Stallergenes Greer Ltd.

BAAR, Switzerland--( BUSINESS WIRE )--Stallergenes Greer, a leading global healthcare company specialising in allergen immunotherapy, today announced that the U.S Food and Drug Administration (FDA) has approved Palforzia ® [Peanut (Arachis hypogaea) Allergen Powder-dnfp], for the treatment of toddlers (ages 1-3 years) with a confirmed diagnosis of a peanut allergy. This approval expands the January 2020 FDA approval for patients ages 4-17 years. Palforzia ® is to date the first and only approved oral immunotherapy treatment (OIT) for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. Peanut allergy currently affects approximately 2% of the general population of Western nations 1 , and the prevalence of peanut allergy doubled among children between 2005 and 2015 2 . Compared with other food allergies, peanut allergy is associated with higher rates of accidental exposure, severe reactions and potentially fatal anaphylaxis 1 . The difficulty in avoiding peanuts, combined with the severity of allergic reactions, shows the need for effective treatment 3 . “ We are delighted that Palforzia ® has received regulatory approval in the U.S. for toddlers as there is a high unmet medical need for this age group and we are confident that this indication extension will alleviate the burden of peanut allergy for younger patients and their families,” says Elena Rizova, MD, PHD, Chief Medical Officer of Stallergenes Greer. The FDA approval in toddlers is based on data from the Phase 3 POSEIDON ( P eanut O ral Immunotherapy S tudy of E arly I ntervention for D esensitizati on ) study that was published in the New England Journal of Medicine Evidence in 2023. The study evaluated the efficacy and safety of Palforzia ® in peanut-allergic children aged 1 to 3 years old, meeting all its primary and secondary efficacy endpoints and demonstrating a favourable safety profile. Stallergenes Greer acquired the rights to Palforzia ® in September 2023. As part of our ongoing commitment to delivering innovative solutions in allergen immunotherapy, our focus in the U.S has been on establishing a specialised Food Allergy business unit and transitioning the product into our AIT portfolio. ABOUT PALFORZIA ® Palforzia ® is in the U.S an oral immunotherapy treatment indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut for patients. The treatment is approved for use in patients with a confirmed diagnosis of peanut allergy and in conjunction with a peanut-avoidant diet. Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis. Palforzia ® is approved by the U.S. Food and Drug Administration (FDA) for ages 1-17 years and for ages 4-17 years by the European Medicine Agency (EMA), by the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K., and by Swissmedic in Switzerland. Pediatric indication extension submissions are currently under review by the EMA and Swissmedic. ABOUT POSEIDON PHASE 3 STUDY POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, clinicaltrials.gov number NCT03736447) is an international, randomized (2:1), double-blind, placebo-controlled Phase 3 study that evaluated the efficacy and safety of Palforzia ® in peanut-allergic children aged 1 to 3 years of age in North America and Europe. The POSEIDON study was completed by Aimmune Therapeutics, part of Nestlé Health Science before Nestlé divested Palforzia ® to Stallergenes Greer in September 2023. Enrollment was based on several entry criteria, including a documented clinical history of peanut allergy, positive skin prick tests and/or elevated blood levels of peanut antibodies, and dose-limiting symptoms after consuming single doses of peanut protein >3 to ≤300 mg in a positive double-blind, placebo-controlled food challenge. In POSEIDON, patients underwent a dose-escalation period of approximately 22 weeks to reach a dose of 300 mg per day of Palforzia ® or placebo, then continued that dose for approximately six months. At the end of the trial, patients underwent an exit double-blind, placebo-controlled food challenge (DBPCFC). ABOUT STALLERGENES GREER INTERNATIONAL AG Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of respiratory, food and venom allergies through the development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). For more information, visit www.stallergenesgreer.com . 1 The global burden of illness of peanut allergy: A comprehensive literature review. Jay A. Lieberman, Ruchi S Gupta, Rebecca C. Knibb, Tmirah Haselkorn, Stephen Tilles, Douglas P. Mack, and Guillaume Pouessel. Online: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8247890/ Accessed August 31, 2023 2 Du Toit G, et al. Randomized Trial of Peanut Consumption in Infants at Risk for Peanut Allergy. N Engl J Med 2015; 372: 803-13. Accessed August 31, 2023. 3 Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107:191-3. Accessed August 31, 2023. Palforzia®: © 2023, Société des Produits Nestlé S.A. or its affiliates

EfficAPSI is a real-world study with the largest number of patients follow-up to date in the field of allergen immunotherapy (AIT).1 The rigorous methodology used in this study provides important insights about Stallergenes Greer SLIT-liquid as allergic asthma disease-modifying medicine. 1 In this study, treatment with Stallergenes Greer SLIT-liquid was associated with a one-third reduction in the incidence of new asthma events in patients, with or without a history of asthma. 1 The findings confirm the real-life long-term effectiveness of personalised SLIT-liquid for the treatment of allergic rhinitis patients (above the age of 5), with and without pre-existing asthma, regardless the allergen. They substantiate SLIT-liquid as a relevant causal treatment option to prevent both asthmatic disease onset and progression. 1 By demonstrating the benefit on the onset and worsening of asthma, SLIT-liquid treatments confirm their impact in terms of public health. 1 BAAR, Switzerland--(BUSINESS WIRE)-- Stallergenes Greer, a global healthcare company specialising in allergen immunotherapy (AIT), today announced that results of its EfficAPSI real-world study evaluating the impact of Stallergenes Greer liquid sublingual AIT (SLIT-liquid) on asthma onset and evolution in patients with allergic rhinitis have been published in the Lancet Regional Health-Europe. The publication is available online ( ) and will be available in print at a later date. This retrospective longitudinal pharmaco-epidemiological real-world study, which evaluated data over a 9-year period, included over 440,000 patients: more than 110,000 patients with allergic rhinitis, with or without asthma, treated with Stallergenes Greer SLIT-liquid and symptomatic drugs; compared to more than 330,000 patients with allergic rhinitis, with or without asthma, treated with symptomatic drugs only. The primary objective of the study was the evaluation of the real-world impact of Stallergenes Greer SLIT-liquid on the prevention of asthma onset or worsening in patients with allergic rhinitis. Study results were consistent across all age groups (patients above the age of 5), allergens and endpoints. In patients undergoing treatment with Stallergenes Greer SLIT-liquid and symptomatic drugs versus patients treated with symptomatic drugs only, the study showed: a 36% reduction in the risk of new asthma events in the overall cohort*; a 38% reduction in the risk of asthma onset in patients without pre-existing asthma; a one-third reduction in Global Initiative for Asthma (GINA) treatment stepping-up, in patients with pre-existing asthma demonstrating the impact of SLIT-liquid to prevent asthma worsening. “I am pleased that the publication of this extensive, large real-world EfficAPSI study in the Lancet Regional Health-Europe is now available for the medical community. The study confirms the role of SLIT- liquid in reshaping asthma management. The findings deliver important insights on the relevance of SLIT liquid as etiological medication which offers the advantage of a personalised treatment tailored to each patient's unique needs for improved outcomes,” said Professor Pascal Demoly, MD, PhD, Head of the Pulmonology, Allergology and Thoracic Oncology Department, Montpellier University Hospital (France), President of the French Society of Allergology, and member of the study’s scientific committee. “Exploring the impact of allergen immunotherapy on asthma onset and progression is crucial, and we're committed to filling those gaps. Through this real-world EfficAPSI study, Stallergenes Greer is honoured to contribute valuable scientific evidence and insights to allergy treatment. We remain focused on advancing disease-modifying solutions, fuelled by strong clinical data, to redefine respiratory care, and dedicated to improving quality of life for people with allergies” declared Dr Elena Rizova, Chief Medical Officer, Stallergenes Greer. By demonstrating the benefit on the onset and worsening of asthma, Stallergenes Greer SLIT-liquid treatments confirm their impact in terms of public health. Stallergenes Greer intends to increasingly use a real-world approach to bolster the evidence supporting the beneficial effects of SLIT. Additional endpoints are currently under evaluation and will be published subsequently. ABOUT EfficAPSI 1 EfficAPSI is to date the largest retrospective real-world, longitudinal cohort study regarding liquid sublingual AIT. Its main objective was to evaluate the real-life impact of SLIT-liquid on the prevention of asthma onset and worsening in patients with allergic rhinitis. This study included more than 110,000 patients in France with allergic rhinitis, with or without asthma, treated with Stallergenes Greer SLIT-liquid and symptomatic drugs and more than 330,000 patients with allergic rhinitis, with or without asthma, treated with symptomatic drugs only. The EfficAPSI study, evaluated data from January 1, 2010 to December 31, 2018. EfficAPSI is the first study in the AIT field in which the French national system database (SNDS), covering 99% of the French population, has been used to gain insight on therapeutic benefits in real life practice by pairing their data with the data of a healthcare company. Onset or worsening of asthma were defined as the first occurrence of a specific pharmacy dispensation, hospitalisation or long-term disease (LTD) for asthma in the sensitive analysis; pharmacy dispensation was omitted for a more specific, secondary definition, focusing on severe forms of asthma. A combined definition, both sensitive and specific, was also used considering specific pharmacy dispensation of major medications (omalizumab or three inhaled corticosteroids associated or not with long-acting beta agonists), hospitalisation or LTD for severe asthma. Analyses were stratified on pre-existing mild or moderate asthma to differentiate between the onset and worsening of asthma. A total of 112,492 exposed (SLIT-liquid) and 333,082 unexposed patients (control) were included. Findings on new asthma events: in allergic rhinitis patients, Stallergenes Greer SLIT-Liquid exposure was associated with a significantly lower risk of new asthma events, when compared to control group (symptomatic drugs only), according to all definitions (sensitive, HR: 0.76, 95% CI 0.75-0.76; specific, HR: 0.66, 95% CI 0.63-0.69; combined, HR: 0.64, 95% CI 0.63-0.65). Findings on onset of asthma: in allergic rhinitis patients without pre-existing asthma, Stallergenes Greer SLIT-liquid exposure was associated with a significantly lower risk of asthma onset when compared to control group (symptomatic drugs only), according to all definitions (sensitive, HR: 0.77, 95% CI 0.76-0.78; specific, HR: 0.67, 95% CI 0.61-0.72; combined, HR: 0.62, 95% CI 0.60-0.63). Findings on worsening of asthma: in allergic rhinitis patients with pre-existing asthma, Stallergenes Greer SLIT-liquid exposure was associated with a significantly lower risk of asthma events when compared to control group (symptomatic drugs only), according to all definitions (sensitive, HR: 0.71, 95% CI 0.70-0.72; specific, HR: 0.62, 95% CI 0.59-0.65; combined, HR: 0.62, 95% CI 0.61-0.63). In addition, a one-third reduction in GINA treatment stepping-up was observed regardless of patients’ GINA treatment step at baseline (HR: 0.72, 95% CI 0.69-0.75 for baseline step 1; HR: 0.73, 95% CI 0.68-0.79 for baseline step 2; HR; 0.71, 95% CI 0·65-0·78 for baseline step 3/4). The EfficAPSI study covers a wide range of allergens including house dust mites, grass, birch and ragweed pollens, and cat dander. Results were positive and consistent for all analysable allergens and all age groups (above the age of 5). The study was designed with a scientific committee composed of Prof. Pascal Demoly, MD, PhD, HDR, Head of the Pulmonology, Allergology and Thoracic Oncology Department, Montpellier University Hospital (France); Prof. Philippe Devillier, Hôpital Foch, Suresnes (France); Prof. Jean François Bergmann, Head of Internal Medicine, Hôpital Lariboisière, Paris, Professor of Therapeutics, Paris-Diderot University (France); Dr. Bertrand Delaisi, Boulogne-Billancourt (France), and Prof. Mathieu Molimard, Head of the Pharmacology Department, Bordeaux University Hospital (France). ABOUT ALLERGIC RHINITIS Allergic rhinitis is a worldwide disease affecting more than 500 million people, who are at higher risk of developing rhinitis exacerbation and asthma than the general population. Allergic rhinitis can include symptoms such as sneezing, a runny or itchy nose, nasal congestion and watery or itchy eyes, among others.2,3 Symptoms may be severe and can worsen over time and have a significant impact on quality of life.2,4,5,6,7 ABOUT STALLERGENES GREER INTERNATIONAL AG Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of respiratory, food and venom allergies through the development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of Greer Laboratories, Inc. (whose registered office is in the United States) and Stallergenes SAS (whose registered office is in France). For more information, visit . *combined score _______________________________ 1 Demoly P, Molimard M, Bergmann JF, et al. Impact of liquid sublingual immunotherapy on asthma onset and progression in patients with allergic rhinitis: a nationwide population-based study (EfficAPSI study). Lancet Reg Health Eur. 2024. 2 Demoly P, Corren J, Creticos P, et al. A 300 IR sublingual tablet is an effective, safe treatment for house dust mite–induced allergic rhinitis: An international, double-blind, placebo-controlled, randomized phase III clinical trial. J Allergy Clin Immunol. 2021;147(3):1020-1030.e10 3 Bousquet J, Khaltaev N, Cruz A, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160. 4 Brozek JL, Bousquet J, Agache I, Agarwal A, Bachert C, Bosnic-Anticevich S, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines— 2016 revision. J Allergy Clin Immunol. 2017;140(4):950–8 5 Linneberg A., Henrik Nielsen N., Frolund L, et al. The link between allergic rhinitis and allergic asthma: a prospective population-based study. The Copenhagen Allergy Study. Allergy. 2002 Nov;57(11):1048-1052. 6 Shin J-W, Sue J-H, Song T-W, et al. Atopy and house dust mite sensitization as risk factors for asthma in children. Yonsei Med J.2005;46: 629- 634. 7 Hankin C. S., Cox L., Lang D., et al. Allergen immunotherapy and health care cost benefits for children with allergic rhinitis: a large-scale, retrospective, matched cohort study. Ann Allergy Asthma Immunol. 2010 Jan;104(1):79-85 View source version on businesswire.com: Contacts Stallergenes Greer Communications Catherine Kress Tel: +33 (0)1 55 50 26 05 Email: catherine.kress@stallergenesgreer.com Source: Stallergenes Greer View this news release online at:

Novartis and Roche's Xolair has been approved by the FDA to prevent severe allergic reactions to common foods such as peanuts, tree nuts, milk, eggs and wheat. People with food allergies finally have a medicine that can help prevent severe outcomes—and it’s a drug that’s been on the market for two decades. The FDA has blessed Roche and Novartis’ Xolair (omalizumab) as the first medicine to reduce allergic reactions that can occur with accidental exposure to certain foods. The drug is approved for people ages 1 year and older with certain allergies. The therapy is for people with IgE-mediated food allergies, a classification that includes 160 foods, the most common of which are peanuts, milk, eggs, wheat, soy and tree nuts. Xolair is not designed to allow patients to freely eat these foods. It just helps them avoid severe reactions, including anaphylaxis, a life-threatening condition that can happen immediately as the immune system releases chemicals that can cause the body to go into shock. There are 3.4 million children in U.S. that have food allergies and more than 40% of them have had at least one severe reaction, according to Roche subsidiary Genentech. Food reactions cause approximately 30,000 emergency room visits each year in the U.S. The approval came just two months after the FDA accepted the companies’ supplemental biologics license application in this indication. After injections of Xolair every two to four weeks—with intervals determined by body weight and serum immunoglobulin E (IgE) level—patients would be protected. Backing the green light are results of a phase 3 trial, which was co-sponsored by the U.S. National Institutes of Health. The phase 3 OUtMATCH study showed that Xolair significantly increased the amount of peanut (primary endpoint) and milk, egg and cashew (secondary endpoints) it took to cause an allergic reaction compared to placebo. Study results showed 68% of patients treated with Xolair for 16 to 20 weeks tolerated at least 600 mg of peanut protein without moderate to severe allergic symptoms, compared to 5% of those treated with placebo. This amount is equivalent to approximately two and a half peanuts, or half a teaspoon of regular peanut butter. Xolair was first approved by the FDA in 2003 for asthma. The drug generated $3.9 billion in sales last year. Xolair works by inhibiting IgE antibodies, which cause chemical reactions that produce inflammation seen in allergy and asthma attacks. In 2018, the FDA granted breakthrough designation for Xolair as a treatment for food allergies. “Many people with food allergies and their loved ones live in constant fear of accidentally coming into contact with the food they are allergic to and the life-threatening allergic reaction,” Reshema Kemps-Polanco, Novartis U.S. chief commercial officer, said in a release. “Today’s approval of Xolair represents a paradigm shift in the way food allergies can be managed.” In September of last year, Nestle sold its peanut allergy drug Palforzia to Stallergenes Greer for an undisclosed sum. In 2020, Palforzia was the first peanut allergy drug approved by the FDA, but its sales never indicated it could reach Evaluate Pharma’s projection of $1.28 billion by 2024. Nestle acquired Palforzia in a $2.1 billion buyout of Aimmune Therapeutics.