Pharmaceutical

  • Submission seeks approval for the treatment of COVID-19 in both vaccinated and unvaccinated individuals at high risk for progression to severe illness from COVID-19; consistent with current emergency use authorization
  • Final results from EPIC-HR study showed an 86% reduction in relative risk of hospitalizations or death from any cause; no deaths were observed in patients treated with PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) through Week 24, compared to 15 deaths observed with placebo
  • 50-60% of the U.S. population is estimated to have at least one risk factor for progressing to severe COVID-19 illness
  • Available safety data generally consistent in more than 3,500 PAXLOVID-treated participants across EPIC clinical development program

Pfizer Inc . (NYSE: PFE) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for patients who are at high risk for progression to severe illness from COVID-19. PAXLOVID is currently authorized for emergency use for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. The submission provides the longer-term follow-up data necessary for acceptance and potential approval.

According to the U.S. Centers for Disease Control and Prevention (CDC), 50-60% of the U.S. population is estimated to have one or more risk factors for progressing to severe COVID-19 illness. 1 These risk factors include any of the following: being aged 65 and older, obesity, diabetes, hypertension, smoking, physical inactivity, chronic kidney or liver disease, and immunocompromised conditions such as cancer, among others. 2

"As the COVID-19 pandemic continues to evolve and be highly unpredictable, we must remain vigilant in protecting those who are at greatest risk of getting very sick from COVID-19, as they remain vulnerable to potential hospitalization or even death," said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. "Data from our clinical development program, coupled with the more than 1.7 million patients around the world who have been prescribed our oral treatment to date, reinforce PAXLOVID as an important treatment option for mild-to-moderate COVID-19 in patients at greater risk of progression to severe symptoms, regardless of vaccination status. We look forward to working with the FDA toward full regulatory approval for PAXLOVID."

The NDA submission is supported by non-clinical and clinical data for PAXLOVID. It includes results from the Phase 2/3 EPIC-HR study ( E valuation of P rotease I nhibition for C OVID-19 in H igh- R isk Patients), which found that, compared to placebo, treatment with PAXLOVID reduced the risk of hospitalization or death from any cause by 88% in non-hospitalized, high-risk adult patients treated within five days of symptom onset; results from the final Clinical Study Report showed an 86% reduction in relative risk. The submission is also comprised of the most recent analyses from the Phase 2/3 EPIC-SR study ( E valuation of P rotease I nhibition for C OVID-19 in S tandard- R isk Patients), which included data from both vaccinated patients with, and unvaccinated patients without, risk factors for severe COVID-19. While the novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days was not met, the data were supportive of the efficacy and safety data observed in EPIC-HR for use in patients at increased risk of progression to severe COVID-19 illness. The NDA submission also includes:

  • An integrated analysis of data across the EPIC-HR and EPIC-SR studies, which showed an 84% reduction (p
  • In EPIC-HR, there was an 86% relative risk reduction in hospitalizations or death through Day 28 in PAXLOVID-treated patients [9/1,039] with no deaths, compared to placebo [66/1,046] which included twelve deaths.
  • In EPIC-SR, there was a 57% relative risk reduction in hospitalizations or death through Day 28 in PAXLOVID-treated patients [3/361] with no deaths, compared to placebo [7/360] which included one death.
  • Available safety data for PAXLOVID, which have been generally consistent in more than 3,500 PAXLOVID-treated participants across the EPIC clinical development program, including EPIC-HR, EPIC-SR, and EPIC-PEP 3 studies, as well as in reported post-authorization safety experience.
  • Data from the EPIC-HR, EPIC-SR and EPIC-PEP studies which showed a consistent reduction in viral load with PAXLOVID, including across both the Delta and Omicron variants.
  • Data which show that the frequency of return of detectable nasal viral RNA following PAXLOVID treatment was low and generally similar among PAXLOVID and placebo recipients.
  • PAXLOVID is currently approved or authorized for conditional or emergency use in more than 65 countries across the globe to treat COVID-19 patients who are at increased risk for progressing to severe illness. As of the end of May 2022, Pfizer had shipped more than 12 million treatment courses of PAXLOVID to nearly 40 countries around the world.

    Please see Full Emergency Use Authorization (EUA) Prescribing Information available at www.fda.gov and www.PAXLOVID.com

    About PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets)

    PAXLOVID is a SARS-CoV-2 main protease (M pro ) inhibitor (also known as SARS-CoV-2 3CL protease inhibitor) therapy. It was developed to be administered orally so that it can be prescribed early after infection, potentially helping patients avoid severe illness (which can lead to hospitalization and death). Nirmatrelvir [PF-07321332], which originated in Pfizer laboratories, is designed to block the activity of the M pro , an enzyme that the coronavirus needs to replicate. Co-administration with a low dose of ritonavir helps slow the metabolism, or breakdown, of nirmatrelvir in order for it to remain active in the body for longer periods of time at higher concentrations to help combat the virus.

    Nirmatrelvir is designed to inhibit viral replication at a stage known as proteolysis, which occurs before viral RNA replication. In preclinical studies, nirmatrelvir did not demonstrate evidence of mutagenic DNA interactions.

    Current variants of concern can be resistant to treatments that work by binding to the spike protein found on the surface of the SARS-CoV-2 virus. PAXLOVID, however, works intracellularly by binding to the highly conserved M pro (3CL protease) of the SARS-CoV-2 virus to inhibit viral replication. Nirmatrelvir has shown consistent in vitro antiviral activity against the following variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1 and BA.2.

    PAXLOVID is generally administered at a dose of 300 mg (two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of ritonavir, given twice-daily for five days. One carton contains five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all required doses for a full five-day treatment course.

    Our Commitment to Access

    Pfizer is committed to working toward equitable access to our oral COVID-19 treatment, PAXLOVID, for high-risk patients in need, aiming to deliver safe and effective oral treatment as soon as possible and at an affordable price. If authorized or approved, during the pandemic, Pfizer will offer its oral therapy through a tiered pricing approach based on the income level of each country to promote equity of access across the globe; high and upper-middle income countries will pay more than lower-income countries. To date, Pfizer has shipped more than 12 million treatment courses of PAXLOVID to nearly 40 countries around the world.

    Pfizer has established a comprehensive strategy in close partnership with worldwide governments, international global health leaders, including WHO's Access to COVID-19 Tools Accelerator (ACT-A), and global manufacturers to optimize supply and access of PAXLOVID all around the world. This includes:

    • Multilateral Supply Agreements : Signed agreement with UNICEF to supply up to 4 million treatment courses of PAXLOVID to low- and middle-income countries in 2022; Signed letter of intent with Global Fund for up to 6 million PAXLOVID treatment courses for supply to 130 Global-Fund eligible countries in 2022 and 2023, subject to the signing of a definitive agreement and regulatory approval or authorization.
    • Expanding Access to Patent-Protected Medicines in Lower-Income Countries : Launched An Accord for a Healthier World, a first-of-its-kind initiative to enable sustained, equitable access to high-quality medicines and vaccines for 1.2 billion people living in lower-income countries. Pfizer has committed to provide its patent-protected medicines and vaccines available in the U.S. or European Union, including PAXLOVID, on a not-for-profit basis to 45 lower-income countries around the world and will collaborate with government and global health leaders to address barriers that limit access beyond supply, like diagnosis, education, infrastructure, storage and more.
    • Accelerating Testing and Treatment : Signed a letter of intent to join COVID Global Accountability Platform (COVID GAP) , a joint initiative of COVID Collaborative and Duke University, along with Open Society Foundations and the Clinton Health Access Initiative (CHAI). Subject to a definitive agreement, the company will provide treatment courses of PAXLOVID, as well as funding and expert resources, to support the consortium's efforts aimed at accelerating testing and improving access to treatment in under-resourced parts of the world.
    • Treatment Donation: As part of its humanitarian response, Pfizer donated 200K treatment courses of PAXLOVID to Ukraine .
    • Voluntary Licensing: Signed a voluntary license agreement with Medicines Patent Pool (MPP) to enable the development and distribution of generic versions of Pfizer's oral treatment to further expand long-term global supply and access. MPP has signed sublicense agreements with 38 manufacturers, who will supply the generic versions in 95 low- and lower-middle-income countries.

    Risk Factors for Severe Illness Due to COVID-19

    People with certain risk factors or medical conditions are more likely to become severely ill with COVID-19. 2 According to the U.S. Centers for Disease Control and Prevention , people more likely to get very sick with COVID-19 include those aged 65 and older and people with certain underlying conditions or risk factors such as cancer, chronic kidney, lung, or liver disease, cystic fibrosis, dementia or other neurological conditions, diabetes (type 1 or 2), disabilities, heart conditions, HIV infection, an immunocompromised condition or weakened immune system, mental health conditions, being overweight or obese, physical inactivity, pregnancy, sickle cell disease or thalassemia, smoking (current or former), recipients of a solid organ or blood stem cell transplant, stroke or cerebrovascular disease, substance use disorders, and tuberculosis. 2 Similarly, according to the World Health Organization , COVID-19 is often more severe in people aged 60 and older or with health conditions like lung or heart disease, diabetes, or conditions that affect their immune system. ​2

    About the EPIC-HR Final Results

    In the final analysis of the primary endpoint from all patients enrolled in EPIC-HR, an 89% reduction in COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset was observed, consistent with the interim analysis. In addition, a consistent safety profile was observed.

    0.7% of patients who received PAXLOVID were hospitalized through Day 28 following randomization (5/697 hospitalized with no deaths), compared to 6.5% of patients who received placebo and were hospitalized or died (44/682 hospitalized with 9 subsequent deaths). The statistical significance of these results was high (p

    Results from the final Clinical Study Report showed an 86% reduction in risk of COVID-19 related hospitalization or death from any cause through Day 28 in PAXLOVID-treated patients, relative to placebo. For the pre-specified endpoint of all-cause mortality at Week 24, no deaths were reported in patients who received PAXLOVID as compared to 15 deaths in patients who received placebo, representing a 100% relative risk reduction (p

    In the EPIC-HR trial, in a secondary endpoint, SARS-CoV-2 viral load at baseline and Day 5 have been evaluated for 1,574 patients. After accounting for baseline viral load, geographic region, and serology status, PAXLOVID reduced viral load by approximately 10-fold relative to placebo when treatment was initiated within three days of symptom onset, indicating robust activity against SARS-CoV-2.

    Treatment-emergent adverse events were comparable between PAXLOVID (23%) and placebo (24%), most of which were mild in intensity. Fewer serious adverse events (1.6% vs. 6.6%) and discontinuation of study drug due to adverse events (2.1% vs. 4.2%) were observed in patients dosed with PAXLOVID, compared to placebo, respectively.

    All other secondary endpoints for this study, which are available on clinicaltrials.gov (NCT04960202) and EudraCT (2021-002895-38), were not yet available for this review.

    U.S. FDA Emergency Use Authorization Statement

    PAXLOVID has not been approved but has been authorized for emergency use by FDA under an EUA, for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS CoV-2 viral testing, and who are at high-risk for progression to severe COVID-19, including hospitalization or death.

    The emergency use of PAXLOVID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization revoked sooner.

    AUTHORIZED USE

    The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the emergency use of the unapproved product PAXLOVID for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

    LIMITATIONS OF AUTHORIZED USE

    • PAXLOVID is not authorized for initiation of treatment in patients requiring hospitalization due to severe or critical COVID-19
    • PAXLOVID is not authorized for use as pre-exposure or post-exposure prophylaxis for prevention of COVID-19
    • PAXLOVID is not authorized for use for longer than 5 consecutive days

    PAXLOVID may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class to which PAXLOVID belongs (i.e., anti-infectives).

    PAXLOVID is not approved for any use, including for use for the treatment of COVID-19.

    PAXLOVID is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of PAXLOVID under 564(b)(1) of the Food Drug and Cosmetic Act unless the authorization is terminated or revoked sooner.

    IMPORTANT SAFETY INFORMATION

    PAXLOVID is contraindicated in patients with a history of clinically significant hypersensitivity reactions (eg, toxic epidermal necrolysis [TEN] or Stevens-Johnson syndrome) to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product.

    Drugs listed in this section are a guide and not considered a comprehensive list of all drugs that may be contraindicated with PAXLOVID. The healthcare provider should consult other appropriate resources such as the prescribing information for the interacting drug for comprehensive information on dosing or monitoring with concomitant use of a strong CYP3A inhibitor such as ritonavir.

    PAXLOVID is contraindicated with drugs that are highly dependent on CYP3A for clearance and for which elevated concentrations are associated with serious and/or life-threatening reactions:

    • Alpha 1 -adrenoreceptor antagonist: alfuzosin
    • Analgesics: pethidine, propoxyphene
    • Antianginal: ranolazine
    • Antiarrhythmic: amiodarone, dronedarone, flecainide, propafenone, quinidine
    • Anti-gout: colchicine
    • Antipsychotics: lurasidone, pimozide, clozapine
    • Benign prostatic hyperplasia agents: silodosin
    • Cardiovascular agents: eplerenone, ivabradine
    • Ergot derivatives: dihydroergotamine, ergotamine, methylergonovine
    • HMG-CoA reductase inhibitors: lovastatin, simvastatin
    • Immunosuppressants: voclosporin
    • Microsomal triglyceride transfer protein inhibitor: lomitapide
    • Migraine medications: eletriptan, ubrogepant
    • Mineralocorticoid receptor antagonists: finerenone
    • Opioid antagonists: naloxegol
    • PDE5 inhibitor: sildenafil (Revatio ® ) when used for pulmonary arterial hypertension
    • Sedative/hypnotics: triazolam, oral midazolam
    • Serotonin receptor 1A agonist/serotonin receptor 2A antagonist: flibanserin
    • Vasopressin receptor antagonists: tolvaptan

    PAXLOVID is contraindicated with drugs that are potent CYP3A inducers where significantly reduced nirmatrelvir or ritonavir plasma concentrations may be associated with the potential for loss of virologic response and possible resistance. PAXLOVID cannot be started immediately after discontinuation of any of the following medications due to the delayed offset of the recently discontinued CYP3A inducer:

    • Anticancer drugs: apalutamide
    • Anticonvulsant: carbamazepine, primidone, phenytoin
    • Cystic fibrosis transmembrane conductance regulator potentiators: lumacaftor/ivacaftor
    • Herbal Products: St. John's Wort ( hypericum perforatum )

    There are limited clinical data available for PAXLOVID. Serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use.

    Risk of Serious Adverse Reactions Due to Drug Interactions: Initiation of PAXLOVID, a CYP3A inhibitor, in patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving PAXLOVID, may increase plasma concentrations of medications metabolized by CYP3A. Initiation of medications that inhibit or induce CYP3A may increase or decrease concentrations of PAXLOVID, respectively. These interactions may lead to:

    • Clinically significant adverse reactions, potentially leading to severe, life-threatening, or fatal events from greater exposures of concomitant medications
    • Clinically significant adverse reactions from greater exposures of PAXLOVID
    • Loss of therapeutic effect of PAXLOVID and possible development of viral resistance

    Consult Table 1 of the Fact Sheet for Healthcare Providers for clinically significant drug interactions, including contraindicated drugs. Drugs listed in Table 1 are a guide and not considered a comprehensive list of all possible drugs that may interact with PAXLOVID. Consider the potential for drug interactions prior to and during PAXLOVID therapy; review concomitant medications during PAXLOVID therapy and monitor for the adverse reactions associated with the concomitant medications.

    Hypersensitivity reactions have been reported with PAXLOVID including urticaria, angioedema, dyspnea, mild skin eruptions, and pruritus. Cases of anaphylaxis, TEN, and Stevens-Johnson syndrome have also been reported with components of PAXLOVID (refer to NORVIR labeling). If signs and symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, immediately discontinue PAXLOVID and initiate appropriate medications and/or supportive care.

    Hepatotoxicity: Hepatic transaminase elevations, clinical hepatitis, and jaundice have occurred in patients receiving ritonavir. Therefore, caution should be exercised when administering PAXLOVID to patients with pre-existing liver diseases, liver enzyme abnormalities, or hepatitis .

    Because nirmatrelvir is co-administered with ritonavir, there may be a risk of HIV-1 developing resistance to HIV protease inhibitors in individuals with uncontrolled or undiagnosed HIV-1 infection.

    Adverse events in the PAXLOVID group (≥1%) that occurred at a greater frequency (≥5 subject difference) than in the placebo group were dysgeusia (6% and

    The following adverse reactions have been identified during post-authorization use of PAXLOVID. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    Immune System Disorders: Hypersensitivity reactions
    Gastrointestinal Disorders: Abdominal pain, nausea
    General Disorders and Administration Site Conditions: Malaise

    Required Reporting for Serious Adverse Events and Medication Errors: The prescribing healthcare provider and/or the provider's designee is/are responsible for mandatory reporting of all serious adverse events and medication errors potentially related to PAXLOVID within 7 calendar days from the healthcare provider's awareness of the event.

    Submit adverse event and medication error reports to FDA MedWatch using one of the following methods:

    In addition, please provide a copy of all FDA MedWatch forms to: http://www.pfizersafetyreporting.com / or by fax (1-866-635-8337) or phone (1-800-438-1985).

    PAXLOVID is an inhibitor of CYP3A and may increase plasma concentrations of drugs that are primarily metabolized by CYP3A. Co-administration of PAXLOVID with drugs highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events is contraindicated. Co-administration with other CYP3A substrates may require a dose adjustment or additional monitoring.

    Nirmatrelvir and ritonavir are CYP3A substrates; therefore, drugs that induce CYP3A may decrease nirmatrelvir and ritonavir plasma concentrations and reduce PAXLOVID therapeutic effect.

    Pregnancy: There are no available human data on the use of nirmatrelvir during pregnancy to evaluate for a drug‑associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Published observational studies on ritonavir use in pregnant women have not identified an increase in the risk of major birth defects. Published studies with ritonavir are insufficient to identify a drug‑associated risk of miscarriage. There are maternal and fetal risks associated with untreated COVID-19 in pregnancy.

    Lactation: There are no available data on the presence of nirmatrelvir in human or animal milk, the effects on the breastfed infant, or the effects on milk production. A transient decrease in body weight was observed in the nursing offspring of rats administered nirmatrelvir. Limited published data reports that ritonavir is present in human milk. There is no information on the effects of ritonavir on the breastfed infant or the effects of the drug on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for PAXLOVID and any potential adverse effects on the breastfed infant from PAXLOVID or from the underlying maternal condition. Breastfeeding individuals with COVID‑19 should follow practices according to clinical guidelines to avoid exposing the infant to COVID‑19.

    Contraception: Use of ritonavir may reduce the efficacy of combined hormonal contraceptives. Advise patients using combined hormonal contraceptives to use an effective alternative contraceptive method or an additional barrier method of contraception.

    Pediatrics: PAXLOVID is not authorized for use in pediatric patients younger than 12 years of age or weighing less than 40 kg. The safety and effectiveness of PAXLOVID have not been established in pediatric patients. The authorized adult dosing regimen is expected to result in comparable serum exposures of nirmatrelvir and ritonavir in patients 12 years of age and older and weighing at least 40 kg as observed in adults, and adults with similar body weight were included in the trial EPIC-HR.

    Systemic exposure of nirmatrelvir increases in renally impaired patients with increase in the severity of renal impairment. No dosage adjustment is needed in patients with mild renal impairment. In patients with moderate renal impairment (eGFR ≥30 to to 150 mg nirmatrelvir and 100 mg ritonavir twice daily for 5 days. Prescriptions should specify the numeric dose of each active ingredient within PAXLOVID. Providers should counsel patients about renal dosing instructions. PAXLOVID is not recommended in patients with severe renal impairment (eGFR

    No dosage adjustment of PAXLOVID is needed for patients with either mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment. No pharmacokinetic or safety data are available regarding the use of nirmatrelvir or ritonavir in subjects with severe hepatic impairment (Child-Pugh Class C); therefore, PAXLOVID is not recommended for use in patients with severe hepatic impairment .

    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 June 30, 2022. Pfizer assumes no obligation to update forward-looking statements contained in this statement 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 and PAXLOVID (including qualitative assessments of available data, potential benefits, expectations for clinical trials, the anticipated timing of data readouts, regulatory submissions, regulatory approvals or authorizations, a new drug application submission in the U.S. for appropriate individuals at high risk of progression to severe illness and potential in high-risk COVID-19 patients, and efforts toward equitable access), 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, 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 data discussed in this release), including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data, including the risk that final results from EPIC-SR could differ from the interim data; the ability to produce comparable clinical or other results including efficacy, safety and tolerability profile observed to date, in additional studies or in larger, more diverse populations following commercialization; uncertainties regarding the commercial impact of the results of the EPIC-SR and EPIC-PEP trials; the ability of PAXLOVID to maintain efficacy against emerging virus variants; the risk that serious and unexpected adverse events may occur that have not been previously reported with PAXLOVID use; 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 regulatory authorities will be satisfied with the design of and results from these and any future preclinical and clinical studies; whether and when any drug applications or submissions to request emergency use or conditional marketing authorization for any potential indications for PAXLOVID may be filed in particular jurisdictions and if obtained, whether or when such emergency use authorization or licenses will expire or terminate; whether and when regulatory authorities in any jurisdictions may approve any applications or submissions for PAXLOVID that may be pending or filed (including the new drug application submission for PAXLOVID in the U.S. for appropriate individuals at high risk of progression to severe illness and submissions in other jurisdictions), 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 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 PAXLOVID, including development of products or therapies by other companies; risks related to the availability of raw materials for PAXLOVID; 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, which would negatively impact our ability to supply the estimated numbers of courses of PAXLOVID within the projected time periods; whether and when additional purchase agreements will be reached; the risk that demand for any products may be reduced or no longer exist which may lead to reduced revenues or excess inventory; 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, 2021 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 .

    1 Percentage of 12+ population derived from a) Analysis conducted flagging all diagnosed patients in claims data with diagnosed conditions that CDC considers to be "high-risk" except for "sedentary", smoking and obesity March – April 2022 b) RWE From July 2020-July 2021
    2 To learn more about who may be at high risk of progression to severe COVID-19, visit the Centers for Disease Control and Prevention or World Health Organization
    3 EPIC-PEP ( E valuation of P rotease I nhibition for C OVID-19 in P ost- E xposure P rophylaxis)

    Pfizer Contacts:

    Media Relations
    +1 (212) 733-1226
    PfizerMediaRelations@pfizer.com

    Investor Relations
    +1 (212) 733-4848
    IR@pfizer.com

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    ICU Medical Inc. (NASDAQ:ICUI) today announced that it has completed its acquisition of the Hospira Infusion Systems business from Pfizer Inc. (NYSE:PFE). The Hospira Infusion Systems business includes IV pumps, solutions, and devices that, when combined with the company’s existing businesses, makes ICU Medical one of the world’s leading pure-play infusion therapy companies.
    “We are pleased that Hospira Infusion Systems is now part of ICU Medical and welcome our new Hospira colleagues to the ICU team. We look forward to working together to continue providing quality, innovation and value to our clinical customers worldwide,” said Vivek Jain, chairman and chief executive officer at ICU Medical.The Hospira Infusion Systems acquisition complements ICU Medical’s existing business to create a company with a complete IV therapy product portfolio from solutions to pumps to non-dedicated infusion sets. In addition, the acquisition gives ICU Medical a significantly enhanced global footprint and platform for continued competitiveness and long-term growth. With an integrated product offering, the company now holds industry-leading positions in key segments and has access to the full US infusion marketplace with a compelling product portfolio.The company plans to announce full FY 2017 guidance on its Q4 Earnings call in late February.Forward Looking Statements
    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements contain words such as ”will,” ”expect,” ”believe,” ”could,” ”would,” ”estimate,” ”continue,” ”build,” ”expand” or the negative thereof or comparable terminology, and may include (without limitation) information regarding the Company’s expectations, goals or intentions regarding the future, including our full year 2016 guidance and our acquisition of the Hospira infusion systems business. These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about the Company and assumptions management believes are reasonable, all of which are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements. These risks and uncertainties include, but are not limited to, decreased demand for the Company’s products, decreased free cash flow, the inability to recapture conversion delays or part/resource shortages on anticipated timing, or at all, changes in product mix, increased competition from competitors, lack of continued growth or improving efficiencies, unexpected changes in the Company’s arrangements with its largest customers and the Company’s ability to meet expectations regarding the timing, completion and integration of the Hospira infusion systems business. Future results are subject to risks and uncertainties, including the risk factors, and other risks and uncertainties, described in the Company’s filings with the Securities and Exchange Commission, which include those in the Annual Report on Form 10-K for the year ended December 31, 2015 and our subsequent filings. Forward-looking statements contained in this press release are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.ICU Medical Investor Contacts:
    Scott Lamb, ICU Medical, Inc.
    949-366-2183
    slamb@icumed.com
    John Mills, ICR, Inc
    646-277-1254
    John.Mills@icrinc.com
    Media Contact:
    Tom McCall, ICU Medical, Inc.
    949-366-4368
    tmccall@icumed.com

    Transgene Announces Collaboration with Merck and Pfizer to Evaluate the Combination of TG4001 with Avelumab

    Transgene (Paris:TNG), a company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases, today announced it has entered a collaboration agreement with the science and technology company Merck KGaA, Darmstadt, Germany, and Pfizer (NYSE: PFE) under which Transgene will sponsor a Phase 1/2 study evaluating the potential of the therapeutic vaccine candidate TG4001 in combination with avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, for the treatment of human papilloma virus- (HPV-) positive head and neck squamous cell carcinoma (HNSCC), after failure of standard therapy.
    Philippe Archinard, Chairman and CEO of Transgene, commented: “We are
    pleased to enter this collaboration with Merck KGaA, Darmstadt, Germany,
    and Pfizer to evaluate our therapeutic vaccine TG4001 in association
    with avelumab. In previous clinical trials, TG4001 has demonstrated
    promising activity in terms of HPV viral clearance and was well
    tolerated. TG4001 is one of the few drugs targeting HPV-associated
    cancers that can be combined with an immune checkpoint blocker such as
    avelumab. The preclinical and clinical data that have been generated
    with both TG4001 and avelumab individually suggest this combination
    could potentially demonstrate a synergistic effect, delivering a step up
    in therapy for HPV-positive HNSCC patients
    .”
    The combination of TG4001 and avelumab aims to target two distinct steps
    in the immune response to target cancer cells. This is an exclusive
    agreement between the parties to study the combination of these two
    classes of investigational agents in HPV-positive HNSCC.
    Prof. Christophe Le Tourneau, M.D., Head of the Early Phase Program at
    Institut Curie, and a world expert in ENT cancers, will be the Principal
    Investigator of the Phase 1/2 study. This trial is expected to begin in
    France, with the first patient expected to be recruited in H1 2017. It
    will seek to recruit patients with recurrent and/or metastatic
    virus-positive oropharyngeal squamous cell carcinoma that have
    progressed after definitive local treatment or chemotherapy, and cannot
    be treated with surgical resection and/or re-irradiation.
    Prof. Christophe Le Tourneau said: “HPV-induced head and neck cancers
    are currently treated with the same regimen as non-HPV-positive HNSCC
    tumors. However, their different etiology clearly suggests that
    differentiated treatment approaches are needed for HPV-positive
    patients. Immunotherapy, and in particular the therapeutic vaccine
    TG4001 together with the PD-L1 blocker avelumab, by targeting two
    distinct steps in the immune response, could deliver improved efficacy
    for patients who have not responded to or have progressed after a first
    line of treatment.”

    TG4001 is an active immunotherapeutic designed by Transgene to express
    the coding sequences of the E6 & E7 tumor-associated antigens of HPV-16
    and the cytokine, IL-2. This therapeutic vaccine, which is based on a
    non-propagative, attenuated vaccinia vector (MVA), has already been
    administered to more than 300 patients with high grade cervical
    intra-epithelial neoplasia (CIN 2/3). It has demonstrated good safety, a
    significant HPV clearance rate and promising efficacy results. Its
    mechanism of action and good safety profile make TG4001 a particularly
    appropriate candidate for combinations with other therapies, such as
    avelumab.
    Avelumab is an investigational, fully human antibody specific for a
    protein found on tumor cells called PD-L1, or programmed death ligand-1.
    As a checkpoint inhibitor, avelumab is thought to have a dual mechanism
    of action that may potentially enable the immune system to find and
    attack cancer cells. By binding to PD-L1, avelumab is thought to prevent
    tumor cells from using PD-L1 for protection against white blood cells
    such as T-cells, exposing them to anti-tumor responses. Avelumab is also
    thought to help white blood cells such as natural killer (NK) cells find
    and attack tumors in a process known as ADCC, or antibody-dependent
    cell-mediated cytotoxicity. In 2014, the science and technology company
    Merck KGaA, Darmstadt, Germany, and Pfizer signed a strategic alliance
    to co-develop and co-commercialize avelumab.
    Alise Reicin, M.D., Head of Global Clinical Development in the biopharma
    business of Merck KGaA, Darmstadt, Germany, which in the US and Canada
    operates as EMD Serono, commented: “We believe combination regimens
    show significant promise in the development of novel and efficacious
    immuno-oncology treatments. Through this study, we hope to discover the
    potential of avelumab as a combination therapy with TG4001 for patients
    fighting this recurring cancer.”

    Chris Boshoff, M.D., Ph.D., Head of Immuno-Oncology, Early Development,
    and Translational Oncology at Pfizer, said: “Through this
    collaboration, we hope to better understand how therapeutic vaccines may
    help support the clinical development program for avelumab as our end
    goal is to find the best treatment options for patients.”

    About HPV-mediated Head and Neck Cancer
    Head and neck squamous cell carcinoma (HNSCC) is a heterogeneous group
    of cancers that can affect the oral cavity, pharynx, and larynx. HPV-16
    infection is recognized to participate in the development of a
    substantial proportion of head and neck cancers and is associated with a
    subset of HNSCC, especially those arising from the oropharynx (more than
    80%), which are the most frequent, and the larynx (~70%).
    The incidence of HPV-16-related head and neck cancer has significantly
    increased in recent years. Although there are more than 100 subtypes of
    HPV, HPV-16 accounts for 90% of all HPV-related head and neck cancers.
    Global spending on head and neck cancer indications amounted to
    $1 billion in 2010.
    Current treatments include surgical resection with radiotherapy or
    chemoradiotherapy. However, better options are needed for advanced and
    metastatic HPV+ HNSCC. It is thought that immunotherapy combined with
    immune checkpoint inhibitors could provide a promising potential
    treatment option that would address this strong medical need.
    About TG4001
    TG4001 is an investigational therapeutic vaccine based on a
    non-propagative, highly attenuated vaccinia vector (MVA), which is
    engineered to express HPV-16 antigens (E6 & E7) and an adjuvant (IL-2).
    It is one of the few therapies targeting HPV+ sub population. TG4001 is
    designed to have a two-pronged antiviral approach: to alert the immune
    system specifically to HPV-16-infected cells that have started to
    undergo precancerous transformation (cells presenting the HPV-16 E6 and
    E7 antigens) and to further stimulate the infection-clearing activity of
    the immune system through interleukin 2 (IL-2). TG4001 has been
    administered to more than 300 patients, demonstrating good safety,
    significant HPV clearance rate and promising efficacy results. Its
    mechanism of action and good safety profile make TG4001 an excellent
    candidate for combinations with other therapies in solid tumors.
    About Avelumab
    Avelumab (also known as MSB0010718C) is an investigational, fully human
    antibody specific for a protein found on tumor cells called PD-L1, or
    programmed death ligand-1. Avelumab is thought to have a dual mechanism
    of action which may enable the immune system to find and attack cancer
    cells. By binding to PD-L1, avelumab is thought to prevent tumor cells
    from using PD-L1 for protection against white blood cells such as
    T-cells, exposing them to anti-tumor responses. Avelumab is also thought
    to help white blood cells such as natural killer (NK) cells find and
    attack tumors in a process known as ADCC, or antibody-dependent
    cell-mediated cytotoxicity. In November 2014, Merck KGaA, Darmstadt,
    Germany, and Pfizer announced a strategic alliance to co-develop and
    co-commercialize avelumab.
    About Transgene
    Transgene S.A. (Euronext: TNG), part of Institut Mérieux, is a publicly
    traded French biopharmaceutical company focused on designing and
    developing targeted immunotherapies for the treatment of cancer and
    infectious diseases. Transgene’s programs utilize viral vector
    technology with the goal of indirectly or directly killing infected or
    cancerous cells. The Company’s two lead clinical-stage programs are:
    TG4010 for non-small cell lung cancer and Pexa-Vec for liver cancer. The
    Company has several other programs in clinical and pre-clinical
    development. Transgene is based in Strasbourg, France, and has
    additional operations in Lyon, as well as a JV in China with Tasly
    Group. Additional information about Transgene is available at www.transgene.fr.
    Disclaimer
    This press release contains forward-looking statements about the
    future development of TG4001. Although the Company believes its
    expectations are based on reasonable assumptions, these forward-looking
    statements are subject to numerous risks and uncertainties, which could
    cause actual results to differ materially from those anticipated. The
    occurrence of any of these risks could have a significant negative
    outcome for the Company’s activities, perspectives, financial situation,
    results and development. The Company’s ability to commercialize its
    products depends on but is not limited to the following factors:
    positive pre-clinical data may not be predictive of human clinical
    results, the success of clinical studies, the ability to obtain
    financing and/or partnerships for product development and
    commercialization, and marketing approval by government regulatory
    authorities. For a discussion of risks and uncertainties which could
    cause the Company’s actual results, financial condition, performance or
    achievements to differ from those contained in the forward-looking
    statements, please refer to the Risk Factors (“Facteurs de Risque”)
    section of the Document de Référence, which is available on the AMF
    website (
    http://www.amf-france.org)
    or on Transgene’s website (
    www.transgene.fr).

    Pfizer to Acquire Medivation

    NEW YORK, NY and SAN FRANCISCO, CA –(Marketwired – August 22, 2016) – Medivation, Inc. (NASDAQ: MDVN) –
    • Propels Pfizer into a leading position in oncology
    • Medivation agrees to transaction valued at $81.50 per Medivation share in cash, for a total enterprise value of approximately $14 billion
    • Expected to be immediately accretive to Pfizer’s Adjusted Diluted EPS upon closing, approximately $0.05 accretive in first full year after close with additional accretion and growth anticipated thereafter

    Pfizer Inc. (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) today announced that they have entered into a definitive merger agreement under which Pfizer will acquire Medivation, a biopharmaceutical company focused on developing and commercializing small molecules for oncology, for $81.50 a share in cash for a total enterprise value of approximately $14 billion. The Boards of Directors of both companies have unanimously approved the merger, which is expected to be immediately accretive to Pfizer’s Adjusted Diluted EPS upon closing, approximately $0.05 accretive in the first full year after close with additional accretion and growth anticipated thereafter. Pfizer does not expect the transaction to impact its current 2016 financial guidance.
    “The proposed acquisition of Medivation is expected to immediately accelerate revenue growth and drive overall earnings growth potential for Pfizer,” said Ian Read, Chairman and Chief Executive Officer, Pfizer. “The addition of Medivation will strengthen Pfizer’s Innovative Health business and accelerate its pathway to a leadership position in oncology, one of our key focus areas, which we believe will drive greater growth and scale of that business over the long-term. This transaction is another example of how we are effectively deploying our capital to generate attractive returns and create shareholder value.”
    Medivation’s portfolio includes XTANDI® (enzalutamide), an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. XTANDI is the leading novel hormone therapy in the United States today and generated approximately $2.2 billion in worldwide net sales over the past four quarters, as recorded by Astellas Pharma Inc., with whom Medivation entered an agreement in 2009 to develop XTANDI globally and commercialize jointly in the U.S. Since its approval for advanced metastatic prostate cancer by the U.S. Food and Drug Administration in 2012, XTANDI has treated 64,000 men to date in the U.S. alone. Medivation and Astellas have built a robust development program for XTANDI, including two Phase 3 studies in non-metastatic prostate cancer and another Phase 3 study in hormone-sensitive prostate cancer. It is also being further developed in Phase 2 studies for the potential treatment of advanced breast cancer and hepatocellular carcinoma.
    In addition, Medivation has a promising, wholly-owned, late-stage oncology pipeline, which includes two development-stage oncology assets, talazoparib and pidilizumab. Talazoparib, currently in a Phase 3 study for the treatment of BRCA-mutated breast cancer, has the potential to be a highly potent PARP inhibitor and could be efficacious across several additional tumors. Pidilizumab is an immune-oncology (IO) asset being developed for diffuse large B-cell lymphoma and other hematologic malignancies and has the potential to be combined with IO therapies in Pfizer’s portfolio.
    “We believe the combination with Pfizer is the right next step in our growth trajectory and is a testament to the passion and dedication by which the Medivation team has delivered on our mission to profoundly transform patients’ lives through medically innovative therapies,” said David Hung, M.D., founder, president and CEO of Medivation. “This compelling transaction will deliver significant and immediate value to our stockholders and provides new opportunities for our employees as part of a larger company. We believe that Pfizer is the ideal partner to extend the reach of our blockbuster XTANDI franchise and take our promising, late-stage assets — talazoparib and pidiluzimab — to their next stages of development so that they can be made available to patients as quickly as possible.”
    “The proposed acquisition of Medivation will build upon Pfizer’s success with our IBRANCE® (palbociclib) launch in HR+/HER2- metastatic breast cancer and with our strong immuno-oncology portfolio, and will transform Pfizer into a leading oncology company,” said Albert Bourla, Group President, Pfizer Innovative Health. “IBRANCE and XTANDI are anchor brands in breast and prostate cancer respectively, giving Pfizer leadership in two hormone-driven cancers. Similar to IBRANCE in the breast cancer setting, XTANDI is being explored for its potential to move from metastatic prostate cancer to treat earlier stages of non-metastatic prostate cancer. In addition, Medivation’s portfolio within prostate cancer and across diverse tumors will complement Pfizer’s broad IO portfolio. Finally, Medivation adds commercial scale to better compete with other top tier oncology companies in advance of the potential emergence of Pfizer’s IO pipeline expected in the next few years. Together, we believe Pfizer and Medivation can bring the full force of our combined research and resources to combat two of the most common cancers, as well as speed cures and make accessible breakthrough medicines to patients, redefining life with cancer.”
    Cancer remains the second leading cause of death in the U.S. and a “Top 10” killer worldwide. According to the American Cancer Society, breast cancer and prostate cancer are among the top three cancers by annual incidence in the U.S. There are several parallels between breast and prostate cancer, including the incidence of prostate cancer in the U.S., which is similar to that of breast cancer with approximately 280,000 cases per year.
    Pfizer expects to finance the transaction with existing cash.
    Under the terms of the merger agreement, a subsidiary of Pfizer will commence a cash tender offer to purchase all of the outstanding shares of Medivation common stock for $81.50 per share, net to the seller in cash, without interest, subject to any required withholding of taxes. The closing of the tender offer is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Medivation common stock. The merger agreement contemplates that Pfizer will acquire any shares of Medivation that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pfizer expects to complete the acquisition in the Third- or Fourth-Quarter 2016.
    Pfizer’s financial advisors for the transaction were Guggenheim Securities and Centerview Partners, with Ropes & Gray LLP acting as its legal advisor. J.P. Morgan Securities and Evercore served as Medivation’s financial advisors, while Cooley LLP and Wachtell, Lipton, Rosen & Katz served as its legal advisors.
    Conference Call
    Pfizer Inc. invites investors and the general public to view and listen to a webcast of a live conference call with investment analysts at 9:00 a.m. EDT on Monday, August 22, 2016.
    To view and listen to the webcast visit our web site at www.pfizer.com and click on the “Pfizer Analyst and Investor Call to Discuss Proposed Acquisition of Medivation” link in the For Investors section located on the lower right-hand corner of that page, or directly at https://www.webcaster4.com/Webcast/Page/748/16852. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com beginning today. Participants are advised to pre-register in advance of the conference call.
    You can also listen to the conference call by dialing either (866) 662-3198 in the United States and Canada or (503) 343-6044 outside of the United States and Canada. The password is “Pfizer Analyst Call.” Please join the call five minutes prior to the start time to avoid operator hold times.
    About Pfizer:
    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. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care products. 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, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
    About Medivation:
    Medivation, Inc. is a biopharmaceutical company focused on the development and commercialization of medically innovative therapies to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their families. For more information, please visit us at http://www.medivation.com.
    DISCLOSURE NOTICE: This release, and statements on the accompanying call, contains forward-looking information related to Pfizer, Medivation and the proposed acquisition of Medivation by Pfizer that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Forward-looking statements in this release and the accompanying call include, among other things, statements about the potential benefits of the proposed acquisition, anticipated earnings accretion and growth rates, Pfizer’s and Medivation’s plans, objectives, expectations and intentions, the financial condition, results of operations and business of Pfizer and Medivation, XTANDI and Medivation’s other pipeline assets, IBRANCE (palbociclib), and the anticipated timing of closing of the acquisition. Risks and uncertainties include, among other things, risks related to the satisfaction of the conditions to closing the acquisition (including the failure to obtain necessary regulatory approvals) in the anticipated timeframe or at all, including uncertainties as to how many of Medivation’s stockholders will tender their shares in the tender offer and the possibility that the acquisition does not close; risks related to the ability to realize the anticipated benefits of the acquisition, including the possibility that the expected benefits from the proposed acquisition will not be realized or will not be realized within the expected time period; the risk that the businesses will not be integrated successfully; disruption from the transaction making it more difficult to maintain business and operational relationships; negative effects of this announcement or the consummation of the proposed acquisition on the market price of Pfizer’s common stock and on Pfizer’s operating results; significant transaction costs; unknown liabilities; the risk of litigation and/or regulatory actions related to the proposed acquisition; other business effects, including the effects of industry, market, economic, political or regulatory conditions; future exchange and interest rates; changes in tax and other laws, regulations, rates and policies; future business combinations or disposals; the uncertainties inherent in research and development, including the ability to sustain and increase the rate of growth in revenues for XTANDI despite increasing competitive, reimbursement and economic challenges; Medivation’s dependence on the efforts and funding by Astellas Pharma Inc. for the development, manufacturing and commercialization of XTANDI; the ability to meet anticipated trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; whether and when any drug applications may be filed in any jurisdictions for any additional indications for IBRANCE, XTANDI or for Medivation’s other pipeline assets; whether and when regulatory authorities may approve any such applications, which will depend on its assessment of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of IBRANCE, XTANDI and Medivation’s other pipeline assets; and competitive developments.
    A further description of risks and uncertainties relating to Pfizer and Medivation can be found in their respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2015 and in their subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission (the “SEC”) and available atwww.sec.gov.
    The information contained in this release is as of August 22, 2016. Neither Pfizer nor Medivation assumes any obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
    Pfizer calculates projections regarding the expected accretive impact of the potential acquisition based on internal forecasts of itsAdjusted Diluted Earnings Per Share (Adjusted Diluted EPS), which forecasts are non-Generally Accepted Accounting Principles (GAAP) financial measures derived by excluding certain amounts that would be included in GAAP calculations. These accretion projections should not be considered a substitute for GAAP measures. The determinations of the amounts that are excluded from the accretion calculations are a matter of management judgment and depend upon, among other factors, the nature of the underlying expense or income amounts. Pfizer is unable to present quantitative reconciliationsbecause management cannot reasonably predict with sufficient reliability all of the necessary components of the comparable GAAP measure. Pfizer has excluded from the accretion calculations the impact of purchase accounting adjustments, acquisition-related costs, discontinued operations and certain significant items. Such items can have a substantial impact on GAAP measures of financial performance. For more information on the Adjusted Diluted EPS measure see Pfizer’s 2015 Financial Report, which was filed as exhibit 13 to Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and Pfizer’s Quarterly Report on Form 10-Q for the quarterly period ended July 3, 2016.
    Additional Information and Where to Find It
    The tender offer referenced in this press release has not yet commenced. This announcement is for informational purposes only and is neither an offer to purchase nor a solicitation of an offer to sell securities, nor is it a substitute for the tender offer materials that Pfizer and its acquisition subsidiary will file with the SEC. The solicitation and offer to buy Medivation stock will only be made pursuant to an Offer to Purchase and related tender offer materials. At the time the tender offer is commenced, Pfizer and its acquisition subsidiary will file a tender offer statement on Schedule TO and thereafter Medivation will file a Solicitation/Recommendation Statement on Schedule 14D-9 with the SEC with respect to the tender offer. THE TENDER OFFER MATERIALS (INCLUDING AN OFFER TO PURCHASE, A RELATED LETTER OF TRANSMITTAL AND CERTAIN OTHER TENDER OFFER DOCUMENTS) AND THE SOLICITATION/RECOMMENDATION STATEMENT ON SCHEDULE 14D-9 WILL CONTAIN IMPORTANT INFORMATION. MEDIVATION STOCKHOLDERS ARE URGED TO READ THESE DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION THAT HOLDERS OF MEDIVATION SECURITIES SHOULD CONSIDER BEFORE MAKING ANY DECISION REGARDING TENDERING THEIR SECURITIES. The Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, will be made available to all holders of Medivation stock at no expense to them. The tender offer materials and the Solicitation/Recommendation Statement will be made available for free at the SEC’s website at www.sec.gov. Additional copies may be obtained for free by contacting Pfizer or Medivation. Copies of the documents filed with the SEC by Medivation will be available free of charge on Medivation’s internet website at http://www.medivation.com or by contacting Medivation’s Investor Relations Department at (650) 218-6900. Copies of the documents filed with the SEC by Pfizer will be available free of charge on Pfizer’s internet website at http://www.pfizer.com or by contacting Pfizer’s Investor Relations Department at 212-733-2323. In addition to the Offer to Purchase, the related Letter of Transmittal and certain other tender offer documents, as well as the Solicitation/Recommendation Statement, Pfizer and Medivation each file annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other information filed by Pfizer or Medivation at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. Pfizer’s and Medivation’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.

    Contacts:
    For Pfizer:
    Investors
    Ryan Crowe
    212-733-2798

    Media

    Joan Campion
    212-733-2798
    For Medivation:

    Investors

    Anne Bowdidge
    Senior Director, Investor Relations
    (650) 218-6900

    Media

    Samina Bari
    Vice President, Corporate Communications
    (415) 275-5893

    Myovant Sciences and Pfizer Receive U.S. FDA Approval of MYFEMBREE®, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis

    • Data from the Phase 3 SPIRIT program showed MYFEMBREE reduced menstrual pain and non-menstrual pelvic pain in premenopausal women with endometriosis, and a loss of mean bone mineral density of less than 1% from baseline through one year of treatment
    • Myovant and Pfizer will continue to jointly commercialize MYFEMBREE, with product available immediately
    • Myovant to host conference call and webcast on Monday, August 8, 2022, at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time

    Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved MYFEMBREE ® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months. The approval is supported by one-year efficacy and safety data, including 24-week data from the Phase 3 SPIRIT 1 and SPIRIT 2 trials, which were published in The Lancet and the first 28 weeks of an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2. MYFEMBREE also is approved for heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. Myovant and Pfizer will continue to jointly commercialize MYFEMBREE in the U.S. and product is available immediately.

    "Endometriosis is a painful, chronic disease with limited therapies to manage symptoms," said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. "The new MYFEMBREE indication helps advance our mission to redefine care for women by helping address a disease with high unmet need, giving women and physicians a new meaningful treatment option to manage moderate to severe pain associated with endometriosis."

    News Provided by GlobeNewswire via QuoteMedia

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    Jamieson Wellness Inc. Reports Second Quarter 2022 Financial Results

    Company Increases Fiscal 2022 Guidance and Raises Second Quarter Dividend

    Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX: JWEL) today reported financial results for its second quarter ended June 30, 2022. All amounts are expressed in Canadian dollars. Certain metrics, including those expressed on an adjusted basis, are non-IFRS and other financial measures. See "Non-IFRS and Other Financial Measures" below.

    News Provided by Business Wire via QuoteMedia

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    LYNPARZA® Approved in the EU as Adjuvant Treatment for Patients With Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer

    First and only PARP inhibitor to improve invasive disease-free survival, the primary endpoint, and overall survival, a key secondary endpoint, in these patients

    AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has approved LYNPARZA as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA 1/2 mutations (g BRCA m), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy.

    News Provided by Business Wire via QuoteMedia

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    Merck and Eisai Provide Update on Phase 3 LEAP-002 Trial Evaluating KEYTRUDA® Plus LENVIMA® Versus LENVIMA Monotherapy in Patients With Unresectable Hepatocellular Carcinoma

    Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the Phase 3 LEAP-002 trial investigating KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, versus LENVIMA monotherapy did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). There were trends toward improvement in OS and PFS for patients who received KEYTRUDA plus LENVIMA versus LENVIMA monotherapy; however, these results did not meet statistical significance per the pre-specified statistical plan. The median OS of the LENVIMA monotherapy arm in LEAP-002 was longer than that observed in previously reported clinical trials evaluating LENVIMA monotherapy in uHCC. The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination. Merck and Eisai plan to present these data at an upcoming medical conference.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220803005211/en/

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    Merck Provides Update on Phase 3 KEYNOTE-921 Trial Evaluating KEYTRUDA® Plus Chemotherapy in Patients With Metastatic Castration-Resistant Prostate Cancer

    Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-921 trial evaluating KEYTRUDA in combination with chemotherapy (docetaxel) compared to chemotherapy alone did not meet its dual primary endpoints of overall survival (OS) and radiographic progression-free survival (rPFS) for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). In the study, there were modest trends toward an improvement in both OS and rPFS for patients who received KEYTRUDA plus chemotherapy compared with chemotherapy alone; however, these results did not meet statistical significance per the pre-specified statistical plan. The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies. Results will be presented at an upcoming medical meeting.

    "Results from this study serve as an important reminder that metastatic prostate cancer remains very difficult to treat, and more research is needed. We will continue to advance our clinical development program to evaluate KEYTRUDA-based combinations and novel candidates for patients with this disease," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "We are grateful to the patients and investigators for their participation in this study."

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    PFIZER REPORTS SECOND-QUARTER 2022 RESULTS

    • Second-Quarter 2022 Revenues of $27.7 Billion, Reflecting 53% Operational Growth, Driven Primarily by Strong Contributions from Paxlovid and Comirnaty (1)
    • Second-Quarter 2022 Reported Diluted EPS (2) of $1.73, Reflecting 77% Growth Over Second-Quarter 2021
    • Second-Quarter 2022 Adjusted Diluted EPS (3) of $2.04, Reflecting 92% Growth Over Second-Quarter 2021; Excluding Foreign Exchange Impacts, Adjusted Diluted EPS (3) Grew 100%
    • Raises Full-Year 2022 Financial Guidance (4) for Revenues and Adjusted Diluted EPS (3) by $2 Billion and $0.24, Respectively, on an Operational Basis (Which Excludes the Impact of Foreign Exchange)
      • Including Foreign Exchange Impacts, Pfizer Reaffirms Revenue Guidance of $98.0 to $102.0 Billion and Raises Lower End of Adjusted Diluted EPS (3) Guidance by $0.05 to a Range of $6.30 to $6.45
      • Reaffirms 2022 Revenue Guidance for Comirnaty (1) and Paxlovid of ~$32 Billion and ~$22 Billion, Respectively, Despite Unfavorable Impacts from Foreign Exchange
    • Pipeline Programs That Have Achieved Milestones Since Previous Earnings Release Include Bivalent mRNA COVID-19 Vaccine, Enhanced mRNA COVID-19 Vaccine, Paxlovid, modRNA Influenza Vaccine, Once-Daily Oral GLP-1 Receptor Agonist and Anti-Interferon-β

    Pfizer Inc. (NYSE: PFE) reported strong financial results for second-quarter 2022 and updated certain components of 2022 financial guidance (4) . Pfizer reaffirmed its previous 2022 revenue guidance, despite unfavorable impacts from foreign exchange, while reaffirming its revenue guidance for Comirnaty (1) , the Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, and for Paxlovid, its oral COVID-19 treatment.

    The second-quarter 2022 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer's R&D pipeline can be found at www.pfizer.com .

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