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), 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

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 41 767 45 45Email Media contact: Lachlan HayClinuvel Pharmaceuticals Ltd     This email address is being protected from spambots. You need JavaScript enabled to view it. About 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 Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that results from its US Phase IIa study of SCENESSE® (afamelanotide 16mg) in vitiligo (CUV102) have been published in the peer-reviewed Journal of the American Medical Association-Dermatology (e-pub doi:10.1001/jamadermatol.2014.1875). Vitiligo is a skin disorder caused by the total or partial loss of function of pigment producing cells of the skin (melanocytes). As a result, lighter depigmented patches of skin (lesions) appear due to the loss of pigment (melanin). CUV102, an open-label Phase IIa study conducted in three US expert centres (The Vitiligo & Pigmentation Institute of Southern California in Los Angeles, The Henry Ford Hospital in Detroit and Mount Sinai Hospital in New York), was designed as the first study to explore the potential Clinuvel’s drug SCENESSE® to repigment skin, using the drug in combination with narrowband UVB (NB-UVB) therapy. Positive results from the study were announced in December 2012, with positive longer-term follow-up results announced in September 2013. The authors of the JAMA publication, all of whom were the treating physicians in CUV102, reported that the drug was well tolerated and the combination therapy “resulted in clinically apparent, statistically significant superior and faster repigmentation compared with NB–UV-B monotherapy”. It was also reported that patients with darker skin types (Fitzpatrick types IV-VI) responded faster to the combination therapy. “We are pleased to learn that the investigators of the CUV102 study have found the time to review all results and that these have been accepted by the JAMA,” Clinuvel’s Acting Chief Scientific Officer, Dr Dennis Wright said. “The academic and clinical interest in our work continues to grow and we welcome the ongoing involvement of the key expert centres in the US as our program progresses.” Clinuvel is currently conducting a Phase II study (CUV103) in Singapore. - End - Lim HW, Grimes PE, Agbai O, et al (2014). “Afamelanotide and Narrowband UV-B Phototherapy for the Treatment of Vitiligo”. JAMA Dermatol. E-Pub Sept 17. Abstract online. Grimes PE, Hamzavi IH, Lebwohl M, Ortonne JP & Lim, HW (2012). “The Efficacy of Afamelanotide and Narrowband UV‐B Phototherapy for Repigmentation of Vitiligo”. Archives of Dermatology. 149(1):69-73. E-Published October 2012. Abstract online. 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 vitiligo Vitiligo is a skin disorder, affecting approximately 1-2% of the global population, in which particular pigment producing cells of the skin (melanocytes) appear to become dysfunctional. As a result, lighter depigmented patches of skin (lesions) appear in different parts of the body due to the loss of melanin (pigment). Vitiligo therapy is primarily intended to arrest depigmentation and to stimulate repigmentation of affected skin as a secondary action. There is no known cure for vitiligo. The current standard of care is treatment with NB-UVB, a controlled light therapy given in 2 to 3 sessions per week over the course of 12 to 18 months. The response rate to NB-UVB is low and repigmentation is incomplete. Combination therapies are often employed in an attempt to enhance repigmentation. Of those vitiligo patients who experience initial success following treatment with NB-UVB, many suffer a recurrence of depigmentation following cessation of therapy, which is recognised as a major clinical challenge in treating vitiligo. 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

Read More
 2014-09-18

Read More
 2014-09-11

Clinuvel Stock Ticker

Clinuvel Latest News

Vitiligo update

Clinuvel has received the necessary ethical and regulatory approvals to commence a Phase II study in Singapore. You can read more here. In 2013 five month follow on results were released from the first Phase II study, conducted in the USA. See here for more....

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), 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®) an...

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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