfizer's efforts to combat COVID-19, the collaboration between BioNTech and Pfizer to develop a COVID-19 vaccine, the BNT162 mRNA vaccine program and the Pfizer-BioNTech COVID-19 Vaccine, also known as COMIRNATY (BNT162b2), including their potential benefits, involving 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 regarding the commercial success of our vaccines; 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 risks associated with preclinical and clinical data (including the Phase 3 data), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the ability to produce comparable clinical or other results, including the rate of vaccine effectiveness and safety and tolerability profile observed to date, in additional analyses of the Phase 3 trial and additional studies or in larger, more diverse populations following commercialization; the ability of BNT162b2 to prevent COVID-19 caused by emerging virus variants; the risk that more widespread use of the vaccine will lead to new information about efficacy, safety, or other developments, including the risk of additional adverse reactions, some of which may be serious; the risk that preclinical and 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 and when additional data from our vaccine programs will be published in scientific journal publications and, if so, when and with what modifications and interpretations; whether regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any biologics license applications may be filed in any other jurisdictions for PREVNAR 20 for the prevention of invasive disease and pneumonia in adults age 18 years or older and in any jurisdictions for any other potential indications, whether and when submissions to request emergency use or conditional marketing authorizations for a potential booster dose, pediatric populations and/or other biologics license and/or emergency use authorization applications or amendments to any such applications may be filed in particular jurisdictions for BNT162b2 or any other potential vaccines that may arise from the BNT162 program, including a potential variant-specific vaccine, and if obtained, whether or when such emergency use authorizations or licenses will expire or terminate; whether and when the MAA pending in the EU for the 20-valent pneumococcal conjugate vaccine candidate may be approved, whether and when any other applications that may be pending or filed for PREVNAR 20 may be approved by particular regulatory authorities and whether and when any applications that may be pending or filed for BNT162b2 (including any requested amendments to the emergency use or conditional marketing authorizations) or other vaccines that may result from the BNT162 program may be approved by particular regulatory authorities, which will depend on myriad factors, including making a determination as to whether the vaccine's benefits outweigh its known risks and determination of the vaccine's efficacy and, if approved, whether it will be commercially successful; decisions by regulatory authorities impacting labeling or marketing, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of a vaccine, including development of products or therapies by other companies; disruptions in the relationships between us and our collaboration partners, clinical trial sites or third-party suppliers; the risk that demand for any products may be reduced or no longer exist; risks related to the availability of raw materials to manufacture a vaccine; challenges related to BNT162b2's formulation, two-dose schedule and attendant storage, distribution and administration requirements, including risks related to storage and handling after delivery by Pfizer; the risk that we may not be able to successfully develop other vaccine formulations, booster doses or new variant-specific vaccines; the risk that we may not be able to create or scale up manufacturing capacity on a timely basis or maintain access to logistics or supply channels commensurate with global demand for our vaccine, which would negatively impact our ability to supply the estimated numbers of doses of our vaccine within the projected time periods as previously indicated; whether and when additional supply agreements for BNT162b2 will be reached; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; challenges related to public vaccine confidence or awareness; uncertainties regarding the impact of COVID-19 on Pfizer's 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, 2020 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.

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    1 Baisells E, Guillot L, Nair H, et al. Serotype distribution of Streptococcus pneumoniae causing invasive disease in children in the post-PCV era: A systematic review and meta-analysis. PlosOne. 2017;12(5): e0177113.

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