Business Wire

STALLERGENES-GREER

31.5.2021 15:31:08 CEST | Business Wire | Press release

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

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

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

VDYNE Receives FDA Approval to Initiate the TRIVITA1 IDE Pivotal Trial of Transcatheter Tricuspid Valve Replacement System1.4.2026 15:30:00 CEST | Press release

VDYNE, Inc. (“VDYNE” or “the Company”), a privately held medical device company developing next generation transcatheter valve replacement technologies, today announced that the U.S. Food & Drug Administration (FDA) has approved an investigational device exemption (IDE) for the company’s pivotal clinical trial evaluating its Transcatheter Tricuspid Valve Replacement (TTVR) system. The IDE approval enables initiation of a U.S. pivotal study at leading clinical centers to evaluate the safety and effectiveness of the VDYNE system in patients with severe tricuspid regurgitation (TR). “This is a defining milestone for VDYNE and an important step toward bringing a much-needed therapy to patients with severe tricuspid regurgitation,” said Mike Buck, Chief Executive Officer. “Our focus now is on disciplined clinical execution and partnering with leading investigators to generate high-quality data that advances the field and improves patient care.” Significant unmet clinical needs exist in the

NetJets Introduces State-of-the-Art, Exclusive-Use Terminal in Augusta, Georgia1.4.2026 15:05:00 CEST | Press release

New facility set to elevate the experience for customers during golf’s most celebrated event—and beyond NetJets, the global leader in private aviation, is well underway on its development of a new exclusive-use terminal at Augusta Regional Airport (AGS). This state-of-the-art facility represents a significant investment in the region and reinforces NetJets’ commitment to delivering unparalleled experiences for its customers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330125414/en/ NetJets to open a new, exclusive-use terminal at Augusta Regional Airport (AGS). Guests arriving this April for golf’s most iconic championship will witness the construction in progress, including the finished ramp and foundational walls of what will soon become a full-service terminal. The private ramp, offering 432,000 square feet of space for aircraft parking, will be completed in time for the 2026 golf tournament. “Augusta is a key desti

Visa Unveils New Services to Modernize Dispute Resolution Process1.4.2026 15:00:00 CEST | Press release

Fraudulent disputes and administrative inefficiencies drive billions in avoidable economic costsSix new and enhanced dispute resolution tools utilize AI and proprietary technology to help provide issuers, acquirers and merchants with increased visibility into costly fraud expenses Visa (NYSE: V), a global leader in digital payments, today announced six new dispute resolution tools designed to reduce the billions of dollars lost annually to inefficient, outdated dispute processes. The expanded suite of dispute resolution services is being designed to help merchants and financial institutions cut administrative costs, reduce fraud-related losses and redirect those resources toward growth, innovation and customer experience. Disputes remain one of the most persistent friction points in commerce, driving rising costs for merchants and financial institutions while simultaneously leaving consumers frustrated and confused. In 2025, Visa processed 106 million disputes globally, a 35% increase

Rimini Street Announces Debt Reduction and Amendment to its Credit Agreement1.4.2026 15:00:00 CEST | Press release

Rimini Street, Inc. (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™, and the leading third-party support provider for Oracle, SAP and VMware software, today announced first quarter debt reduction activities and a recent amendment to its credit agreement. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260401160360/en/ Rimini Street Announces Debt Reduction and Amendment to its Credit Agreement Debt reduction activities during the first quarter of 2026 totaled $10.9 million, reducing the Company’s outstanding term loan to $58.4 million as of March 31, 2026. The Company’s credit agreement was amended effective as of March 27, 2026 to increase to $20.0 million the value of Company common stock that could be repurchased per annum, beginning with the Company’s 2026 fiscal year and for each fiscal year thereafter, with a revised total of $50.0 million in permitted stock repurchases from the period beginning January

Neuphonic and Rapport Bring Real-Time Digital Humans to Everyday Hardware1.4.2026 15:00:00 CEST | Press release

New partnership delivers sub-100ms, fully on-device avatars — unlocking scalable, lifelike AI characters for games, film and interactive media Neuphonic and Rapport (a division of Speech Graphics) today announced a partnership to deliver what they believe is among the first fully real-time, photorealistic digital human systems running entirely on standard CPU hardware. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260401782320/en/ Rapport and Neuphonic announce a partnership to deliver next-generation conversational AI experiences. The collaboration combines Neuphonic’s ultra-low latency text-to-speech technology with Rapport, an interactive AI avatar role play platform powered by production-proven real-time facial and full-body animation technology from Speech Graphics, used in video games such as Call of Duty, The Last of Us Part II and Hogwarts Legacy. Together, the system generates natural voice, perfectly synchronised

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye