CLINUVEL PHARMACEUTICALS LTD (Seite 1423)

[Jerome@]

Hallo, wer kann denn etwas zu der Aussage sagen...von der Clinuvel Homepage:

Die Proof-of-Concept-Studie, die in zwei Porphyria-Expertenzentren durchgeführt wird, hilft uns, die Sicherheit und Wirksamkeit von SCENESSE® bei einer kleinen Gruppe von Patienten zu beurteilen, nach denen wir den weiteren potenziellen Einsatz des Produkts bewerten können. Es wird auch die erste Erfahrung eines 28-tägigen Dosierungszyklus bei jeder Porphyrie sein, die die unseres Vitiligo-Programms widerspiegelt ", sagte Dr. Rodenburger.

[-Morpheus-]

Scenesse in adult VP Patients jetzt auch offiziell in die Produkt-Pipeline bei Clinuvel aufgenommen (siehe Homepage)

[Aongrodt]

Antwort auf Beitrag Nr.: 58.839.924 von Labsolute am 01.10.18 10:11:22

Ist doch am ende des tages egal welches, solang nur eins von den vielen möglichen ereignissen eintritt ist eine historische neubewertung angezeigt und damit einhergehend ein entsprechend höherer aktienkurs.

[Labsolute]

!

Dieser Beitrag wurde von FairMOD moderiert. Grund: Tatsachenbehauptung ohne Beleg

[-Morpheus-]

XP werden die bestimmt aber auch noch vorstellen. Sonst hätten die kein Patent beantragt

[Macquarie]

Es ist definitiv ein steiniger Weg, und dennoch um soviel einfacher als das, was Clinuvel seit der Umbenennung (vorher Epitan mit FDA Rejection für Afamelanotid) schon alles erreicht. Ich denke in diesem Investement Case wird sich die Geduld noch weiter auszahlen, auch für noch nicht Investierte.

[DoktorBen]

Antwort auf Beitrag Nr.: 58.838.556 von emittex am 01.10.18 07:14:07

Guten Morgen zusammen,

unglaublich. Da schaut jeder auf XP weil Sie da extra ein Patent gelöst haben und dann zieht CUV VP aus dem Ärmel was nur nebenbei mal einem Patent genannt ist...

https://patentimages.storage.googleapis.com/d0/ce/48/4134688…

XP Patent:
https://patentimages.storage.googleapis.com/ca/2c/21/368fc30…

Meine erste oberflächliche Suche ergibt das wir hier auf ähnliche Patientenzahlen kommen wie EPP. Sexy... Das Potential von Clinvuel ist schon unglaublich was da kommen könnte... aber ist halt alles könnte...

Könnte EPP US... könnte XP... könnte Vitiligo... könnte ALS... Alles nur Träume - Muss alles erst (fertig) erforscht werden... VP Mein Bauch sagt frühestens in 2 Jahren kommerziell...

[emittex]

Neues Accouncement:
https://www.asx.com.au/asx/statistics/displayAnnouncement.do…

Dazu der sehr interessante Post von Farma aus dem Sharescene:

Choosing VP as the new orphan indication is a brilliant move. I was expecting XP, but this makes much more sense from a business perspective.
First, they will use the established framework of the EPP centers in Europe to conduct the trial(s). Likely, they will do the same in the US for the pivotal
phase 2/3 or 3 that will follow the initial 2a. This is less costly and scientifically easier than stating all over in XP where they have
no network yet. If they follow the same strategy, they will probably initiate XP trials in Japan once Scenesse
is approved for EPP there in a year to two.

Also prevalence is much higher for VP than in XP. VP = 1:100.000 (much higher in South Africa) and XP 1:1.000.000.
That gives us at least app. 6000 patients in Europe and 3000 in the US. 15.000 in South Africa.

They will dose VP patients every 28 days mirroring the dosing cycle in treating Vitiligo. It seems they plan to use
the data collected during the upcoming VP trials to also support the future NDA for Vitiligo. Smart move using synergies.

Even if they cut the price per implant down to $6000 that’s a very significant business case. We don’t know how many implants
they plan to administer yearly to VP patients but let’s assume 6 to be conservative.

Uptake will probably be fairly high since there is no alternative, so let’s assume we can treat 4000 patients in Europe and 2000 in the US
which is probably still conservative.

6000 patients paying 6000 USD 6 times a year = 216 m. USD. In my book that represents <60 USD pps. Add South Africa and that number
explodes but I will leave that out for now. Also, they may not lower the price per implant at all and then my numbers double (!).

Add EPP at the new lower price per implant administered 6 times a year (which is probably coming up) to 3000 patients coming up
and that’s 108 m. USD = < 30 USD. Add Australia and Japan and the number is even higher.

VP and EPP combined represents a future share price of 100 USD at the very least. 150 - 200 USD if they don’t lower the implant price.

The FDA and EMA are very likely to approve an sNDA and I expect the best possible scenario is a PDUFA for VP sometime in 2021 but
already now it should represent a risk weighted value of somewhere between 10-30 %. If they show good results in the phase 2a
which I expect they will the value will be higher also given the fact that the likelyhood of regulatory approval is extremely high for
a second indication.

At the current price per implant stand by my previous calculations and think that EPP is worth at least
50 USD in Europe and the US combined short to medium term. That number will go down if they lower the price per implant, of course.

I’d say that neither Vitiligo nor any of the other opportunities are reflected in today’s pps. Enfance, topicals etc. Right now, the pps
merely reflects the opportunity for EPP in Europe and we’re still on the very low side. VP ought to add a few Bucks today and 5-10 USD when the market realizes that it’s
a less risky endeavor than gaining regulatory approval for a new drug.

There’s still a lot of work to be done and it will be interesting to follow the work with VP and hopefully soon also Vitiligo.

My 12-18 months target is 50 USD. By then, we are either approved in the US or very close to be approved. VP trials
have hopefully been successful in Europe, the cosmetic line is underway, Vitiligo is revived, regulatory approval in Australia and
Japan is underway and Enfance for treating the pediatric population is hopefully also moving along.

[Zedington]

wann werden endlich Optionen von CUV aufgelegt !?

[Jerome@]

Und sowas bekommt, Breakthrough Therapy and Priority Review

The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. This is the first FDA approval of a drug specifically for advanced CSCC.

Libtayo works by targeting the cellular pathway known as PD-1 (protein found on the body’s immune cells and some cancer cells). By blocking this pathway, the drug may help the body’s immune system fight the cancer cells.

“We’re continuing to see a shift in oncology toward identifying and developing drugs aimed at a specific molecular target. With the Libtayo approval, the FDA has approved six immune checkpoint inhibitors targeting the the PD-1 / PD-L1 pathway for treating a variety of tumors, from bladder to head and neck cancer, and now advanced CSCC,” said Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This type of cancer can be difficult to treat effectively when it is advanced and it is important that we continue to bring new treatment options to patients.”

CSCC is the second most common human cancer in the United States with an estimated annual incidence of approximately 700,000 cases. The most common form of skin cancer is basal cell cancer. Squamous cells are thin, flat cells that look like fish scales and are found in the tissue that forms the surface of the skin. CSCC usually develops in skin areas that have been regularly exposed to the sun or other forms of ultraviolet radiation. While the majority of patients with CSCC are cured with surgical resection, a small percentage of patients will develop advanced disease that no longer responds to local treatments including surgery and radiation. Advanced CSCC may cause disfigurement at the site of the tumor and local complications such as bleeding or infection, or it may spread (metastasize) to local lymph nodes, distant tissues and organs and become life-threatening.

The safety and efficacy of Libtayo was studied in two open label clinical trials. A total of 108 patients (75 with metastatic disease and 33 with locally-advanced disease) were included in the efficacy evaluation. The study’s primary endpoint was objective response rate, or the percentage of patients who experienced partial shrinkage or complete disappearance of their tumor(s) after treatment. Results showed that 47.2 percent of all patients treated with Libtayo had their tumors shrink or disappear. The majority of these patients had ongoing responses at the time of data analysis.

Common side effects of Libtayo include fatigue, rash and diarrhea. Libtayo must be dispensed with a patient Medication Guide that describes uses of the drug and its serious warnings. Libtayo can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These reactions can sometimes become severe or life-threatening and can lead to death. These reactions include the risk of immune-mediated adverse reactions including lung problems (pneumonitis), intestinal problems (colitis), liver problems (hepatitis), hormone gland problems (endocrinopathies), skin (dermatologic) problems and kidney problems. Patients should also be monitored for infusion-related reactions.

Libtayo can cause harm to a developing fetus; women should be advised of the potential risk to the fetus and to use effective contraception.