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I remember the Ohio connection. But I was not sure Mako was identified for sure. I would be great to see justice be done.
To my knowledge DMSO is not yet approved by the FDA for conditions other than a bladder disorder even though it is know to have the properties you mention. I don't think Clinuvel would use a compound surrounded by such controversy as DMSO given the fact that Scenesse is already a controversial compound.
Usually, the 500 dalton rule apply to any compound that's supposed to penetrate the skin. Scenesse is above 1600 daltons and thereby unable to penetrate the dermis. CUV9900 is 900 daltons but I don't know what VLRX001 is.
Maybe VLRX and / or CUV9900 is only supposed to penetrate the epidermis and not the dermis in order to reach the melanocytes. Perhaps that would make the dalton issue of less importance.
Also, other researchers have made strides in developing methods to penetrate the dermis.
Abdel-Malek claims to have successfully made a melanocortin analogue penetrate he skin of mice and Ken Kirby also did this many years ago if I remember it correctly.
Clinuvel is not revealing much in order to protect the IP so I guess we'll have to wait and see how they do it till they are further ahead with the development.
Excuse me if I have missed some detail along the way: But hasn't Sullivan identified Mako ? I know his name is not made public, but I was assuming that Sullivan knows his name by now ? Thanks.
It doesn't say specifically but I assume that they mean that enough results from a USFDA ph2 will be available in 2017 in order to shed light on efficacy and hence boost the valuation of CTIX.
ValueFox of SS has posted this. I appreciate the conservative approach but I personally assume higher figures.
Thanks a lot for sharing. Along with a possible partnership for P I see this as the elephant in the room:
"A successful Ph2 study of Kevetrin in ovarian cancer will command a much higher valuation for CTIX. If data can further define the mechanism of action of Kevetrin with respect to p53, the possibility of expanding into different cancers should attract global licensing under very attractive terms and all this should happen within in 2017 or earlier!"
Dr. Bertolino and Jane Harness have a long history of working together. This paper's authors thank them both for their contributions (last page). It's published in 2007.
http://www.jlr.org/content/49/3/686.full.pdf
Netherlands announces official reimbursement price of Scenesse.
Source:
https://www.nza.nl/1048076/1048120/TB_CU_21...amelanotide.pdf
Afamelanotide, toedieningsvorm implantaat, per gebruikte eenheid Pagina
van 16 m g bijde indicatie: 2 van 6 'Preventie van fototoxiciteit bij volwassen patienten met
erytropoetische protoporfyrie (EPP).'
Maximumtarief inclusief 6% BTW: € 17852,52 per 16 mg Zorgactiviteitencode2:194640
€17852.52 equals $19.919 US. Minus 6 % VAT = $18.724 US
This is the Dutch maximum price for one implant and probably close to the price Germany will end up
paying after the negotiated rebate.
Italy is paying €16.842 per implant today so app. a €1000 difference per implant there.
I'm beginning to love everything about Dr. Bertolino. Cudos to the CEO for hiring him.
A couple of very good posts from CUV101 of HotCopper from May this year.
-------
Still we wait for EU sales. The Clinuvel update provided little in the way of new information except that subsidised product will no longer be supplied in Italy and Switzerland and also that each EPP centre’s ethics committee needs to approve the PASS. This last point is holding up administration in Germany, but should not be a major hurdle.
More significantly information that is not included in the announcement but is publicly available is the document from IQWIG which details the approved price of 22,000 Euros per implant. Also a Q and A with Wolgen and the German EPP patient group. This details that the number of implants is not restricted to 4, as recommended by the EMA and also for the first time an insight is given into the delay of the last 18 months. Wolgen describes the PRAC discussions as “futile and superfluous” and describes how the PRAC reviewers embarked on a mission outside their competence and mandate. The efficacy of the drug was questioned when the mandate was to assess the safety only. Difficult times for a CEO who had just endured the longest review process ever in the EMA. Wolgen also defends the price in the Q and A stating that Scenesse is priced at the low end for an ultra orphan indication. “SCENESSE® is one of the cheapest drugs made available for a rare, severe disorder. “ The price is fair at AUD 120,000 to 180,000 per year!
The published paper on long term use in 115 patients tells all that is needed and is unheralded prior to the commercial launch of a NME for an ultra rare disease. The patients do not drop out, they seek repeated use year after year because the drug changes their lives. Also the demand for the drug is known as patient groups are actively lobbying the EMA, their government agencies and Clinuvel. Just like investors they are tired of waiting.
Even with recent share price rises the market cap is 233 million. Income will be 100 million in the next 2 years (conservatively based on 1000 patients), costs will be low with distribution restricted to probably no more than 50-100 centres and performed in house. Sirtex have revenue of 176 million and net profit before tax of 52 million SRX market cap is 1.7 billion. I think Clinuvel will have a net profit of more than 50 million in 12-18 months with FDA approval to follow.(I expect PASS data to be included in the US dossier). A 1.7 billion market cap is totally comparable and realistic giving a share price of around $30!
This is about as close to a sure thing there is on the ASX casino. (just my thoughts)
28/05/1617:44:17Post #: 17892582
After my rough comparison to SRX, I got to thinking more about the valuation of Clinuvel. Clearly by almost any metric Clinuvel is currently massively undervalued if predicted revenues come to fruition. It is just not on anyones agenda. Investors have been burnt and bored and Wolgen treats them with contempt. Clinuvel has no analyst coverage and no exposure. A mention in the Murdoch press last week rated Clinuvel a sell. ASX long tail described Clinuvel as junk, to be avoided.
We learned this week for the first time the extent that Wolgen also has been frustrated by the regulators however that now is mostly history in Europe, Clinuvel’s largest market for EPP.
So what is a fair way to value Clinuvel at this point in time. This depends on 3 things :
The risk ascribed to Clinuvel
The anticipated revenue
How long before that revenue is realised
With the release of the information last week there is now less mystery in addressing these issues.
1. Risk : Just focussing on European distribution, the risk is now very, very low. The drug is approved and all regulatory hurdles have been cleared (other than hospital HREC in each EPP centre). The EPP population are demanding access. The drug has a long history of safe, effective administration.
2. Revenue: The release of the pricing in Germany of 22,000 Euros per implant is revealing and integral to a valuation. Whilst this is not a final negotiated price (this will occur in Germany in 12 months and sooner in UK and Holland), it gives a strong indication as to what Clinuvel thinks is fair. Wolgen supported this with his comment that Scenesse is priced at the lower end for ultra orphan medications for serious diseases. Final agreed pricing from NICE or Holland will be revealing but I do not see the price differing by more than 25% (say 18,000). We also learnt that the number of implants per patient is not capped at 4 by the EMA but will be determined by the treating physician, possibly with input from the payor.
Previously reported long-term observation data from the Swiss and Italian programs showed that 97% of patients considered afamelanotide to be effective in ameliorating EPP symptoms and 93% adhered to treatment for prolonged time, if there were no compelling reasons to discontinue, indicating clinical effectiveness. 173 patients were known to the treating centres, 115 were treated, indicating a take up rate of over 65%. The number of patients treated increased during the 8 year observation period. So lets work on 65% of EPP patients staying on 3 implants per year. These are conservative assumptions based on the 8 year published data. How many EPP individuals between the age of 18 and 70 are there. This is going to be a guess but we roughly know the Swiss and Italy (Rome) numbers at 173, we also know that the numbers are higher in Holland, Germany and UK. German numbers were released last week as between 450 and 900. I have been using 2000 as a conservative total EU number.
The anticipated revenue then is 65% of 2000 = 1300 patients to be treated. 3 implants each = 3900 implants @ 18,000 Euros = 70 million Euros per year. (AUD 110 mil)
3. When: Revenue will begin from Q1 FY17 (Germany) and build as more countries come on board. Negotiating revenue can be difficult and is not always successful. However, there is no other treatment and the numbers are very small from a health budget perspective. For an emerging biotech revenues are real and imminent. I expect most large countries (3-6) will be providing Scenesse with 12 months.
So what PE should we apply to this projected revenue. Given that these numbers will potentially double with a positive FDA outcome (which I attribute a 70% probability). I think a PE of 50-60 is consistent with Aus biotechs. With a state of likely increased revenue growth as US and more Eu countries come on board. CSL, Australia’s biggest pharma has a PE of over 30, Cochlear has a PE of 40 with very stable growth. PE’s reflect the future where revenue is expected to accelerate PE’s can be in the 100’s because shares are priced well ahead of the actual revenue.
Cochlear : revenue 900 million, Net profit after tax around 100 mil, MC 7 billion
Sirtex : revenue 200 million, Net profit after tax 50 million, MC 1.8 billion
Nanosonics : revenue 30 million, Net Loss, MC 666 million
Clinuvel Predicted: revenue 110 million, Net profit 80 million, MC 1 billion (share price $20)
So, how can I calculate that the share price could/ should be $20 in 12 months when the market currently values Clinuvel at $5 (a 10 year high)? I must have made a mistake somewhere, tell me please. I could have erred in risk, but I don’t think so, remember this is just EU EPP. I could have erred in revenue, we have the price and we have 8 year usage data. The numbers may be less than 1300 but I don’t think so. Maybe it will take more than 12 months to reach these numbers. Seeing a pricing outcome from Holland or UK would reduce the risk but is this delay worth a discount of 300%?
Preliminary final report.
http://www.asx.com.au/asxpdf/20160825/pdf/439ml3qn8rmdwl.pdf
Only 8 days of sales before FY 15/16 ended ~ 80 implants =
A$2.597 m.
This is great. Can't wait to see the next quarterly. Things are about to get very interesting.
CLINUVEL DUE DILIGENCE REPORT – UPDATED AUGUST, 23rd, 2016
WELCOME
Welcome to the Clinuvel iHub. There are some very active forums out there with valuable information about this company, but awarenes about both the stock and the products is very limited in the US so my goal is to provide a comprehensive walk through of the company, the products and the investment opportunity it represents so new investors have a place to start their DD.
In my view this is one of the most interesting and undervalued biotech companies right now. The fact that the lead drug obtained EMA approval late last year for the absolute light intollerance disorder, EPP and is now rolled out in Europe de-risks the stock. The company is also peforming mid to late stage trials in the depigmentation disorder, Vitiligo and resluts seem very good. Moreover, the company will seek label extensions for other uv related disorders once roll out of Scenesse for EPP is underway.
The clever investor with a little patience will see, that the historic approval of the World’s first tanning agent holds an extreme upside when the first medical indications are rolled out and broader use can commence. Eventually, Scenesse could be a general preventative for skin cancer due to the protective tan it provides and then the numbers get very big. But EPP alone will make the company very profitable very soon, and roll out in Europe is now a fact.
LATEST NEWS:
EU countries coming online:
Holland and Austria are now online. Germany is likely to follow in September, 2016. Norway is also evaluating Scenesse and is likely to decide within 6 months.
On May 17th Clinuvel announced that preparations for launch are now active in 9 EU countries and that more will follow in 2016.
Link to the announcement:
http://www.clinuvel.com/index.php?option=com_k2&Itemid=8&id=528_db768a583c49d195c5bc87a1899dfb19&lang=en&task=download&view=item
Price per implant:
Clinuvel gets favorable validation of the new asking price per implant from the German drug watch dog, IQWIG. According to the newly released report, IQWIG finds that $21.971 is a fair price for one Scenesse implant. This is major news, as it is now possible to roughly calculate the future revenue stream for EPP in Europe. In Germany, the MAH negotiates a rebate with the Statutory Health Insurance (SHI). This rebate might be between 5-20 %. While NICE HST is also evaluating Scenesse at present time and is expected to make a final decision within 6 months, we will probably know the final price per implant in the reference countires Germany and Britain by January 2017. Clinuvel says it is aiming for a uniformed pricing model in Europe, but variations will of course occur. A final price between $18.000 – 21.000 is not unreasonable.
Link to the IQWIG report:
https://www.g-ba.de/downloads/92-975-1359/2016-05-10_Bewertung-Therapiekosten-Patientenzahlen-IQWiG_Afamelanotid.pdf
Furthermore, IQWIG estimates that there are 450-900 adult EPP patients in Germany. This is significantly more than most people thought, and I expect the picture to be the same throughout Europe which again will lead to higher than anticipated revenues from EPP.
BACKGROUND:
Clinuvel is an Australian biotech company with headquarters in Melbourne, Australia and an operating office in Baar, Switzerland. The company was formely know as EpiTan but changed it’s name to Clinuvel in 2006 following a change in management.
http://www.lifescientist.com.au/content/biotechnology/news/epitan-opts-for-name-change-854737925
EpiTan tried to promote EPT1647 (later known under the trade name, Scenesse) as a cosmetic drug which wasn’t very popular with the FDA or the EMA. No regulator wants to approve a drug solely for cosmetic use, and Epitan almost went bankrupt.
A new CEO was brought in, Philippe Wolgen, and under his guidance the company has performed er very successfull and well managed turnaround. Off label is now an absolute no-go if you ask the CEO and the strategy is to devellop Scenesse for patients with legit conditions. Last year this strategy resulted in a historic marketing approval of Scenesse following the longest review process in the EMA’s history. It too several years and heavy involvement by patients, patients advocates and scientists who spoke in favor of the drug in person in front of the CHMP – the council that desides whether a drug gets approval or not.
http://www.clinuvel.com/en/investors/news-publications/announcements/2014-announcements/clinuvel-invited-to-emas-chmp-plenary-session-for-an-oral-explanation-on-scenesse%C2%AE-maa
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002548/smops/Positive/human_smop_000747.jsp&mid=WC0b01ac058001d127
http://www.clinuvel.com/en/news/company-news/new-england-journal-of-medicine-publishes-pivotal-phase-iii-scenesse%C2%AE-studies
http://www.nejm.org/doi/full/10.1056/NEJMoa1411481?af=R&rss=currentIssue&;;;
It appears that the EMA was and still is worried that Scenesse will be used by people who just want a nice glow through sunless tanning. Therefore, the scrutiny reached the absurd, but finally, the CHMP approved Scenesse as a profylactic treatment for people suffering from the extreme light intollerance disorder, EPP in all European countries.
http://www.clinuvel.com/en/scenesse/epp
Investors were thrilled. For more than a decade many had witnessed the PPS decline or stay at depressing levels. But many, my self included, didn’t want to sell because of the potential of Scenesse. In my view, this is truely a drug that can change the world. Now, the historic approval paved the way for some exictement, and the stock went up quite a bit following approval. But the EMA had more hurdles in store for Clinuvel. They wanted a comprehensive post-marketing risk plan (RMP) in place to avoid off label use of the tanning agent. They seems to be afraid that people will stop using the dangerous tanning beds and turn to the safe and protective alternative: Scenesse. It seems stupid but that’s the way the regulative system works. For almost a year, Clinuvel has been working on such a safety program involving monitoring of all the patients who recieve Scenesse and a post marketing study as well. That has led to the declining share price but lately the share price seems to be going in the right direction due to imminent and final PRAC approval of Clinuvel’s safety program.
Another reason for the declining share price was that New York Based company, Retrophin (RTRX) tried but didn’t succeed with an unsolicited take over of Clinuvel.
http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CB4QFjAAahUKEwihwr39x93HAhXFaT4KHdJmBjs&url=http%3A%2F%2Fwww.clinuvel.com%2Fen%2Finvestors%2Fnews-publications%2Fannouncements%2F2014-announcements%2Fclinuvel-declines-unsolicited-proposal-from-retrophin&usg=AFQjCNHJzsB_oq-_PKPuSSnpCWqugPlx7Q
Prior to the takeover proposal Retrophin, under the supervision of the former CEO Martin Shkreli, had been accumulating millions of shares in Clinuvel, and when Clinuvel declined the offer and Shkreli was ousted from Retrophin, the new management decided to sell all shares in Clinuvel.
http://biz.yahoo.com/e/150511/rtrx10-q.html
This caused a huge selling pressure and most likely caused the share price to depreciate along with investor fatigue because of the new safety requirements following the long awaited EMA approval.
But now we seem to approach crunch time. Scenesse will be sold in the first European countries this spring and the company is in talks with the FDA about accelerated approval in the US while patients and organizations put tremendous pressure on the FDA to approve. Furthermore, full trial results from the Company’s Phase IIb in Vitiligo performed in Singapore are due anytime. If the results are positive, investors will probably begin to see how extremely undervalued this company is. Former trial results bode well:
http://www.medscape.com/viewarticle/832214
Now, lets play with some numbers.
Shares out: App. 47m.
Market Cap: $150m. (USD)
EPP:
Prevalence is said to be 1:75.000 to 1:200.000.
Many patients are know by the specialized porphyria centers in Europe and the US but due to general unawareness of the conditions many patients are believed to be undiagnosed. Roll out of Scenesse will most likely change that.
Europe: App. 4500 patients.
Price per implant is now roughly $25.000 USD. I expect the price to fall to app. $22.000 when negotiations have taken place in Germany and the British HST under NICE has evaluated Scenesse later this year. Patients will get 3-4 implants per year to be protected from UV and visible light throughout the months with the most sun.
That’s + $400 million per year for Europe alone with full coverage. Costs will be low because Clinuvel is distributing Scenesse directly to the porphyria centers who have already been working closely with the company throughout the past decade. Lets be conservative and assume that 25 % is spent on running the business and that 1000 patients will get the implant fairly quickly. Considering how desperately they are awaiting the implant, that’s not a long shot.
That's app. $66 million / 47 m s/o = 1.4 EPS. A ratio of 20 is not unimaginable. That's $28 for EPP alone. Low ball.
With more European patients this number will go up exponentially. Add FDA approval and that number will probably double.
Also, the company is develloping a melanocortin analog for topcal use through their 82 % stake in the Singapore joint venture, Vallaurix. It’s meant as a pediatric version for of the implant in the treament of EPP and as a follow up for Vitiligo. But imagine when the word gets out that the already approved tanning implant is about to be released as a cream. Future on and off label use is not priced in the EPP numbers at all.
VITILIGO:
http://www.ncbi.nlm.nih.gov/pubmed/19608058
http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=4&ved=0CDkQFjADahUKEwj7tMC0z93HAhXKNj4KHcHVAPE&url=http%3A%2F%2Fwww.clinuvel.com%2Fen%2Finvestors%2Fnews-publications%2Fannouncements%2F2014-announcements%2Fscenesse%25C2%25AE-vitiligo-study-results-published-in-jama-dermatology&usg=AFQjCNGIu_G_tcUZDDLMDrZ1quPpQbKxKA
Prevalence is app. 50 m. world wide. Let’s assume that the price per implant drops significantly when such a broad patient population will have access. But even with a very low price per implant of let’s say $500 and 5-10 required implants in the combination therapy that’s $2500 – 5000 per patient.
With app. 3.200.000 Vitiligo sufferers in the US (Michael Jackson was one of them) let’s say that 5 % will use what I believe will become the new standard of care: Scenesse in combination with narrowband UVB.
That’s 160.000 patients yearly and between $400 – 800 m. Clinuvel will most likely require a partner to perform the last Phase III trail and to bring Scenesse to market to treat Vitiligo, so let’s assume that Clinuvel can keep 40 % (on top of up fronts and milestones that I leave out just to be conservative.)
That’s a share price of <$71 for Vitligo in the US using very very conservative numbers. I believe that Vitiligo could cause the share price to go above $200 but I don’t want to be ridiculed as a dreamer.
LABEL EXTENSIONS:
Clinuvel has stated that they will seek label extensions for some of the many other conditions that involves intollerance to light. They have performed numerous phase II and III trials and I see many obvious label extensions down the road.
http://www.clinuvel.com/en/scenesse/clinical-results
http://www.clinuvel.com/en/scenesse/ongoing-clinical-trials
OWNERS:
Facebook founder Sean Parker owns app. 4.5 % ow the company. Lagoda Investment Management owns a little more than 10 % but it does not show in their 13F filings but it shows in the ASX filings:
http://www.asx.com.au/asxpdf/20160411/pdf/436fg7v0dtxdll.pdf
Besides some vert loyal significant private investors there is also strong institutional backing.
Latest institutional ownership:
Fidelity Funds SICAV - Pacific Fu... 6.74% 3,170,824 10,526,184 +700,100 +28.34%
Fidelity Asian Values Plc 1.45% 682,942 2,267,163 +150,721 +28.32%
Fidelity Funds SICAV - Asian Smal... 0.81% 381,567 1,266,688 +84,211 +28.32%
Fidelity Japan Japan/Asia Growth ... 0.28% 132,512 439,900 -5,323 -3.86%
Perinvest (Lux) SICAV - Global He... 0.14% 66,000 219,100 +66,000 --
NEF - Azionario Pacifico 0.12% 57,072 189,462 0 0.00%
Wagner & Florack PIC Fund AMI 0.12% 56,302 186,906 0 0.00%
DFA Asia Pacific Small Company Se... 0.10% 46,902 155,701 -1,919 -3.93%
Fidelity Funds SICAV - FAWF Pacif... 0.09% 43,113 143,122 +4,887 +12.78%
Smith & Williamson Unit Trusts - ... 0.08% 37,441 124,293 0 0.00%
Disclaimer: I am long Clinuve and I am still accumulating. I have been in this stock for + 10 years and I have never sold a share.
I believe that Scenesse will revolutionize the way humans protect themselves against the sun and UV. I also believe that off label use will be the norm sooner rather than later when the FDA approves Scenesse for EPP and / or Vitiligo.
This article clarifies it somewhat:
Sorry for the poor Google Translate quality. The original is in Italian.
Source:
http://www.osservatoriomalattierare.it/farmaci-orfani/11039-protoporfiria-eritropoietica-san-gallicano-di-roma-garantisce-la-distribuzione-del-farmaco
Translation:
Soon there may be important news. The current context, it is likely to trigger further discrimination among the sick. Errors that would sound like a sentence for hundreds of people who, without being able to rely on a drug therapy, would be forced to not being able to expose to direct sunlight; especially during the hottest months of the year.
Observatory for Rare Diseases has decided to shed light on the whole affair listening to the leaders of the Roman structure and a sufferer. Marta Branca, special commissioner of "San Gallicano", explains how it was possible to ensure the delivery of the drug: "We chose to act in order not to leave the patients alone, we are talking about people who were likely to have an impossible life. Obviously the decision to triple the price of the drug from the company can not be considered secondary; we still continue to raise awareness of the AIFA, the Ministry of Health and the Regions to bring more merciful the manufacturing company. I want to emphasize that we have made direct pressure on AIFA during these months. "
The ruling shows specifically how it was possible to unblock a stalled condition: "I am committed to ask the Latium region to be able to use the budget we had available for the current year, for many months we have blocked purchases of the product. We are therefore making efforts to bridge the difference between the old price demanded by the company and the new. Through the agreements you will be then possible to treat patients living in other regions. Currently there are doing against two residents in Tuscany. This means that by the end of the year, or directly the next year, the problem will reoccur. I for one am confident that the drug company can return to a position of dialogue with the institutions. Our structure is trying to do the maximum in spite of the recovery plan that burden on the health system of the Lazio ".
The doctor responsible for rare diseases at the "San Gallicano", Giovanni Leone, recognizes the importance of therapy for people suffering from erythropoietic protoporphyria and remembers how the Roman structure was essential to achieve the commercialization of the treatment: "In recent years we took part experimentation with conviction by providing an adequate number of patients to research needs. In our structure we have never had problems until last year; In fact, the drug was dispensed through the provisions included in the Law 648. Then the decision to triple the price from the company. Request that the manufacturers do not seem inclined to change in the short term. We want to commit to eliminate disparities and ensure continuity of care. "
But we need to clarify the exact number of Italian patients: "The interested public should be about 140 sick even if the number is underestimated: I think the real number is around 200 people. The cases may still increase. We are faced with a genetic disorder that occurs not always at birth or early in life. "
Gerardo Tiso is a patient-physician, a member of an association representing sufferers protoporphyria. Years ago he participated directly in the experiments carried out in Rome. Choice that allowed to market the drug worldwide based Afamelanotide, compound created in the laboratory that stimulates melatogenesi and therefore able to protect the skin from ultraviolet rays. John describes his experience: "I have a certain age and have lived when there was no kind of drug treatment. I had to wear huge hats or gloves in the warmer months by the year: from May to September everything became more difficult. The consequences were not trivial. Exposure to direct sunlight meant risking burns of first or second degree and having to stand at rest for two weeks. "
The Scenesse drug has revolutionized the lives of patients but you are likely to make a jump in the past: "We are receiving many reports as an association. Patients tell us how it is becoming increasingly difficult to obtain the drug. Now they can rest assured only residents in Lazio, Lombardy, Veneto and Tuscany. Residents in Lombardy can be followed by the general hospital Ca 'Granda at coordinated by Professor Sunday Cappellini center. The Venetian may instead be borne by Professor Mauro Alaibac of Padua University Hospital. Residents in other regions should contact San Gallicano. The structure is ready to meet our medical needs. We have the impression that they have become standard sick B. Until a few months ago the situation was much better. " According to the doctor the situation could change, however: "We were able to talk to the President of AIFA, Mario Melazzini. The Agency wants to get to a market that is useful to patients' needs. For this reason it is important to continue beating the path of dialogue with Clinuvel ".
I'm sorry. But you're going on ignore. Your attitude is not constructive.
Historically, touting your intent to uplist isn't the brightest thing to do.
Execute. Then comment.
I can't believe the CEO keeps making these childish mistakes. He hired a president and I think that was a brilliant move. Now, he should stop commenting - on anything - and let the good doctor be the face and voice. He seems to be a lot more levelheaded and strategic in his approach.
I believe Switzerland is paying app. $20k per implant and that several insurance companies have agreed to reimburse at this level for the next 6 months. I think Switzerland will come around and eventually pay up on a permanent basis. It is tricky, though, because Clinuvel hasn't yet applied for formal approval in Switzerland and it seems it's not a high priority issue for them right now, which is understandable from a fiscal point of view.
Italy: I don't know what happened but but it sure seems that the compassionate use scheme is boomeranging on Clinuvel today going into the commercial phase. I wouldn't worry, though. Germany is prepared to pay a rather high price and after negotiations with the statutory health insurance (SHI) I think we will end up at app. $20-22k excluding VAT per implant. At some point Italy will have to come around too.
Once NICE HST has negotiated a price with Clinuvel in (hopefully) 4-6 months I think the German and British price level will become a benchmark price for many of those counties who usually look to the bigger counties when agreeing to reimburse.
The Scandinavian countries (excluding Norway who has a NICE-like institute) usually pay full price without asking many questions. It puzzles me why Sweden and Denmark aren't online yet. Usually, these are first mover markets with very little red tape. Perhaps Clinuvel hasn't had time to submit the need documentation yet as is seems is also the case in Norway. Here, Helse Bergen has unilaterally initiated the reimbursement process but it seems that the process is stalled because Clinuvel hasn't yet submitted the data package. They must be very busy and prioritizing the bigger markets.
Italy is paying 16.842 EURO per implant today. They seem to have gotten a rebate on the initial commercial price. I guess this is what Dr. Wolgen is calling a continuance of the special access scheme even though it really is not. It's significantly more than the old compassionate use price of app. 6000 EURO. I don't know how many Itaial patients have access to the implant but it appears that they are working on including all patients. Not only the ones living in the 3 regions with treatment centers.
Interesting. Thanks for sharing. I think $20k will be the median price in Europe which is a very good price. I appreciate your views on valuation but there is no doubt the company is undervalued right now. Another few years with continuous good news and progress and we will be much higher. I still use 100 patients = $1.5 - $2 pps as an easy model for trying to asses future value. But no model will ever be correct once reality kicks in.
No matter how many times you reiterate your views and no matter how many times you insult other people it does not make your statements correct.
Please keep it civil. Your attitude is not helping anyone. Besides, it makes no sense about whether Italy pays this or that, or if all European countries will pay exactly the same price. It's not going to happen. Please understand this. Clinuvel might be able to obtain a somewhat similar price in some EU countries. But it is very naive to believe that it will be the same down to the penny.
As for Italy, that are now paying 16.842 EURO per implant. That might change down the road but this is the price today. Including VAT.
Please read this carefully. It will help you understand how the drug is currently priced:
AZIENDASOCIOSANITARIA TERRITORIALEDEGLI Hospital of Brescia CIVILIANS Management Resolution 887 / fg of 29.07.2016 Identification n.1584 / 2016 SUBJECT: Urgent Purchase drug SCENESSE - Award. - P remesso: - That, by Decree 484 of 06.29.2016 the General Manager of ASST's Spedali Civili di Brescia authorized the purchase of 9 plants of the medicinal product "Scenesse", which needs, reported in the Company's Pharmacy Service, needed to the 7 patients therapy, suffering from Protoporphyria Erythropoietic (PPE) in care at the OU Dermatology; - What, the case of specific production and marketing of medicinal and exclusive single company refundable via "File F"; - What issue of drug for rare genetically determined disease, referred ASST of Brescia Civil Hospital is the only authorized center in the Lombardy Region in addition to the 1 Medical Clinic of the University of Milan, not entered into any bidding process previous; - What has been gained the approval of the appropriateness of the Director treatments Health, in acts; - That, in compliance with the provisions of Prot note. H1.2015.0018027 of 06/16/2015, was communicated to Lombardy ARCA the need to purchase urgent and overdue of the medicinal product in question, pending procedure centralized at regional level; - D atoatto: - What, for this acquisition, in line with the current system of rules in the region, it is It was launched a negotiated procedure without prior publication of a contract notice, in accordance with art. 63 paragraph 2, letter b) of Legislative Decree n.50 / 2016, and the implementing guidelines of the new The Procurement Code; - That, consequently, the procedure in question was published on the platform Regional Sintel and that the invitation was addressed to the same company Clinuvel AG Zurich (Switzerland), trader sole agent for the marketing of drug in question; - That the results of the above procedure are found in the documentation acts; - That the total amount of the supply of 9 plants of the medicinal product "Scenesse" refers to the requirement until 31/12/2016, amounts to Euro 151,578.00 (VAT excluded), as detailed in the following table: COMPANIES AMOUNT (VAT excluded) Clinuvel AG EURO 151,578.00 - What, among the agreements signed by ARCA and Consip, when active, does not figure the supply object of this Act; - That the Company will examine the possibility to adhere to conventions arising from Centralized client procedures, where ARCA or CONSIP aggiudichino before
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the conclusion of this reliance, products tally with the interests of their own interest; - That the acquisition of the provision in question is proposed as aforesaid, subject prejudice to possible changes arising from corporate initiatives organizational or related to the rationalization of expenditure; - In the exercise of the powers conferred by the General Manager with 740 of deliberation 26/11/2003 Hospital of the then Civil Hospital of Brescia, as well as amended by Resolution 932 of 30/12/2008, implementing article 4, paragraph 2, of the Legislative Decree no. 165 of 30/03/2001, and acknowledged the completeness, legality and regularity of the technical hereof; - The Director of the Procurement Service, in charge of procedures, establishe a) to award, for the reasons and with the reservations expressed in the introduction, the provision of 9 plants of the drug "Scenesse" refers to the requirement until the 31/12/2016, the company Clinuvel Zurich Ag for a total amount of Euro 151,578.00 (VAT excluded); b) to acknowledge that since the purchase by EU country, the VAT amount, equal Euro 15,157.80, will be paid to the State by Italian Intrastat, c) to acknowledge that the accounting cost allocation in the Company financial statements are the following: Exercise N ° Account N ° Aut. Amount in Euro N ° Prog. Notes 2016 3.67.3.21 / 15157.80 / / 2016 3.40.1.10 / 151,578.00 / / Total 166,735.80 d) to provide for the transmission of this decision to the Board of Auditors pursuant Law n.111 / 91 and pursuant to article 3-ter of Legislative Decree no. 502/1992, as well as amended by Legislative Decree no. 229/1999.
Pinguin, you're a very stubborn person and with all due respect, you're not correct. Clinuvel is aiming for a uniformed pricing model which is totally unheard of. They might succeed in obtaining a somewhat equal price in many countries. But, obviously there they can't dictate the price. Do you really believe NICE HST will just nod and accept whatever price Clinuvel dictates ? Do you thing they give a hoot about Germany. Clinuvel will have to negotiate with these counties and they are aiming at a price level that is more or less the same. Please be realistic in your expectations.
I didn't know about Austria. That's news. Holland is the second country online. Germany is only waiting for the final rubber stamp and could be online in a few weeks.
Switzerland and Italy is mentioned as still being part of the special access scheme which I think is a tad misleading. The two countries are hesitant to pay the new price for Scenesse because that have gotten used to the compassionate use price. However, Italy is now paying app. $19k per implant and in Switzerland several insurance companies have agreed to pay a new higher price too. Maybe not the full $25k like we see in Germany. But still a higher price. Clinuvel calls this a continuance of the special access scheme but we will se higher revenues deriving from these counties nonetheless.
In the coming months we will see the European countries go online with Scenesse as peals on a string. GB is slow because of NICE bureaucracy but it will be the most significant achievement for Clinuvel as GB is one of the major - and in many cases the major - reference countries in the EU. When we get the news that NICE has received formal referral we will still be looking at app. 5 months of bureaucracy before Scenesse could be formally reimbursed in GB. I expect it to happen in January or February 2017.
In the mean time, Clinuvel will negotiate the final price in Germany in the coming months and I expect it to settle at $20-22k per implant. France will most likely follow Germany and the Scandinavian countries are known to be fairly progressive in allowing new medicines, so I expect them to follow soon too.
All in all, the next many quarters revenues will go up significantly while we wait for the next big market to open up: The US.
As you write, the patient meeting in October is indeed open to the public (at least as a webcast) and I expect the company to file the first module of its NDA for EPP under rolling review around EOY. If we - and the patients - are lucky, we might see PDUFA sometime next summer / autumn. Distribution and uptake should be an easier task in the US than in Europe and hence also quicker once approval is granted.
Vitiligo is the elephant in the room. It seems from the recent newsletters that the company is aiming at ph3 trials without another ph2. This would be significant.
Everything is happening slower than most investors anticipated and I reckon that many are getting bored, frustrated, angry, nervous, freaked out or spooked because their investment hasn't yet made them rich. This company has a history of messing with investors minds but that's biotech right there. It takes time. And then more time.
IMO this is the best time ever to be in Clinuvel and those of us who have been here for years will soon begin to see the price action we have been waiting for. New investors are the lucky ones. Hopefully, patients will soon all be lucky, too.
Karin, what he means is that the Australian site ShareScene has more activity and more posters than iHub on its Clinuvel board.
Good job. Thanks
Someone should inform him about this inaccuracy. Better avoid another lawsuit.
Someone is betting that the share price will go down = is short the stock. Nothing that changes my
sentiment, but hardly good news either.
Conservative and prudent. I like it.
4C quarterly out. Steady increase in revenues even though very few implants at new price can be reflected in these numbers. This is a boom in the making.
http://www.asx.com.au/asxpdf/20160729/pdf/438xckd0tlvgrx.pdf
The old style didn't work. The new approach is aligning CTIX with other serious biotechs but obviously we will need substantial news to move the share price.
Yes, the G-BA will put Scenesse in a category from 1 to 6 where 1 is significant benefit and 6 equivalent to a glass of water. Due to the orphan status I'm pretty sure they will categorize Scenesse in the high bracket. The 50 million cap is not going to be an issue.
Certainly good news. I don't know, though, how much goes to the pharmacy etc. but yes, the price is higher than expected. I don't expect the pps to move until we get hard numbers and significant revenues.
Karin, the next trial in the US will be another phase II for Vitiligo. There will be no more trials for EPP - only NDA and (hopefully) subsequent approval sometime next year.
As for the Vitiligo Phase II I think they need money before initiating that. Either they will sign with a partner or they will self finance with EPP money.
I think we can expect the trial to begin sometime H1 2017.
The price is not final. The G-BA has not published their final assessment and Clinuvel has not negotiated the rebate with the German insurers yet. This is the preliminary price set autonomously by the company as an initial asking price for the first 12 months in Germany. The final price will probably end up around $20k per implant as in Switzerland and Italy.
Thanks a lot for your post. Appreciate it.
Italy seems to be online. At least 140 patients according to this article.
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Afamelanotide available again. The sun shines for patients with Protoporphyria
OF INSALUTENEWS · July 21, 2016
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First plant of the year this morning at San Gallicano, Reference Center for Porphyria leaders. Branca: "Thanks to AIFA and to the Region for having authorized the release of the drug distribution to patients of Lazio and also for the sick outside the region"
torque-guys-scaleRoma, July 21, 2016 - Good news for patients suffering from Protoporphyria Erythropoietic (EPP): green light to the use of this medicine "Afamelanotide". So far this year, in fact, the distribution of the drug had been blocked. A price four times higher than established by AIFA was asked by the manufacturer to each individual system, and this has caused an objective difficulty for patients in getting the therapy.
Now, thanks to the commitment of the General Directorate of the IFO Institute Regina Elena and San Gallicano, and the Lazio Region has obtained the rights to the rig, at the San Gallicano, for 21 patients living in the Region. But not limited to, the Lazio Region has authorized, by agreement with other regions, also treat patients outside the region. There are at least 140 in Italy those affected by the disease.
It is so that finally this morning at the Porphyria Centre Rare Diseases and ISG, directed by Giovanni Leone, was made the first plant of the season on a patient with EPP.
The Protoporphyria Erythropoietic is a rare disease that prevents the sun exposure, and is especially debilitating in the summer, it can also result after a few minutes of sun exposure the erythema and burns all over his body. The one and only existing cure for the disease is the subcutaneous implantation of Afamelanotide drug.
"I am very proud - said Marta Branca, special commissioner IFO - with the result. I want to express gratitude to AIFA and the Lazio Region for having authorized the release of the valuable drug distribution. With the plant this morning at the San Gallicano it puts an end to the ordeal and suffering of these our patients' rare ''.
A rare disease, unknown even to many medical specialists who often mistake the symptoms for trivial photosensitivity, urticaria or special solar erythema. Until 2008 there were no cures for Protoporphyria Erythropoietic (EPP). The patients did not respond to steroid therapy, to antihistamine therapy, it 'to painkillers and had to settle for simple compresses of cool water for relief. But in 2008 its San Gallicano Institute was held the trial of the new drug Afamelanotide, now available in a few centers in the world and in only three centers in Italy including the San Gallicano, one of the Old South.
It is to administer a subcutaneous implant the size of a grain of rice that stimulates the production of melanin and make sure that these parties take symptoms, at least until they are covered by the drug. From here you understand the importance of not deprive patients of the therapy, which would force them to not have a normal life in the open air.
In an effort to solve the problem of the drug block, because of the price quadrupled by the manufacturer, the extraordinary Marta Branca Commissioner has promoted since early this year to AIFA meeting, with the participation of the Institution San Gallicano, the doctors involved and the patients association, to find a solution to the problem.
"The association of the EPP patients - declares Branca- has also played a key role in informing all patients residing in different regions about their rights and to create a coordination. Today, after so much trouble and thanks to the support of the Lazio Region, we can claim to have won the battle, being able to re-administered to our patients the drug saves - quality of life ".
"This EPP - precise Giovanni Leone - represents the limiting case as regards the treatment of pathologies induced by exposure to sunlight, which include less severe and less rare, affecting a wide segment of the population and for which it is operating the clinic dedicated to the diagnosis and treatment of photodermatosis active this year at the Porphyria Centre of the San Gallicano ".
Source: Press Office
I agree. Let's give Dr. B. a chance to work. Nothing in biotech / pharma is quick. Within a year we can begin judging him on a number of parameters. It's way too early now.
I think you're right
It's the first time in the company's history that a PR touting possible efficacy is accompanied by a word of caution:
"While impressed and optimistic about the initial feedback, Cellceutix needs to strongly caution that this is limited feedback from only the first patient in the trial and the initial results may not be durable for the patient or indicative of future outcomes in the study."
It suits CTIX well IMO and adds to the credibility which the CEO was running low of in the eye of the general market. I like it.