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).
Name: Stallergenes Greer
ISIN: GB00BZ21RF93 1 - Ticker: STAGR
ICB Classification: 4577
Market: Euronext Paris regulated market
Additional information is available at http://www.stallergenesgreer.com.
This document (including information incorporated by reference in this document), oral statements made and other information published by the Company contain statements that are or may be forward-looking with respect to the financial condition and/or results of operations and businesses of the Company. These statements can be identified by the use of forward-looking terminology such as "believe," "expects," "project," "estimated," "forecast," "should," "plan," "may" or the negative of any of these, or other variations thereof, or comparable terminology indicating expectations or beliefs concerning future events. These forward-looking statements include risk and uncertainty because they relate to events and depend on circumstances that will occur in the future. Without being exhaustive, such factors include economic situations and business conditions, including legal and product evaluation issues, fluctuations in currencies and demand, and changes in competitive factors. These and other factors are more fully described in the Company's 2016 annual report published on 28 April 2017 on the Company's website www.stallergenesgreer.com . Actual results may differ from those set forth in the forward-looking statements, due to various factors. Save as required by applicable law, neither the Company nor any other person assumes any obligation to update these forward-looking statements or to notify any person of any such update.