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Stallergenes Greer Updates on the ANSM Injunction - Antony Site (France)

Freitag, 19.04.2019 15:40



LONDON --(BUSINESS WIRE)--

Regulatory News:

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Stallergenes Greer (Euronext:STAGR), a biopharmaceutical company specialising in treatments for respiratory allergies, today announced that the French National Agency for Medicines and Health Products Safety (ANSM) published today a partial extension of its injunction dated January 4, 2018.

The original injunction related to the quality management systems and processes at Stallergenes Greer’s facility in Antony (France) and primarily impacted the production of subcutaneous products. Sublingual products were not impacted.

In its 2019 decision, the ANSM noted the full resolution offour points among the seven raised in the January 2018 injunction. The ANSM decided to extend its injunction concerning the remaining three points: two related to the production of subcutaneous products and one related to pharmacist training as to batch releases. In accordance with the deadlines set by the ANSM, two of these points are expected to be concluded by the end of May 2019, the other by September 15, 2019.

ABOUT THE POTENTIAL FINANCIAL PENALTY

As announced in June 2018, the ANSM informed the Company that it may impose a financial penalty. The ANSM has not notified Stallergenes Greer of its decision in that regard.

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 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 2018 annual report published on 21 March 2019 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.

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