December 07, 2015 02:00 AM Eastern Standard Time
LONDON--(BUSINESS WIRE)--Regulatory News:
Stallergenes Greer plc (the "Company") (Euronext: STAGR)(Paris:STAGR), a biopharmaceutical company specialized in treatments for respiratory allergies, today communicated that its subsidiary, Stallergenes SAS ("Stallergenes") is proceeding with a recall of allergy immunotherapy products which were shipped from its Antony (France) plant after August 13, 2015.
In France, this product recall is conducted according to a risk management plan agreed with the French Health Authority, l'Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM). In other countries, the appropriate course of action will be discussed and agreed upon with each national Health Authority.
This follows a notification received by Stallergenes from the French Health Authority on December 2, 2015, as previously announced, arising from certain technical problems encountered following the launch of its new IT system in August 2015. Production is expected to resume when the Stallergenes' IT system issues have been resolved and all observations made by the ANSM have been satisfactorily addressed.
Stallergenes is collaborating fully with the Health Authorities with a view to ensuring timely resumption of production and distribution of products at the facility. Patients and their physicians are Stallergenes' top priority and the company is working closely with them to minimise the impact on care and treatment of patients.
The French Health Authority has advised that, as allergy immunotherapy is a disease modifying treatment with mid to long term effects, the treatment interruption resulting from the product recall is unlikely to present a risk for patient's health. For the sake of transparency, Stallergenes is also informing healthcare professionals prescribing its products in all concerned countries about this product recall.
Patients and healthcare professionals who have questions can contact Stallergenes' call center at the following toll free numbers:
Patient: +33 0800 940 390
Healthcare professional: +33 0800 940 377
ABOUT STALLERGENES GREER PLC
Headquartered in London (UK), Stallergenes Greer plc is a global 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 U.S.) and Stallergenes S.A.S. (whose registered office is in France).
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB classification: 4577
Market: Euronext Paris regulated market
Additional information is available at http://www.stallergenesgreer.com
This document (including information incorporated by reference in this document), oral statements made and other information published by the company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the company. These statements can be identified by the use of forward-looking terminology such as "believe", "expects", "project", "estimated", "forecast", "should", "plan", "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in our prospectus filed with the French Autorité des marchés financiers on September 3, 2015. 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
Investor and analyst relations
Peter Bühler, +33 1 55 59 23 22
Chief Financial Officer
Lise Lemonnier, + 33 1 55 59 20 96
Head of Global Communications
Media relations agency
Robin Wrench / Agnès Catineau
+44 (0) 20 7404 5959 / +33 (0) 6 19 17 16 67