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CUV, CLINUVEL PHARMACEUTICALS LIMITED
PunkassDerm
post Posted: Feb 4 2019, 01:59 PM
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In Reply To: Fortescue Bullrout's post @ Feb 4 2019, 12:34 PM

Not sure if there was any more than a pilot study for acne, 3 patients. Acne Rosacea is a variant of acne. As an anti-inflammatory should help. But there are so many effective treatments out there. Isotretinoin can be curative in a 6 month course. There is no superior treatment for hidradenitis suppurativa (HS) though, maybe a more severe under-treated disease to focus on.

https://www.ncbi.nlm.nih.gov/pubmed/22845050

Beneficial effects of the melanocortin analogue Nle4-D-Phe7-α-MSH in acne vulgaris.
J Eur Acad Dermatol Venereol. 2014 Jan;28(1):108-11. doi: 10.1111/j.1468-3083.2012.04658.x. Epub 2012 Jul 27.


Böhm M1, Ehrchen J, Luger TA.

Abstract

BACKGROUND:
α-Melanocyte-stimulating hormone (α-MSH) is a melanocortin peptide that increases skin pigmentation during ultraviolet light-mediated tanning. As α-MSH has been shown to possess anti-inflammatory effects, we assessed the clinical potential of a superpotent α-MSH analogue, afamelanotide (Nle(4)-D-Phe(7)-α-MSH), in patients with acne vulgaris, the most common inflammatory skin disorder.

METHODS:
Afamelanotide (16 mg) was given in a phase II open-label pilot study subcutaneously as a sustained-release resorbable implant formulation to 3 patients with mild-to-moderate facial acne vulgaris. Evaluation included lesion count, adverse effects and patient-reported outcome. Monitoring of laboratory parameters included differential blood counts, electrolytes, urine analysis, and liver and kidney function tests. Skin melanin density was measured by reflectance spectrophotometry.

RESULTS:
The total number as well as the number of inflammatory acne lesions declined in all patients 56 days after the first injection of afamelanotide. Life quality as measured by Dermatology Life Quality Index likewise improved in all 3 patients 56 days after the first injection of afamelanotide. There were no adverse effects except mild and short-term fatigue in one patient. All patients experienced increased pigmentation especially on the face. Clinically relevant changes in laboratory parameters were not detected.

CONCLUSIONS:
Afamelanotide appears to have anti-inflammatory effects in patients with mild-to-moderate acne vulgaris. Future trials are needed to confirm the anti-inflammatory action of this melanocortin analogue in patients with acne vulgaris.


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Fortescue Bullro...
post Posted: Feb 4 2019, 12:34 PM
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Wasn’t rosacea a possible application for Scenesse?

 
Boat2float
post Posted: Feb 4 2019, 08:57 AM
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Maybe Trump uses Scenesse

https://www.nytimes.com/2019/02/02/us/polit.../trump-tan.html


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FarmaZutical
post Posted: Feb 3 2019, 09:35 PM
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In Reply To: LevelHeaded2000's post @ Feb 3 2019, 05:31 PM

I hope, the FUD comment wasn't aimed at me. And if it was aimed at Helse Bergen, I sincerely doubt that a public hospital in Norway is in the business of creating FUD through PR. The reason why I find their PR disturbing is because of Clinuvel's history of non-disclousure. France could in fact have rejected Scenesse without us knowing it. I don't think thats realistic, though, so the PR from Helse Bergen was probably just based on wrong info. I wish Clinuvel would keep us informed about which countries they are negotiating with and what the negotiations result in. That would prevent all the uncertainty.

Regarding the many poephyria centers throughout Europa and wether Scenesse can be purchased there. Clinuvel has to train the staff at each individual center and certify them. I don't think a Spanish or Swedish EPP patient can just purchase treatment out of pocket at their regional center as long as Clinuvel hasn't trained the staff, and why should they bother doing so before the national reimbursement is up and running ? Patients can travel to Switzerland and pay out of pocket - that we know for sure.







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Verharven
post Posted: Feb 3 2019, 06:52 PM
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The article is about CSL, but this quote certainly makes for nice reading for the company CUV is discussed with though based on market cap, outside of the 'Big 3' of CSL, Resmed and Cochlear, CUV is just about leading all other biotechs on the ASX

https://www.raskmedia.com.au/2019/01/29/pri...n-the-buy-zone/

"The CSL share price has been choppy but fallen slightly since hitting $227 in September. This is in line with similar declines for other top ASX healthcare companies, such as Clinuvel Pharmaceuticals Limited (ASX: CUV), Cochlear Limited (ASX: COH) and obstructive sleep apnea device maker Fisher & Paykel Healthcare Corp Ltd (ASX: FPH)."


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LevelHeaded2000
post Posted: Feb 3 2019, 05:31 PM
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In Reply To: macgyver's post @ Feb 2 2019, 04:32 PM

Based on this: http://www.more-ir.de/d/16065.pdf that report claims there is centres in France / Spain. I think the previous report is inaccurate and is creating FUD. Clinuvel maintains a Website with centers: http://www.epp.care/
Of course there is a difference between being able to purchase something and having the country's national insurance cover it. My guess is that the drug is purchasable at all those centers (insurance may be another matter).



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LevelHeaded2000
post Posted: Feb 3 2019, 05:22 PM
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In Reply To: sharelooker's post @ Feb 1 2019, 11:48 PM

Based on this Clinuvel would be about 174. So, if it just stays in that position relative to everyone else, then it will likely be included into the ASX200.

 
macgyver
post Posted: Feb 3 2019, 09:23 AM
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In Reply To: royco's post @ Feb 3 2019, 06:08 AM

Given how much Clinuvel has spent on getting Scenesse to market in the E.U and now the U.S, the price is by all means fair. Only thing that bugs me is the opportunity cost of Clinuvel’s pricing strategy, that being lost earnings (no matter how low versus established price regime) and costly court battles. I imagine shortly this statement will be a moot point once FDA approval is received.

 
royco
post Posted: Feb 3 2019, 06:08 AM
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In Reply To: NewToCli's post @ Feb 2 2019, 11:58 PM

Lets not forget that until today cuv never stopped at a no or non.

Cuv had a big nono/jamais from the start, everywhere. The fda sent them walking, ema sent them in hyper space several times. Cuv has a viable safe treatment for epp and they know it.
Look at the uk, cuv will keep fighting until all uk epp patients receive treatment.

Imho the pricing of scenesse is fair and the benefit for patients is apparent and significantly so.
If not the ema half year reports would have already resulted in withdrawal.
Did anyone ever read a report from a patient saying scenesse has no significant (positive) impact on their life?
Never written.

Back to narcosis.
:-)



--------------------
Ἀρτεμίσιον

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NewToCli
post Posted: Feb 2 2019, 11:58 PM
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In Reply To: macgyver's post @ Feb 2 2019, 04:32 PM

The info given below is just not accurate. They don’t even mention that treatment is available in Germany and Austria too and compassionate use in Spain (that was written once in a newsletter or yearly report). Also we have never heard from anywhere about a refusal from France..

Let’s see what happens in March with UK...


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