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 |
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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 |