Announcements

Clinuvel's company releases, including archives.

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…
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…
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…
Tuesday, 16 September 2014 09:01

Response to Price Query for Clinuvel Pharmaceuticals Ltd

Thursday, 11 September 2014 19:03

Form 604

Monday, 25 August 2014 08:19

Appendix 4E - Preliminary Final Report 2013/14

Monday, 18 August 2014 08:17

Chairman's Update

August 18, 2014   Dear Shareholders and friends of Clinuvel, Clinuvel is approaching its first landmark regulatory decision in October and the directors of Clinuvel keenly await European Medicines Agency’s (EMA) decision on SCENESSE® (afamelanotide 16mg), our first ethical pharmaceutical product to be marketed. The expectations of the company are building and the recent unsolicited bid proposal to acquire all of Clinuvel’s outstanding shares is just one example of the heightened anticipation. The EMA is being presented with a new molecular entity which is released in the human body by a propriety and unique formulation used in a previously untreated…
Non-binding offer materially undervalues Clinuvel As announced on 28 July, Clinuvel Pharmaceuticals Ltd (ASX: CUV) received an unsolicited proposal from Retrophin, Inc. (NASDAQ: RTRX) on 17 July to acquire all of the shares in Clinuvel via scheme of arrangement, for either: 0.175 Retrophin shares per Clinuvel share (valued at A$2.14 per share based on the one month VWAP of Retrophin shares on 16 July 2014); or A$2.17 in cash per Clinuvel share. The proposal was subject to numerous conditions. Retrophin has acquired a stake of approximately 6.7% in Clinuvel. The Clinuvel Board has evaluated the proposal in conjunction with its…
Thursday, 07 August 2014 16:15

Appendix 3B - August 7

Thursday, 31 July 2014 15:09

Appendix 4C (Q4 2013-14)

Page 1 of 35

Share Price

Buy : 4.2

Sell : 4.1

First : 0

Last : 0

High : 0

Low : 0

ASX: CUV 20 mins delay.

Volume : Trades:

Last Traded : 23-Sep-2014 16:10:08

Popular Articles

Investor Spotlight

Clinuvel Stock Ticker

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...

Investors' 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...

Clinuvel Non-Executive Director Brenda Shanahan has been honoured at The Australian Financial Review and Westpac Group Woman of Influence...

Since we publicly announced our vitiligo program in 2010, the entire Clinuvel team has aimed to gain a better understand this disease, its...

Related 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...

Quick Links