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CUV, CLINUVEL PHARMACEUTICALS LIMITED
investek
post Posted: Apr 24 2020, 09:25 AM
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In Reply To: PortugueseMan's post @ Apr 24 2020, 05:29 AM

Seeva had previously posted a good summary of countries/patients that were receiving SCENESSE, however the most recent version I could find was from circa 2017, see below.

Perhaps we should set up a Google doc or similar where ‘ShareCafe’ readers can keep track of this?

QUOTE
Sizing the EPP market. Made some adjustments. Please correct any errors. (damn formatting)

Current Potential
Cost (in AUD) $22,500

Current Potential
Q3 Implants (est) 1.7 1.7
Quarter Revenue $11,054,250 $84,705,900

Current Potential
Ann Implants (est) 3.0 3.0
Ann Revenue $19,507,500 $149,481,000

Current Potential

USA - | 1,000
Germany 55 | 400
England - | 400
France - | 350
Netherlands 104 | 250
Italy 50 | 50
Norway - | 41
Austria 40 | 40
Switzerland 40 | 40
Sweden - | 40
Belgium - | 40
Czech - | 40
Portugal - | 40
Hungary - | 40
Sweden - | 40
Scotland - | 25
Denmark - | 25
Finland - | 25
Slovakia - | 25
Ireland - | 20

Total 289 | 2,931


As for the question regarding how many countries CUV is targeting, I thought someone had already made a list (years ago?) based on all the expert centres featured on http://EPP.care
I just realised this is no longer comprehensive enough, e.g. Poland doesn’t have an expert centre listed on epp.care, hmm this is sloppy if CUV want to make it easy for those suffering EPP to understand where treatment is available in the EU/EEA, however it could be intentional as we know they love keeping (a subset) of shareholders in the dark...


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seeva222
post Posted: Apr 24 2020, 08:40 AM
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In Reply To: mrdax's post @ Apr 24 2020, 05:52 AM

How many others are we targeting? Seems like a lot of greenfield between Europe and the US. Just give us one more indication (and I'm certain vitiligo will be one) and we're off to the races.

 
mrdax
post Posted: Apr 24 2020, 05:52 AM
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In Reply To: PortugueseMan's post @ Apr 24 2020, 05:29 AM

http://www.epp.care/
At least they have some sort of hospital / centres where the knowledge would be available:
Ireland
Spain
Finland
Norway (rejected it, right?)
Sweden
Belgium

Do we have information w.r.t reimbursement on these countries?

 
endymion96
post Posted: Apr 24 2020, 05:50 AM
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In Reply To: Billy Boots's post @ Apr 23 2020, 03:17 PM

The CCP should be shunned by all countries at this point. People should stop doing business with them.


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endymion96
post Posted: Apr 24 2020, 05:48 AM
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In Reply To: LJS's post @ Apr 23 2020, 10:28 AM

Vaccine will be useless against a constantly mutating virus. There is the potential for these mutations to acquire gain of function and attack other cell types over time. But allowing the immune system to regulate the inflammatory response brought on by COVID-19, COVID-20, COVID-21, etc. via Afamelanotide is a better way to go in my estimate. I'm telling you that I am on to something here. I need others who have familiarity with what I am getting at to look into this.


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Johnny H
post Posted: Apr 24 2020, 05:44 AM
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In Reply To: PortugueseMan's post @ Apr 24 2020, 05:29 AM

He also used the term "standard of care", as opposed to a clinical trial, experimental treatment, or a compassionate use scheme. Standard of care implies a commercially available treatment which has been approved by regulators.


If this is their way of making it public, it wouldn't be the first time that they've released privileged information through Pink Sheet.



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PortugueseMan
post Posted: Apr 24 2020, 05:29 AM
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In Reply To: mrdax's post @ Apr 24 2020, 04:26 AM

QUOTE
To date, more than a dozen European countries have made Scenesse available as standard of care to EPP patients, including Germany and the Netherlands, Hay said.



Okay, this is really shocking (in a good and in a bad way)! More than a dozen is at least 13...


According to the data I am collecting, at this moment Scenesse is authorized/is being distributed in the following European countries:

  • Germany
  • The Netherlands
  • Austria
  • Italy
  • Switzerland
  • Slovenia
  • Poland

This gives us a total of 7 (seven!) European countries!

Yes, there are countries where the reimbursement dossier has already been submitted, such as France, Denmark and Sweden, but even if we add those countries we will only get a total of 10... Nevertheless, Lachlan says very clearly that more than 12 European countries have made Scenesse available. So we cannot count the countries that have not yet approved Scenesse.

My questions: Which 6 other European countries have already approved Scenesse? And why hasn't Clinuvel made that information public yet?


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sharelooker
post Posted: Apr 24 2020, 04:29 AM
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In Reply To: mrdax's post @ Apr 24 2020, 04:26 AM

Thanks, dude! Much appreciated!

 
mrdax
post Posted: Apr 24 2020, 04:26 AM
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In Reply To: sharelooker's post @ Apr 24 2020, 04:15 AM

QUOTE
Clinuvel is to make its phototoxicity product Scenesse (afamelanotide) available to patients in China under a named-patient program while it prepares a formal marketing approval dossier for submission to the regulator.

Scenesse, which treats the rare genetic metabolic disorder, erythropoietic protoporphyria (EPP), will be distributed by Clinuvel and the local pharmaceutical firm, Winhealth Pharma Group, under an exclusive collaboration agreement.

Clinuvel, which is headquartered in Melbourne, Australia, estimates that about 5,000 people in China have EPP, based on a prevalence of 1:75,000 to 1:211,000, and says that no therapy is yet approved there for the condition.

EPP causes incapacitating burns and internal damage to vessels whenever patients are exposed to visible light, particularly sunlight. “Patients are forced to live indoors, deprived from birth onwards of social contacts and a normal life,” the company said. It noted that afamelanotide acts as an anti-oxidative, strengthens blood vessels and reduces swelling, protecting patients against any light source and ultraviolet radiation.

Under the named-patient program, Clinuvel and Winhealth Pharma will distribute Scenesse to selected large Chinese medical centers and hospitals, and will also provide training and accreditation for medical staff in providing long-term care to patients. “Local subsidies are available to enable eligible EPP patients to receive treatment,” the company noted.

Clinical data on Scenesse generated in the US and the EU, as well as from the Chinese named-patient program, “will be filed to the National Medical Product Administration to obtain full registration of Scenesse,” it added. Scenesse was approved for marketing in the EU in 2014 and the US in 2019. (Also see "Clinuvel Completes Arduous Journey To US Approval Of Scenesse" - Scrip, 9 Oct, 2019.)

Clinuvel will remain responsible for the pharmacovigilance and safety monitoring of the product while Winhealth will be responsible for the selection and management of Chinese hospitals and health care professionals. The commercial terms of the collaboration have not been disclosed.

“In Winhealth Pharma we believe we have identified a trustworthy counterpart who will work towards the same goals as Clinuvel’s team,” said Lachlan Hay, the Australian firm’s director of global operations. “The long-term thinking of Winhealth’s management fits well within our horizon.”

The move is also seen as part of Cinuvel’s strategy to penetrate the Chinese and wider Asian marketplace. In February, it announced an investment in the further expansion of its R&D facilities in Singapore, including new state-of-the-art labs.

“With the expansion of our R&D facilities in Singapore, we progressively became focussed on China as part of our long-term entry to Asia,” Hay said. The period following the approval of Scenesse in the EU and the US was identified as “the optimum moment to enter China and start facilitating the first ever treatment for Chinese EPP patients,” he noted. Clinuvel is now establishing an office in Shanghai to coordinate its activities in the region, he added.


Elsewhere In The World

To date, more than a dozen European countries have made Scenesse available as standard of care to EPP patients, including Germany and the Netherlands, Hay said.

However, the company has hit problems with NICE, the health technology assessment body for England, which has so far not recommended the product’s use on the National Health Service. (Also see "UK Appeal Panel Tells NICE To Revisit Scenesse Rejection" - Pink Sheet, 12 Oct, 2018.) “We attended a meeting of NICE’s HST [highly specialized technologies] Committee on 14 March 2019 following the appeal hearing of 30 July 2018,” Hay told the Pink Sheet. “No further details have been published by NICE following the 2019 Committee meeting.”

In Scotland, where the drug is under assessment by the Scottish Medicines Consortium, Clinuvel is currently “engaging with the relevant stakeholders”, Hay said, adding that “it is expected that Scenesse fits the criteria for ultra-orphan disorders.”

An approval dossier for Scenesse is pending with the Australian regulator, the Therapeutic Goods Administration, “with an expected response in Q4,” Hay said. “Other submissions are planned for countries with recognised EPP patient populations (such as Japan).”



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sharelooker
post Posted: Apr 24 2020, 04:15 AM
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Does anyone have access to this article?

Clinuvel Provides EPP Therapy Scenesse To Chinese Patients
Move Is Part Of Asian Entry Strategy


https://pink.pharmaintelligence.informa.com...hinese-Patients


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