Investor Area

News

Announcements by type

  • Presentation

  • Corporate

  • Newsletter

  • Regulatory

  • Financial

  • Clinical

  • Reset

 

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.

Download PDF

 
 

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.

Download PDF

 
 

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.

Download PDF

 
 

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.

Download PDF

 
 
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

Download PDF
 
 

  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 […]

Download PDF
 
 
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. […]

Download PDF
 
 
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 […]

Download PDF
 
 
Thursday, 12 March 2020

Chair Letter to Shareholders

Fellow shareholders, Let me start a first welcome letter by wishing you a successful and great year ahead without health issues, pertinent at the time that Corona virus is taking over the world news. Since appointed in my position I have taken on the task to oversee our Company, one with immense potential. The first […]

Download PDF
 
 

CLINUVEL PHARMACEUTICALS LTD [ASX:CUV; XETRA-DAX: UR9; Nasdaq International Designation: CLVLY] today received confirmation that the US Food and Drug Administration (FDA) has designated 29 April to discuss and agree the North American development program for SCENESSE® (afamelanotide 16mg) for the pigment loss disorder vitiligo.1 PROPOSED STUDIES CUV104 AND CUV105 IN NORTH AMERICA   The proposed […]

Download PDF
 
 

CLINUVEL PHARMACEUTICALS LTD today communicated in response to a number of public queries that neither the drug substance nor the excipients of SCENESSE® (afamelanotide 16mg) are affected by the coronavirus.1 The coronavirus (COVID-19) is a class 1 viral fusion protein and is not affecting the supply chain or manufacturing of SCENESSE®. THE CORONAVIRUS DISEASE (COVID-19) […]

Download PDF
 
 
Thursday, 27 February 2020

Corporate Presentation Half Year Results

Download Presentation

Download PDF
 
 
Wednesday, 26 February 2020

Appendix 4D Half Yearly Report

CLINUVEL PHARMACEUTICALS LTD, a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders, today announced its financial result for the six months ended 31 December 2019. All figures are rounded and reported in Australian dollars. FINANCIAL RESULT CLINUVEL achieved positive results in the half […]

Company Announcement, 10 February 2020. CLINUVEL PHARMACEUTICALS LTD announced it has requested a Type C Guidance meeting with the FDA to seek agreement on the design of a multicentre Phase IIb vitiligo clinical study (CUV104) and the data package necessary to support a supplemental New Drug Application (sNDA) filing for CLINUVEL’s drug SCENESSE® in vitiligo.

3
Refer Company Announcement, 24 February 2020. CLINUVEL PHARMACEUTICALS LTD announced it is expanding its Singapore laboratories with the support of a grant from the Singapore Economic Development Board.

Download PDF

 
 
Tuesday, 25 February 2020

Appendix 3B and Appendix 3Y Withdrawn

Melbourne, Australia 25 February 2020   CLINUVEL PHARMACEUTICALS LTD (“Company”) withdraws the Appendix 3B (“Appendix 3B”) and Change of Director’s Interest Notice (“Appendix 3Y”) filed by the Company on 5 December 2019. The Appendix 3B and Appendix 3Y relate to the proposed grant of 1,513,750 unlisted performance rights to the CEO (the “Unlisted Performance Rights”) […]

Download PDF
 
 
Monday, 24 February 2020

CLINUVEL Expands Singapore Laboratories

CLINUVEL PHARMACEUTICALS LTD today announced that it is investing in the further expansion of its facilities in Singapore with new state of the art and expanded laboratories to open 1 July 2020. The research and development capacity of its wholly owned subsidiary, VALLAURIX PTE LTD, will be expanded through both a new biological and analytical […]

Download PDF
 
Wednesday, 29 January 2020

CLINUVEL Kommuniqué I

Sehr geehrte Aktionärinnen und Aktionäre, liebe FreundeIm Namen des CLINUVEL-Ausschusses wünsche ich Ihnen allen ein gutes neues Jahr in der Hoffnung, dass es Ihnen Gesundheit und Wohlstand verleiht. Wir bedanken uns vielmals bei Stan McLiesh, …

Download PDF
 
Thursday, 16 January 2020

CLINUVEL Newsletter

Dear shareholders, friendsOn behalf of the CLINUVEL Board, I wish you all a good new year in the hope that it confers you with good health and prosperity, in that particular sequence. We thank and …

Download PDF
 
Thursday, 05 December 2019

Appendix 3B

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

Download PDF
 
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 …

Download PDF
 

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.[...]

Download PDF
 

 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 …

Download PDF
 
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 …

Download PDF
 
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 …

Download PDF
 
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. [...]

Download PDF
 
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 …

Download PDF