Press releases
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Stallergenes Greer Confirms Appointments to the Board of Directors
LONDON--(BUSINESS WIRE)-- Regulatory News:
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, today announced that the following appointments to the Company’s corporate leadership and Board of Directors were confirmed and approved by the Company’s Board of Directors on 12 December 2018. Stefan Meister is appointed Chairman of the Board of Directors, Michele Antonelli is appointed member of the Board of Directors and Chief Executive Officer and Elmar Schnee is appointed Lead Independent Director.
The board of directors thanks Fereydoun Firouz, who will retire from his position as Chairman and Chief Executive Officer at the end of 2018, for his contribution to the company. Effective 4 January 2019, and as announced in August 2018, Stefan Meister will take over as Chairman of the board of Directors and Michele Antonelli as Chief Executive Officer.
Stefan Meister is Group Chief Operating Officer of the Waypoint Group, a business enterprise for the managers and advisers of the funds and investments associated with the Bertarelli family, which is also the indirect owner of Ares Life Sciences I S.a.r.l., Stallergenes Greer’s largest shareholder. Prior to his role at Waypoint Group, Mr Meister was Chief Financial Officer of the Haniel Group, before which he was a member of the Executive Management Board of Celesio Group. Mr Meister began his career in 1991 at Novartis AG (Switzerland), holding various positions including Head of Controlling for the Pharma Division. Until May 2016, Mr Meister was a Member of the Board of Directors of the Swiss group, Straumann. Mr Meister is Swiss and holds a degree in economics from Basel University.
Michele Antonelli has more than 20 years of international experience in the biopharmaceutical industry with extensive expertise in manufacturing, commercial and general management. Mr Antonelli joined Stallergenes Greer in November 2015 as Executive Vice President, Head of International Operations. In February 2016, Mr Antonelli was appointed Executive Vice President, Head of Europe and International, overseeing both commercial and technical operations for the Company’s Europe and International region. During the same period he also served as President of Stallergenes SAS. Prior to Stallergenes Greer, Mr Antonelli worked at UCB, the multinational biopharmaceutical company, as an Executive Committee Member where he held roles of various responsibility and scope in Belgium, Italy and France, most recently serving as Executive Vice President and Head of Immunology Europe, overseeing the region’s commercial, medical and market access activities. Prior to joining UCB, Mr Antonelli spent 16 years at Merck Serono, ultimately serving as Senior Vice President and Global Head of Biotech Manufacturing and Process Development. He is Swiss and Italian, and graduated as Doctor in Sciences from University of Bari. He trained in Biotechnology at Catholic University in Piacenza and at Iowa State University in Ames, Iowa.
Elmar Schnee has more than 25 years’ experience in the pharmaceutical industry. Mr Schnee is currently Board Secretary of Mindmaze SA and was, from 2016 to March 2017, Chief Operating Officer. Mr Schnee is Chairman of the Board of Directors of Santhera AG, a Swiss speciality pharmaceutical company developing medicines for rare diseases. He is also a Member of the Board of Directors of Jazz Pharmaceuticals. From November 2013 to August 2015, Mr Schnee served as a Non-Executive Director of Cardiorentis Ltd., a biopharmaceutical company, where he served as Chairman and Chief Executive Officer from October 2011 until November 2013. From 2003 to 2011, Mr Schnee held various positions at Merck KGaA, a global pharmaceutical and chemical group, having joined in 2003 as Managing Director of Merck Santé SAS. In 2004, Mr Schnee assumed responsibility for global commercial operations of the ethical pharmaceuticals division of Merck KGaA, and in November 2005, Mr Schnee was appointed as Deputy Member of the Executive Board responsible for the pharmaceuticals business. In 2006, he was appointed as a member of the Executive Board and General Partner of Merck KGaA, with responsibility for global pharmaceutical activities, and served in this position until 2011. Prior to Merck KGaA, Mr Schnee held senior positions in strategy, business development and marketing at UCB SA, Sanofi-Synthélabo SA, Migliara / Kaplan Associates, Inc. and Fisons Pharmaceuticals PLC. He currently serves on the Board of Directors of four privately held life sciences companies. Mr Schnee holds a BA in marketing and a masters in marketing and general management from the Swiss Institute of Business Administration in Zurich.
ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specialising 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
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market
Further information disclosed pursuant to the AFEP-MEDEF Code can be found in the Investors section of our website.
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,” “will” 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 2017 annual report published on 16 April 2018 on the Company's website www.stallergenesgreer.com. Actual results may differ materially from those set forth in the forward-looking statements, due to these and other 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.
Stallergenes Greer Announces That the Phase III Trial for Its Sublingual Allergy Immunotherapy Tablet STAGR320 to Treat House Dust Mite-Induced Allergic Rhinitis Achieved Its Primary Endpoint
LONDON--(BUSINESS WIRE)-- Regulatory News:
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced topline results for its phase III clinical trial to evaluate the efficacy and safety of its sublingual allergy immunotherapy tablet STAGR320 for the treatment of house dust mite (HDM)-induced allergic rhinitis. The study met its primary endpoint. Results indicated a statistically significant reduction of the Total Combined Score, the sum of the Rhinitis Total Symptom Score and the Rescue Medication Score, in patients treated with STAGR320 compared to patients on placebo. The study also reached key secondary endpoints, including overall quality of life, and showed that the treatment was generally well tolerated, confirming the favorable safety profile observed in previous studies.
This was the largest phase III study to evaluate the treatment of HDM-induced allergic rhinitis in adult and adolescent patients, recruiting more than 1,600 patients from 231 participating investigative sites in 13 countries.
“We are very pleased that the results from this confirmatory, double-blind and placebo controlled trial met its efficacy endpoints, demonstrated a favorable safety profile and validated previous clinical studies which showed that STAGR320 can bring relief to patients suffering from house dust mite-induced allergies,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “House dust mite allergy is one of the most common allergies, impacting the quality of life for patients across ages and geographies. The results of this study provide us with the confidence to seek further market registrations, including in Europe and the United States. We look forward to working with regulatory authorities around the world to make this therapy available to patients as part of our comprehensive portfolio of allergy immunotherapy products.”
Allergic rhinitis is a worldwide disease affecting more than 500 million people and the risk of developing asthma is about six times higher in patients with an allergy to house dust mites than those allergic to pollens1-4. Allergic rhinitis can include symptoms such as sneezing, runny or itchy nose, nasal congestion and watery or itchy eyes, among others1,2. Symptoms may be severe and can worsen over time with progression towards asthma, as well as have a significant impact patients’ quality of life1-3,5-8.
“Meeting the primary endpoint of this important study confirms the clinical value that STAGR320 is effective for the treatment of house dust mite allergies,” said Pascal Demoly, Professor at the Department of Pneumology and Addiction Heart Poumons Center at the University Hospital of Montpellier, France, President of the College of Allergology Teachers, President of the French Allergy Federation and a coordinating investigator. “In addition, these study results provide the physician community with compelling evidence that STAGR320 can address some of the most severe symptoms that patients experience, which ultimately has an impact on quality of life.”
“More than 500 million people globally are affected by allergic rhinitis, a condition that can be a factor of asthma onset and progress,” said Thomas Casale, MD, Professor of Medicine and Pediatrics at the University of South Florida and a coordinating investigator. “These study results demonstrate the clinical benefit that STAGR320 can offer to patients. By changing the immune response to the allergen and addressing the underlying cause of the allergy, patients have an alternative to treatment options that only affect the symptoms of the disease.”
The multi-center, randomized, double-blind and placebo-controlled study evaluated the efficacy and safety of STAGR320 at a daily dose of 300IR administered for approximately 12 months to adult and adolescent patients aged 12-65 with HDM-associated allergic rhinitis.
The study met its primary efficacy endpoint and demonstrated a statistically significant difference (p<0.0001) on the Total Combined Score (TCS) after one year of treatment in the treated group versus placebo. The TCS combined the Rhinitis Total Symptom Score (RTSS) and the Rescue Medication Score (RMS). In addition, all key secondary endpoints achieved statistical significance and, overall, the product was well tolerated.
A full assessment of the data is ongoing, with detailed results expected to be presented at future scientific congresses, including the annual European Academy of Allergy and Clinical Immunology (EAACI) Congress.
ABOUT THE STAGR320 PHASE III CLINICAL TRIAL
The phase III trial was a global, multi-center, randomized, double-blind and placebo controlled study. It evaluated the efficacy and safety of STAGR320 at a daily dose of 300IR administered to adult and adolescent patients aged 12-65 with HDM-induced allergic rhinitis. Patients who experienced HDM-associated allergic rhinitis for at least one year, who were sensitized to D. pteronyssinus and/or D. farinae mites as determined by a skin prick test and HDM-specific serum immunoglobulin E, were eligible for participation.
This was the largest phase III clinical trial conducted to evaluate the treatment of house dust mite allergy in adult and adolescent patients. The study recruited more than 1,600 patients from 231 participating investigative sites in 13 countries. International coordinating investigators were Pascal Demoly, Professor at the Department of Pneumology and Addiction Heart Poumons Center at the University Hospital of Montpellier, France, President of the College of Allergology Teachers and President of the French Allergy Federation, and Thomas Casale, MD, Professor of Medicine and Pediatrics at the University of South Florida.
ABOUT STAGR320
STAGR320 is Stallergenes Greer’s investigational sublingual allergy immunotherapy (AIT) tablet for the treatment of HDM-induced allergic rhinitis. AIT is a disease-modifying treatment that treats the underlying cause of allergy and can provide long-lasting reduction of allergy symptoms. STAGR320 is registered in Australia, Japan, New Zealand and South Korea. Results from the recent phase III trial, together with other clinical data, will form the clinical basis for the company’s potential submission of a Biologics License Application (BLA) in the United States, as well as for additional marketing authorizations in European and international markets.
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
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) 596/2014.
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,” “will” 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 2017 annual report published on 16 April 2018 on the Company's website www.stallergenesgreer.com. Actual results may differ materially from those set forth in the forward-looking statements, due to these and other 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. 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. 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.
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. 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.
7. Meltzer E. O. Quality of life in adults and children with allergic rhinitis. J Allergy Clin Immunol. 2001 Jul;108(1 Suppl):S45-53
8. 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.
Stallergenes Greer Announces U.S. FDA Approval of Pediatric Indication Extension for Oralair® Sublingual Immunotherapy Tablet for the Treatment of Grass Pollen Allergy
LONDON--(BUSINESS WIRE)-- Regulatory News:
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for the extension of the indication for Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract), an allergy immunotherapy sublingual tablet, to treat patients ages five to nine with grass pollen-induced allergic rhinitis. Oralair is the only allergy immunotherapy tablet that contains grass pollens from five of the most common grasses in the United States and received FDA approval in patients ages ten to 65 in 2014.
“We are very pleased to be able to make this effective and convenient treatment option with a demonstrated safety profile available for children ages five and over as well as adults,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “AIT can offer a valuable benefit to patients to help treat the underlying cause of allergies. Oralair provides an important option to patients who seek the relief of AIT but want the convenience of taking a tablet at home. We are committed to enabling physicians to determine the treatment method that best meets the disease and lifestyle needs of the patient.”
Allergic rhinitis affects approximately 40 to 60 million people in the U.S.1 and treatment options include allergy immunotherapy, a disease-modifying treatment that treats the underlying cause of allergy and can provide long-lasting improvements of allergy symptoms. In the U.S. AIT can be administered sublingually as a tablet, such as Oralair, or as an injectable formulation. Today, fewer than 3 million allergy sufferers (i.e., 5% of the U.S. allergic population), are treated with allergy immunotherapy.
ABOUT ORALAIR
Oralair is a sublingual tablet administration of allergy immunotherapy that contains a mix of five grass pollens: Kentucky Blue, Orchard, Perennial Rye, Sweet Vernal and Timothy. The five grass pollens contained in Oralair represent those to which most patients in the U.S. are exposed.
Oralair is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis for any of the five grass species contained in this product. Oralair has been approved based on results from an extensive clinical development program and has been studied in double-blind, placebo-controlled trials in Europe and the United States in over 2,500 adults and children. The results of these trials demonstrated that pre-seasonal and co-seasonal treatment reduces patients’ allergy symptoms and their need for symptom-relieving medication (Oralair is not indicated for immediate relief of allergy symptoms). In the clinical development program, the most common adverse reactions for Oralair (reported in ≥5% of patients) were oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough and oropharyngeal pain.
1 https://acaai.org/allergies/types/hay-fever-rhinitis
To support administration of Oralair in the pediatric population, an open-label study was conducted to evaluate the 30-day safety profile of Oralair in 307 children five through nine years of age. Adverse reactions reported at an incidence of ≥2% were: throat irritation (22.1%), oral pruritus (11.7%), oral paresthesia (11.1%), tongue pruritus (8.1%), mouth edema (6.2%), cough (6.2%), oropharyngeal pain (4.2%), ear pruritus (5.2%), eye pruritus (4.6%), lip edema (3.3%), vomiting (2.6%), tongue edema (2.3%), abdominal pain (2.3%), oral discomfort (2.3%), and ocular hyperemia (2.0%).
ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global healthcare company specialising in the diagnosis and treatment of allergies through the development and commercialisation 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
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market
Additional information is available at https://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 2017 annual report published on 16 April 2018 on the Company's website www.stallergenesgreer.com. Actual results may differ from those set forth in the forward-looking statements, due to those and other 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.
Stallergenes Greer to Report First Half Financial Results on 29 August 2018
LONDON--(BUSINESS WIRE)-- Regulatory News:
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced it will report financial results for the first half of its 2018 fiscal year after the market closes on 29 August 2018. The Company’s management will host a live audio webcast of its earnings conference call the following day, 30 August 2018, at 10:30 am London / 11:30am Paris / 5:30 am Boston to discuss the results.
Members of the financial community may access the conference through the dial-in information provided on the company’s website at http://stallergenesgreer.com/financial-calendar-events. The live audio webcast will be accessible to the general public via the following link: https://edge.media-server.com/m6/go/STAGR_18HY. Participants are asked to connect at least 15 minutes prior to the conference call to register, download and install any necessary audio software.
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
LEI: 213800CYVZA7GJQEME86
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 2017 annual report published on 16 April 2018 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.
Stallergenes Greer Shareholders Approve All Resolutions Proposed by the Board of Directors at the Annual General Meeting
LONDON--(BUSINESS WIRE)-- Regulatory News:
The shareholders of Stallergenes Greer plc (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, announces that all resolutions proposed by the Board of Directors at the company’s Annual General Meeting (AGM) were duly passed today. All resolutions were set out in the Notice of Meeting posted to shareholders on 23 April 2017.
Notably, shareholders re-elected Chairman and CEO Fereydoun Firouz, and Directors, Jean-Luc Bélingard, Rodolfo Bogni, Stefan Meister, Yvonne Schlaeppi and Elmar Schnee – each for a further term of one year.
The terms of Patrick Langlois and Paolo Ricci have expired at the end of the AGM. The Board would like to thank both Patrick for his contributions to Stallergenes Greer as a Board member and Chair of the Audit Committee, and Paola for her contributions as a Board member.
In addition, Philip Broadley was elected as a Director with a one-year term. Mr Broadley has significant financial and international business experience, having previously been Group Finance Director of Prudential plc for eight years and Old Mutual plc for six years. He is currently a director of AstraZeneca plc and serves on their Audit Committee, and is also a director and the Audit Committee chairman of Legal & General Group plc. He is a member of the Oxford University Audit Committee, Treasurer of the London Library and Chairman of Governors at Eastbourne College. He is a Fellow of the Institute of Chartered Accountants in England and Wales. Mr Broadley started his career at Arthur Andersen where he was a partner for seven years. He is a past Chairman of the 100 Group of Finance Directors in the UK and served as a member of the Code Committee of the Takeover Panel. He graduated in Philosophy, Politics and Economics from St Edmund Hall, Oxford and has an MSc in Behavioural Science from the London School of Economics.
“2017 continued a transformation at Stallergenes Greer to improve our operations, serve our customers and deliver a strong performance. I would like to thank all of our Directors for their contributions and guidance, and our shareholders for their continued support. I would also like to welcome Philip Broadley to our Board of Directors. Philip has extensive experience in corporate finance and will be a valuable contribution to our Board and Audit Committee where he will serve as Chair,” said Chairman and CEO, Fereydoun Firouz, “We remain focused and committed to strengthening our leadership position, driving excellence across our business and positioning our company for long-term growth in order to deliver value to our shareholders, customers and employees.”
The full text of each resolution is set out in the Notice of Annual General Meeting, which is available on Stallergenes Greer's website at www.stallergenesgreer.com.
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
LEI: 213800CYVZA7GJQEME86
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 16 April 2018 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.
Stallergenes Greer Provides Business Update and Refines Its 2018 Financial Outlook
LONDON--(BUSINESS WIRE)-- Regulatory News:
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today provided an update on its business performance and refined its 2018 business outlook. The revised outlook reflects a solid start to the year with company-wide operational efficiency improvements; market share gains across the portfolio and geographies; and improved clarity on market access in Europe.
“Our performance during the first months of 2018 confirm the strength of Stallergenes Greer’s business fundamentals. We have continued the momentum from 2017 and, we are executing on our commercial priorities,” said Fereydoun Firouz, Chairman and Chief Executive Officer. “With increased profitability, we can now confidently focus on our future, by sustaining our investments in both innovation and the upgrades of our manufacturing sites and quality systems.”
Performance through the first months of 2018 was driven by several factors:
- Operational Efficiency: The company was able to effectively manage its expenses through a series of efficiency measures that resulted in earlier than expected cost savings. As the year progresses, the company will continue its commitment to operational efficiency while investing in manufacturing upgrades and innovation, including the completion of the phase III trial for the company’s House Dust Mite tablet candidate, STAGR320.
- Commercial Excellence in Europe and International: Strong sales and marketing execution in Europe and International have continued to result in market share gains, especially in France, Italy and Eastern Europe. Staloral has consistently outpaced competition and Oralair has continued to gain shares in key markets. Data from the BREATH real-world evidence program presented last week at the European Academy of Allergy and Clinical Immunology Congress continue to strengthen the value proposition of these products.
- Leadership in North America: Stallergenes Greer continues to lead the core bulk allergen business in the U.S. and Canada. While the U.S. grass tablet market has declined versus 2017, the recalibration of the commercial strategy has improved the profitability of the Oralair franchise and the company is building a sustainable platform to capture future growth in the tablet market.
- Market access in Europe: The recent clarification of the reimbursement framework in France for Named Patient Products and the confirmation of the increase of governmental funding for Oralair in Italy have provided clarity and therefore better predictability into the business.
Investments in Quality and Technical Operations Continue
On the manufacturing front, Stallergenes Greer has made major investments in the quality systems and modernization of the manufacturing sites in Antony and Amilly, France and in Lenoir, in the U.S. In addition, the company increased the manufacturing and supply of sublingual products to meet market demand and partially offset the temporary shortage of injectable products in the European and International markets.
The company has continued to progress through its remediation plan in Antony, following the injunction received on 4 January 2018 from the French National Agency for Medicines and Health Products Safety (ANSM). Several actions are underway and the company is committed to addressing all the observations of the agency and strengthening its quality culture across the organization. For example, significant renovation work is underway and extensive training has been completed for the employees working on aseptic operations, traceability of pharmaceutical operations and deviations.
As part of the proceedings related to the injunction, the company received notification of potential financial penalties in the event of non-compliance with the agreed timelines. Stallergenes Greer is engaging with the ANSM regarding this notification and it would be premature to make any conclusion about the outcome. If sanction applied, the penalties are expected to be €1 million or less.
2018 Revised Financial Perspectives
With the current performance and clarity of market access in Europe, the company now expects 2018 net sales to be in the range of €270 million to €280 million and EBITDA to be in the range of €40 million to €50 million. This is updated from the outlook provided on 22 March 2018. At that time, the company expected mid-single digit revenue growth and EBITDA to be higher than 2017’s EBITDA of €21.9 million.
The financial data that support the statements presented in this press release are the company’s current and best estimates and have not been audited or reviewed by the statutory auditors. The company will provide an update to the market during its earnings call on 30 August 2018.
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
LEI: 213800CYVZA7GJQEME86
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 2017 annual report published on 16 April 2018 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.
Stallergenes Greer plc: Two New Real-World Evidence Studies Show Long-Term Benefits of Sublingual Allergy Immunotherapy
LONDON--(BUSINESS WIRE)-- Regulatory News:
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, announced positive results from two real-world evidence studies regarding the use of allergy immunotherapy (AIT) compared to the use of only symptomatic treatments to treat patients with respiratory allergies. These studies were retrospective longitudinal analyses of French and German prescription databases and further substantiated the long-term benefits of AIT to significantly reduce the need for allergic rhinitis and asthma medication in patients suffering from grass pollen- and birch tree pollen-induced allergies. These studies are part of the BREATH real-world evidence program, which is designed to understand the real-world benefits of allergy immunotherapy outside of a clinical trial setting.
“As a global leader in allergy immunotherapy, we are pleased to be able to provide further evidence into the real-world effectiveness of allergy immunotherapy for patients across Europe,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer. “The BREATH program has allowed us to deepen our knowledge and understanding of real-life patient outcomes. We look forward to bringing these outcomes to international forums to provide further evidence on the benefits that AIT can offer to a broader range of patients suffering from respiratory allergies. Today, less than 1% of patients are treated with allergy immunotherapy.1”
Grass pollen tablets demonstrate effectiveness in reducing allergic rhinitis and asthma medication intake for allergic rhinitis patients in France 6,7,8
This retrospective analysis is based on four years’ worth of prescription data from 28,574 patients in France and demonstrated the statistically significant long-term benefit of grass pollen AIT sublingual tablets, including Stallergenes Greer’s Oralair®, on grass pollen-induced allergic rhinitis compared to only symptomatic treatments. The study included 1,099 patients treated with AIT sublingual tablets as well as symptomatic medications, and a non-AIT control group of 27,475 patients receiving only symptomatic medications. Study results showed that the number of symptomatic medication prescriptions per patient per year decreased by 50 percent in the post-treatment follow-up in the AIT group, compared to an increase of prescriptions (30 percent) for patients in the non-AIT group who were using only symptomatic treatments. In addition, the risk of new asthma medication onset in the AIT group during the follow-up period was 63 percent lower when compared to the non-AIT group (p=0.0025). Among patients who were already taking asthma medications at the onset of the study, AIT was associated with a 40 percent decrease in asthma medication prescriptions during post-treatment follow-up versus baseline, compared to a 20 percent increase of asthma medication prescriptions among the non-AIT group.
“The results from this study are significant and further demonstrate the positive impact allergy immunotherapy can bring to allergic patients,” said Professor Pascal Demoly, from Montpellier University’s Pneumology and Addiction Department and a member of the study’s scientific committee. “First, there is a clear benefit to AIT, showing that AIT reduced symptomatic medication prescriptions where patients who received only symptomatic treatments saw their need for medication increase. Second, these results are consistent with those obtained in Germany, confirming the scientific solidity of the methodology and suggesting transferability to other countries.”
Birch tree AIT demonstrates effectiveness in reducing allergic rhinitis and asthma medication intake for allergic patients in Germany 9,10,11
The retrospective analysis based on eight years’ worth of prescription data from 54,006 patients in Germany demonstrated the statistically significant long-term benefit of birch tree pollen AIT treatments, including Stallergenes Greer’s Staloral® sublingual drops, on birch tree-induced allergic rhinitis and asthma compared to only symptomatic treatments. The study included 9,001 patients treated with AIT (administered as either a sublingual or subcutaneous formulation) as well as symptomatic treatments, and a non-AIT control group of 45,005 patients receiving only symptomatic treatments. During the follow-up period, significantly more patients in the AIT group (65 percent) were free of allergic rhinitis symptomatic medications compared to the non-AIT group (47 percent). In addition, during the follow-up period, 49 percent of AIT patients using asthma therapy at baseline were asthma medication free compared to 35 percent of non-AIT patients. Finally, during treatment, new onset of asthma medication was significantly reduced in the AIT group compared to the non-AIT group (p=0.001)
“This data provides new insight on allergy immunotherapy benefits for asthmatic patients,” said Professor Ulrich Wahn, Department for Pediatric Pneumology and Immunology, Charité Medical University, Berlin and a member of the study’s scientific committee. “This study builds upon our understanding of AIT and will help health care providers around the globe to make more informed decisions about how to treat patients suffering from respiratory allergies.”
Data from both studies were presented this week at the annual European Academy of Allergy and Clinical Immunology (EAACI) Congress, held in Munich, Germany. The studies are part of the BREATH real-world evidence program. The first BREATH study to be released, Zielen, et. al12, followed a similar study design and analyzed prescription data from patients with grass pollen-induced allergic rhinitis in Germany. The study was published in the peer-reviewed journal Allergy in May 2017 and its results were consistent with those released today. The three studies, funded by Stallergenes Greer, were conducted in collaboration with IQVIA (formerly Quintiles IMS), a 3rd party clinical research organization, and designed by independent scientific committees.
ABOUT BREATH
The BREATH (Bringing Real-World Evidence to Allergy Treatment for Health) real-world evidence program, sponsored by Stallergenes Greer, is designed to gather real-world data about the benefits of allergy immunotherapy (AIT). Allergy Immunotherapy is a disease-modifying treatment that treats the underlying cause of allergy and can provide long-lasting improvements of allergy symptoms. AIT can be administered sublingually (oral drop, tablet) or as an injectable formulation.
Real world data has the potential to supplement randomized controlled trial data by providing additional information about how AIT performs in routine medical practice, nevertheless, they have several limitations and cannot be used as stand-alone evidence to validate the efficacy and/or safety of a treatment.
The BREATH studies reviewed prescription data for a variety of AIT products, including Stallergenes Greer’s Oralair and Staloral. Oralair is a sublingual allergy immunotherapy tablet with a mix of five grass allergen extracts (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) currently authorized in more than 30 countries around the world, including most European countries, the United States, Canada, Australia, and Russia for the treatment of grass pollen allergic rhinitis. Staloral is a sublingual immunotherapy oral drop, currently available in more than 40 countries, including most European countries for the treatment of allergy involving rhinitis, conjunctivitis, rhino-conjunctivitis or asthma (mild to moderate) of a seasonal or perennial nature, in adults and children (from the age of 5 year). Staloral is not approved in the U.S.
ABOUT STALLERGENES GREER
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
LEI: 213800CYVZA7GJQEME86
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 2017 annual report published on 30 April 2018 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. Ozdoganoglu T, Songu M. The burden of allergic rhinitis and asthma. Ther Adv Respir Dis. 2012;6(1):11-23.
2. Simons FE. Allergic rhinobronchitis: the asthma-allergic rhinitis link. J Allergy Clin Immunol. 1999;104(3 Pt 1):534-40.
3. Greiner AN, Hellings PW, Rotiroti G, Scadding GK. Allergic rhinitis. Lancet. 2011;378:2112-22.
4. Van Bever HP, Samuel ST, Lee BW. Halting the allergic march. World Allergy Organ J. 2008;1:57-62.
5. Shaker M. New insights into the allergic march. Curr Opin Pediatr. 2014;26:516-20.
6. Devillier P., Demoly P., Ansolabehere X., Coulombel N., Molimard M., Impact of grass pollen sublingual immunotherapy tablets on allergic rhinitis and asthma: methodological aspects of a real-life, retrospective database analysis performed in France, EAACI 2018
7. Demoly P., Devillier P., Ansolabehere X., Molimard M., A real-life, long-term, retrospective analysis evidencing slower progression of grass pollen allergic rhinitis in patients treated with sublingual immunotherapy tablets, EAACI 2018
8. Demoly P., Molimard M., Ansolabehere X., Maurel F., Devillier P., A real-life, retrospective analysis evidencing slower long-term progression of asthma in grass pollen allergy patients treated with sublingual immunotherapy tablets, EAACi 2018
9. Ulrich Wahn, Claus Bachert, Joachim Heinrich, Hartmut Richter and Stefan Zielen, AIT has long-term benefits for patients with allergic rhinitis and/or asthma induced by birch family pollen: refinement of real-world study methodology designed to increase robustness of findings, EAACI 2018
10. Claus Bachert, Ulrich Wahn, Joachim Heinrich, Hartmut Richter and Stefan Zielen, Allergy immunotherapy provides long-term relief of birch family pollen-associated allergic rhinitis up to 6 years following treatment cessation: a real-world dataset analysis, EAACI 2018
11. Stefan Zielen Ulrich Wahn, Claus Bachert, Hartmut Richter and Joachim Heinrich, AIT is associated with reduced risk of asthma medication initiation and evolution up to 6 years after stopping AIT in patients with birch family pollen-induced allergic rhinitis and/or asthma, EAACI 2018
12. Zielen, S., Devillier, P., Heinrich, J., Richter, H. and Wahn, U. Sublingual immunotherapy provides long-term relief in allergic rhinitis and reduces the risk of asthma: a retrospective, real-world database analysis. Allergy. May 2017. doi:10.1111/all.13213
2018-04-23 - Notification to Stallergenes Greer Shareholders of Annual General Meeting on 7 June 2018
Notification to Stallergenes Greer Shareholders of Annual General Meeting on 7 June 2018
LONDON--(BUSINESS WIRE)-- Regulatory News:
The shareholders of Stallergenes Greer plc (Paris:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, are hereby informed that they are invited to attend the Company’s Annual General Meeting at la Maison de la Recherche, 54 rue de Varenne, 75007 Paris, France, on 7 June 2018 at 2:00p.m. (CET).
Notice of the meeting is available in the “Investors” section of the Company website at www.stallergenesgreer.com. It contains the draft resolutions proposed by the Board of Directors, the explanatory notes and the main conditions under which shareholders may participate, vote and exercise their rights.
All documents are at the disposal of shareholders, as part of the Annual General Meeting, and are available at the registered office of the Company in London (40 Bernard Street, 3rd Floor, London WC1N 1LE, United Kingdom), in Antony (6 rue Alexis de Tocqueville, 92160 Antony, France), and also in the “Investors” section of the Company’s website (www.stallergenesgreer.com), in “Results & Presentations / Annual General Meeting / 2018”.
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
LEI: 213800CYVZA7GJQEME86
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.
Stallergenes Greer Announces Publication of Its 2017 Annual Report
LONDON--(BUSINESS WIRE)-- Regulatory News:
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced the publication of its 2017 Annual Report.
Approved by the Company’s Board of Directors on 13 April 2018, the report can be downloaded via the link below.
http://stallergenesgreer.com/sites/default/files/investors/documents/2017_annual_report.pdf
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
LEI: 213800CYVZA7GJQEME86
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.
2018-03-22 - Stallergenes Greer Reports Solid Growth and Continued Recovery in 2017, Delivering on Full Year Guidance
Stallergenes Greer Reports Solid Growth and Continued Recovery in 2017, Delivering on Full Year Guidance
LONDON--(BUSINESS WIRE)-- Regulatory News:
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced its full year results for the year ended 31 December 2017.
|
FY 2017 Financial Highlights |
|||||||||||||||||||||||||||
| (in € million) | H1 (unaudited) | H2 (unaudited) | Full Year (audited) | ||||||||||||||||||||||||
| 2017 | 2016 | % change | 2017 | 2016 | % change | 2017 | 2016 | % change | |||||||||||||||||||
| Net sales | 129.6 | 78.0 | 66% | 130.6 | 108.2 | 21% | 260.2 | 186.2 | 40% | ||||||||||||||||||
| Gross profit | 83.4 | 34.7 | 140% | 82.4 | 66.3 | 24% | 165.8 | 101.1 | 64% | ||||||||||||||||||
| Gross margin | 64% | 45% | 19 points | 63% | 61% | 2 points | 64% | 54% | 10 points | ||||||||||||||||||
| EBIT | (3.5) | (58.5) | n.a. | (1.9) | (37.5) | n.a. | (5.4) | (96.0) | n.a. | ||||||||||||||||||
| Net profit/(loss) | (8.9) | (39.0) | n.a. | (1.0) | (21.5) | n.a. | (9.9) | (60.5) | n.a. | ||||||||||||||||||
| EBITDA | 6.3 | (45.1) | n.a. | 15.7 | (22.9) | n.a. | 21.9 | (67.9) | n.a. | ||||||||||||||||||
| EBITDA margin | 5% | n.a. | n.a. | 12% | n.a. | n.a. | 8% | n.a. | n.a. | ||||||||||||||||||
Fereydoun Firouz, Chairman and Chief Executive Officer of Stallergenes Greer, commented:
“2017 was a pivotal year and the results we delivered are evidence of the Group’s transformation which began two years ago. We met our financial guidance and returned to a positive EBITDA representing a €90 million swing over 2016. We reached key innovation milestones, including the completion of patient enrolment in a Phase III trial for our house-dust mite tablet candidate, STAGR320, and the publication of real-world data from the BREATH studies, which notably demonstrated that Oralair® improved control of allergic rhinitis and may have a preventive effect on allergic asthma onset and progression compared to symptomatic treatments.
We made significant progress commercially, delivering a 40% increase in net sales year-over-year as a result of recapturing market share across our product portfolio in all European geographies and continuing to hold market leadership in the U.S. subcutaneous treatment market.
In 2018, we will continue to focus on commercial execution, optimizing our current product portfolio to gain further market share, and developing new offerings to expand allergy immunotherapy penetration in market segments where we see growth opportunities. Our operational plan is focused on driving top line growth, improving profitability, continuing our innovation path and upgrading our technical operations capabilities.”
Full-year net sales increased 40% as a result of market share gains in European and International markets and sales growth of the sublingual product category
Net sales by region: Europe and International grew significantly; Leading position held in the U.S.
| (in € million) | H1 (unaudited) | H2 (unaudited) | Full Year (audited) | ||||||||||||||||||||||||
| 2017 | 2016 | % change | 2017 | 2016 | % change | 2017 | 2016 | % change | |||||||||||||||||||
| Southern Europe | 53.7 | 17.8 | 202% | 65.3 | 44.3 | 47% | 119.0 | 62.1 | 91% | ||||||||||||||||||
| North & Central Europe | 18.5 | 10.7 | 73% | 15.2 | 12.4 | 22% | 33.7 | 23.1 | 45% | ||||||||||||||||||
| International | 11.8 | 4.7 | 151% | 7.8 | 7.4 | 6% | 19.6 | 12.1 | 63% | ||||||||||||||||||
| United States | 45.6 | 44.8 | 2% | 42.3 | 44.1 | (4)% | 87.9 | 88.9 | (1)% | ||||||||||||||||||
The 40% increase year-over-year in net sales reflects the continued recapture of share in European markets and success in new international markets following the temporary suspension of production and distribution at our Antony site in late 2015, which impacted sales in 2016. As of 31 December 2017, Oralair holds 38% of the grass tablet market in France, a 13-percentage point gain over 2016, and 34% of the grass tablet market in Germany, a 3-percentage point gain over last year.2 In addition, the Group holds a market leadership position in Russia, Poland, the Balkans and the Middle East, and regained share in Czech Republic and Slovakia. Sales growth and market share gains were the result of a refocused commercial organization and improved product supply lead time.
In local currency (US$), revenue in the U.S. was up 1% in 2017. In the grass tablet market, Oralair nearly doubled its share from December 2016 while the overall market declined by 5% year-over-year3. In the subcutaneous immunotherapy market, Stallergenes Greer maintained its leading position with a strong demand that exceeded supply.
Net sales by product category: Staloral ® drove 83% growth in sublingual; Subcutaneous grew 3%
| (in € million) | H1 (unaudited) | H2 (unaudited) | Full Year (audited) | ||||||||||||||||||||||||
| 2017 | 2016 | % change | 2017 | 2016 | % change | 2017 | 2016 | % change | |||||||||||||||||||
|
Sublingual 4 |
76.9 | 27.3 | 182% | 79.8 | 58.4 | 37% | 156.7 | 85.7 | 83% | ||||||||||||||||||
|
Subcutaneous 5 |
36.9 | 34.2 | 8% | 33.5 | 33.8 | (1)% | 70.4 | 68.0 | 3% | ||||||||||||||||||
|
Other products 6 |
10.8 | 11.1 | (3)% | 12.1 | 10.0 | 21% | 22.9 | 21.1 | 9% | ||||||||||||||||||
| Veterinary | 5.0 | 5.4 | (7)% | 5.2 | 6.0 | (14)% | 10.2 | 11.4 | (11)% | ||||||||||||||||||
Full year 2017 sublingual product sales increased 83% to €156.7 million from full year 2016, primarily due to the performance of Staloral, which saw total sales increase 98%, or €61.7 million, compared to 2016. The growth was mainly driven by market share gains and, to some extent, by the industry-wide shortage of subcutaneous immunotherapy treatments in Europe, which resulted in switching of some patients to sublingual therapy. Within the sublingual category, total tablet sales in 2017 reached €30.5 million compared to €21.4 million in 2016, mainly driven by Oralair market share growth in established markets. In the U.S., Oralair market share gained 15 points from 16% in 2016 to 31% in 2017. However, the market is growing more slowly than expected.
In the subcutaneous product category, the Group reported 2017 sales of €70.4 million, a 3% increase compared to 2016, driven by growth in European and International markets while the U.S. market remains flat. Sales from the other product category grew 9% year-over-year to €22.9 million, and veterinary sales declined 11% to €10.2 million compared to 2016, due to increased competition in this segment.
Operational efficiencies delivered margin improvement
The Group’s full year 2017 gross margin of €165.8 million represented 64% of net sales, compared to 54% in full year 2016. The improvement is largely due to a global commitment to cost management and a result of ongoing operational efficiency initiatives. In addition, 2016 margins were impacted by costs incurred during the temporary suspension of production and distribution as well as the product recall in 2015.
The Group reduced its net loss from €60.5 million in 2016 to a net loss of €9.9 million in 2017, and reported a positive 2017 EBITDA of €21.9 million, compared to an EBITDA loss of €67.9 million in 2016. EBITDA increased overall by €89.8 million fuelled by a €74.0 million increase in sales and a decline in Selling, General and Administrative expenses of 11%, from €148.2 million in 2016 to €131.9 million in 2017. In 2018, the Group will continue to recalibrate operating expenditures and will further review areas where efficiencies can be made, including the Group’s footprint and overhead costs. This commitment resulted in a decision to reduce its administrative offices in the U.K., France and the U.S.
As a result of the business recovery and robust measures to contain costs, Stallergenes Greer continues to have a solid balance sheet. At 31 December 2017, the Group’s shareholders’ equity represented 83% of the balance sheet total.
As part of our annual reviews, the Group has performed an impairment analysis of its intangible assets and goodwill in accordance with IAS 36 (Impairment of Assets) for its cash-generating units (CGU’s). Based on our long range business plan and related sensitivity scenarios around it, the value-in-use of each CGU exceeds its carrying value and therefore no impairment of goodwill has been recorded in the consolidated Group accounts.
Group continues to invest in innovation to fuel long-term growth
Stallergenes Greer is committed to developing innovative therapies for major respiratory allergies and invested €45.6 million in R&D in 2017, primarily to fund STAGR320, the Group’s Phase III global multi-centre clinical trial for house dust mite (HDM)-induced allergic rhinitis. In July 2017, Stallergenes Greer announced completion of patient enrolment. With more than 1,600 patients enrolled, this study is the largest conducted study to assess the efficacy and safety of a sublingual immunotherapy tablet treatment.
This followed Stallergenes Greer’s announcement in January 2017 of positive top-line results from its Phase III study for paediatric HDM-induced allergic rhinitis in Japan. Results from this study supported the March 2017 submission of a new drug application for paediatric use of Actair (Stallergenes Greer’s commercial name for STAGR320 in registered markets) in Japan, which was approved post-period in February 2018.
In September 2017, the Group received market approval to commercialize STAGR320 in New Zealand under the Actair brand name and in October 2017, Health Canada accepted for review the New Drug Submission for STAGR320.
In addition to STAGR320, in June 2017, Stallergenes Greer published results from BREATH (Bringing Real-World Evidence to Allergy Treatment for Health), the first global, real-world evidence studies demonstrating the long-term benefits of sublingual immunotherapy to control allergic rhinitis and may reduce the risk of the onset and progression of allergic asthma.
Investments in Quality and Technical Operations to continue
The AIT industry’s manufacturing model is based on that of a compounding pharmacy, with processes that must be continuously updated to meet evolving regulatory requirements and comply with the latest Good Manufacturing Process (GMP) biological manufacturing standards. To address this and to ensure product quality and patient safety for all released and distributed products, Stallergenes Greer has made significant investments in its Technical Operations and Quality capabilities over the past two years, including modernizing manufacturing processes and facilities.
As a result of these efforts and the Group’s ongoing commitment to quality, Stallergenes Greer successfully completed three U.S. Food and Drug Administration (FDA) inspections in 2017 at its U.S. facilities. Investments in Lenoir and San Diego will continue in 2018.
In France, the Group made significant progress on operational systems upgrades at its Antony facility, resulting in the reduction of the average product lead time to less than seven days7 compared to the industry standard of two to three weeks. In addition, work has continued to enhance quality control methods used for product manufacturing and release. Meanwhile, an inspection conducted in the fourth quarter of 2017 by the National Agency for Medicines and Health Products Safety (ANSM) in France resulted in the issuance of an injunction received on 4 January 2018. The injunction was primarily related to the quality management system and processes at the Antony facility, mostly for the production of subcutaneous products. The remediation plan is well underway and the Group is committed to working with the French authorities. Shipment delays and temporary shortages of subcutaneous products are expected in European and International markets through 2018.
2018 Business outlook
Stallergenes Greer made substantial progress in 2017 and will continue to make strategic decisions in order to improve its competitiveness and solidify its business fundamentals. This includes investing in growth opportunities and delivering cost efficiencies across the organization. The Group expects continued progress in 2018, both through sales growth and strengthened profitability. Stallergenes Greer expects:
- net sales to grow mid-single digit percent in constant currency, and
- EBITDA to be higher than 2017
---------------------------------------------------------
Stallergenes Greer plc recognized non-cash impairment with no impact on Group consolidated accounts
As part of our annual reviews, Stallergenes Greer plc has performed an impairment analysis of its “investments in subsidiary undertakings” on its statutory accounts based on the latest long range business plan and related sensitivity scenarios around it and an impairment of €234 million was recorded. The impairment in the statutory accounts for Stallergenes Greer plc has no impact on the Group consolidated accounts, its 2017 operating result, EBITDA or Equity8.
Webcast and Conference Call Information
Stallergenes Greer will host an Investors and Analysts meeting today, 22 March 2018. The event will be available via live webcast at 10:30 am GMT / 11:30 am CET / 6:30 am EDT. The webcast will be available via the following link: https://edge.media-server.com/m6/p/ptqhwgnv and on the company’s website, http://stallergenesgreer.com/financial-calendar-events.
Please connect at least 15 minutes prior to the conference to register, download and install any necessary audio software.
Financial Calendar
- 16 April 2018: 2017 Annual Report Publication
- 7 June 2018: Annual General Meeting
- 30 August 2018: H1 2018 Results
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
LEI: 213800CYVZA7GJQEME86
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.
TABLE OF CONTENTS
Consolidated income statement as of 31 December 2017
Consolidated balance sheet as of 31 December 2017
Consolidated cash flow statement as of 31 December 2017
The financial information set out above does not constitute the Group’s financial statements for the period-ended 31 December 2017 but are derived from those statements. The annual report for 2017 will be made public on or before 30 April 2018 and delivered to the UK Companies House on or before 30 June 2018. The auditor has reported on those statements. Their report was unqualified, did not draw attention to any matters by way of emphasis and did not contain statements under Section 498 (2) or (3) Companies Act 2006 or equivalent preceding legislation. While the financial information included in this preliminary announcement has been computed in accordance with International Financial Reporting Standards (IFRS), this announcement itself does not contain sufficient information to comply with IFRS.
The Group published full financial statements that comply with IFRS that are available on its website at http://stallergenesgreer.com/annual-report .
The financial statements were approved by the Board of Directors on 21 March 2018.
Consolidated income statement as of 31 December 2017
| € thousands |
31 December |
31 December |
||
| Net sales 1 | 260,195 | 186,247 | ||
| Other revenues | 36 | 141 | ||
| Total revenues | 260,231 | 186,388 | ||
| Cost of goods sold | (94,458) | (85,331) | ||
| Gross margin | 165,773 | 101,057 | ||
| Distribution costs | (11,413) | (11,783) | ||
| Selling and marketing expenses | (60,624) | (63,943) | ||
| Administrative expenses | (57,588) | (67,316) | ||
| Other general expenses | (2,281) | (5,154) | ||
| Selling, general and administrative expenses | (131,906) | (148,196) | ||
| Research and Development expenses (R&D) | (45,630) | (52,783) | ||
| R&D related income | 6,412 | 7,379 | ||
| Net R&D expenses | (39,218) | (45,404) | ||
| Operating loss (EBIT) before transformation costs | (5,351) | (92,543) | ||
| Transformation costs | – | (3,506) | ||
| Operating loss (EBIT) | (5,351) | (96,049) | ||
| Financial income | 20 | 609 | ||
| Financial expenses | (1,817) | (699) | ||
| Net financial expense | (1,797) | (90) | ||
| Loss before tax and associates | (7,148) | (96,139) | ||
| Income tax | (2,145) | 35,773 | ||
| Share of loss from associated companies | (578) | (156) | ||
| Loss for the period attributable to: | ||||
| Owners of the parent | (9,871) | (60,522) | ||
| Non-controlling interest | – | – | ||
| Group share of net loss | (9,871) | (60,522) | ||
| 1. | The 2017 net sales figure includes a €5,112k unused reversal of the recall provision against sales. | |
Consolidated balance sheet as of 31 December 2017
| € thousands | 31 December 2017 |
31 December 2016 |
|||
| Goodwill | 195,187 | 216,550 | |||
| Other intangible assets | 70,913 | 90,428 | |||
| Property, plant and equipment | 69,138 | 80,304 | |||
| Non-current financial assets* | 3,957 | 6,011 | |||
| Deferred tax assets | 26,754 | 35,377 | |||
| Other non-current assets | 237 | – | |||
| Non-current assets | 366,186 | 428,670 | |||
| Inventories | 56,793 | 63,786 | |||
| Trade receivables | 33,199 | 41,826 | |||
| Current financial assets* | 684 | 13 | |||
| Other current assets | 9,231 | 8,810 | |||
| Current income tax receivable | 611 | 529 | |||
| Research tax credit and subsidies receivable | 22,708 | 15,468 | |||
| Cash and cash equivalents | 50,849 | 71,262 | |||
| Current assets | 174,075 | 201,694 | |||
| Total assets | 540,261 | 630,364 | |||
| Share capital | 19,788 | 19,788 | |||
| Share premium | 539 | 539 | |||
| Merger and contribution premium | 342,149 | 342,149 | |||
| Revaluation reserve | (236) | – | |||
| Retained earnings | 85,086 | 126,733 | |||
| Group shareholders’ equity | 447,326 | 489,209 | |||
| Non-controlling interests | – | – | |||
| Total shareholders’ equity | 447,326 | 489,209 | |||
| Provision for employee retirement obligations and related benefits | 3,442 | 4,488 | |||
| Non-current provisions | 514 | 1,651 | |||
| Non-current financial liabilities | 6,318 | 6,753 | |||
| Deferred tax liabilities | 6,283 | 17,750 | |||
| Non-current liabilities | 16,557 | 30,642 | |||
| Trade payables | 19,793 | 26,658 | |||
| Current provisions | 2,115 | 3,180 | |||
| Current financial liabilities | 12,204 | 16,366 | |||
| Income tax payable | 1,313 | 1,217 | |||
| Other current liabilities | 40,953 | 63,092 | |||
| Current liabilities | 76,378 | 110,513 | |||
| Total equity and liabilities | 540,261 | 630,364 | |||
*The liquidity contract of the Group for €670k at 31 December 2017 (31 December 2016: €742k) has been reclassified from non-current financial assets to current financial assets.
Consolidated cash flow statement as of 31 December 2017
| € thousands | 31 December 2017 |
31 December 2016 |
||||
| Cash flow from operating activities | ||||||
| Group share of net loss | (9,871) | (60,522) | ||||
| Share of undistributed earnings from investments accounted for using the equity method | 578 | 156 | ||||
| Tax | 2,145 | (35,773) | ||||
| Net financial result | 1,798 | 90 | ||||
| Amortisation and depreciation charges | 23,404 | 27,682 | ||||
| Change in provision | (1,904) | (1,096) | ||||
| Share-based compensation | 2,429 | 1,117 | ||||
| Capital losses from disposal of assets | 4,466 | 578 | ||||
| Financial losses excluding interests | (35) | 56 | ||||
| Operating cash flow before changes in working capital | 23,010 | (67,712) | ||||
| Current income tax paid | (3,768) | 4,612 | ||||
| Change in subsidies and R&D tax credit receivables | (7,240) | (7,066) | ||||
| Change in working capital of operating activities | (16,231) | (7,244) | ||||
| Change in deferred income | 11 | (675) | ||||
| Net cash flow from operating activities | (4,218) | (78,085) | ||||
| Cash flow from investing activities | ||||||
| Purchase of non-current assets | (12,643) | (22,015) | ||||
| Acquisition of investments in consolidated undertakings, net of cash acquired | (1,403) | – | ||||
| Proceeds from sale of non-current assets1 | 5,269 | 19,509 | ||||
| Change in working capital of investment activities | (1,400) | (2,547) | ||||
| Net cash flow from investing activities | (10,177) | (5,053) | ||||
| Free cash flow after investing activities | (14,395) | (83,138) | ||||
| Cash flow from financing activities | ||||||
| Proceeds from issuance of ordinary shares | – | – | ||||
| Treasury shares transactions | (72) | 20 | ||||
| Net financial interest paid | (1,407) | (583) | ||||
| Use / (repayment) of bank overdrafts | (227) | (133) | ||||
| Repayment of borrowings | (15,054) | (17,018) | ||||
| Proceeds from borrowings | 12,095 | 22,115 | ||||
| Net cash flow from financing activities | (4,665) | 4,401 | ||||
| Change in cash and cash equivalents | (19,060) | (78,737) | ||||
| + cash and cash equivalents – opening balance | 71,262 | 150,183 | ||||
| +/- effect of translation adjustment on foreign currency denominated cash | (1,353) | (184) | ||||
| = cash and cash equivalents – closing balance | 50,849 | 71,262 | ||||
| 1. | Included within proceeds from sale of non-current assets are the proceeds from sale of the DBV Technologies shares of €16,834k in 2016. | |
| 1 | Guidance for 2017 was stated as “total revenue”; there is no material difference between “net sales” and “total revenue”. Net sales stated in “constant currency” were determined using the same exchange rates as the half-year 2017 results. | |
| 2 | Source: IMS MIDAS | |
| 3 | Source: Symphony Health Solutions and US Specialty Pharmacy aggregated data internal data audit | |
| 4 | Product category includes oral drops (Staloral) and tablets (Oralair and Actair®) | |
| 5 | Product category includes Named Patient Prescription products and bulk allergens | |
| 6 | Product category includes diagnostic and ancillary products | |
| 7 |
Not including backorders |
|
|
8 |
For more information, please refer to note 4.5 in the Stallergenes Greer plc, Company financial statements - www.stallergenesgreer.com. |
Stallergenes Greer to Report Full Year Financial Results on 22 March 2018
LONDON--(BUSINESS WIRE)-- Regulatory News:
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced it will report financial results for the second half and full fiscal year ended 31 December 2017 on 22 March 2018. The Company’s management will host a live audio webcast of its earnings conference call at 10:30 am London / 11:30 am Paris / 6:30 am Boston that same day to discuss the results.
Members of the financial community may access the conference call through the dial-in information provided on the company’s website, at http://stallergenesgreer.com/financial-calendar-events. The live audio webcast will be accessible to the general public via the following link: https://edge.media-server.com/m6/p/ptqhwgnv. Participants are asked to connect at least 15 minutes prior to the conference call to register, download and install any necessary audio software.
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
LEI: 213800CYVZA7GJQEME86
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.
Stallergenes Greer Announces Approval in Japan of Pediatric Use for ACTAIR®, Sublingual Immunotherapy Tablet for the Treatment of House Dust Mite Allergy
LONDON--(BUSINESS WIRE)-- Regulatory News:
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today announced that its partner in Japan, Shionogi & Co. Ltd., received approval for the extension of the indication for ACTAIR®, an allergy immunotherapy sublingual tablet for the treatment of house dust mite (HDM) induced allergic rhinitis, to treat patients under the age of 12. ACTAIR is already approved for the treatment of HDM-induced allergic rhinitis in patients 12 years of age and older in Japan since March 2015.
“The approval of ACTAIR for pediatric use in Japan will provide a valuable treatment option for patients under the age of 12 suffering from allergic rhinitis caused by an allergy to house dust mites. We are very pleased that this product will be available to even more patients in Japan,” said Fereydoun Firouz, Chairman and CEO of Stallergenes Greer.
The New Drug Application submission was supported by data from Shionogi’s positive Phase III trial, which was announced in January 2017. The multi-center, randomized, double-blind, placebo-controlled study evaluated the efficacy of ACTAIR at a daily maintenance dose of 300IR administered for 12 months to children between 5 and 16 years old with HDM-associated allergic rhinitis. The active group demonstrated a statistically significant difference (p=0.0005) versus placebo on the Average Adjusted Symptom Score after one year of treatment, achieving the primary efficacy endpoint.
In addition to Japan, Stallergenes Greer’s HDM tablet is registered in Australia, New Zealand and South Korea under the brand name ACTAIR for the treatment of HDM-induced allergic rhinitis in patients 12 years of age and older.
Stallergenes Greer has exclusive partnership agreements with Shionogi for the clinical development, registration and commercialization of HDM and Japanese cedar pollen sublingual immunotherapy tablets in Japan.
ABOUT SHIONOGI’S PHASE 3 TRIAL IN CHILDREN 5 TO 11 YEARS OLD
The primary endpoint was the AAdSS over the last month of the one-year treatment period. The AAdSS is the average of the total score of four rhinitis symptoms (sneezing, rhinorrhea, nasal congestion and nasal pruritus) adjusted for rescue medication use. This was a multi-center, randomized, double-blind, placebo-controlled study to assess the efficacy of HDM sublingual immunotherapy tablets for the treatment of allergic rhinitis. Patients aged 5 to 16 years old with medical history consistent with HDM-induced allergic rhinitis were eligible. A total of 438 patients were randomized to receive 12 months of treatment with HDM sublingual immunotherapy tablets or placebo. The active group showed statistically significant difference (p=0.0005) compared to placebo. Local adverse reactions were observed, with most of them mild in nature with no marked safety concerns.
ABOUT RESPIRATORY ALLERGIES IN JAPAN IN PEDIATRIC PATIENTS
Allergic rhinitis affects 25% of Japan’s population. House dust mites and Japanese cedar pollen are the two main causes of respiratory allergies in the country. From early childhood, house dust mites can trigger allergic rhinitis, which worsens over time with a potential progression towards asthma. The symptoms may be severe, significantly impairing patients’ quality of life. With 32 million respiratory allergy sufferers, there is a strong, and as yet unmet, demand for allergy treatment in Japan.
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
LEI: 213800CYVZA7GJQEME86
Market: Euronext Paris regulated market
Additional information is available at https://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.
Stallergenes Greer comments on share price movement
LONDON--(BUSINESS WIRE)-- Regulatory News:
Stallergenes Greer (Paris:STAGR), a biopharmaceutical company specializing in treatments for respiratory allergies, today noted a drop of its share price that may be related to the publication of an injunction received from the French National Agency for Medicines and Health Products Safety (ANSM) following the inspection of one production area at the company’s facility in Antony, France.
The company clarifies that the injunction published by the ANSM on January 9, 2018 does not impact supply and does not require a product recall. Stallergenes Greer will continue to supply the market with allergy immunotherapy treatments while it addresses the ANSM observations identified in the injunction.
The company also confirms that most of the observations noted by the agency either have been addressed or are in the process of being resolved as part of the ongoing upgrade of the manufacturing operations at the Antony facility. The current manufacturing upgrades and investments began two years ago in order to ensure that Stallergenes Greer meets the required quality standards.
“We are fully cooperating with the ANSM and we have already taken corrective actions voluntarily to upgrade our manufacturing operations. We are now focused on completing the remaining items identified by the agency within the agreed-upon timeline,” said Fereydoun Firouz, Chairman and Chief Executive Officer.
The injunction was issued following an ANSM inspection of one of the facility’s production areas. The observations relate to the quality management system and processes, such as the procedures to investigate and close manufacturing deviations from agreed manufacturing specifications, primarily for the production of subcutaneous immunotherapy (SCIT) products.
The company does not expect the ANSM injunction to have a material impact on its business and will provide an update on the progress of its manufacturing upgrade during its next earning call on March 22, 2018.
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
LEI: 213800CYVZA7GJQEME86
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.