The presented market report on the global Hormone Replacement Therapy market published by Fact.MR is a comprehensive analysis of the leading parameters that are likely to determine the growth of the Hormone Replacement Therapy market in the forthcoming decade. Further, the study dives in deep to investigate the micro and macro-economic factors that are projected to influence the global scenario of the Hormone Replacement Therapy market during the forecast period (2019-2029).

The market study reveals that the Hormone Replacement Therapy market is expected to grow at a CAGR of ~XX% and reach a value of ~USXX by the end of 2029. The report examines the current trends, growth opportunities, restraints, and market drivers that are projected to influence the overall dynamics of the Hormone Replacement Therapy market in the assessment period. The market study predicts the course of the global Hormone Replacement Therapy market post the COVID-19 pandemic and offers resourceful insights to market players pertaining to their business continuity strategies and more.

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Hormone Replacement Therapy Market Segmentation

The report bifurcates the Hormone Replacement Therapy market into multiple segments to provide a clear picture of the Hormone Replacement Therapy market at a granular level. The key segments covered in the report include region, product type, application, and more.

Competitive Landscape

The report on hormone replacement therapy market offers intelligence on key participants in the hormone replacement therapy market. The key companies involved in the formulation of hormone replacement therapy products are thoroughly assessed and profiled in the report. Various facets of competition including SWOT analysis, product portfolio analysis, drug developments and innovations, strategies and key financials are covered. Key companies profiled in the report include Novartis AG, Novo Nordisk A/S, Teva Pharmaceuticals, Mylan N.V and Pfizer Inc.

Major companies in the hormone replacement therapy market are concentrating on expanding their current product portfolio. New hormone replacement therapy formulations being the core focus, companies are carrying out trials and gain FDA approvals. For instance, Novartis AGs research and development department delivered 6 critical FDA breakthrough therapy designations and 16 submissions in 2017. In May 2017, Novartis AG announced U.S. FDAs approval for its hormone replacement therapy tablets for hormone receptor positive and metastatic breast cancer treatment in postmenopausal women.

In February 2018, Novo Nordisk A/S concluded main phase of REAL 1 the pivotal phase 3 trial along with somapacitan, a long-acting growth hormone to treat adults with growth hormone deficiency.

Teva Pharmaceuticals Industries Ltd. introduced Vagifem in 2017 for the treatment of atrophic vaginitis. In January 2018, the company launched Estrace cream to treat moderate and severe symptoms of vaginal and vulgar atrophy occurring due to menopause. Likewise, Mylan N.V expanded its US portfolio in the womens healthcare range with U.S. FDA approval for Estradiol Vaginal Cream to treat vaginal atrophy.

Private equity firms are focused on acquiring emerging participants that are involved in drug delivery systems in the hormone replacement therapy space. For instance, Riverside Company has acquired DoseLogix in a bid to provide innovative dosing dispensers for ensuring accurate dosing medications of hormone replacement therapy and other conditions.

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Definition

Hormone replacement therapy, also referred to as menopausal hormone therapy, is used to treat various symptoms related to menopause among women. Hormone replacement therapy replaces hormones that are low in level as women near menopause. There are various types of hormone replacement therapy such as estrogen hormone replacement therapy, thyroid hormone replacement therapy and growth hormone replacement therapy.

About the Report

The report on hormone replacement therapy market provides incisive insights on all aspects influencing growth in demand for hormone replacement therapy worldwide. The report provides a thorough analysis on demand of hormone replacement therapy across key regions in the globe along with sales of various hormone replacement therapy products.

Key drivers, challenges, trends and opportunities shaping the growth of the hormone replacement therapy market are also covered in the hormone replacement therapy market report. The hormone replacement therapy market report provides historical data assessment on use of hormone replacement therapy, current hormone replacement therapy scenario and future demand of hormone replacement therapy. The forecast projections provided cover a timeline of 10 years (2018-2028).

Market Structure

The hormone replacement therapy market is segmented in detail to cover every angle of the hormone replacement therapy space. The hormone replacement therapy market has been segmented on the basis of product type, by dosage form, by indication, by distribution channel and by region.

Various hormone replacement therapy products such as estrogen hormone replacement therapy, thyroid hormone replacement therapy and growth hormone replacement therapy is covered. By dosage form, hormone replacement therapy market is segmented into tablets, patches, injections, implants and creams. By indications, hormone replacement therapy market is categorized into menopause, osteoporosis, thyroid and growth hormone deficiency. By distribution channel, it is segmented by hospital pharmacies, clinics, retail pharmacies and online pharmacies.

The hormone replacement therapy market is assessed across key regions such as North America, Latin America, Europe, Asia Pacific excluding Japan (APEJ), Middle East and Africa (MEA) and Japan.

Additional Questions Answered

Apart from key findings mentioned above, the hormone replacement therapy market report also answers additional questions such as:

Research Methodology

The hormone replacement therapy market is drafted using a unique research methodology comprising of a combination of secondary and primary research methodologies. The data gleaned from primary and secondary research is assessed along with information from external sources. All the statistics are compiled using triangulation method to gain highly accurate projections on hormone replacement therapy market.

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The growth projection of each of these segments and sub-segments is accurately tracked in the report along with east-to-understand graphs and tables. Further, the market share, size, value, and Y-o-Y growth of the Hormone Replacement Therapy market segments are included in the report.

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Essential Takeaways from the Hormone Replacement Therapy Market Report

Important queries related to the Hormone Replacement Therapy market addressed in the report:

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Hormone Replacement Therapy Market Progresses for Huge Profits During 2018 to 2028 - The Daily Chronicle

Keith Roach, To Your Health Published 8:25 p.m. ET Sept. 13, 2020

Dear Dr. Roach: If women are prescribed a hormone replacement for hot flashes, do the hot flashes return once the medicine is discontinued. If you take hormone replacement therapy, are you just delaying the symptoms for a while and will have to deal with hot flashes either way?

C.H.

Dear C.H.: Hot flashes are a common symptom when women go into menopause -- 60% to 80% of women will experience them. About half of women will stop having hot flashes after about five years. The remainder will have a longer duration. A third of women will still experience them after 10 years, and in about 10%, they continue for 20 or more years after menopause.

Dr. Keith Roach(Photo: Reed Brennan)

The most effective treatment is hormone replacement therapy -- specifically, estrogen. But estrogen should not be given without a progestin in women who have a uterus, i.e., those who have not had a hysterectomy. HRT neither shortens nor lengthens the duration of symptoms. If a woman was destined to have hot flashes for seven years, and takes HRT for five years with relief, she will still have two more years of hot flashes.

Although women are generally not treated with HRT for longer than five years, some choose to continue treatment longer, even knowing that HRT increases risk of blood clotting and may increase risk of breast cancer and heart disease. The degree of risk is debated and likely depends on many factors.

Dear Dr. Roach: I am a 63-year-old female who has suffered with Epstein-Barr virus twice in the past two years. My understanding is that for many people, this virus lies dormant until a trigger, such as stress, causes it to emerge.

My symptoms consisted of fever, extreme exhaustion and weakness. After three weeks, I am slowly feeling better. I never want to feel like this again! Aside from maintaining a healthy diet, exercising and stressing less, do you have any suggestions as to how I can stay symptom-free in the future?

R.K.

Dear R.K.: Epstein-Barr virus is the classic cause of infectious mononucleosis, which is a common condition in children and adolescents. Its symptoms of early fever followed by days or weeks of fatigue are nonspecific. Other viruses and even a parasite can cause a similar symptoms. Blood testing can confirm the diagnosis.

EBV is in the herpes family, and like all herpesviruses, it does lay dormant in the body. Unlike herpes simplex or varicella-zoster, it is very unlikely to recur. It is very rare to get mononucleosis from EBV more than once, although it happens occasionally if the immune system is severely depleted, such as in advanced HIV. It is almost unheard-of to get it at age 63.

Blood test results for EBV can be misinterpreted. If you ever had EBV -- say, in childhood -- you will have a positive antibody test for the IgG antibodies. Active infection stimulates the IgM antibodies. I suspect you may have had the IgG antibodies that were misinterpreted as active infection. If you really had recurrent EBV with positive IgM antibodies (or other, more precise tests of viral activity), then a visit with an immunologist and an infectious disease specialist is wise.

Your own advice -- healthy diet, regular exercise, decreasing stress -- are all good, commonsense ways of improving your immune system. I would add regular sleep to the list, and unless you really have had active EBV, which would surprise me, you shouldnt need more than that.

Readers may email questions to ToYourGoodHealth@med.cornell.edu

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Dr. Roach: Does HRT affect the duration of hot flashes? - The Detroit News

Study on the Global Hormone Replacement Therapy Market

Fact.MR, recently published a market study which indicates that the global Hormone Replacement Therapy market is anticipated to grow at a CAGR of ~XX% during the forecast period (2018-2028). The growth of the Hormone Replacement Therapy market is predominantly driven by rising demand for Hormone Replacement Therapy from multiple end-use industries.

Due to the pandemic, we have remembered an uncommon segment for the Impact of COVID 19 on the Scientific Research Satellites Services Market which would make reference to How the Covid-19 is influencing the Market Trends and Potential Opportunities in the COVID-19 Landscape, Covid-19 Impact on Key Regions and Proposal for Hormone Replacement Therapy Market Players to Combat Covid-19 Impact.

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The presented study addresses the following queries related to the Hormone Replacement Therapy market:

Competitive Landscape

The presented market report dives deep into understanding the business strategies adopted by leading market players in the global Hormone Replacement Therapy market. Further, the SWOT analysis for leading market players is enclosed in the report along with the revenue share, pricing analysis, and product overview of each company.

Detailed profiles of the providers are also included in the scope of the report to evaluate their long-term and short-term strategies, product portfolio of Hormone Replacement Therapy manufacturers, and recent developments in the Hormone Replacement Therapy market space. Some of the key players analyzed are:

Global Hormone Replacement Therapy Market By Product

Global Hormone Replacement Therapy Market By End Use

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Global Hormone Replacement Therapy Market By Region

The data scrutiny for the global Hormone Replacement Therapy market is estimated in terms of value and volume consumption. To arrive at the volume consumption of Hormone Replacement Therapy, production data of countries producing raw materials across the globe has been taken into consideration. In addition, the production of application of Hormone Replacement Therapy in top producing countries is also tracked for benchmarking purposes. Furthermore, Fact.MR estimated volume data on the consumption of Hormone Replacement Therapy for several countries by understanding the demand and supply of Hormone Replacement Therapy. It includes production, growth, volume and value sales, transition, pricing, population, consumer preference, and consumption of Hormone Replacement Therapy among end user verticals.

Fact.MR then determined the volume consumption of Hormone Replacement Therapy across various regions such as North America, Latin America, Europe, Asia Pacific, and Middle East and Africa. Forecasting is done on an internal proprietary model using different macro-economic, industry-based demand driving factors impacting the market and its forecast trends, by identifying and allocating a weighted score to the forecast factors that influence the demand for Hormone Replacement Therapy. These factors were the representative of an entire value chain, as well as macro-economic indicators such as production have been taken into consideration to arrive at the volume consumption of Hormone Replacement Therapy in respective countries.

The weighted average selling price for Hormone Replacement Therapy was considered to estimate the market size for top Hormone Replacement Therapy consuming countries. These prices were captured in their respective countries, and then converted into USD to offer forecasts in one consistent currency standard.

Given the characteristics of the market, Fact.MR triangulated the data based on supply side, demand side, and dynamics of the global Hormone Replacement Therapy market. To develop the global Hormone Replacement Therapy market forecast, Fact.MR analyzed various factors to understand their respective impact on the target market. However, quantifying the market across the abovementioned segments is more a matter of quantifying expectations and identifying opportunities rather than rationalizing them after the forecast has been completed.

It is imperative to note that, in an ever-fluctuating economy, we not only provide forecasts in terms of CAGR but also analyze on the basis of key parameters, such as year-on-year (Y-o-Y) growth, to understand the predictability of the market and identify the right opportunities.

Another key feature of this report is the analysis of the global Hormone Replacement Therapy market and the corresponding revenue forecast in terms of absolute dollar opportunity. This is usually overlooked while forecasting the market. However, absolute dollar opportunity is critical in assessing the level of opportunity that a provider can look to achieve, as well as to identify potential resources from a sales perspective in the global Hormone Replacement Therapy market.

To understand key segments in terms of their growth and performance in the global Hormone Replacement Therapy market, Transparency Market Research has also presented a market attractiveness index. The resulting index should help providers identify existing market opportunities in the global Hormone Replacement Therapy market.

The report covers an in-depth analysis of all components of the value chain in the global Hormone Replacement Therapy market. In the final section of the report on the global Hormone Replacement Therapy market, a competitive landscape is included to provide a dashboard view of global Hormone Replacement Therapy manufacturers.

Regional Assessment

The extensive study on the Hormone Replacement Therapy market pinpoints the different factors that are likely to influence the prospects of the Hormone Replacement Therapy market in each region. The different regions covered in the report include:

Application Analysis

The report offers crucial insights related to the various applications of the Hormone Replacement Therapy along with the Year-on-Year growth analysis of each application.

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Assessing the COVID-19 Effect: Hormone Replacement Therapy Production Moderately Disrupted by Labor Shortages of Labor in Pandemic, Says Fact.MR - The...

Women who experience an early menopause are at a significantly higher risk of depression, according to a McMaster University study based on the largest Canadian data sample to date.

Dr. Alison Shea, an assistant professor at McMaster and an obstetrician and gynecologist at St. Josephs Healthcare Hamilton, led the study which was published in Menopause.

The most striking finding was that those who had an early menopause so before age 40 had a significantly higher risk for depression, she said. Theres more than a doubling of depression risk for these women.

The research used baseline data from 13,216 women aged 45 to 64 collected as part of the Canadian Longitudinal Study on Aging.

In North America, the average age a woman experiences menopause is 51.

The main theory behind the higher risk for depression has to do with estrogen levels, said Shea, who is a specialist in menopause and reproduction mental health. Women who are exposed to estrogen longer from an earlier period and a later menopause have a lower risk of depression later in their life.

There could be social factors, too.

Menopause is a loss of reproductive function, Shea said. That loss is profound for many women. She noted that whether women have had their own children before the onset of menopause is also a significant factor for their mental health.

The study also found that women who had an early menopause were also more likely to experience depression if they had low education, low income, no children, lived alone and had little social support.

While some factors such as ovary removal, radiation, chemotherapy and smoking can cause people to experience menopause early, in most cases, the reason for early menopause is unknown, said Shea, noting that it is believed to be related to auto-immune mechanisms.

She noted that the research can help health practitioners identify women at risk of depression for hormone replacement therapy, which she said not all doctors do.

Its astounding how many women I see in my menopause clinic who they had lost their period at 41 and Im not seeing them until 48. They had all those years of not having any hormones, Shea said. Some family doctors are attuned to this, but others are not.

Ideally, women should begin hormone replacement therapy four to six months after a woman stops having her period, but Shea said most women dont get treatment until they reach the average age of menopause. She noted doctors can refer patients to a gynecologist or a menopause specialist if theyre not comfortable prescribing hormones directly.

Women who may not have begun therapy right away should still speak to a gynecologist, Shea said, adding that hormone therapy can begin within 10 years of the onset of menopause.

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She noted that without hormone replacement, women are at a higher risk for other diseases, including heart disease and osteoporosis at an earlier age.

The study also found that those who were using hormone therapy had a higher risk for depression, but Shea said the depression was likely attributed to more severe symptoms of menopause, rather than the hormone therapy itself.

We know that the No. 1 reason for hormone therapy is hot flashes, she said. Hot flashes in the menopause time are a very strong risk factor for depression. Its their more severe menopausal symptoms that are driving their depression rather than the hormone therapy.

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Early menopause puts women at 'significantly' higher risk of depression, study finds - TheSpec.com

ROCKLAND, Mass. and NEW YORK, Sept. 18, 2020 /PRNewswire/ -- EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Inc. (NYSE: PFE) today announced the publication of detailed results from the Phase III JAVELIN Bladder 100 study online ahead of print in The New England Journal of Medicine. These results were published simultaneously with additional analyses being presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 and describe the efficacy of BAVENCIO(avelumab) as a first-line maintenance treatment across various subgroups of patients with locally advanced or metastatic urothelial carcinoma (UC) and highlight exploratory biomarkers as well as patient-reported outcomes. In June, the US Food and Drug Administration (FDA) approved BAVENCIO for the maintenance treatment of patients with locally advanced or metastatic UC that has not progressed with first-line platinum-containing chemotherapy based on the JAVELIN Bladder 100 results.

In the JAVELIN Bladder 100 study, BAVENCIO plus best supportive care (BSC) significantly extended overall survival (OS) compared with BSC alone in the two primary populations of all randomized patients and patients whose tumors were PD-L1+, and significantly more patients who received BAVENCIO as first-line maintenance were alive at one year.1 The clinical benefits of BAVENCIO were seen across a range of patient populations.1,2

"These data, which supported the recent FDA approval and updates to NCCN and ESMO guidelines, establish that BAVENCIO first-line maintenance treatment could fundamentally change clinical practice for the treatment of patients with locally advanced or metastatic urothelial carcinoma," said Thomas Powles, MBBS, MRCP, MD, Professor of Genitourinary Oncology, Lead for Solid Tumour Research at Barts Cancer Institute, Queen Mary University of London, and Director of Barts Cancer Centre, London, UK. "It is notable that the longer overall survival with BAVENCIO maintenance therapy was observed across all pre-specified subgroups examined and that this prolonged overall survival was gained without a detrimental impact on patients' quality of life."

Primary AnalysisIn the JAVELIN Bladder 100 study, OS was significantly longer with BAVENCIO plus BSC compared to BSC alone in the primary population of all randomized patients (n=700) whose disease had not progressed on first-line platinum-containing chemotherapy:

In the other primary population of patients with PD-L1+ tumors (n=358):

All endpoints were measured from the time of randomization, after completion of four to six cycles of chemotherapy.

Subgroup AnalysisResults of an exploratory subgroup analysis show that consistent results were observed with the JAVELIN Bladder regimen of BAVENCIO first-line maintenance across pre-specified subgroups, including best response to first-line chemotherapy, type of chemotherapy regimen, site of baseline metastasis, and other baseline factors.1 In particular, hazard ratios for OS based on response to first-line chemotherapy were as follows:

With regard to first-line chemotherapy regimen, hazard ratios were as follows:

Further detail from the subgroup analysis were presented in an on-demand mini oral session at the meeting (Presentation #704MO). Additional data evaluating the association between clinical outcomes and exploratory biomarkers will be presented in the Proffered Paper 1 - GU, non prostate session on Saturday, September 19 (Presentation #699O), and patient-reported outcomes are featured in an on-demand e-poster display (Presentation #745P).

Safety No new safety signals were identified in the JAVELIN Bladder 100 study, and the safety profile was consistent with previous studies of BAVENCIO monotherapy.1 Treatment-related adverse events of grade 3 or higher occurred in 57 patients (16.6%) treated with BAVENCIO plus BSC; no grade 3 or higher treatment-related events occurred in the control arm.1 No grade 4 or fatal immune-related adverse events occurred.1 Investigators attributed two patient deaths in the BAVENCIO plus BSC arm (0.6%), due to sepsis and ischemic stroke, to study treatment toxicity.1

About JAVELIN Bladder 100JAVELIN Bladder 100 (NCT02603432) is a Phase III, multicenter, multinational, randomized, open-label, parallel-arm study investigating first-line maintenance treatment with BAVENCIO plus BSC versus BSC alone in patients with locally advanced or metastatic UC. The primary endpoint was OS in the two primary populations of all patients and patients with PD-L1+ tumors defined by the Ventana SP263 assay. Secondary endpoints included progression-free survival, anti-tumor activity, safety, pharmacokinetics, immunogenicity, predictive biomarkers and patient-reported outcomes in the co-primary populations. All primary and secondary endpoints are measured from the time of randomization.

About Urothelial Carcinoma Bladder cancer is the tenth most common cancer worldwide.4 In 2018, there were over half a million new cases of bladder cancer diagnosed, with around 200,000 deaths from the disease globally.4 In the US, an estimated 80,470 cases of bladder cancer were diagnosed in 2019, with around 12,500 locally advanced or metastatic cases presented annually.5,6 UC, which accounts for about 90% of all bladder cancers,7 becomes harder to treat as it advances, spreading through the layers of the bladder wall.8 Only 25% to 55% of patients receive any second-line therapy after first-line chemotherapy.9-15 In the US and EU5 markets, approximately 40% to 50% of patients receive an immune checkpoint inhibitor in second-line therapy.3 For patients with advanced UC, the five-year survival rate is 5%.5

About BAVENCIO (avelumab)BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.16-18 In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved IndicationsBAVENCIO (avelumab) is indicated in the US for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. BAVENCIO is also indicated for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

BAVENCIO in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

BAVENCIO is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

BAVENCIO Important Safety Information from the US FDA-Approved Label BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients, including one (0.1%) patient with fatal, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause hepatotoxicity and immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% of patients, including two (0.1%) patients with fatal, and 11 (0.6%) with Grade 3.

BAVENCIO in combination with axitinib can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy. Withhold BAVENCIO and axitinib for moderate (Grade 2) hepatotoxicity and permanently discontinue the combination for severe or life-threatening (Grade 3 or 4) hepatotoxicity. Administer corticosteroids as needed. In patients treated with BAVENCIO in combination with axitinib, Grades3 and 4 increased ALT and AST occurred in 9% and 7% of patients, respectively, and immune-mediated hepatitis occurred in 7% of patients, including 4.9% with Grade3 or 4.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis until resolution. Permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and control hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO as a single agent or in 489 patients who received BAVENCIO in combination with axitinib: myocarditis including fatal cases, pancreatitis including fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barr syndrome, and systemic inflammatory response.

BAVENCIO can cause severe or life-threatening infusion-related reactions. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO in combination with axitinibcan cause major adverse cardiovascular events (MACE) including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and axitinib for Grade 3-4 cardiovascular events. MACEoccurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4 congestive heart failure (1.8%).

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

A fatal adverse reaction (sepsis) occurred in one (0.3%) patient with locally advanced or metastatic urothelial carcinoma (UC) receiving BAVENCIO plus best supportive care (BSC) as first-line maintenance treatment. In patients with previously treated locally advanced or metastatic UC, fourteen patients (6%) who were treated with BAVENCIO experienced either pneumonitis, respiratory failure, sepsis/urosepsis, cerebrovascular accident, or gastrointestinal adverse events, which led to death.

The most common adverse reactions (all grades, 20%) in patients with locally advanced or metastatic UC receiving BAVENCIO plus BSC (vs BSC alone) as first-line maintenance treatment were fatigue (35% vs 13%), musculoskeletal pain (24% vs 15%), urinary tract infection (20% vs 11%), and rash (20% vs 2.3%). In patients with previously treated locally advanced or metastatic UC receiving BAVENCIO, the most common adverse reactions (all grades, 20%) were fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection.

Selected laboratory abnormalities (all grades, 20%) in patients with locally advanced or metastatic UC receiving BAVENCIO plus BSC (vs BSC alone) as first-line maintenance treatment were blood triglycerides increased (34% vs 28%), alkaline phosphate increased (30% vs 20%), blood sodium decreased (28% vs 20%), lipase increased (25% vs 16%), aspartate aminotransferase (AST) increased (24% vs 12%), blood potassium increased (24% vs 16%), alanine aminotransferase (ALT) increased (24% vs 12%), blood cholesterol increased (22% vs 16%), serum amylase increased (21% vs 12%), hemoglobin decreased (28% vs 18%), and white blood cell decreased (20% vs 10%).

Fatal adverse reactions occurred in 1.8% of patients with advanced renal cell carcinoma (RCC) receiving BAVENCIO in combination with axitinib. These included sudden cardiac death (1.2%), stroke (0.2%), myocarditis (0.2%), and necrotizing pancreatitis (0.2%).

The most common adverse reactions (all grades, 20%) in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities (all grades, 20%) worsening from baseline in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were blood triglycerides increased (71% vs 48%), blood creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), alanine aminotransferase increased (ALT) (50% vs 46%), aspartate aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), and hemoglobin decreased (21% vs 65%).

Please see full US Prescribing Informationand Medication Guideavailable at http://www.BAVENCIO.com.

About Merck KGaA, Darmstadt, Germany-Pfizer AllianceImmuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany and Pfizer. The global strategic alliance between Merck KGaA, Darmstadt, Germany and Pfizer enables the companies to benefit from each other's strengths and capabilities and further explore the therapeutic potential of BAVENCIO, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance is jointly developing and commercializing BAVENCIO. The alliance is focused on developing high-priority international clinical programs to investigate BAVENCIO as a monotherapy as well as combination regimens, and is striving to find new ways to treat cancer.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to http://www.emdgroup.com/subscribeto register again for your online subscription of this service as our newly introduced geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

About EMD Serono, Inc.EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt,Germany, in the U.S. andCanada- is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state ofMassachusetts.www.emdserono.com.

About Merck KGaA, Darmstadt, GermanyMerck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany, generated sales of 16.2 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Pfizer Inc.: Breakthroughs that change patients' livesAt 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 http://www.pfizer.com.In addition, to learn more, please visit us on http://www.pfizer.comand follow us on Twitter at @Pfizerand @Pfizer_News, LinkedIn, YouTubeand like us on Facebook at Facebook.com/Pfizer.

Pfizer Disclosure Notice The information contained in this release is as of September 18, 2020. Pfizer assumes no obligation to update forward-looking statementscontained in this release as the result of new information or future events or developments.

This release contains forward-looking information about BAVENCIO (avelumab), including an indication for first-line maintenance therapy for BAVENCIO for the treatment of patients with locally advanced or metastatic urothelial carcinoma, the alliance between Merck KGaA, Darmstadt, Germanyand Pfizer involving BAVENCIO and clinical development plans, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of BAVENCIO; 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; risks associated with interim 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 whenany drug applications may be filed in any other jurisdictions for BAVENCIO for first-line maintenance therapy for locally advanced or metastatic urothelial carcinoma in any jurisdictions or for any other potential indications for BAVENCIO or combination therapies in any jurisdictions; whether and when regulatory authorities in any jurisdictions where any applications are pending or may be submitted for BAVENCIO or combination therapies, including BAVENCIO for locally advanced or metastatic urothelial carcinoma may approve any such applications, 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 they 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 BAVENCIO, including BAVENCIO for locally advanced or metastatic urothelial carcinoma; the impact of COVID-19 on our business, operations and financial results; and competitive developments.

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

References

Your Contacts

EMD Serono Inc.

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Noelle Piscitelli

+1 781 427 4351

Investor Relations

+49 6151 72-3321

Pfizer Inc., New York, USA

Media

Dervila Keane (EU)

+353 86 2110834

Jessica Smith

+1 646 899 3178

Investor Relations

Ryan Crowe

+1 215 260 0914

SOURCE EMD Serono

https://www.emdserono.com

Original post:
BAVENCIO Pivotal Phase III JAVELIN Bladder 100 Results Published in The New England Journal of Medicine - PRNewswire

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