LONDON--(BUSINESS WIRE)--Regulatory News:
Stallergenes Greer plc (the “Company”) (Euronext:STAGR), a biopharmaceutical company specialized in treatments for respiratory allergies, today announced that its subsidiary, Stallergenes SAS (“Stallergenes”) has received a notification from the French Health Authority, l’Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), arising from certain technical problems encountered in the launch of its new IT business operations system.
This notification temporarily suspends the production and distribution of products manufactured at the Antony (France) plant. Stallergenes will also proceed with a withdrawal of products in France according to a risk management plan agreed with the French Health Authority.
This notification follows observations made by the ANSM regarding the implementation of a new IT system aimed at providing upgraded supply and delivery of Stallergenes’ products. The launch of this new IT system has resulted in operational disruptions and some incorrect product deliveries.
Production is expected to resume at the Antony plant when the Stallergenes’ IT system issues have been resolved and all observations made by the ANSM have been satisfactorily addressed.
Fereydoun Firouz, Chairman and Chief Executive Officer of Stallergenes Greer said:
“The patients who need our treatments and their physicians are our top priority. Nothing is more important to Stallergenes Greer than ensuring the complete quality, safety and supply of our products. We deeply regret this situation and are working diligently with the authorities in order to resume full supply to the market as quickly as possible. We are confident about the quality of our products produced in Antony and our ability to resolve this technical issue. We expect the impact will be temporary.”
The Company is collaborating fully with the competent Health Authorities with a view to ensuring timely resumption of production and distribution of products at the facility, and will work closely with physicians, patients and regulators to minimize the impact on care and treatment of patients. The timing and extent of the supply constraints are being clarified with the Authorities concerned. The Company will follow up with additional communication as soon as possible.
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).
Trading information:
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB classification: 4577
Market: Euronext Paris regulated market
Additional information is available at http://www.stallergenesgreer.com
This document (including information incorporated by reference in this document), oral statements made and other information published by the company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the company. These statements can be identified by the use of forward-looking terminology such as "believe", "expects", "project", "estimated", "forecast", "should", "plan", "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in 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.
