EUZ Eckert & Ziegler Strahlen- und Medizintechnik AG

DGAP-News: Eckert & Ziegler: EMA Grants Drug Designation to EZAG Affiliate

DGAP-News: Eckert & Ziegler Strahlen- und Medizintechnik AG / Key word(s): Miscellaneous/Miscellaneous
Eckert & Ziegler: EMA Grants Drug Designation to EZAG Affiliate

26.07.2019 / 15:50
The issuer is solely responsible for the content of this announcement.


Press Release

Berlin, July 26, 2019. Myelo Therapeutics GmbH, an Affiliate of Eckert & Ziegler Strahlen- und Medizintechnik AG (ISIN DE0005659700) has announced that the European Medicines Agency (EMA) has granted an Orphan Drug Designation to its orally applied new chemical entity Myelo001 (Imidazolyl ethanamide pentandioic acid) for the treatment of Acute Radiation Syndrome (ARS). The positive EMA ruling follows the United States (US) Food and Drug Administration's (FDA) 2018 decision to award an Orphan Drug Designation to Myelo001 for the treatment of ARS.

ARS, also known as radiation toxicity or radiation sickness, is an acute illness that presents after exposure to high levels of radiation, caused by a nuclear accident or attack. It can lead to severe health consequences, including death. The European Union (EU) and the US government, amongst other countries, are encouraging the development of new drugs to prevent or treat ARS.

Myelo001 is a new, clinical-stage adjuvant cancer therapy for the treatment of chemotherapy- and radiotherapy-induced myelosuppression. Preclinical and clinical studies have shown that Myelo001 applied orally is effective in reducing hematopoietic symptoms caused by chemotherapy and radiation. Comprehensive chronic toxicology and safety studies, as well as clinical studies, have confirmed an excellent safety profile of Myelo001.
The EU orphan designation program provides incentives to companies that are developing therapies for diseases which affect fewer than 5 in 10,000 people within the territory of the EU. The benefits of achieving Orphan Drug Designation include scientific advice by EMA on study protocols, regulatory fee reductions and waivers, as well as access to EU grants for drug development. Upon marketing approval, Myelo001 will benefit from 10 years of market exclusivity for the ARS indication within the EU's territory.

Therapies for ARS qualify as medical countermeasures (MCMs), which may be used in the event of a potential public health emergency caused by a biological, chemical, or radiological/nuclear material. MCMs are purchased and stockpiled by the EU through its Joint Procurement Agreement for MCMs, the US Department of Health and Human Services and US Department of Defense, as well as various other foreign governments and militaries

About Myelo Therapeutics.
Myelo Therapeutics is a pharmaceutical company based in Berlin and Dresden, Germany, that is developing innovative treatments in areas of high unmet medical needs, such as Chemotherapy-induced Myelosuppression (CIM), Radiation-induced Myelosuppression (RIM), and Acute Radiation Syndrome (ARS). For more information, visit .

About Eckert & Ziegler.
Eckert & Ziegler Strahlen- und Medizintechnik AG has been listed on the stock exchange since 1999 and is listed in the Prime Standard of the German Stock Exchange in Frankfurt am Main (ISIN DE0005659700). With around 800 employees, it is one of the world's largest providers of isotope-related components for radiation therapy and nuclear medicine.
Contributing to saving lives.

Contact:
Eckert & Ziegler AG, Karolin Riehle, Investor Relations
Robert-Rössle-Str. 10, 13125 Berlin, Germany
Tel.: +49 (0) 30 / 94 10 84-138, ,



26.07.2019 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases.
Archive at


Language: English
Company: Eckert & Ziegler Strahlen- und Medizintechnik AG
Robert-Rössle-Str.10
13125 Berlin
Germany
Phone: 38
Fax: 12
E-mail:
Internet:
ISIN: DE0005659700
WKN: 565970
Indices: SDAX
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 847589

 
End of News DGAP News Service

847589  26.07.2019 

fncls.ssp?fn=show_t_gif&application_id=847589&application_name=news&site_id=research_pool
EN
26/07/2019

Underlying

Reports on Eckert & Ziegler Strahlen- und Medizintechnik AG

 PRESS RELEASE

EQS-News: Eckert & Ziegler: Record year 2024 with new all-time highs

EQS-News: Eckert & Ziegler SE / Key word(s): Annual Results/Forecast Eckert & Ziegler: Record year 2024 with new all-time highs 27.03.2025 / 07:45 CET/CEST The issuer is solely responsible for the content of this announcement. Berlin, 27 March 2025. Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) achieved a new record in the 2024 financial year with sales of € 295.8 million based on the preliminary annual financial statements*. Compared to the previous year, sales increased by almost € 50 million (+20%). EBIT before special items from continuing operations (adjusted EBIT)...

 PRESS RELEASE

EQS-News: Eckert & Ziegler: Rekordjahr 2024 mit neuen Höchstmarken

EQS-News: Eckert & Ziegler SE / Schlagwort(e): Jahresergebnis/Prognose Eckert & Ziegler: Rekordjahr 2024 mit neuen Höchstmarken 27.03.2025 / 07:45 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Berlin, den 27. März 2025. Die Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) erreichte auf Basis des vorläufigen Jahresabschlusses* im Geschäftsjahr 2024 mit einem Umsatz von 295,8 Mio. € eine neue Rekordmarke. Im Vergleich zum Vorjahr stieg der Umsatz um knapp 50 Mio. € (+20%). Das EBIT vor Sondereinflüssen aus fortgeführten Geschäftsbereic...

 PRESS RELEASE

EQS-News: Eckert & Ziegler to Supply Actinium Pharmaceuticals with Ac-...

EQS-News: Eckert & Ziegler SE / Key word(s): Agreement/Incoming Orders Eckert & Ziegler to Supply Actinium Pharmaceuticals with Ac-225 for Comprehensive Development Activities 25.03.2025 / 09:30 CET/CEST The issuer is solely responsible for the content of this announcement. Berlin, DE & New York, USA, 25 March 2025. Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) and Actinium Pharmaceuticals, Inc. announced that they have entered into an agreement for the supply of Actinium-225 (Ac-225). With this agreement, Actinium Pharmaceuticals will have access to Eckert & Ziegler’s ...

 PRESS RELEASE

EQS-News: Eckert & Ziegler beliefert Actinium Pharmaceuticals mit Ac-2...

EQS-News: Eckert & Ziegler SE / Schlagwort(e): Vereinbarung/Auftragseingänge Eckert & Ziegler beliefert Actinium Pharmaceuticals mit Ac-225 für umfangreiches Entwicklungsprogramm 25.03.2025 / 09:30 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Berlin, DE & New York, USA, 25. März 2025. Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) und Actinium Pharmaceuticals, Inc. gaben bekannt, dass sie eine Vereinbarung über die Lieferung von Actinium-225 (Ac-225) geschlossen haben. Mit dieser Vereinbarung erhält Actinium Pharmaceuticals Zugang...

 PRESS RELEASE

EQS-News: Eckert & Ziegler und AtomVie Global Radiopharma unterzeichne...

EQS-News: Eckert & Ziegler SE / Schlagwort(e): Auftragseingänge/Vereinbarung Eckert & Ziegler und AtomVie Global Radiopharma unterzeichnen weltweite Vereinbarung über die Lieferung von Lutetium-177 20.03.2025 / 14:00 CET/CEST Für den Inhalt der Mitteilung ist der Emittent / Herausgeber verantwortlich. Berlin, DE & Hamilton, ON, CA, 20. März 2025. Eckert & Ziegler SE (ISIN DE0005659700, TecDAX) und AtomVie Global Radiopharma Inc. (AtomVie) haben heute eine globale Liefervereinbarung bekannt gegeben. Eckert & Ziegler wird sein trägerfreies, qualitativ hochwertiges Lutetium-...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch