Rosacea Support Group » melanotan

Afamelanotide (Scenesse) now available in Italy

David Pascoe — Mon, 17 May 2010 02:08:23 +0000

Clinuvel has announced today that Italy has pre-empted the approval of Afamelanotide by the FDA in the US by approving it for the treatment of erythropoietic protoporphyria (EPP).

Despite the relatively small number of participants in the Italian trial to treat EPP, and the small number of EPP sufferers thought to directly benefit from this therapy, the approval by Italian Medicines Agency (AIFA) is significant because it confirms Afamelanotide’s efficacy and safety and also that national medicine agencies are willing to rapidly approve afamelanotide.

This announcement represents one more small step towards the approval of afamelanotide worldwide as a treatment for the conditions chosen by Clinuvel, namely; Erythropoietic Protoporphyria, Actinic Keratosis and Squamous Cell Carcinoma in Organ Transplant Recipients, Polymorphic Light Eruption, and Solar Urticaria.

Despite not being currently targeted as rosacea treatment, Afamelanotide remains interesting for rosacea sufferers who identify exposure to the sun as a significant trigger for their symptoms.

Unexpected news for afamelanotide from Italy

An unprecedented and unexpected announcement over the weekend has lead to the company’s announcement this morning that afamelanotide will be first made available to Italian erythropoietic protoporphyria (EPP) patients prior to its formal approval anywhere else in the world.

A governmental publication in Italy has confirmed that Clinuvel’s afamelanotide implant formulation can now be prescribed for patients diagnosed with EPP under Law 648/96, while marketing authorisation for the European Community is being prepared.

and from;

Italian Medicines Agency (AIFA) provides reimbursement for the treatment of EPP with afamelanotide

Through inclusion in the 648/96 list, afamelanotide can now be prescribed on an individual basis to adult patients diagnosed with EPP. Beneficiaries may be either former participants in clinical studies (CUV017) or other patients who are positively diagnosed with EPP.

Although the exact prevalence of EPP in Italy is unknown, it is estimated that approximately 60 patients will initially benefit from this treatment. Afamelanotide’s inclusion on the 648/96 list has been formally announced by Italian legislators, allowing the drug to be prescribed to patients with immediate effect.

[update:] Clinuvel have also announced that afamelanotide will be marketed under the brand name of Scenesse (pronounced “sen-esse”). From today onwards, Clinuvel will adopt SCENESSE in all references to the drug in its further global clinical development.

Q&A with Clinuvel on Afamelanotide and Melanotan

David Pascoe — Fri, 26 Feb 2010 06:13:43 +0000

There is a lot of interest amongst rosacea sufferers surrounding the possibility of some kind of systemic treatment that will offer better UV protection. Especially for those with severe triggers from sun exposure, treatments like Afamelanotide look promising.

The CEO and Director of Clinuvel, Dr Philippe Wolgen, was kind enough to answer some questions relating to their developments and any potential tie-in with rosacea. Thanks Dr. Wolgen for taking the time to help us understand what Clinuvel is up to and how that fits in with what we can find on the internet.

1. We have heard of Melanotan, what is that?

In the early eighties, ‘Melanotan’ was a trade name for a series of peptides developed as potential skin cancer preventatives at the University of Arizona. These names are no longer used by the University and related companies.

In more recent times, the term ‘Melanotan’ has been associated and used by online vendors selling illegal chemicals over the net, whereby these pirates falsely claim that they are selling clean hormonal drugs. These chemicals have never been tested, have not received regulatory approval anywhere in the world and are a health hazard to consumers buying them online. Most of these consumers believe that these chemicals are safe tanning alternatives.

On the other hand, pharmaceutical drugs developed under controlled conditions and which receive regulatory approval for testing are subject to strict regulations, including controls on how they are manufactured, their purity levels and ingredients, their methods of administration and close monitoring by medical experts. Chemicals sold online as ‘Melanotan’ undergo none of these tests, and the public is warned to refrain from these substances.

2. How about afamelanotide, where does that fit in?

Afamelanotide is an optimized synthetic peptide manufactured under supervision of a global manufacturer, which is authorized by the FDA and EMA to synthesize legitimate amino acids to peptides.

Clinuvel has the exclusive worldwide rights to develop afamelanotide and it has chosen to develop the drug as the world’s first ‘medicinal photoprotective’ – that is, a drug that provides endogenous (from within) skin protection from UV and light.

Clinuvel has refined this drug since its early development; refining both the active pharmaceutical ingredient’s method of manufacture and ingredients, as well creating a novel delivery system: a controlled-release dissolvable implant. The drug is now administered by physicians as a subcutaneous implant – roughly the size of a grain of rice – which disappears after days. The effect of the drug lasts two months.

We’ve identified the most severe UV and -light related skin disorders and have tested afamelanotide for the past 10 years in humans to measure its photoprotective effect. Not only have we seen clinical response in these patients, more important is that we have seen a very safe profile in afamelanotide.

EPP is the lead indication, meaning where this drug is first used, and, we believe, the one for which patients have the greatest need for medicinal photoprotection.

3. There might be confusion surrounding some of the terminology people find on the internet. Please could you tell help us distinguish Epitan, Melanotan, Melanotan 2 and Afamelanotide?

Afamelanotide is the generic name of Clinuvel’s molecule and is not related to the chemicals sold today as ‘Melanotan’. Afamelanotide is a legitimate pharmaceutical ingredient being developed into a therapeutic product with a safe track record.

‘Melanotan’ and ‘Melanotan 2’ are self-injectable or inhalable chemicals and their names have been used by unscrupulous vendors online to sell chemicals of unknown origin purporting to have a cosmetic tanning effect or causing weightloss and libido enhancing. These are not pharmaceutical products: their manufacture, ingredients and use are unknown and their potential effects are unknown.

Nowhere in the world are products being sold online as ‘Melanotan’ or ‘Melanotan 2’ being tested in legitimate clinical trials; unfortunately those selling these chemicals are linking legitimate scientific research to their products in an attempt to legitimize their operations.

Epitan is a company that is no longer in existence.

4. Products seem to take years and years to become available. When might afamelanotide be available to doctors?

The approval and sale of drugs is regulated in every country or territory by a different regulatory agency (such as the FDA in the USA, EMA in Europe or TGA in Australia). Regulators review the history and development of a drug in depth once a final dossier of data is submitted by a sponsor company. The key regulatory review is whether a drug is safe and well tolerated by the patients for whom it is intended. Regulators then review the data to determine whether a drug is effective in preventing or treating the patients for whom it is intended and whether a drug is safe for human use. A drug is approved when a regulatory agency completes a review of the data presented by the sponsor and agrees that the effect of the drug in patients outweighs the possible risks or side effects posed by that drug. The process up until the regulatory review can take many years; the average time for a drug to reach the market from the lab is 10 years. Companies may spend an average of $US1billion getting drugs to market and, sadly, the vast majority of drugs fail well before they reach the market. It’s estimated that about one in every 10,000 molecules discovered in the lab will reach the market as a pharmaceutical product. Of every three drugs to reach Phase III (the last stage of clinical development), roughly two will fail.

Clinuvel is nearing the completion of its development program after more than a decade, and it is in this context that Clinuvel is developing a first-in-class drug, afamelanotide. We have taken a cautious and conservative approach by generating data preclinically and clinically, perhaps more than is strictly necessary to evaluate the safety of afamelanotide.

We are due to release full results from our first ever completed Phase III study before the end of March. Pending the results of this trial, we will make the decision of when to file a dossier for Marketing Authorisation with regulators. This will happen with European regulators first (a central procedure through the European Medicines Agency), followed by Switzerland, Australia and then the US. The timing is then dependant upon the regulatory process, which can take anywhere from 3-9 months. We’re posting overviews and discussion related to pharmaceutical development on our blog.

5. What are your thoughts about off-label usage of prescription products?

I have published my thoughts in an exploration of the subject of off-label use on the Clinuvel blog.

As a physician, I think off-label use is risky as most drugs have been tested in one disease only. The decision to prescribe the same drug for other diseases is often not founded on the testing data. A physician has certain autonomy, but the health of his patients should dominate his or her decisions. In this sense I am risk averse and conservative.

6. There are a number of individuals with rosacea who believe that afamelanotide may be an appropriate treatment for them; have you ever trialled the drug in rosacea?

We have not trialled afamelanotide in rosacea, so the drug’s effects are unknown.

7. Is there a possibility that afamelanotide may be effective in rosacea?

Unless a trial is conducted, it is impossible to speculate on the drug’s effects.

It is important to note, however, that a drug’s effects will vary from patient group to patient group; it is not wise to assume that what works in one indication will necessarily work in another.

8. Do you think your company might maintain an interest in the future with respect to rosacea?

For the moment we are focused on our chosen regulatory program

While we welcome the interest generated by individuals with rosacea, at present we are focused on completing our program in the other diseases.

9. Various `melanin enhancers’ (for want of a better term) seem to be available on the internet. What advice would you offer to those who are desperate or are interested in experimenting?

Consumers should note that there are currently NO prescriptive or pharmaceutically approved drugs to enhance pigmentation. Individuals should not use any product which has not been prescribed by a physician.

The internet phenomenon is a new challenge for the pharmaceutical industry, with consumers becoming gate keepers, but people need to be aware of the risks that these products can pose to their health.

10. Thanks for doing this Q&A, where can I find more information about Clinuvel?

The website at www.clinuvel.com is the best way to keep in touch with the company’s updates. We also maintain a twitter feed @ClinuvelNews and support a group on Facebook, the Photoprotection Network.

Clinuvel also maintains an extensive resource library online on UV, light, skin and melanin which may be of interest to your readers.

Finally, as part of our ongoing commitment to quality online information, many of these networks will be upgraded in the coming months to help people better understand what the company does and the industry in which we work.

Thanks Dr. Wolgen, we are grateful for your time and expertise.

Suffering as bad as it gets; Erythropoietic Protoporphyria

David Pascoe — Thu, 11 Feb 2010 12:01:42 +0000

A blog posting at Clinuvel interviews a family struggling with the severe disease Erythropoietic Protoporphyria. Parents Wendy and Ralph talk about the distress and anguish at seeing their young children suffer the pain of EPP.

Also known as absolution light intolerance, Erythropoietic Protoporphyria (EPP) is caused by a build up of protoporphyrin in the skin. Exposure to the sun causes these molecules to be phototoxic.

Clinuvel is targeting Afamelanotide as a treatment for a handful of skin diseases including EPP. Afamelanotide is a synthetic hormone that stimulates the production of melanin without the need for exposure to sunlight.

Afamelanotide is the international nonproprietary name for a molecule originally known as melanotan 1. Clinuvel has stated publicly that products sold online as melanotan are not afamelanotide.

Even though there are no studies currently planned to target afamelanotide at rosacea sufferers, it remains interesting to rosacea sufferers, especially those who have severe sun triggers.

See the video below and visit the full blog post; The fear of what lay ahead

Afamelanotide continues promising results

David Pascoe — Mon, 21 Dec 2009 08:51:14 +0000

Clinuvel is announcing more positive results with its trial of the melanin boosting drug afamelanotide for the disease polymorphic light eruption (PLE).

Even though this condition is rare and it is a stretch to say that treating rosacea with this drug is a given, it is still interesting to follow the development of this drug.

Today’s press release relate to the continuing good results, this time from the Phase III (randomised, double blind, placebo controlled) clinical trials.

The Rosacea Question

For those who do suffer from PLE, simple events like venturing outside can be a trauma. Environmental trauma is experienced by some rosacea sufferers so for them, developments like afamelanotide are interesting.

Just to what extent those with severe sun triggers will experience relief from afamelanotide is completely up for question. How easily rosacea sufferers will be able to be prescribed this drug is another open question.

Clinuvel announces PLE Phase III preliminary results

Friday 18th December 2009, Melbourne, Australia

Trial in polymorphic light eruption (PLE) to support the final registration dossier of afamelanotide

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has
obtained preliminary results in its multicenter randomised double-blind placebo controlled PLE study (CUV015) evaluating the safety and efficacy of afamelanotide 20 mg implants. PLE is a recurrent seasonal UV-related skin disorder seen mostly in fair-skinned patients (10-20% incidence) in the northern hemisphere.

afamelanotide positive Phase III results for erythropoietic protoporphyria

David Pascoe — Tue, 27 Jan 2009 00:38:55 +0000

Clinuvel has announced positive interim Phase III results from the first of the trialists to complete a 12 month study in Switzerland. The 14 patients in Switzerland will form part of 101 to undergo long term study around the world. Further participants and Europe and Australia are also taking part in the trial.

This is good news for those who might want to try afamelanotide, it is one small step closer to being approved.

Trial participants received subcutaneous doses of 16 mg of afamelanotide or placebo, blinded, alternating every 2 months for a period of 12 months. The dose is delivered via a bioabsorbable implant around the size of a grain of rice, injected under the skin.

The trial’s main measure of success was a reduction in the pain experiences during an episode of phototoxity. The pain associated with EPP is described as intolerable, causing blistering and swelling.

The second measure of effectiveness of afamelanotide was melanin density which is seen as skin darkening.

Interestingly the 14 patients involved in the trial asked to continue to take the drug for a further 12 months – such was their benefit. This request was granted.

This interim, small trial didn’t show that afamelanotide reduced the number of phototoxic episodes, rather reduced the severity.

Clinuvel Pharmaceuticals announced in mid 2008 that they had been granted orphan-drug status for afamelanotide to treat the skin condition erythropoietic porphyrias. Orphan drug status is granted to new drugs that treat rare conditions and is used as an instrument to obtain accelerated review by the FDA. The FDA allows tax reductions and market exclusivity for orphan drugs to encourage otherwise un-profitable drugs targeting rare conditions to be developed. See a recent post for more information about when afamelanotide will be available.

Clinuvel are “on schedule in our development of afamelanotide and look modestly but confidently ahead to late 2009, when we anticipate the final Phase III results.”

For more details, see the release from Clinuvel to the Australian Stock Exchange.

UK Warns about Melanotan usage

David Pascoe — Tue, 18 Nov 2008 00:40:54 +0000

The mainstream UK press has several articles today about the risks of an using a yet to be approved injectible tan, even go so far as to name Melanotan.

The Independent: Warnings over ‘injectable tan’ product

People seeking a glow this winter should avoid an "injectable tan" being sold illegally, regulators warned today.

The Medicines and Healthcare products Regulatory Agency (MHRA) issued a notice over an unlicensed product called Melanotan.

It is being advertised and sold illegally on the internet and in some tanning salons and body building gyms

From the BBC: Unlicensed tanning drug use rises

A growing number of people in the UK are injecting themselves with an unlicensed tanning drug, a BBC investigation has found.

Melanotan is still undergoing clinical trials but is sold illegally online and in salons and gyms, Newsbeat reports.

It is a synthetic hormone which stimulates the body’s production of melanin, a substance that gives the skin its colour.

Experts are worried that the long-term effects are not yet known.

The BBC story links to several videos from users of and also opponents to Melanotan.

From The Daily Telegraph: Illegal tanning injection on sale in gyms and online

The Medicines and Healthcare products Regulatory Agency (MHRA) has said that injecting Melanotan could have serious side-effects.

The self-tanning product, which has not been official safety-tested, is being illegally sold over the internet and in some tanning salons and body building gyms.

The chemical boosts the body’s production of melanin, the natural substance that gives skin its pigmentation and helps protect it from the sun’s rays.

There has been a rapid increase in the number of people seeking such drugs, who want an all-round tan but are unwilling to subject themselves to potentially damaging UV light from sun beds.

But David Carter, from the MHRA, warned: "Don’t be fooled into thinking that Melanotan offers a short cut to a safer and more even tan. The safety of these products is unknown and they are unlicensed in the UK."

He said the side effects could be extremely serious.

It is obviously a pretty big thing to get this sort of massive coverage from papers and online in the UK.

I sometimes get the impression that the online communities are over represented by those who are willing to take risks with treatments. Forums are full of people sharing anecdotal information about how to supposedly safely use unapproved treatments. Certainly the internet and the whole globalisation of drug development and testing has made the exchange of this sort of information easy.

How about you ? are you willing to try unproven and risky treatments ?

Photoprotection expertise from Clinuvel

David Pascoe — Fri, 03 Oct 2008 08:11:37 +0000

Perhaps Clinuvel is best known as the Australian company that is developing Afamelanotide.

As some background: Melanotan is the proprietary name for afamelanotide (CUV1647) which is being development by Clinuvel Pharmaceuticals. Afamelanotide has been designated by the world health organisation as the International Nonproprietary Name for the melanocyte stimulating hormone under development by Clinuvel.

Clinuvel is promoting this drug as a photoprotective agent, firstly against the rare condition Erythropoietic Protoporphyria (EPP).

Clinuvel have an excellent web site dedicated to photoprotection – the conditions, current and future treatments, expert opinion and news updates.

If you are interested in ;

Actinic Keratosis (precancerous lesions of the skin)
Squamous Cell Carcinoma (malignant tumour of the skin)
Erythropoietic Protoporphyria (a rare inherited metabolic disorder of the heme pathway)
Polymorphous Light Eruption (a distressing seasonal skin condition likened to sun poisoning)
Photodynamic Therapy and Phototoxicity (phototoxicity after PDT treatment)
Solar Urticaria (anaphylactic reaction to sun)

then have a look at their excellent Photoprotection website.

Afamelanotide (Clinuvel CUV1647) gets orphan drug status in the US

David Pascoe — Wed, 30 Jul 2008 01:45:58 +0000

Clinuvel Pharmaceuticals has announced that they have been granted orphan-drug status by the FDA to treat the skin condition erythropoietic porphyrias. Orphan drug status is granted to new drugs that treat rare conditions and is used as an instrument to obtain accelerated review by the FDA. The FDA allows tax reductions and market exclusivity for orphan drugs to encourage otherwise un-profitable drugs targeting rare conditions to be developed.

Afamelanotide (formerly Melanotan) is currently being tested by Clinuvel to treat 3 UV related skin disorders and 2 cancer related treatments: Erythropoietic Protoporphyria, Phototoxicity associated with Photodynamic Therapy, Polymorphous Light Eruptions, Actinic Keratosis and Solar Urticaria.

The official answer to whether afamelanotide can be used to treat rosacea is given via Clinuvel’s FAQ:

Could afamelanotide (CUV1647) be used to treat Vitiligo or Rosacea?

Clinuvel is not currently testing for the indications of Vitiligo or Rosacea, and at present no clinical trials are planned for the foreseeable future. By subscribing to our database, you will receive company updates on any clinical trials.

Despite these official designations, there continues to be interest in whether afamelanotide or Melanotan 2 can provide any benefits for rosacea symptoms.

Melanotan is the proprietary name for afamelanotide (CUV1647) which is being development by Clinuvel Pharmaceuticals. Afamelanotide has been designated by the world health organisation as the International Nonproprietary Name for the melanocyte stimulating hormone under development by Clinuvel.

Note that Melanotan 2 is a different peptide to afamelanotide and is not connected with Clinuvel Pharmaceuticals. Afamelanotide is being promoted as a photoprotective product, with any cosmetic tanning effects being downplayed.

[Update:]

When will afamelanotide be available ?

What does this announcement mean for the availability of products based on afamelanotide ? Sadly, it is still difficult to say – even if everything goes well; when you might be able to get hold of it.

Here are the best comments towards an answer that I can find so far; (this is all corporate speak, sorry).

some quotes from Clinuvel CEO Philippe Wolgen:

"While the drug continues to exhibit its pharmacological action, one could say that commercialisation has now become a function of our execution and ability to test the drug in the required amount of patients. However, the worldwide management of an orphan indication is far from simple and still bears risks. Physicians and patients remain our most precious assets for Clinuvel to be successful in our efforts to commercialise afamelanotide."

and

"The current statistics demonstrate that the FDA is looking at novel drugs more critically than ever. According to the FDA, there were only 17 new approvals for new molecular entities [in 2007]"

and

"In afamelanotide, we identified a first-in-class drug which delivers novel pharmaceutical activity. We anticipate and plan to file for our first Investigational New Drug (IND) this year, 2008. Much technical work to generate compelling data on the drug and formulation has been done over the past 10 months to compile a dossier that meets US regulatory standards. Our one and only goal is to build a dossier that will be robust enough to withstand critique by US FDA examiners, all set against background of stricter regulatory review process."

Clinuvel trialling CUV1647 (melanotan) for skin cancer for transplantees

David Pascoe — Thu, 01 Nov 2007 12:36:46 +0000

Getting some press in Australia currently is a story about a trial starting today in Melbourne. The trial will assess the efficacy of CUV1647 (also known as melanotan) to protect against skin cancer in patients who have had organ transplants. Patients who have received organ transplants are at a much higher risk of contracting skin cancer because of the immune suppressive drugs that they must take.

The trial will continue for 2 years and will involve 150 patients receiving a dose every 2 months.

This will be the first trial for skin cancer, previous CUV1647 trials have been for Polymorphic Light Eruption (PLE) and fair skinned individuals.

The Courier Mail and Herald Sun lead with a quite enticing sentence –

A PILL that gives a perfect tan in two days and may prevent skin cancer could be available within two years.

Trials begin on ‘perfect tan in two days’ pill

Aaaah if only it was that easy.

It is definitely a good move ; finding a main stream condition like skin cancer to trial against. This will surely speed up the approval process of this melanin stimulating hormone. Lots of work to be done to meet the suggested 2010 approval date.

I think the "grain of rice under the skin" sounds so much better than regularly sticking a needle into your side as those experimenting with Melanotan II describe !

From: Our Product > CUV1647

In-vitro studies demonstrated that CUV1647 is between 10 to 1000 more potent1 than our endogenous (natural) peptide, a-MSH. In fact, clinical studies conducted by Clinuvel have confirmed the increased effects by CUV1647.
…
A subset of this program will be a study to determine the effects of CUV1647 in immune-compromised individuals. These subjects will be chosen from a population of organ transplant patients who are particularly prone to develop AK’s and skin cancer after only minimal exposure to UVR.
…
Clinuvel Pharmaceuticals has the worldwide licence to intellectual property covering the use of analogues of -MSH invented by scientists at the University of Arizona.

Melanotan causing vision problems ?
melanotan: could it cause skin cancer ?
topical forskolin: possible rub on tan
Melanocorp gets warning from FDA for melanotan II
melanotan (epitan) offers sun protection for fair skin individuals
Steve’s Melanotan 2 Log thread at the Rosacea Forum.

Melanocorp gets warning from FDA for melanotan II

David Pascoe — Thu, 06 Sep 2007 04:12:31 +0000

Looks like the FDA has finally caught up with Melanocorp for selling Melanotan II over the internet. Their web site currently down.

FDA Issues Warning Letter to Melanocorp, Inc. For Illegal Sale of Melanotan II

Melanocorp, Inc. advertises the product Melanotan II on its Web site as an injectable tanning product, with additional claims that it is effective in protecting against skin cancer and rosacea (a flushing and redness of the skin). These claims cause Melanotan II to be classified as a drug under the Federal Food, Drug and Cosmetic Act, as well as a new drug because there is no evidence that it is generally recognized as safe and effective for its labeled uses.

I’m still of the impression that it is too early to be getting excited about Melanotan and rosacea. There seems to be too many unanswered questions about efficacy and side effects. So here we can see the FDA stepping and saying that it is too early for it to be generally available.

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