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Thursday, 21 May 2020

Kommuniqué III

Liebe Aktionäre, Freunde, Die außergewöhnlichen Zeiten, in denen wir leben, haben alle Kontinente beeinflusst. Jedes verlorene Leben war eins zu viel. Ich kann unseren italienischen medizinischen Kollegen, Patienten und Familien, die mit der Tragödie kämpfen, nicht genug Empathie entgegenbringen. Das Virus hat alle Ecken der Welt befallen und Italien nicht verschont, insbesondere die Regionen Lombardei, […]

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Tuesday, 19 May 2020

CLINUVEL Newsletter

Dear shareholders, friends, The extraordinary times in which we are living have affected all continents. Each life lost has been one too many. I cannot express enough empathy to our Italian medical colleagues, patients and families battling it out with the tragedy. The virus has affected all corners of the world and has not spared […]

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Friday, 08 May 2020

Chair Letter to Shareholders

Fellow shareholders, In my March letter I wished all good health during uncertain times. It is now clear the extent of damage COVID-19 has caused and will cause for many years in the future. I want to again share my thoughts on the long-term view of CLINUVEL, and how the business was set up to […]

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Wednesday, 06 May 2020

过度曝光

With thanks to Andrea Minoglio we are able to share a copy of his intimate EPP documentary Overexposed with Mandarin subtitles. What’s your life like when your skin, like an ultra-sensitive film, gets burned as soon as you expose it to the slightest amount of light? Using a series of interviews and stories, included that […]

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EXECUTIVE SUMMARY CLINUVEL, FDA and global vitiligo experts attended FDA meeting on 29 April Type C Meeting followed up with further amendments to CUV104 clinical study protocol CLINUVEL PHARMACEUTICALS LTD today confirmed that it attended a Type C meeting on 29 April with the US Food and Drug Administration (FDA) and global clinical experts in […]

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Tuesday, 28 April 2020

Appendix 4C

  EXECUTIVE SUMMARY ACTIVITY REPORT QUARTER ENDING 31 MARCH 2020  Key Activity Highlights: Continued supply of SCENESSE® in Europe  SCENESSE® launch in USA following Prior Authorization by US insurers Expansion of in-house R&D capabilities, Singaporean government provides financial incentives Throughout the quarter CLINUVEL has continued to focus on expanding its business activities during a time […]

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Australian-based company CLINUVEL is launching SCENESSE® (afamelanotide 16mg) in the People’s Republic of China for the treatment of the rare genetic metabolic disorder erythropoietic protoporphyria (EPP).1 It is estimated that 5,000 Chinese residents live with EPP – based on a prevalence of 1:75,000 to 1:211,000 – with no therapy approved prior to SCENESSE®. Under a […]

www.clinuvel.com

 

1 SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. Information on the product, including the approved prescribing information, can be found on CLINUVEL’s website at www.clinuvel.com.

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EXECUTIVE SUMMARY CLINUVEL and Winhealth sign Collaboration Agreement to serve Chinese EPP population CLINUVEL remains responsible for clinical care and pharmacovigilance, Winhealth in charge of hospital management Named Patient Program (NPP) initiated to supply SCENESSE® to 10 Chinese EPP patients Local Chinese subsidies in place for EPP patients NPP data, FDA and EMA submission count […]

www.clinuvel.com.

2 He et al (2018). China has officially released its first national list of rare diseases. Intractable Rare Dis Res. 2018 May; 7(2): 145–147.

3 Casanova-González (2010). Liver disease and erythropoietic protoporphyria: A concise review. World Journal of Gastroenterology, 16(36), 4526. Elder, et al (2013). The incidence of inherited porphyrias in Europe. Journal of Inherited Metabolic Disease, 36(5), 849–857.

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Innovative drug launched for rare, isolating, “light intolerance” disorder Americans living with a rare genetic disorder that forces them to choose between self-isolation in the dark, or burning reactions from exposure to light, are welcoming an approved treatment for the first time ever. Australian-based company CLINUVEL has launched SCENESSE® (afamelanotide)1 in the USA for the […]

www.clinuvel.com

 

1 SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase pain free light exposure in adult EPP patients with a history of phototoxicity. Information on the product, including the approved prescribing information, can be found on CLINUVEL’s website at www.clinuvel.com.

2 Biolcati et al. (2015). Long-term observational study of afamelanotide in 115 patients with erythropoietic protoporphyria. The British Journal of Dermatology. 172(6), 1601–1612. Langendonk et al. (2015). Afamelanotide for Erythropoietic Protoporphyria. The New England Journal of Medicine. 373(1), 48–59. Wensink et al. (2020). Association of Afamelanotide With Improved Outcomes in Patients With Erythropoietic Protoporphyria in Clinical Practice. JAMA Dermatology. EPub 18 March 2020.

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CLINUVEL PHARMACEUTICALS LTD today announced that US insurance companies have agreed to reimburse SCENESSE® (afamelanotide) for patients diagnosed with erythropoietic protoporphyria (EPP).1 SCENESSE® was approved by the US Food and Drug Administration (FDA) in October 2019 to increase pain free light exposure in adult patients with a history of phototoxic reactions from EPP, a rare […]

www.clinuvel.com.

2 Further details and terms and conditions are available from www.scenesse.com. This site is intended for US residents only.

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Monday, 23 March 2020

CLINUVEL Kommuniqué II

Sehr geehrte Aktionäre, liebe Freunde, im Laufe des Jahres haben wir einen deutlichen Rückgang der globalen Aktienmärkte erlebt, der den Wertverlust von CLINUVEL noch verstärkt hat. Obwohl dies für viele unserer Aktionäre, einschließlich der Mitarbeiter, die CUV besitzen, bedauerlich und schmerzhaft ist, ist die Realität, dass eine umfassendere Marktkorrektur lange vorhergesagt wurde […] Download PDF

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  CLINUVEL PHARMACEUTICALS LTD today announced plans to launch its novel drug SCENESSE® (afamelanotide) in the USA, with the first patient to be treated after 15 April 2020. SCENESSE® was approved by the US Food and Drug Administration in October 2019 to increase pain free light exposure in adult patients with a history of phototoxic […]

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Monday, 23 March 2020

US Distribution Update

  This overview provides an update to financial markets and CLINUVEL’s owners on the distribution plan of SCENESSE® in the United States, following marketing authorization granted by the US Food and Drug Administration (FDA) on 08 October 2019. Comprehensive information is publicly disclosed while various parts of knowhow and expertise are retained for commercial reasons. […]

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Thursday, 19 March 2020

CLINUVEL Newsletter

Dear shareholders, friends, As the year unfolds, we have witnessed the significant downturn of global stock markets which has compounded the decline of CLINUVEL’s value. While regretful and painful for many of our shareholders, including staff who own CUV, the reality is that a wider market correction was long predicted. In this Communiqué II, we […]

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Thursday, 05 December 2019

Appendix 3B

 New issue announcement, application for quotation of additional securities and agreement. 

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Monday, 02 December 2019

CEO Letter

Dear shareholders, On 8 October 2019, CLINUVEL obtained its first and historic US Food and Drug Administration (FDA) approval, some 39 years since the afamelanotide technology was first discovered in a university laboratory. On this day …

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Dearest Shareholders, As the incoming Chair of the Company, in short letters I will try to provide you with updates and inform you about our business.[...]

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 CLINUVEL PHARMACEUTICALS LTD today announced that Mr Stan McLiesh will retire from his role as Non-Executive Director and Chair of the Board on 30 November 2019. Non-Executive Director Mr Willem Blijdorp has been elected Chair …

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Thursday, 17 October 2019

CLINUVEL Newsletter

  In this News Communiqué VII, we pause to reflect on the outstanding US regulatory outcome and look back one last time at all the events which led to the long-desired outcome on 8 October, the …

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Tuesday, 15 October 2019

Chair Letter to Shareholders

  Dear All, In my career in life sciences, I have served on public Boards, was part of the management team that led CSL to its position and oversaw several executive transitions in our beloved Company, first …

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Tuesday, 20 August 2019

CLINUVEL Newsletter - August 2019

  Dear patients, shareholders, friends, In this News Communiqué VI for the year we report further on CLINUVEL’s regulatory progress in the US and the latest quarterly results for the period ending 30 June 2019. [...]

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Thursday, 11 July 2019

CLINUVEL Newsletter - July 2019

  In this Communiqué we turn our attention to the most recent news communicated to the Company on 31 May by the US Food and Drug Administration (FDA): an extension of the scientific review time for …

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Thursday, 02 May 2019

CLINUVEL Newsletter

02 May 2019  Dear patients, shareholders, friends,In this Communiqué we concentrate on CLINUVEL’s programs and US market access for SCENESSE®.As the European season unfolds, we report on the back of quarterly financials (released 30 April) …

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Wednesday, 24 April 2019

Chair Letter to Shareholders

24 April 2019   Dear All,On a continent where very few biotechnology and pharmaceutical companies have ever succeeded in taking a first-in-class and first-in-line therapy from concept to commercialisation, CLINUVEL has all the makings of becoming …

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