Business Wire

Positive Outcome of European Decentralised Registration Procedure for Stallergenes Greer’s Sublingual House Dust Mite Allergen Immunotherapy Tablet

Share

Stallergenes Greer, a biopharmaceutical company specialising in treatments for respiratory allergies, announces the positive outcome of the European decentralised registration procedure for its sublingual house dust mite (HDM) allergen immunotherapy tablet Actair®. The Paul-Ehrlich-Institut (PEI), Germany, acted as reference member state on behalf of 21 European countries. Each member state involved in the procedure will now issue individual national marketing authorisations at the end of their national phase.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210531005167/en/

“We are pleased to have achieved this significant milestone which demonstrates our commitment to patients and marks a major step forward for the company’s further development in the European market. Stallergenes Greer’s sublingual allergen immunotherapy tablet is an important option for people suffering from house dust mite-induced allergic rhinitis or rhinoconjunctivitis and illustrates our engagement to provide patients with a range of administration modes tailored to individual needs and profiles,” declares Michele Antonelli, Chief Executive Officer.

Stallergenes Greer offers a wide range of treatment options and is paving the way for personalised precision medicine-based allergen immunotherapy: tablet and liquid sublingual solutions as well as subcutaneous formulations.

The tablet is already registered in Australia, Japan, New Zealand and South Korea under the brand name Actair® for treatment of moderate to severe house dust mite-induced allergic rhinitis or rhinoconjunctivitis.

This sublingual allergen immunotherapy (SLIT) tablet will strengthen the company’s tablet portfolio in Europe which already includes Oralair®.

About the STAGR320 Clinical Trial

The STAGR320 Phase III clinical trial, which included 1,607 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 STAGR3201. The study results provide the medical community with compelling evidence that STAGR320 induces clinically relevant improvement of rhinitis symptoms in patients with HDM allergy, which ultimately has an impact on all parameters relating to quality of life.

The randomised, double-blind, placebo-controlled trial was the largest Phase III clinical trial conducted to evaluate the treatment of house dust mite allergy1.

About Allergic Rhinitis and STAGR320

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 others2,3. Symptoms may be severe and can worsen over time and have a significant impact on quality of life2,3,4,5,6.

STAGR320 is Stallergenes Greer’s sublingual allergen immunotherapy (AIT) tablet for the treatment of HDM-induced allergic rhinitis. Allergen immunotherapy uniquely alters the natural course of respiratory allergies by inducing tolerance in the immune system.

STAGR320 will be marketed under the brand names Actair®, Orylmyte® or Aitmyte® in selected European countries.

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/

1. 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
2. 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.
3. 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
4. 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.
5. 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.
6. 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.

Contact information

Communications
Catherine Kress
Tel: +33 (0)1 55 50 26 05
Email: catherine.kress@stallergenesgreer.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

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

Manx Telecom Partners With Mavenir to Transform Its Mobile Voice and Data Network and Trials Open RAN With Mavenir’s Leading Cloud-Native Solutions24.6.2021 10:00:00 CEST | Press release

Mavenir, the Network Software Provider building the future of networks with cloud-native software that runs on any cloud and transforms the way the world connects, announces today that Isle of Man-basedcommunications service provider, Manx Telecom will be using the MAVcore solution to deliver both voice (VoLTE) and data networks (Packet Core). Mavenir will be delivering and deploying an end-to-end solution to Manx Telecom for its On-Island and OV businesses, comprising cloud-native virtualised IMS and Packet Cores. In addition, Manx Telecom will use the MAVair solution to undertake an Open RAN trial. Manx Telecom selected Mavenir as the best fit to meet the company’s overall requirement today and its future architecture needs for IMS, Packet Core and RAN solutions. The MAVcore family includes Mavenir’s global leading VoLTE IMS and voice services delivering VoLTE based virtualised IMS solution including VoLTE roaming and PCRF capability, and its leading-edge Packet Core solution deliver

Philip Morris International: New Study Shows Near-Doubling in Counterfeit Cigarettes in the European Union Drives Increase of Total Illicit Consumption in 202024.6.2021 10:00:00 CEST | Press release

Philip Morris International Inc. (PMI) (NYSE: PM) is calling for public and private representatives to jointly combat illicit trade as a new report produced by KPMG was released on the consumption and flows of illicit cigarettes in 30 European countries—the 27 European Union (EU) member states, as well as U.K., Norway and Switzerland. The study estimates that, while total cigarette consumption continues to decline, the share of illicit cigarettes increased by one half of a percentage point to 7.8% of total consumption in 2020, reaching 34.2 billion cigarettes consumed across the EU 27 member states (EU27). The increase of illicit cigarettes—which consist of contraband, counterfeit, and illicit whites—was driven by an unprecedented 87% surge in counterfeit consumption. The tax loss for governments in the EU27 now amounts to approximately €8.5 billion. The annual study, conducted independently by KPMG and commissioned by PMI, shows how legal and illicit cigarette consumption was impacted

Mavenir and Qualcomm Collaborate to Deliver Open RAN 4G/5G Indoor and Outdoor Radio Solutions for Public and Private Networks24.6.2021 10:00:00 CEST | Press release

Mavenir1, the Network Software Provider building the future of networks with cloud-native software that runs on any cloud and transforms the way the world connects, today announced a collaboration with Qualcomm Technologies, Inc. to develop indoor and outdoor solutions for both private and public network deployments aiming to broaden the choices for Open RAN customers. With rising capacity and coverage demands of 5G, driven by diverse enterprise and consumer requirements, there is a growing need for network densification that harnesses all available spectrum based on flexible and cost-effective radio solutions. This collaboration aims to leverage the power of Mavenir’s software solutions and Qualcomm Technologies’ platform leadership, to deliver a suite of radio solutions based on Open RAN architecture. Mavenir software running on the Qualcomm® 4G and 5G RAN Platforms for Small Cells (FSM), providing a full range of Open RAN software upgradable radio solutions is designed to meet the s

Habu Expands Internationally, Appointing Tim Norris-Wiles as Managing Director EMEA24.6.2021 10:00:00 CEST | Press release

Habu, the Global Innovator in Data Clean Room software, today announced the appointment of industry veteran, Tim Norris-Wiles as the Managing Director of EMEA, as Habu expands internationally and continues to grow its global customer base and business. Building on its tremendous growth in the first half of 2021, Habu’s Data Clean Room software allows brands to benefit from the full value of data in a safe environment, providing measurement, targeting, personalization and access to unique insights for the best marketing results. Through its proprietary methods for cloud data integration and distributed data processing, Habu continues to innovate in ways that enable organizations like Activision, ASICS, Insider and Digital Trends to safely collaborate and fully utilize data within their clean rooms. As the Managing Director of EMEA, Norris-Wiles will oversee Habu’s global growth strategy and execution. He will expand and lead Habu’s international sales organization in Europe and ensure d

Panasonic Announces Signing of Professional Women’s Tennis Player Naomi Osaka as Brand Ambassador24.6.2021 09:48:00 CEST | Press release

Panasonic Corporation has signed a brand ambassador agreement with professional women's tennis player Naomi Osaka. The period of agreement is two years starting from April 22, 2021. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210624005399/en/ Panasonic’s Brand Ambassador Naomi Osaka (Graphic: Business Wire) Panasonic sought the agreement with Ms. Osaka after observing that her values and perspectives on society deeply resonate with its own management philosophy, primarily with regard to the following three points: First, Ms. Osaka takes social issues seriously, looking beyond tennis to share her views on what a better society would look like in her own words. The founder of Panasonic, Konosuke Matsushita, held the notion that a stable state of happiness comes only when both mental stability and material prosperity are secured. Based on this idea, the company endeavors to create an ideal society where all of us can enjoy l

ADVA makes virtual routing simple and affordable with Ensemble SmartWAN24.6.2021 09:00:00 CEST | Press release

ADVA (FSE: ADV) today launched its fully featured Ensemble SmartWAN secure networking solution. Integrated into ADVA’s Ensemble network functions virtualization (NFV) suite, the new technology offers enterprises a simple and affordable way to leverage the core benefits of software-defined WAN (SD-WAN), while removing the need for additional virtual network functions (VNFs). Now businesses can deploy a turnkey solution that delivers dynamic virtual routing, centralized management, and full visibility of network topology. With zero-touch provisioning for easy deployment and temperature-hardened servers, Ensemble SmartWAN significantly improves return on investment for applications such as dynamic and fully meshed networking and smart city services. At the same time, it preserves the benefits of an open system that supports runtime additions of new VNFs or user applications. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210624

Global Banks Preparing to Leverage SWIFT’s New Platform for International Payments Flows24.6.2021 09:00:00 CEST | Press release

Six leading global banks today announced their endorsement for SWIFT’s new transaction management platform and are preparing to use its expanded capabilities to enable new services, improve efficiency and reduce costs when the platform goes live in November 2022. Bank of China, Bank of New York Mellon, BNP Paribas, Citi, Deutsche Bank, and Standard Chartered confirmed their preparations for the platform as the co-operative detailed an ambitious roadmap it will roll out over the next 18 months. New features – including upfront validation of beneficiary details, central management of exceptions, extension of SWIFT’s high-speed gpi rails to lower-value payments and new rich data services based on the ISO 20022 standard – will serve as the building blocks of the enhanced platform. These are integral components of SWIFT’s strategy to facilitate instant and frictionless end-to-end transactions anywhere in the world. The platform evolution builds on extensive work by the SWIFT community in th