Clinuvel Pharmaceuticals

We are a global biopharmaceutical company committed to developing drugs for the treatment of a range of severe skin disorders.

Clinuvel’s lead compound, SCENESSE® (afamelanotide 16mg), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe. In February 2012 SCENESSE® was filed for review by the European Medicines Agency for EPP. Further trials of SCENESSE® are underway in the pigmentary disorder vitiligo.

Our website has been developed to help share our expertise on the interaction of light and human skin as well as provide a thorough overview of our global drug development programs.

Latest Company Announcements

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) wishes to advise in accordance with the terms and conditions of issue that the following unquoted conditional performance rights have lapsed and forfeited. Class Number Exercise price CUVAK Conditional Performance Rights subject to various performance milestones 50,000 $Nil Consequently, there are now 1,341,482 unlisted conditional performance rights on issue. - End - Investor relations contacts: Australia: Clinuvel Pharmaceuticals Limited, T: +61 3 9660 4900Europe: Clinuvel AG, T: +41 41 763 54 30Email About Clinuvel Pharmaceuticals LimitedClinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified three groups of patients with a clinical need for photoprotection and another group with a need for repigmentation. These patient groups range in size from 10,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been filed for review by the European Medicines Agency. Based in Melbourne, Australia, Clinuvel has operations in Europe, the US and Singapore. Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE® (afamelanotide) for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following: actual results may and often will differ materially from these forward-looking statements; no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for SCENESSE® can or will be achieved; no assurances can be given by Clinuvel that, even if its development programme for SCENESSE® is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place

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 2014-10-10

In accordance with ASX listing rules 3.13.1 and 14.3, Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced it will hold its 2014 Annual General Meeting of shareholders on Friday November 28, 2014 at 10.00am AEST at Karstens Conference Centres, Level 8, Room 803, 123 Queen Street, Melbourne, Victoria, Australia 3000 A formal Notice of Meeting and the Company’s Annual Report will be lodged with the ASX no later than October 27, 2014. – End – Investor relations contacts: Australia: Clinuvel Pharmaceuticals Limited, T: +61 3 9660 4900Europe: Clinuvel AG, T: +41 41 763 54 30Email About Clinuvel Pharmaceuticals LimitedClinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified three groups of patients with a clinical need for photoprotection and another group with a need for repigmentation. These patient groups range in size from 10,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been filed for review by the European Medicines Agency. Based in Melbourne, Australia, Clinuvel has operations in Europe, the US and Singapore. Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE® (afamelanotide) for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following: actual results may and often will differ materially from these forward-looking statements; no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for SCENESSE® can or will be achieved; no assurances can be given by Clinuvel that, even if its development programme for SCENESSE® is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place

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 2014-10-10

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that data from the use of its drug SCENESSE® (afamelanotide 16mg) in clinical trials and special access schemes are being presented at the European Academy for Dermatology and Venereology (EADV) meeting in Amsterdam, held from 8-12 October. Results from the Phase II US study in vitiligo (CUV102) and clinical experiences of treating erythropoietic protoporphyria (EPP) patients during seven years in Switzerland and Italy are being discussed among specialists and dermatologists at the ‘MSH Society Meeting’ on October 8. This is the sixth consecutive year that clinical data from physicians using SCENESSE® have been presented at the EADV, Europe’s largest dermatology conference. - End - References Lebwohl M. “Afamelanotide in vitiligo – the first experience”. MSH-Society meeting, October 8, 11:40, Room G104. Minder E. “Update on treatment of erythropoietic protoporphyria with afamelanotide”. MSH-Society meeting, October 8, 9:50, Room G104. Investor relations contacts: Australia: Clinuvel Pharmaceuticals Limited, T: +61 3 9660 4900Europe: Clinuvel AG, T: +41 41 763 54 30Email Media contact: Lachlan HayClinuvel Pharmaceuticals Ltd      This email address is being protected from spambots. You need JavaScript enabled to view it. About Clinuvel Pharmaceuticals LimitedClinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified three groups of patients with a clinical need for photoprotection and another group with a need for repigmentation. These patient groups range in size from 10,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been filed for review by the European Medicines Agency. Based in Melbourne, Australia, Clinuvel has operations in Europe, the US and Singapore. Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE® (afamelanotide) for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following: actual results may and often will differ materially from these forward-looking statements; no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for SCENESSE® can or will be achieved; no assurances can be given by Clinuvel that, even if its development programme for SCENESSE® is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place

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 2014-10-08

Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it has attended the plenary meeting of the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) in London. The meeting was held as part of the scientific review of the marketing authorisation application (MAA) for SCENESSE® (afamelanotide 16mg) as a potential therapy for adult patients diagnosed with the orphan disease erythropoietic protoporphyria (EPP). The EPP patient community was represented during this meeting. An outcome may be expected during the plenary session of the CHMP in October. - End - Investor relations contacts: Australia: Clinuvel Pharmaceuticals Limited, T: +61 3 9660 4900Europe: Clinuvel AG, T: +41 41 763 54 30Email Media contact: Lachlan HayClinuvel Pharmaceuticals Ltd      This email address is being protected from spambots. You need JavaScript enabled to view it. About Clinuvel Pharmaceuticals LimitedClinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified three groups of patients with a clinical need for photoprotection and another group with a need for repigmentation. These patient groups range in size from 10,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been filed for review by the European Medicines Agency. Based in Melbourne, Australia, Clinuvel has operations in Europe, the US and Singapore. Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE® (afamelanotide) for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following: actual results may and often will differ materially from these forward-looking statements; no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for SCENESSE® can or will be achieved; no assurances can be given by Clinuvel that, even if its development programme for SCENESSE® is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place

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 2014-09-26

CHMP meeting scheduled September 23 Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that it will present at the plenary meeting of the Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) in London. Clinuvel’s presentation to all CHMP members (and/or alternates) forms part of the EMA’s review of the marketing authorisation application (MAA) of Clinuvel’s drug SCENESSE® (afamelanotide 16mg) for the preventative treatment of the orphan disease erythropoietic protoporphyria (EPP). The Oral Explanation is scheduled for September 23. Clinuvel filed the MAA with the EMA in February 2012. - End - Investor relations contacts: Australia: Clinuvel Pharmaceuticals Limited, T: +61 3 9660 4900Europe: Clinuvel AG, T: +41 41 763 54 30Email Media contact: Lachlan HayClinuvel Pharmaceuticals Ltd     This email address is being protected from spambots. You need JavaScript enabled to view it. About Clinuvel Pharmaceuticals LimitedClinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified three groups of patients with a clinical need for photoprotection and another group with a need for repigmentation. These patient groups range in size from 10,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been filed for review by the European Medicines Agency. Based in Melbourne, Australia, Clinuvel has operations in Europe, the US and Singapore. Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE® (afamelanotide) for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following: actual results may and often will differ materially from these forward-looking statements; no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for SCENESSE® can or will be achieved; no assurances can be given by Clinuvel that, even if its development programme for SCENESSE® is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place

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 2014-09-22

Development of pediatric formulations for EPP and a topical melanocortin peptide [CUV9900] for dermatology ClinuvelPharmaceuticalsLimited (ASX:CUV;XETRA-DAX:UR9;ADR:CLVLY) today announced that it has reached agreement on terms and conditions with Biotech Lab Singapore (BLS) Pte Ltd to enter a joint venture (to be called Vallaurix Pte Ltd) for the final development of formulations for paediatric use of afamelanotide, and CUV9900, a novel melanocortin peptide for topical application for skin care. Clinuvel retains a majority interest in the partnership. The financial terms have not been disclosed. In the joint venture, Clinuvel will lead and oversee the scientific aspects including the regulatory development of the melanocortins whereas BLS will be managing chemistry and formulation development in Asia. RATIONALE FOR FOLLOW-ON PRODUCTS The innovative clinical use of SCENESSE® (afamelanotide 16 mg - Clinuvel’s lead product, currently under European regulatory review) over the past decade has provided Clinuvel with specific knowledge of clinical use and safety of melanocortins in dermatology. The feedback received during the regulatory review of SCENESSE® played an important role in the timing of the joint venture’s establishment. Vallaurix will focus on the development of the paediatric formulations of afamelanotide for erythropoietic protoporphyria (EPP), as well as CUV9900, a melanocortin peptide intended to be used as complementary therapy in photodermatoses and depigmentation disorders such as vitiligo. INTELLECTUAL PROPERTY The paediatric formulations and CUV9900 will be part of the proprietary portfolio of the joint venture. TIMELINES Subject to a positive regulatory outcome of SCENESSE® in Europe in October 2014, the formulations for paediatric use in EPP will be developed to stay within the timelines committed to the European Medicines Agency. The development of CUV9900 for topical use follows a strategic plan to evaluate its stability, clinical efficacy and safety. “In view of the progress of the SCENESSE®, we identified this as the right time to advance new formulations for paediatric use in EPP and CUV9900 for the complementary treatment of skin disorders,” Clinuvel’s Acting Chief Scientific Officer, Dr Dennis Wright said. “After months of negotiations, the Board has found a good commercial outcome with BLS, a local partner providing us access to Asia and China and capable of proportionally sharing in the development costs and commercial upside of future products,” Clinuvel’s Chair, Mr Stan McLiesh said. “SCENESSE® has been a central part of our business plan to catalyse further downstream development of complementary formulations and next products,” Mr McLiesh added. “For years the Board has strived to realise the vision of furthering the development of SCENESSE® into complementary treatments. This vision was shared by our recently departed and much respected Board member Jack Wood and I am excited to play a part in realising this vision.” - End - Investor note: please see  https://www.youtube.com/watch?v=45DakoK5KtY for a 2009 video of Mr Jack Wood referencing the development vision of SCENESSE® into complementary products. Investor relations contacts: Australia: Clinuvel Pharmaceuticals Limited, T: +61 3 9660 4900Europe: Clinuvel AG, T: +41 41 767 45 45Email Media contact: Lachlan HayClinuvel Pharmaceuticals Ltd    This email address is being protected from spambots. You need JavaScript enabled to view it. About SCENESSE® (afamelanotide 16mg)SCENESSE® is a first-in-class therapeutic being developed by Clinuvel, with the generic name (or INN) afamelanotide. An analogue of α-MSH, afamelanotide is a linear peptide which activates eumelanin of the skin, the dark pigment which is known to provide photoprotective properties (offering skin protection against light and UV radiation). SCENESSE® is administered underneath the skin as a dissolvable implant approximately the size of a grain of rice. For more information on SCENESSE® go to    http://www.clinuvel.com/scenesse. SCENESSE® is a registered trademark of Clinuvel Pharmaceuticals Ltd. About Clinuvel Pharmaceuticals LimitedClinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) is a global biopharmaceutical company focused on developing drugs for the treatment of a range of severe skin disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified three groups of patients with a clinical need for photoprotection and another group with a need for repigmentation. These patient groups range in size from 10,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe, and has been filed for review by the European Medicines Agency. Based in Melbourne, Australia, Clinuvel has operations in Europe, the US and Singapore. Clinuvel is an Australian biopharmaceutical company focussed on developing its photoprotective drug, SCENESSE® (afamelanotide) for a range of UV-related skin disorders resulting from exposure of the skin to harmful UV radiation. Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments (forward-looking statements), investors should note the following: actual results may and often will differ materially from these forward-looking statements; no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for SCENESSE® can or will be achieved; no assurances can be given by Clinuvel that, even if its development programme for SCENESSE® is successful, it will obtain regulatory approval for its pharmaceutical products or that such products, if approved for use, will be successful in the market place

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 2014-09-18

Clinuvel Stock Ticker

Clinuvel Latest News

Afamelanotide mentioned in EMA release

Clinuvel's drug SCENESSE® (afamelanotide 16mg) has been mentioned in a press release issued by the European Medicines Agency. To read the release, click on the following link: Patients to discuss benefit-risk evaluation of medicines with the Committee for Medicinal Products for Human Use...

Vitiligo Latest News

SCENESSE® vitiligo study results published in JAMA Dermatology

Results from Clinuvel's first Phase II study of SCENESSE® (afamelanotide 16mg) have been published in the peer-reviewed journal JAMA Dermatology. Access the article abstract Read Clinuvel's release Watch an interview with CUV102 investigator Dr Henry Lim...

Clinuvel Spotlight

Company History

The technology behind Clinuvel’s lead drug, SCENESSE® (afamelanotide 16mg), has been in research and development since the 1980s when a small team of scientists set out to investigate methods of preventing skin cancer in humans. Clinuvel licensed this technology and has spent over A$20million optimising the chemistry of afamelanotide (the active ingredient in SCENESSE...

Clinuvel Blog Posts

In 2010, Clinuvel announced that it would commence a clinical trial of a new drug for vitiligo. In late 2012 the first treatment results...

The biennial Porphyrins & Porphyrias conference is the only international meeting of global key opinion leaders on the group of...

Today, February 28, marks Rare Disease Day: an annual event to help highlight the effects of rare diseases on individuals, families and the...

Clinuvel Webcasts

What can vitiligo patients do? - Lee Thomas and Dr ...

Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut...

The future of vitiligo treatment - Lee Thomas and D...

Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut...

Vitiligo trials of SCENESSE® - Lee Thomas and Dr Ph...

Taking on Vitiligo, a depigmentation disorder of the skin. In 2010, Clinuvel ventured into an area of dermatology where no other pharmaceut...

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