Eosinophilic Sinusitis

DUBLIN, Aug. 9, 2022 /PRNewswire/ -- The "Intranasal Drug Delivery - Global Market Trajectory & Analytics" report has been added to ResearchAndMarkets.com's offering. Global Intranasal Drug Delivery Market to Reach $71.3 Billion by 2026 Nasal drug delivery route is suitable for systematic drug delivery, needleless vaccination, and for drug candidates with low oral absorption or vulnerable to first-pass effect in the human body. Intranasal drug delivery is a method involving the administration of drugs through the nasal cavity to produce a systemic or local therapeutic activity, with the exceptional vascular structure of the human nose making it suitable for administering small molecule drugs and biologics, and highly effective for treating local infections, and acute and chronic allergies. A plethora of local anesthetics, antibiotics, antihistamines, bronchodilators, calcium, corticosteroids, decongestant sprays, pain relief drugs, snuffs, supplements, vasoconstrictors and other drugs are administered through the intranasal route for chronic and acute treatments. Intranasal drugs are primarily administered in the form of ointments, sprays, powders, gels, and drops for treating allergic infections, analgesics, osteoporosis, vaccinations, pain management, anxiety, depression, and sexual dysfunction, among others. Amid the COVID-19 crisis, the global market for Intranasal Drug Delivery estimated at US$55.5 Billion in the year 2022, is projected to reach a revised size of US$71.3 Billion by 2026, growing at a CAGR of 6.2% over the analysis period. Liquid Delivery Devices, one of the segments analyzed in the report, is projected to grow at a 5.8% CAGR to reach US$31.3 Billion by the end of the analysis period. After a thorough analysis of the business implications of the pandemic and its induced economic crisis, growth in the Powder Delivery Devices segment is readjusted to a revised 7% CAGR for the next 7-year period. This segment currently accounts for a 31.5% share of the global Intranasal Drug Delivery market. The U.S. Market is Estimated at $23.2 Billion in 2022, While China is Forecast to Reach $5.7 Billion by 2026 The Intranasal Drug Delivery market in the U.S. is estimated at US$23.2 Billion in the year 2022. The country currently accounts for a 42.05% share in the global market. China, the world second largest economy, is forecast to reach an estimated market size of US$5.7 Billion in the year 2026 trailing a CAGR of 8.4% through the analysis period. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 4.8% and 5% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 5.9% CAGR while Rest of European market (as defined in the study) will reach US$6.1 Billion by the close of the analysis period. North America represents the leading global market for intranasal drug delivery, driven by the growing prevalence of respiratory disorders, such as asthma and COPD; the high adoption of drug delivery technique in healthcare institutions; and the growing affinity of patients for affordable generic drugs. Technological developments are among the major factors driving the growth of the US drug delivery industry. Select Competitors (Total 77 Featured): AptarGroup, Inc. AstraZeneca Plc. Becton Dickinson and Company GlaxoSmithKline Plc. Johnson & Johnson Inc. Merck & Co., Inc. Nemera Novartis AG OptiNose US Inc. Pfizer, Inc. Key Topics Covered: I. METHODOLOGY II. EXECUTIVE SUMMARY 1. MARKET OVERVIEW 2. FOCUS ON SELECT PLAYERS 3. MARKET TRENDS & DRIVERS Rise in Prevalence of COPD Drives Opportunities Pharmaceutical and Medical Device Companies Vie to Develop New Intranasal Therapeutics for Allergic Rhinitis Patients Intranasal Corticosteroids : A Potential Treatment for Debilitating Chronic Rhinosinusitis Disease Manufacturers Focus on Improved Nasal Delivery Platforms Controlled Release Technology is the Buzz Word Research on Nanocarrier-Based Intranasal Drug Delivery Systems Picks Up Pace Potential Role in Treatment and Management of Coronavirus Infection Self-Administration of Drugs Brings Intranasal Drug Delivery into the Spotlight Nasal Drug Delivery Offers New Opportunities for Drug Developers as Patent Cliffs Usher in Dusk of Blockbuster Era Increasing R&D Unlocks New Therapeutic Areas for Nasal Drug Delivery Intranasal Therapeutics Delivery: A High Potential Method for Treating CNS Diseases Researchers Develop Nasal Spray Treatment for Parkinson's Disease Future Opportunities in CNS Space Intranasal Delivery of Stem Cells: A Primary Strategy for Treatment of CNS Disorders Intranasal Delivery of Stem Cells: Limitations Diagnosed Prevalence Cases of Parkinson's Disease Across Select Countries Intranasal Delivery of Peptide-Based Pharmaceuticals Select Protein, Peptide & Non-Peptide Drugs Available as Nasal Spray Solutions in the Marketplace Select List of Nasal Biologics Available in the Market Benefits of Bi-Directional Nasal Drug Delivery Rise in Interest in Preservative-free Nasal Spray Formulations Burgeoning Geriatric Populace Spurs Growing Demand for Intranasal Drug Therapies 4. GLOBAL MARKET PERSPECTIVE III. MARKET ANALYSIS IV. COMPETITION. For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1904 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

Paris and Tarrytown, N.Y. June 7, 2022. The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. A regulatory filing for this age group is under review by the European Medicines Agency and submissions to regulatory authorities in additional countries are underway. Julie Block President and Chief Executive Officer, National Eczema Association “Moderate-to-severe atopic dermatitis in babies and young children is more than just a rash – the intense itch can make them scratch uncontrollably throughout the day and night and cause their skin to crack and bleed. Caregivers do their best to manage skincare routines multiple times a day, but for many, topical treatments are not enough. We’re pleased to see how scientific innovation and research continues to address unmet needs for the atopic dermatitis community, and we’re hopeful for the positive impact Dupixent can have for these children and their families.” Atopic dermatitis is a chronic type 2 inflammatory skin disease. Eighty-five to ninety percent of patients first develop symptoms before 5 years of age, which can often continue through adulthood. Symptoms include intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, redness or darkening, and crusting and oozing, along with increased risk of skin infections. In the U.S., more than 75,000 children aged 5 years and younger have uncontrolled moderate-to-severe disease and are most in need of new treatment options. Naimish Patel, M.D. Senior Vice President, Head of Global Development, Immunology and Inflammation, Sanofi “Until today, treatment options in the U.S. for infants and children under the age of 6 suffering from moderate-to-severe atopic dermatitis have been limited to topical steroids – which may be associated with significant safety risks when used long-term. This has left patients and their caregivers in desperate need of medicines that can better address the chronic, long-term nature of the disease. These young people, and their families, often struggle to cope with the significant impact itch can have on them. This approval means that Dupixent, with its well-established safety and efficacy profile, is now available to some of the youngest people living with this disease.” George D. Yancopoulos, M.D., Ph.D. President and Chief Scientific Officer, Regeneron “Young children with moderate-to-severe atopic dermatitis are a significantly underserved population of patients, who spend vulnerable years of their lives suffering through the relentless and far-reaching effects of this chronic disease. Dupixent has changed the atopic dermatitis treatment paradigm – significantly clearing skin and reducing itch – by targeting an underlying cause of this disease without broadly suppressing the immune system. Today’s approval brings the proven efficacy and, importantly, well-established safety profile of Dupixent to these young children, making it the first of its kind to be approved for any U.S. patient aged six months or older living with this debilitating disease.” The FDA evaluated Dupixent under Priority Review, which is reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions. The approval is based on data that include a Phase 3 trial evaluating Dupixent every four weeks (200 mg or 300 mg, based on body weight) plus low-potency topical corticosteroids (TCS) or TCS alone (placebo). The trial met the primary and all secondary endpoints. At 16 weeks, patients who received Dupixent with TCS experienced the following, compared to TCS alone: 28% achieved clear or almost-clear skin compared to 4% with placebo, the primary endpoint. 53% achieved 75% or greater improvement in overall disease severity from baseline compared to 11% with placebo TCS alone, the co-primary endpoint outside of the U.S. 48% achieved clinically meaningful reduction in itch compared to 9% with placebo. The safety profile of Dupixent observed through 16 weeks in children aged 6 months to 5 years was similar to the safety profile in patients 6 years and older with atopic dermatitis. The long-term safety profile of Dupixent in children aged 6 months to 5 years through 52 weeks was also similar to the safety profile observed in the pivotal trial and consistent with what was observed in older patients with atopic dermatitis. Hand-foot-and-mouth disease and skin papilloma were, respectively, reported in 5% and 2% of Dupixent patients aged 6 months to 5 years, and none of these cases led to treatment discontinuation. About the Dupixent Trial The Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent added to standard-of-care low-potency TCS compared to low-potency TCS alone (placebo) in 162 children aged 6 months to 5 years with uncontrolled moderate-to-severe atopic dermatitis. The primary endpoints assessed the proportion of patients achieving an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and 75% improvement in Eczema Area and Severity Index (EASI-75) at week 16. Additional outcome measures included itch reduction which was assessed using a caregiver-reported 0 to 10 Numerical Rating Scale, with a clinically meaningful improvement defined as ≥4-point improvement at week 16. Children who completed the trials were eligible to enroll in an open-label extension trial to assess the safety and efficacy of long-term treatment with Dupixent in this age group. About Dupixent Dupixent is administered as an injection under the skin (subcutaneous injection) at different injection sites. In patients aged 6 months to 5 years, Dupixent is administered with a pre-filled syringe every four weeks based on weight (200 mg for children ≥5 to <15 kg and 300 mg for children ≥15 to <30 kg). Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. In children younger than 12 years of age, Dupixent should be administered by a caregiver if given at home. Dupixent does not require initial lab testing or ongoing lab monitoring. Sanofi and Regeneron are committed to helping patients in the U.S. who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay® program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com. Dupixent is approved for use in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) or eosinophilic esophagitis in different age populations in a number of countries around the world. Dupixent is currently approved across these indications in the U.S. and for one or more of these indications in the European Union and Japan and more than 60 countries. More than 400,000 patients have been treated globally. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, CRSwNP and eosinophilic esophagitis, as well as investigational diseases such as prurigo nodularis. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including prurigo nodularis, pediatric eosinophilic esophagitis, hand and foot atopic dermatitis, chronic inducible urticaria-cold, chronic spontaneous urticaria, chronic pruritis of unknown origin, chronic obstructive pulmonary disease with evidence of type 2 inflammation, chronic rhinosinusitis without nasal polyposis, allergic fungal rhinosinusitis, allergic bronchopulmonary aspergillosis and bullous pemphigoid. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous FDA-approved treatments and product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions.

Paris and Tarrytown, N.Y. May 20, 2022. The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) 300 mg weekly to treat patients with eosinophilic esophagitis (EoE) aged 12 years and older, weighing at least 40 kg. With this approval, Dupixent becomes the first and only medicine specifically indicated to treat EoE in the United States. A regulatory filing for EoE is under review by the European Medicines Agency, and submissions to regulatory authorities in additional countries are planned by the end of 2022. Mary Jo Strobel Executive Director, American Partnership for Eosinophilic Disorders (APFED) “We have waited a long time for an FDA-approved treatment option for eosinophilic esophagitis - an underdiagnosed and misunderstood disease of the esophagus that can make it extremely challenging and uncomfortable to eat and swallow. Before today, there were no approved treatments specifically for eosinophilic esophagitis, resulting in many people needing to maintain a strict diet and live in constant fear of food getting stuck in their throat. We welcome therapeutic options that can provide much-needed relief for these patients.” EoE is a chronic inflammatory disease driven by type 2 inflammation that damages the esophagus and prevents it from working properly. For people with EoE, swallowing even small amounts of food can be a painful and worrisome choking experience. They are often left to contend with the frustration and anxiety of a constantly evolving list of foods to avoid, a poor quality of life and a higher risk of depression. In cases where EoE causes the esophagus to narrow, forced and potentially painful dilation (physical expansion) of the esophagus may be needed. In severe cases, a feeding tube may be the only option to ensure proper caloric intake and adequate nutrition. About 160,000 patients are living with EoE in the U.S. These individuals are currently treated with therapies not specifically approved for the disease, of whom approximately 48,000 continue to experience symptoms despite multiple treatments. John Reed, M.D., Ph.D. Global Head of Research and Development, Sanofi “Eating regularly throughout the day is essential, yet significant difficulty swallowing food is a common symptom for people living with eosinophilic esophagitis. This can be incredibly upsetting and often leads to fear of pain or choking with every meal, every day. A large unmet need exists for treatment options that can provide meaningful symptom relief. Our Phase 3 clinical program showed that Dupixent weekly improved the ability to swallow and reduced inflammation in the esophagus, underscoring the role of type 2 inflammation in this complex disease. This is a landmark FDA approval for patients and their caregivers who now have a new option for treating this devastating disease.” George D. Yancopoulos, M.D., Ph.D. President and Chief Scientific Officer, Regeneron “It is gratifying that Dupixent, a medicine that we invented in our laboratories, is now approved in yet another disease marked by allergic or type 2 inflammation, namely eosinophilic esophagitis. Eosinophilic esophagitis can be debilitating for patients, by inflaming and damaging the esophagus and limiting the ability to eat normally. Dupixent is the first and only medicine specifically indicated to treat eosinophilic esophagitis in the United States, and today’s approval marks the fourth disease for which Dupixent is now indicated, reinforcing the promise of targeting IL-4 and IL-13 to effectively treat diseases with underlying type 2 inflammation.” The FDA approval is based on data from a Phase 3 trial with two parts (Part A and Part B) evaluating the efficacy and safety of Dupixent 300 mg weekly, compared to placebo, in patients aged 12 years and older with EoE, weighing at least 40 kg. After 24 weeks, patients treated with Dupixent 300 mg weekly experienced the following changes in Part A and Part B, respectively: 69% and 64% reduction in disease symptoms from baseline compared to 32% and 41% for placebo. Disease symptoms were measured by the Dysphagia Symptom Questionnaire (DSQ), where patients receiving Dupixent experienced a 21.9- and 23.8-point clinically meaningful improvement compared to 9.6- and 13.9-point improvement for placebo. Approximately 10 times as many patients achieved histological disease remission (peak esophageal intraepithelial eosinophil count of ≤6 eos/high power field [hpf]) compared to placebo: 60% and 59% compared to 5% and 6% of patients receiving placebo. The safety results were generally consistent with the known safety profile of Dupixent in its approved indications. Pooled adverse events from Parts A and B that were more commonly (≥2%) observed with Dupixent than placebo were injection site reactions (38% Dupixent, 33% placebo), upper respiratory tract infections (18% Dupixent, 10% placebo), arthralgia (2% Dupixent, 1% placebo) and herpes viral infections (2% Dupixent, 1% placebo). The FDA evaluated the Dupixent application under Priority Review, which is granted to therapies that have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. About the Dupixent Eosinophilic Esophagitis Trial The Phase 3 randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of Dupixent in patients aged 12 years and older with EoE. Part A enrolled 81 patients and evaluated Dupixent 300 mg weekly (42 treated with Dupixent and 39 with placebo). Part B enrolled 159 patients and evaluated Dupixent 300 mg weekly (80 with Dupixent and 79 with placebo). At 24 weeks, the co-primary endpoints in Parts A and B assessed patient-reported measures of difficulty swallowing (change from baseline in the DSQ on a 0-84 scale) and esophageal inflammation (proportion of patients achieving histological disease remission, defined as peak esophageal intraepithelial eosinophil count of ≤6 eos/hpf). About Dupixent Dupixent is administered as an injection under the skin (subcutaneous injection) at different injection sites. In patients aged 12 years and older, weighing at least 40 kg, with EoE, Dupixent is administered as a 300 mg dose with a pre-filled syringe or pen every week. Dupixent is intended for use under the guidance of a healthcare professional and can be given in a clinic or at home by self-administration after training by a healthcare professional. In children aged 12 to 17 years, Dupixent should be administered under the supervision of an adult. Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent such as asthma, atopic dermatitis, chronic rhinosinusitis with nasal polyposis (CRSwNP) and eosinophilic esophagitis, as well as investigational diseases such as prurigo nodularis. Regeneron and Sanofi are committed to helping patients in the U.S. who are prescribed Dupixent gain access to the medicine and receive the support they may need with the DUPIXENT MyWay® program. For more information, please call 1-844-DUPIXENT (1-844-387-4936) or visit www.DUPIXENT.com. Dupixent is also approved for use in certain patients with atopic dermatitis, asthma or CRSwNP in different age populations in a number of countries around the world, including the U.S., European Union and Japan. Dupixent is currently approved for one or more of these indications in more than 60 countries, and more than 400,000 patients have been treated globally. Dupilumab Development Program Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Sanofi and Regeneron are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes including pediatric atopic dermatitis (6 months to 5 years of age, Phase 3), hand and foot atopic dermatitis (Phase 3), chronic obstructive pulmonary disease with evidence of type 2 inflammation (Phase 3), pediatric eosinophilic esophagitis (Phase 3), bullous pemphigoid (Phase 3), prurigo nodularis (Phase 3), chronic spontaneous urticaria (Phase 3), chronic pruritis of unknown origin (Phase 3), chronic inducible urticaria-cold (Phase 3), chronic rhinosinusitis without nasal polyposis (Phase 3), allergic fungal rhinosinusitis (Phase 3) and allergic bronchopulmonary aspergillosis (Phase 3). These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for nearly 35 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, infectious diseases and rare diseases. Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune®, which uses unique genetically humanized mice to produce optimized fully human antibodies and bispecific antibodies, and through ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter. About Sanofi We are an innovative global healthcare company, driven by one purpose: we chase the miracles of science to improve people’s lives. Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to turn the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Sanofi Media Relations Sally Bain | + 1 617 834 6026 | sally.bain@sanofi.com Sanofi Investor Relations Eva Schaefer-Jansen | + 33 7 86 80 56 39 | eva.schaefer-jansen@sanofi.com Arnaud Delépine | + 33 06 73 69 36 93 | arnaud.delepine@sanofi.com Corentine Driancourt | + 33 06 40 56 92 | corentine.driancourt@sanofi.com Felix Lauscher | + 1 908 612 7239 | felix.lauscher@sanofi.com Priya Nanduri |+617 764 6418 | priya.nanduri@sanofi.com Nathalie Pham | + 33 07 85 93 30 17 | nathalie.pham@sanofi.com Regeneron Media Relations Ashleigh Dixon | + 1 914 374 2422 | ashleigh.dixon@regeneron.com Regeneron Investor Relations Vesna Tosic | + 914 847 5443 | vesna.tosic@regeneron.com