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Sunday, August 21, 2022 12:17:48 PM
On November 16, 2020, the Company announced that it had entered into the Novo Amendment related to the development and commercialization of macimorelin. Novo is currently marketing macimorelin in the U.S. under the trade name Macrilen™ for the diagnosis of AGHD. Aeterna, in collaboration with Novo, is currently developing the expanded use of macimorelin for the diagnosis of CGHD, an area of significant unmet medical need.
On December 7, 2020, the Company entered into an exclusive licensing agreement with Consilient Health Limited (“CH” or “Consilient”) for the commercialization of macimorelin in the European Economic Area and the United Kingdom. In December 2021, the Department of Health and Social Care in the United Kingdom approved a list price which triggered a $226 (€0.2 million) pricing milestone payment from CH to the Company. In Germany, a list price was approved on June 15, 2022 which triggered a second $226 (€0.2 million) pricing milestone payment from CH to the Company. We shipped initial batches of macimorelin (Ghryvelin®) to Consilient in the first quarter of 2022. Consilient launched the product in the United Kingdom, Sweden and Denmark in May 2022 and launches in Germany and Finland are scheduled for July 2022.
We entered into license and supply agreements with NK Meditech Ltd. (“NK”), a subsidiary of PharmBio Korea, effective November 30, 2021, and a distribution and commercialization agreement with ER Kim Pharmaceuticals Bulgaria Food (“ER-Kim”), effective February 1, 2022. The agreements with NK are related to the development and commercialization of macimorelin for the diagnosis of AGHD and CGHD in the Republic of Korea, while the agreement with ER-Kim is related to the commercialization of macimorelin for the diagnosis of growth hormone deficiency in children and adults in Turkey and some non-European Union Balkan countries.
On April 19, 2022, we announced that European Patent Office had issued a patent providing intellectual property protection of macimorelin in 27 countries within the European Union as well as additional European non-EU countries, such as the UK and Turkey, for macimorelin (Ghryvelin®; Macrilen™) for use to diagnose GHD in adults.
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Recent AEZS News
- Aeterna Zentaris Announces Results of Virtual 2024 Meeting of Shareholders • GlobeNewswire Inc. • 07/16/2024 08:05:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 06/13/2024 01:20:29 PM
- Aeterna Zentaris Announces Last Patient Last Visit in Pivotal DETECT-Trial for the Diagnosis of Childhood-Onset Growth Hormone Deficiency • GlobeNewswire Inc. • 06/13/2024 01:10:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 06/10/2024 05:31:28 PM
- Form SC 13G - Statement of acquisition of beneficial ownership by individuals • Edgar (US Regulatory) • 06/06/2024 05:46:51 PM
- Form EFFECT - Notice of Effectiveness • Edgar (US Regulatory) • 06/05/2024 04:15:07 AM
- Aeterna Zentaris and Ceapro Complete Merger Transaction • GlobeNewswire Inc. • 06/03/2024 01:15:41 PM
- Aeterna Zentaris and Ceapro Complete Merger Transaction • GlobeNewswire Inc. • 06/03/2024 01:15:00 PM
- Form S-8 - Securities to be offered to employees in employee benefit plans • Edgar (US Regulatory) • 05/31/2024 01:58:07 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 05/31/2024 01:56:49 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 05/31/2024 01:56:35 AM
- Form POS AM - Post-Effective amendments for registration statement • Edgar (US Regulatory) • 05/31/2024 01:55:30 AM
- Form 6-K/A - Report of foreign issuer [Rules 13a-16 and 15d-16]: [Amend] • Edgar (US Regulatory) • 05/30/2024 01:31:16 AM
- Aeterna Zentaris Provides Update on Timing for Annual Meeting of Shareholders and Due Bill Redemption Date • GlobeNewswire Inc. • 05/29/2024 10:35:00 PM
- Form 6-K - Report of foreign issuer [Rules 13a-16 and 15d-16] • Edgar (US Regulatory) • 05/17/2024 12:00:34 PM
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