investek
Well-known member
This thread is a repository of research links and milestones.
It originally was in the Research Forum, but was moved here so anonymous can view.
The first post will be updated regularly.
Add suggestions for updates to the thread below.
Major changes will be noted in the thread.
Categories Below:
Major milestones
Trials
Approvals
Reimbursement (add to milestones?)
Future Pipeline
Patents
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It originally was in the Research Forum, but was moved here so anonymous can view.
The first post will be updated regularly.
Add suggestions for updates to the thread below.
Major changes will be noted in the thread.
Categories Below:
Major milestones
Trials
Approvals
Reimbursement (add to milestones?)
Future Pipeline
Patents
| Major Milestones | Date (Updated or Expected) | Comments | Link to resources/source |
| Patient Growth | |||
| EPP Market Penetration - Europe Label extension from 4 to 6 implants per annum | 01/02/2019 | Label extension target date as indicated in 2017 AGM | Link |
| - More specialty centres in the US | Now aiming for 120 | Link | |
| Book on Clinuvel by Columbia Univ | |||
| Trials | |||
| CUV011 (OTR) | Trial site last updated 06/12/2010 AGM - 21/11/2018 | Phase II AK Study in Organ Transplant Patients Comment from 2018 AGM Slide 25 "no malignancies" | Trial link ASX link |
| CUV151 (DNA Repair) | Estimated Study Completion Date: Oct 2022 | Interim results out | Trial Link News link ASX Link |
| CUV152 (XP-C & XP-V) | Estimated Study Completion Date 01/07/2023 | First XP-V Patient Treated - 30/03/2022 | https://clinicaltrials.gov/ct2/show/NCT05370235?term=clinuvel&draw=2&rank=2 |
| CUV153 (XP | |||
| CUV156 (XP-C) | Estimated Study Completion Date 23/01/2023 | Interim results out | https://clinicaltrials.gov/ct2/show/NCT05159752?term=clinuvel&draw=2&rank=4 |
| North African XP Trial?? | |||
| CUV801 (Stroke Trial, AIS) | Actual Study Completion Date 04/02/2022 | NIHSS scores improved in five patients | https://clinicaltrials.gov/ct2/show/NCT04962503?term=clinuvel&draw=2&rank=9 https://www.clinuvel.com/wp-content/uploads/2022/05/stroke-study-cuv801-20220504.pdf |
| CUV803 | 20/03/2023 | First Patient Dosed |
CUV803 Trial Page |
| CUV104 (Vitiligo Phase 2 Trial USA) | Estimated Study Completion Date 01/06/2023 | https://clinicaltrials.gov/ct2/show/NCT05210582?term=clinuvel&draw=2&rank=8 | |
| CUV040 (VP Trial) | Two centres, Erasmus (Netherlands) and Switzerland The study (CUV040) will start patient treatment in the northern hemisphere spring of 2019. 10/07/2022 trial status ongoing, trial duration 10mths Commented on at 2022 AGM (not as severe as EPP) | https://www.porfiria.org/wp-content/uploads/2018/10/20181001VPCUV040.pdf https://adisinsight.springer.com/trials/700300275 https://www.clinicaltrialsregister.eu/ctr-search/trial/2018-004164-60/NL#A | |
| Approvals | |||
| Japan Submission/Approval | 01/01/2019 | Filing SCENESSE in Japan (as per 2017 AGM) Commented on at 2022 AGM, they are interested in Japan, probably requires another trial | https://www.asx.com.au/asxpdf/20171128/pdf/43pn6c5k23mn2y.pdf |
| China (Winhealth) | Commented on at AGM | we the board and the company are very keen to grow a business in China and sell our products in China and you're asking why that why we haven't achieved that as yet and there are three reasons for that for the slowdown in progress the first is of course covert I mean China is largely locked down with covert we've been locked down and business uh interchange has been it's been challenging to say the least the second reason is that um the the business uh if you like permission to work in China has been very challenging for Australia in the last year or two because of the restrictions that China has placed on on Australian business interchange the third reason is that and we hope that will improve by the way the third reason is that the regulatory environment in China is is I would say significantly more challenging than other jurisdictions and also their insurance arrangements are very complex and difficult to navigate and so these are these are other other reasons but we hope over time that these three factors will improve and that we will be able to sell our product in China because there is a quite a large potential market there thank you | |
| EMA - Lose additional monitoring (black triangle) - Lose exceptional circumstances | |||
| ACTH (Neuracthel) - Dossier Prepared - sNDA Submitted - Approval (FDA?) | 2022 AGM | can you tell us a little bit more about the commercialization of new actual its purpose and including you know why is the company uh working uh to to get this product onto Market given that it's already used by other companies? I can say that Neuracthel which is Adrenocorticotropic hormone (ACTH) is short-term i.e. less than three years why is this molecule important? there's two aspects to this question one is the molecule itself Adrenocorticotropic hormone (ACTH) is an important antioxidant agent lack of a long-acting product and so Clinuvel has come up with a novel solution to that and that is to provide the market with a long-acting ACTH product in doing so we will add something to the ACTH market where there has been little or no innovation in a long time why is ACTH an important molecule first of all it has a potent anti-inflammatory properties as well as antioxidant properties and so it will affect patients positively and hopefully preventing deaths from neurodegenerative as well as neurological diseases two of these include infantile spasm and relapsing Multiple Sclerosis The drug master file (DMF) for Neuracthel is expected to be filed in the second half of 2023 | Link to 2023 Communique II |
| Reimbursement | |||
| PBS Addition Australia | Still not on the agenda Mentioned at 2022 AGM, wanted to get German renewal approved first | https://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/agenda | |
| NICE (UK addition to NHS) | Committee meeting: 4 06/07/2022 | Recent update in March 2023 is not looking positive | https://www.nice.org.uk/guidance/indevelopment/gid-hst10009 |
| Future Pipeline | |||
| 6th Indication | Luger Patent? AGM 2022 comments, should hear about the 6th in 2023 | ||
| OTCs | Launch Skincare Solutions 2018! CUVA (Ambassadors) First OTC launched 01/03/2023! | https://www.asx.com.au/asxpdf/20171128/pdf/43pn6c5k23mn2y.pdf https://www.lightskinscience.com/ 
Cosmetics - CLINUVELCyacêlle The next generation ofPOLYCHROMATIC SOLAR PROTECTIONThis advanced cream is formulated for skin at higher risk of damage from harmful UV and HEV
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| Rx Topicals - CUV9900 - | 01/07/2019 01/01/2020 | PK Study CUV9900 Topical Rx First results | https://www.asx.com.au/asxpdf/20171128/pdf/43pn6c5k23mn2y.pdf |
| SCENESSE Enfance | 01/02/2020 09/05/2016 | First PK trial in children proposed as per 2017 AGM We will develop the paediatric formulation provided we can secure the funds for this development. We are hopeful that the paediatric dose will be available in 4 years. At the time of submission of the application, the PIP P/292/2011 was not yet completed as some measures were deferred. A waiver was granted for all subsets of the paediatric population from birth to less than 2 years of age and a deferral for the completion of the paediatric investigational plan by June 2022 for paediatric patients from 2 years to less than 18 years of age (EMEA-000737-PIP01-09). | https://www.asx.com.au/asxpdf/20171128/pdf/43pn6c5k23mn2y.pdf https://www.porfiria.org/ceo-qa-scenesse-afamelanotide-16mg-in-europe-may-9-2016/ https://www.ema.europa.eu/en/docume...gation-plan-granting-deferral-granting_en.pdf https://file.wuxuwang.com/ema/scenesse-epar-public-assessment-report_en.pdf |
| PRENUMBRA | Being used in Stroke trial 803 | ||
| CEO Tenure & Pay | 2022 AGM | board has extended Dr Wolgen's Employment contract until the 30th of June 2025 WB - my personal opinion is I hope for Clinuvel that he will be there for the next five six seven eight years from performance rights issued three years ago by the shareholders only 16 percent have been achieved next year the performance plans comes to an end of its vesting the board will address Philips Equity position in the company | |
| Patents |
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