Research Links & Milestones


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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
Reimbursement (add to milestones?)
Future Pipeline

Major MilestonesDate (Updated or Expected)CommentsLink to resources/source
Patient Growth
EPP Market Penetration
- Europe
Label extension from 4 to 6 implants per annum
01/02/2019Label extension target date as indicated in 2017 AGMLink
- More specialty centres in the USNow aiming for 120Link
Book on Clinuvel by Columbia Univ
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 2022Interim results outTrial Link

News link

ASX Link
CUV152 (XP-C & XP-V)Estimated Study Completion Date 01/07/2023First XP-V Patient Treated - 30/03/2022
CUV153 (XP
CUV156 (XP-C)Estimated Study Completion Date 23/01/2023Interim results out

North African XP Trial??
CUV801 (Stroke Trial, AIS)Actual Study Completion Date 04/02/2022
NIHSS scores improved in five patients
CUV80320/03/2023First Patient Dosed
CUV803 Trial Page
CUV104 (Vitiligo Phase 2 Trial USA)Estimated Study Completion Date 01/06/2023
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)
Japan Submission/Approval01/01/2019Filing SCENESSE in Japan (as per 2017 AGM)

Commented on at 2022 AGM, they are interested in Japan, probably requires another trial
China (Winhealth)Commented on at AGMwe 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
- Lose additional monitoring (black triangle)
- Lose exceptional circumstances
ACTH (Neuracthel)
- Dossier Prepared
- sNDA Submitted
- Approval (FDA?)
2022 AGMcan 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
PBS Addition AustraliaStill not on the agenda

Mentioned at 2022 AGM, wanted to get German renewal approved first
NICE (UK addition to NHS)Committee meeting: 4 06/07/2022Recent update in March 2023 is not looking positive
Future Pipeline
6th IndicationLuger Patent?

AGM 2022 comments, should hear about the 6th in 2023
OTCsLaunch Skincare Solutions 2018!

CUVA (Ambassadors)

First OTC launched 01/03/2023!

Rx Topicals
- CUV9900

PK Study CUV9900
Topical Rx

First results
SCENESSE Enfance01/02/2020

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).

PRENUMBRABeing used in Stroke trial 803
CEO Tenure & Pay2022 AGMboard 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

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