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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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Monday, 12 February 2018

CLINUVEL Newsletter - February 2018

12 February 2018 We started this year with limitless optimism and energy, and I attribute this to a foundation of internal changes made over the past 16 months. Our fascinating journey is marred with frequent need …

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Wednesday, 10 January 2018

Chair Letter to Shareholders

11 January 2018 Whilst the Board of CLINUVEL looks back on a very successful 2017 it must now look forward to exciting times ahead. The Group will engage in many activities on several continents, and we …

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Thursday, 07 December 2017

CLINUVEL Newsletter - December 2017

07 December 2017 The CLINUVEL team is looking with much optimism and energy to the start of 2018. I believe the year ahead is one where the Company will make great strides on various fronts: research, …

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