AEZS vs. KERX
Was mich wundert, verhandelt Aeterna nicht mit den Chinesen? Na ja dachte es wäre vielleicht sinnvoll wegen Wachstumshormon.......
Novo Nordisk: milliardenschwere Übernahme
Der dänische Insulinspezialist Novo Nordisk baut sein Portfolio mit einer milliardenschweren Übernahme weiter aus. Das Unternehmen hat eine definitive Vereinbarung zum Kauf von Corvidia Therapeutics aus den USA unterzeichnet und zahlt in einem ersten Schritt 725 Millionen Dollar. Die amerikanische Firma hat sich auf die Forschung und Entwicklung von Therapien für Herz- und Nierenerkrankungen spezialisiert.
Oder hält Novo nach der Übernahme von Corvidia Therapeutics sein Pulver trocken und stellt Gespräche mit Aeterna hinten an?
Meinungen?
Wir werden es hoffentlich bald sehen. Ich bin weiterhin sehr optimistisch, wenn auch langsam meine Geduld sehr strapaziert ist.
OPKO/Pfizer Topline Results
Okt 2019 Phase3 children https://www.globenewswire.com/news-release/2019/...ne-Deficiency.html
Jun 2020 Japanese Childrenhttps://www.opko.com/news-media/press-releases/...-results-of-phase-3
FDA / EMA ?????
Novo
21 Sep ----------FDA APPROVAL Novo Somapacitan
Pediatic Phase 3 https://clinicaltrials.gov/ct2/show/NCT02968004
Estimated Primary Completion Date : | June 5, 2021 |
Estimated Study Completion Date : | December 1, 2024 |
March 2015 registered direct offering - Series A 28,144 1.07$ March 10, 2020
November 2016 registered direct offering 945,000 4.70$ May 1, 2020
December 2015 registered direct offering 2,331,000 7.10$ December 13, 2020
September 2019 registered direct offering 3,325,000 1.65$ September 24, 2024
Februar 2020 Investor Warrant 2,608,696 1.20$ Juli 21, 25
Februar 2020 Wainwright Warrants 243,478 1.61719$ February 19, 2025
(Die 2020 Warrants dürfen m.E. ausgeübt aber nicht verkauft werden, da unregistriert!)
Termine 2020:
Q1 ---- Ende PIP 01 (Kindrstudie)
10. März --- Ende der Serie A Warrants
24. März ----- Die 1,65$ September 2019 Warrants dürfen ausgeübt werden
1 April -------Beneficial Ownership Determination Date/ Record Date for Voting
6.April ------- Finale Ergebnisse PIP 01 (positive Results In Dose-finding)
1. Mai ------- Ende der 945T 4,7$ Warrants
15. Mai ------- Annual Meeting
Q2/Q3-------- Anfang PIP 02
21 Sep ----------FDA APPROVAL Novo Somapacitan
13. Dez ---------- Ende der 2,33 Mio 7,1$ Warrants
Ende Kohle
2022------- Ende PIP 02
? ------ EMA/FDA Zulassung
Table 1 Summary of long-acting recombinant human growth hormone preparations
Class | Company | Product | Design | Status |
---|---|---|---|---|
Depot Formulations | ||||
Genentech (South San Francisco, USA) Alkermes (Dublin, Ireland) | Nutropin Depot | Encapsulated in Polylactide-Coglycolide Microspheres | FDA approved, but removed from the market in 2004. | |
BioPartners (Los Angeles, USA) LG Life Sciences (Seoul, South Korea) | Declage LB03002 | Growth hormone incorporated into sodum hyaluronate and suspended in MCT for injection | Approved for pediatric growth hormone deficiency in South Korea | |
PEGylated Formulations | ||||
Ambrx (La Jolla, USA) | ARX201 | 30-kDa PEG incorporated into recombinant human growth hormone | Drug development stopped due to PEG accumulation in ependymal cells of choroid plexus | |
Novo Nordisk (Bagsvaerd, Denmark) | NNCI126-0083 | 43-kDa PEG linked to recombinant human growth hormone | Drug development stopped | |
Pfizer (New York City, USA) | PHA-794428 | Branched 40-kDa PEG linked to amino end of recombinant human growth hormone | Drug development stopped | |
GeneScience Pharmaceuticals (Changchun, China) | Jintrolong | 40-kDa PEG linked to growth hormone | Approved for pediatric growth hormone deficiency in China | |
Pro-drug Formulations | ||||
Ascendis Pharma (Hellerup, Denmark) | TransCon Growth Hormone | Recombinant human growth hormone transiently bound to mPEG | Phase 3 testing concluding. Seeking regulatory approval in 2020 | |
Non-Covalent Albumin Binding Growth Hormone | ||||
Novo Nordisk (Bagsvaerd, Denmark) | Somapacitan | Recombinant human growth hormone with a single point mutation attached to a terminal fatty acid that reversibly binds albumin | Ongoing pediatric phase 3 testing | |
Growth Hormone Fusion Proteins | ||||
Genexine (Seongnam, South Korea) Handok (Seoul, South Korea) | HyTropin GX-H9 | Recombinant human growth hormone fused to hybrid Fc | Pending phase 3 trial | |
OPKO Health (Miami, USA) Pfizer (New York City, USA) | Somatrogon Lagova MOD-4023 | Recombinant human growth hormone fused to 3 copies of carboxy-terminal of hCG’s beta subunit | Phase 3 testing in children underway. | |
Teva (Petah Tikva, Israel) | TV-1106 | Recombinant human growth hormone fused to albumin | Blocking/inactivating antibodies developed, drug abandoned. | |
Versartis (Menlo Park, USA) | Somavaratan VRS-317 | Recombinant human growth hormone fused to hydrophilic strings of amino acids | Discontinued due to inferiority to daily recombinant human growth hormone in increasing adult height |
https://www.scielo.br/...359-39972019000900601&lng=en&nrm=iso