Stallergenes Greer Submits a Marketing Authorisation Application in Europe for Its Sublingual House Dust Mite Allergen Immunotherapy Tablet
4.5.2020 10:00:00 EEST | Business Wire | Press release
Stallergenes Greer, a biopharmaceutical company specialising in treatments for respiratory allergies, announces the submission of a marketing authorisation application for STAGR320, its sublingual house dust mite (HDM) immunotherapy (SLIT) tablet, via a European decentralized procedure.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200504005266/en/
“By further developing its portfolio of allergen immunotherapy solutions, Stallergenes Greer enables physicians and patients to determine the treatment alternative that best meets the clinical and immunological profile and the lifestyle needs of each individual. This significant milestone demonstrates our determination to offer patients and the medical community an extensive portfolio of personalised treatment options including injectable and sublingual therapies such as drops and tablets,” stated Michele Antonelli, CEO of Stallergenes Greer.
The STAGR320 phase III clinical trial, which included 1,600 patients from 231 participating investigative sites in 13 countries, assessed the treatment of HDM-induced allergic rhinitis in adult and adolescent patients. The trial achieved both its primary efficacy endpoint and key secondary endpoints and showed a comparable safety profile to that observed in other clinical studies with STAGR320. The randomized, double-blind, placebo-controlled trial was the largest phase III clinical trial conducted to evaluate the treatment of house dust mite allergy.
Allergic rhinitis affects more than 500 million people worldwide, 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 others1,2. Symptoms may be severe and can worsen over time and have a significant impact on quality of life1-3,4-5.
ABOUT STAGR320
STAGR320 is Stallergenes Greer’s investigational sublingual allergen immunotherapy (AIT) tablet for the treatment of HDM-induced allergic rhinitis, with or without intermittent asthma. Allergen immunotherapy uniquely alters the natural course of respiratory allergies. It is the only therapeutic class capable of modifying disease progression and potentially preventing the onset of the disease by inducing tolerance in the immune system. STAGR320 is registered under the brand name Actair® in Australia, Japan, New Zealand and South Korea for the treatment of HDM-induced allergic rhinitis in adults and adolescents. The indication is extended in Japan for use in children below 12 years of age.
The review by Health Canada of the New Drug Submission for STAGR320 is underway.
Stallergenes Greer’s STAGR320 HDM sublingual immunotherapy tablet strengthens the company’s tablet portfolio, which already includes Oralair® for the treatment of grass pollen allergies. STAGR320 contains the same active ingredient as the company’s Staloral® HDM sublingual solution formulation. Stallergenes Greer’s wide range of treatment options provides physicians with solutions tailored to the needs of each patient: sublingual tablet formulation for ease of use and convenience, and sublingual solution for flexible dosing according to each individual profile.
ABOUT STALLERGENES GREER Ltd
Headquartered in London (UK), Stallergenes Greer Ltd is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer Ltd 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).
Additional information is available at https://www.stallergenesgreer.com/
REFERENCES
1. 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.
2. Brożek JL, Bousquet J, Agache I, et al. Allergic Rhinitis and its Impact on Asthma (ARIA) Guidelines – 2016 Revision, Journal of Allergy and Clinical Immunology (2017), doi: 10.1016/j.jaci.2017.03.050.
3. 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.
4. 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.
5. 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200504005266/en/
Contact information
Communications
Catherine Kress
Tel: +33 01 55 59 26 05
Email: catherine.kress@stallergenesgreer.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
FDA Authorizes ZYN ULTRA Nicotine Pouches Following Scientific Review21.8.2026 22:11:00 EEST | Press release
Philip Morris International Inc. (NYSE: PM) today announces that the U.S. Food and Drug Administration (FDA) issued Marketing Granted Orders to PMI’s U.S. affiliate, Swedish Match USA, Inc., authorizing the marketing of 11 ZYN ULTRA moist oral nicotine pouch products, including all 9mg variants and one 11mg variant. Additional 11mg variants remain under scientific review. Today’s action further enhances PMI’s leadership role in the smoke-free category. “We are delighted with the FDA’s decision to authorize a range of ZYN ULTRA products, which will build on ZYN’s position as America’s leading smoke-free product brand,” said Stacey Kennedy, PMI U.S. CEO. “We look forward to expanding our portfolio of better choices for the 45 million Americans who consume nicotine products.” ZYN ULTRA positions the brand to further extend its category leadership among legal-age consumers of nicotine products. Like the flagship FDA-authorized ZYN pouches, ZYNULTRA, with its higher moisture content, is fre
58% of Consumers Say They Don't Care Whether a Product is a National Brand or Private Label. They Just Buy What They Need21.8.2026 13:00:00 EEST | Press release
As fast-moving consumer goods (FMCG) prices rose 26% globally between 2021 and 2025, consumers have become more deliberate about where they save and where they spend. NielsenIQ (NYSE: NIQ) has released new findings showing that private label is no longer viewed simply as a lower-cost substitute, but as a credible competitor across value, mainstream, and premium segments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260819950224/en/ Private label is no longer just a value play. The findings, published in NIQ’s latest report, A Tale of Two Consumers: The Polarized Mindsets Reshaping Global Consumption, created in collaboration with World Data Lab, show how consumer polarization is redefining value and reshaping competition on the shelf. The report also draws on insights from NIQ's 2025reportFinding Harmony on the Shelfwhich documented changing perceptions of private label products. Key findings from these reports include: 58
Tanium Reappoints Co-Founder Orion Hindawi as CEO to Drive Next Chapter of Growth20.8.2026 22:10:00 EEST | Press release
Tanium, a leader in Autonomous IT, today announced that Co-Founder and Executive Chairman Orion Hindawi has been appointed Chief Executive Officer, effective immediately. Dan Streetman is stepping down as CEO and as a member of the Board after leading Tanium for the last three years, during which time Tanium scaled its go-to-market operations and secured strong industry analyst recognition for innovation within the Tanium platform. Streetman will continue to advise Tanium as part of the transition and co-founder David Hindawi will return to the role of Chairman of the Board. With this foundation in place, this transition positions Tanium to deepen its Autonomous IT capabilities and further expand AI offerings across its portfolio and strengthen customer and partner engagement. The Hindawis co-founded Tanium in 2007 to build the central nervous system of enterprise security, giving organizations unified visibility and control over their endpoints. During his prior tenure as CEO from 201
PCI Energy Solutions to Join Mitsubishi Electric, Reinforcing Long-Term Commitment to Customers, Employees, and the Energy Industry20.8.2026 20:46:00 EEST | Press release
PCI Energy Solutions ("PCI"), a leading U.S.-based provider of enterprise software for energy management and optimization, announced today that it has entered into a definitive agreement to be acquired by Mitsubishi Electric Corporation. The agreement was executed on August 20, 2026 (Japan Standard Time). The Transaction represents a strong endorsement of PCI's business, technology, employees, customer relationships and position in the energy industry. Mitsubishi Electric intends to retain PCI's core management team following completion of the Transaction, enabling PCI to preserve leadership continuity, industry expertise and its customer-focused operating model while benefiting from Mitsubishi Electric's global scale, complementary capabilities and long-term investment capacity. The agreement has been signed, but the Transaction has not yet closed. PCI and Mitsubishi Electric will continue to operate as separate companies until closing, which is subject to applicable regulatory approv
Perma-Pipe Secures More Than $67 Million in New Orders in the Second Quarter of 202620.8.2026 20:02:00 EEST | Press release
Perma-Pipe International Holdings, Inc. (Nasdaq: PPIH), a global leader in engineered piping and corrosion protection solutions, today announced that the Company secured more than $67 million in new orders during the second quarter of fiscal 2026, representing strong demand across its strategically important end-markets and geographies. The orders further strengthen Perma-Pipe's backlog and provide increased visibility into future revenue growth. The Company's backlog remains well diversified across geographies, customers and end-markets. The Company continued to see strong demand across its core Oil & Gas and infrastructure markets, while also securing important new business in emerging applications, including advanced leak detection and monitoring solutions. During the quarter, Perma-Pipe secured sizable Oil & Gas awards in both MENA and Canada, reinforcing the Company's position as a trusted supplier to customers undertaking significant energy infrastructure investments. The Company
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom