Stallergenes Greer advances its house dust mite allergy pipeline with acceptance of regulatory submission and new market approval

LONDON--(BUSINESS WIRE)-- Regulatory News:

Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, today announced that Health Canada accepted for review the company’s New Drug Submission (NDS) for STG320, an investigational sublingual immunotherapy tablet for the treatment of house dust mite (HDM) induced allergic rhinitis. Once a New Drug Submission is accepted for review it takes usually between nine to twelve months for Health Canada to issue the results of the evaluation.

Stallergenes Greer’s HDM tablet is already available in Japan, Australia and South Korea under the brand name Actair and was approved for commercialization in New Zealand on September 8, 2017.

“We continue to make progress on delivering on our pipeline and expanding our portfolio. We believe STG320 has the potential to be a very important allergy immunotherapy treatment option for patients suffering from allergic rhinitis.”, said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer.

In July 2017, Stallergenes Greer announced the completion of enrollment for the largest Phase III clinical trial to evaluate the safety and efficacy of STG320 in adult and adolescent patients with HDM-induced allergic rhinitis. The study recruited over 1,600 patients from 13 countries. Together with other clinical data, it will form the company’s clinical submission of a Biologics License Application (BLA) in the United States currently planned for 2019, as well as for additional marketing authorizations in European and international markets.

ABOUT HOUSE-DUST MITE INDUCED ALLERGIC RHINITIS IN CANADA

About 20-25 percent of the population in Canada is estimated to be suffering from allergic rhinitis¹. Most common sources of allergens in Canada include pets, house dust mites, indoor/outdoor mold, trees (especially oak trees), and grasses and weeds². Allergic rhinitis can include symptoms such as sneezing, runny nose, wheezing, cough, itching, and watery/itchy eyes, among others^3,4. Symptoms may be severe and significantly impact the patient’s quality of life, as well as worsen over time with progression towards asthma^{3-5, 7-10}.

ABOUT STALLERGENES GREER PLC

Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specializing in the diagnosis and treatment of allergies through the development and commercialization of allergy immunotherapy products and services. Stallergenes Greer plc is the parent company of Greer Laboratories, Inc. (whose registered office is in the US) and Stallergenes SAS (whose registered office is in France).

TRADING INFORMATION

Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
Market: Euronext Paris regulated market
Additional information is available at http://www.stallergenesgreer.com.

This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2016 annual report published on 28 April 2017 on the Company's website (www.stallergenesgreer.com). Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.

REFERENCES

1. Keith, Paul K., Martin Desrosiers, Tina Laister, Robert R. Schellenberg, and Susan Waserman. "The burden of allergic rhinitis (AR) in Canada: perspectives of physicians and patients." Allergy, Asthma & Clinical Immunology, 2012.
2. Richard, Joanne. "Canada's 10 most common seasonal allergies." The Weather Network. April 11, 2017. https://www.theweathernetwork.com/news/articles/canadas-10-most-common-seasonal-allergies/81059.
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. 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.
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. Calderon M. A., Linneberg A., Kleine-Tebbe J., De Blay F., Hernandez Fernandez de Rojas D., Virchow J. C., Demoly P. Respiratory allergy caused by house dust mites: What do we really know? J Allergy Clin Immunol. 2015 Jul;136(1):38-48.
7. 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
8. Leger D., Annesi-Maesano I., Carat F., et al. Allergic rhinitis and its consequences on quality of sleep: An unexplored area. Arch Intern Med. 2006 Sep 18;166(16):1744-1748.
9. Meltzer E. O. Quality of life in adults and children with allergic rhinitis. J Allergy Clin Immunol. 2001 Jul;108(1 Suppl):S45-53
10. 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 2010 Jan;104(1):79-85.