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 16mg), a first-in-class drug targeting erythropoietic protoporphyria (EPP), has completed Phase II and III trials in the US and Europe. In December 2014 the European Commission granted SCENESSE® marketing authorisation under exceptional circumstances for the prevention of phototoxicity in adult patients with 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

Strategy driven by key learnings from Phase II studies (CUV102, CUV103) EXECUTIVE SUMMARY ·         Patients of darker skin complexion respond best to SCENESSE® combination therapy with NB-UVB ·         Physicians’ and patients’ assessment of SCENESSE® is positive ·         Six-month preclinical study of SCENESSE® in combination with NB-UVB to fulfil request from US FDA to demonstrate ongoing safety ·         Advanced vitiligo trials planned in North America Melbourne, Australia and New York, USA, December 3, 2015 Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced its comprehensive North American development program for its drug SCENESSE® (afamelanotide 16mg) in vitiligo. CLINICAL AND REGULATORY STATUS Following the completion of a Phase II study of SCENESSE® in US vitiligo patients (CUV102), the FDA has requested that one preclinical study be conducted, simulating the anticipated human dose regimen, ahead of advanced US trials. It is common for the FDA to request additional preclinical evidence to further demonstrate the safety of novel combination therapies. Vitiligo patients are presently treated with a range of therapies, with narrowband UVB (NB-UVB) phototherapy two to three times weekly for 12-18 months considered a standard of care. SCENESSE® is being evaluated as a combination therapy with NB-UVB with the aim of reducing both the cumulative irradiation dose and overall treatment time. Clinuvel is currently conducting the six month placebo-controlled preclinical study combining six monthly doses of SCENESSE® with NB-UVB administered three times per week. The total accumulated irradiation and dose per session simulates the treatment regimen in man. This study concludes Clinuvel’s fourth non-human model study evaluating afamelanotide in the past 15 years. Once the final study report is completed Clinuvel will then request a meeting with the FDA’s Division for Dermatology and Dental Products to discuss these results and the North American protocol for evaluating SCENESSE® in vitiligo patients. The Company anticipates that two or three concurrent advanced clinical trials will be required prior to submitting a new drug application in the US. Vitiligo therapy is primarily intended to arrest depigmentation and to stimulate repigmentation of affected skin as a secondary action. Clinuvel’s scientific hypothesis that SCENESSE® in combination with NB-UVB would elicit a positive response in vitiligo patients seemed to be confirmed by the clinical results of trial CUV102 and preliminary results from trial CUV103.1 In particular it is now thought that SCENESSE® accelerates the follicular repigmentation response.2 COMMENTARY “SCENESSE® is a promising agent that has undergone a randomised, multi-centre trial for the treatment of vitiligo,” Dr Henry Lim, Chair of the Department of Dermatology of Henry Ford Hospital Detroit said. “It boosts the follicular pigmentary response in vitiligo when used in combination with narrowband UVB.  The ability of this new drug to accelerate repigmentation in vitiligo is very exciting for our patients and for the physicians who take care of these patients.” “We have always focused on the safety of SCENESSE® and continue to do so as we seek to determine whether SCENESSE® may set a new standard of care for vitiligo patients,” Dr Emilie Rodenburger, Clinuvel’s Director of Clinical Affairs said. “The current preclinical study reflects Clinuvel’s commitment towards meeting the FDA’s criteria for novel combination therapies.” “It is rewarding to see our R&D efforts crystallising into a real treatment for patients with a constitutional dark skin colour. Having put our minds towards a medical solution for vitiligo for years, we have well recognised the medical problem vitiligo patients have to endure. It is meaningful for our team to be able to do something for a large group of patients who are in need of an effective therapy,” Dr Rodenburger said. GLOBAL VITILIGO CONSORTIUM Clinuvel has worked closely with a group of leading global academics and clinicians specialising in vitiligo and pigmentation (Global Vitiligo Consortium) to design its vitiligo program. This group’s clinical feedback from trials to date has added value to the analyses. The Consortium will actively assist in developing and reviewing the final clinical protocols for the North American vitiligo program. Consensus has been reached to focus the development of SCENESSE® on vitiligo patients with darker skin complexions (Fitzpatrick types IV-VI3) due to the high disease burden and impact in this group. Pending the final results of CUV103 in Singapore (expected in the first half 2016) the definitive selection of targeted vitiligo patient population will be made. - End - 1 Lim et al (2015). Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. JAMA Dermatol. 151(1):42-50. E-pub September 2014. Abstract online at http://www.ncbi.nlm.nih.gov/pubmed/25230094. Clinuvel announcement “Positive preliminary results in Singaporean vitiligo study”, December 1, 2015. 2 Falabella (2009). Vitiligo and the melanocyte reservoir. Ind J Dermatol. 54(4):313-318. Abstract online at http://www.ncbi.nlm.nih.gov/pubmed/20101329. 3 The Fitzpatrick scale is a tool used to categorize skin types based on visible melanisation and propensity for skin to burn and/or tan when exposed to ultraviolet light. It ranges from type I (very pale skin, never tans, always burns) to type VI (dark brown to black skin, always tans, never burns). For more information, see https://www.youtube.com/watch?v=HZ_LU9GtP1A. Fitzpatrick (1988). The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 124(6):869-871. About Vitiligo Vitiligo is a skin disorder in which particular pigment producing cells of the skin (melanocytes) appear to lose their function. As a result, lighter depigmented patches of skin (lesions) appear in different parts of the body due to the loss of melanin (pigment). Vitiligo is a disease of unknown origin which can start at any anatomical site at any age. It is hypothesised that autoimmune factors may play a role in some subtypes of vitiligo. Vitiligo often affects the face, trunk and extremities and may gradually spread over various body sites. Patients are most affected when extensive visible parts of the body show the loss of pigmentation. Although vitiligo is seen in all skin types (Fitzpatrick I-VI), the highest psychological and societal impact is seen in darker skin complexions (types III-VI). About Clinuvel Pharmaceuticals Limited Clinuvel 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 disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified patient populations with a clinical need for photoprotection and for repigmentation. The worldwide prevalence of these patient groups range from 5,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014 for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). Headquartered in Melbourne, Australia, Clinuvel has operations in Europe, Switzerland, the US and Singapore. For more information go to http://www.clinuvel.com. SCENESSE® is a registered trademark of Clinuvel Pharmaceuticals Ltd. Media enquiries Lachlan Hay, Clinuvel (UK) Ltd.                               +44 1372 860 765          This email address is being protected from spambots. You need JavaScript enabled to view it. Nick Miles, Cabinet Privé de Conseils s.a.                             +41 22 321 4540             This email address is being protected from spambots. You need JavaScript enabled to view it. Ted Agne, The Communications Strategy Group Inc.     +1 718 631 3117             This email address is being protected from spambots. You need JavaScript enabled to view it. Investor enquiries This email address is being protected from spambots. You need JavaScript enabled to view it. Forward-Looking Statements This release to the Australian Securities Exchange and to press may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause Clinuvel’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that the FDA may require additional studies beyond the studies planned for product candidates or may not provide regulatory clearances, including for SCENESSE®; that the FDA may not provide regulatory approval for any use of SCENESSE® or that the approval may be limited; that Clinuvel may never file an NDA for SCENESSE® regulatory approval in the US; that the Company may not be able to access adequate capital to advance its vitiligo programs; that the Company may not be able to retain its current pharmaceutical and biotechnology key personnel and knowhow for further development of its product candidates or may not reach favourable agreements with potential pricing and reimbursement agencies in Europe and the US. Level 5, 160 Queen Street  T +61 3 9660 4900             www.clinuvel.com Melbourne, Victoria 3000 F +61 3 9660 4999 Australia  

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 2015-12-02

Preliminary results of Singaporean Phase II study CUV103 in patients with naturally darker skin are consistent with results from the previous US Phase II trial (CUV102) EXECUTIVE SUMMARY PRELIMINARY RESULTS CUV103 ·         Positive pigmentary response to SCENESSE® in combination with narrowband ultraviolet B (NB-UVB) in patients of darker skin complexion ·         Combination therapy appears safe and effective ·         Physicians’ and patients’ assessment of SCENESSE® is positive Melbourne, Australia and Leatherhead, UK, December 3, 2015 Clinuvel Pharmaceuticals Ltd (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced positive preliminary results from a Singaporean Phase II trial (CUV103) evaluating its drug SCENESSE® (afamelanotide 16mg) as a repigmentation therapy in patients with vitiligo (a depigmentation disorder). The results are consistent with earlier findings from the US Phase II trial (CUV102).1 In both studies SCENESSE® was well tolerated and increased repigmentation in patients with darker skin complexions, for whom vitiligo has an intense psychological and significant social impact. CURRENT STANDARD OF CARE IS UNSATISFACTORY No effective pharmaceutical therapy has yet been developed for vitiligo patients.  Vitiligo therapy is primarily intended to arrest the loss of skin pigmentation and to stimulate repigmentation of affected skin as a secondary action. The current standard of care for vitiligo globally is treatment with narrowband UVB (NB-UVB) light, a controlled light therapy administered in the clinic in two to three sessions per week over the course of 12 to 18 months. The response rate to NB-UVB therapy alone is reported to be low and clinically unsatisfactory to patients and physicians. COMMENTARY “Together with the leading clinicians from two continents we are evaluating SCENESSE® as a new treatment for patients who have lost their pigmentation and which often affects their lives through a permanent change in appearance,” Clinuvel’s Director of Clinical Affairs, Dr Emilie Rodenburger said. “From the encouraging results in two Phase II studies in the US and Singapore, and our ongoing safety program, we are confident that we have sufficient data to optimise the further development of SCENESSE® in vitiligo in specific populations,” Dr Rodenburger said. “Vitiligo has a high impact and is associated with a tragic stigma in our US population of various ethnic descent,” Dr Mark Lebwohl, Professor and Chair of Dermatology at Mount Sinai Medical Center in New York, said. “We look forward to playing a part in developing the SCENESSE® therapy for the US patients with darker skin colour where the disease has a significant effect on their identity and lives.” PRELIMINARY SINGAPOREAN TRIAL RESULTS The preliminary results of the Singaporean Phase II trial (CUV103) showed that increased repigmentation occurred in the four patients who received the SCENESSE® and NB-UVB combination treatment in comparison to the three patients who received NB-UVB with placebo treatment only. The physicians’ assessment of vitiligo treatment offered was positive and in favour of the patients who received SCENESSE®. Although first analyses were made on a small number of patients, preliminary statistical analyses (intention to treat population) comparing the change from baseline over time in the Vitiligo Area Scoring Index (VASI2) score (all body surfaces) between the treatment groups showed a positive trend in favour of SCENESSE® (p=0.052 at Day 168; Wilcoxon test). The analyses showed a higher decrease of the average VASI scores (indicating an increased repigmentation) after the second SCENESSE® dose for the trunk, lower and upper extremities compared to placebo. Overall, these patients with Fitzpatrick skin types3 V and VI showed a good clinical response to SCENESSE® in combination with NB-UVB. The safety of SCENESSE® in combination with NB-UVB was good and no serious drug-related adverse events were reported in the preliminary analysis cohort. All reported drug-related adverse events to date have been in line with previous clinical experience with SCENESSE®. The preliminary observations seen in the CUV103 study are consistent with the previous experience with SCENESSE® in combination with NB-UVB in the CUV102 study conducted in the US, where SCENESSE® combination therapy seems to provide a near complete and progressive repigmentation of skin areas affected. Final results from CUV103 are expected in the first half of 2016. Images of vitiligo patients have not yet been released due to restrictions in the newly implemented Personal Data Protection Act 2012 (PDPA) in Singapore and its amendment of 2013. TRIAL DESIGN – CUV103 The Phase II study was conducted at the National Skin Center, Singapore’s leading dermatology clinic.  The objective was to evaluate the effectiveness of six doses of SCENESSE® as a combination treatment with NB-UVB phototherapy in vitiligo patients with a naturally darker skin colour. In total 21 patients were enrolled using an adaptive trial design. The primary endpoint of effectiveness was assessed through the Vitiligo Area Scoring Index (VASI), a standard validated scoring system for measuring the repigmentation achieved from vitiligo treatment. The secondary endpoint of effectiveness was measured through the Vitiligo Quality of Life (VitiQoL4). Under a double-blind placebo controlled parallel design, eight vitiligo patients with Fitzpatrick skin types4 V and VI involving 15% to 50% of their total body surface were enrolled. Four patients received six doses of SCENESSE® at 28 days intervals in combination with NB-UVB twice a week, and three patients received placebo and NB-UVB treatment twice a week. One patient received one dose of SCENESSE® but withdrew consent and discontinued the study early.  In an expanded open-label protocol, 13 patients with Fitzpatrick skin types IV, V and VI vitiligo involving 10% to 50% of their total body surface were enrolled. 11 patients are still being treated under this protocol, with treatment scheduled to be received up to February 2016. All patients treated under the open-label protocol are administered six doses of SCENESSE® at 28 days intervals in combination with NB-UVB administered twice weekly. ABOUT VITILIGO Vitiligo is a skin disorder in which particular pigment producing cells of the skin (melanocytes) appear to lose their function. As a result, lighter depigmented patches of skin (lesions) appear in different parts of the body due to the loss of melanin (pigment). Vitiligo is a disease of unknown origin which can start at any anatomical site at any age. It is hypothesised that autoimmune factors may play a role in some subtypes of vitiligo. Vitiligo often affects the face, trunk and extremities and may gradually spread over various body sites. Patients are most affected when extensive visible parts of the body show the loss of pigmentation. Although vitiligo is seen in all skin types (Fitzpatrick I-VI), the highest psychological and societal impact is seen in darker skin complexions (types IV-VI). – End – 1 Lim et al (2015). Afamelanotide and narrowband UV-B phototherapy for the treatment of vitiligo: a randomized multicenter trial. JAMA Dermatol. 151(1):42-50. E-pub September 2014. Abstract online at http://www.ncbi.nlm.nih.gov/pubmed/25230094. 2 The Vitiligo Area Scoring Index (VASI) is a validated quantitative scale initially developed to measure the response of vitiligo to NB-UVB treatment, but has since been used to evaluate various possible vitiligo therapies. In this assessment, the patient’s body is separated into six regions: head and neck area, the hands, upper extremities (including auxiliary regions), trunk, lower extremities (including inguinal regions and buttocks), and the feet. A decrease in the VASI score indicates an improvement in the extent and/or degree of repigmentation as a response to treatment. Hamzavi et al (2004). Parametric modeling of narrowband UV-B phototherapy for vitiligo using a novel quantitative tool: the Vitiligo Area Scoring Index. Arch Dermatol. 140(6):677-683.  Abstract online at http://www.ncbi.nlm.nih.gov/pubmed/15210457. 3 The Fitzpatrick scale is a tool used to differentiate skin types based on visible melanin density and propensity for skin to burn and/or tan when exposed to ultraviolet light. It ranges from type I (very pale skin, never tans, always burns) to type VI (dark brown to black skin, always tans, never burns). For more information, see https://www.youtube.com/watch?v=HZ_LU9GtP1A. Fitzpatrick (1988). The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 124(6):869-871. 4 The Vitiligo-specific health-related quality of life instrument (VitiQoL) is used to capture disease-targeted concerns and issues. Lilly et al (2013). Development and validation of a vitiligo-specific quality-of-life instrument (VitiQoL). JAAD. 69(1):e11-18. Abstract online at http://www.ncbi.nlm.nih.gov/pubmed/22365883. About Clinuvel Pharmaceuticals Limited Clinuvel 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 disorders. With its unique expertise in understanding the interaction of light and human skin, the company has identified patient populations with a clinical need for photoprotection and for repigmentation. The worldwide prevalence of these patient groups range from 5,000 to 45 million. Clinuvel’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014 for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). Headquartered in Melbourne, Australia, Clinuvel has operations in Europe, Switzerland, the US and Singapore. For more information go to http://www.clinuvel.com. SCENESSE® is a registered trademark of Clinuvel Pharmaceuticals Ltd. Media enquiries Lachlan Hay, Clinuvel (UK) Ltd.                                               +44 1372 860 765          This email address is being protected from spambots. You need JavaScript enabled to view it. Nick Miles, Cabinet Privé de Conseils s.a.                             +41 22 321 4540             This email address is being protected from spambots. You need JavaScript enabled to view it. Ted Agne, The Communications Strategy Group Inc.     +1 718 631 3117             This email address is being protected from spambots. You need JavaScript enabled to view it. Investor enquiries This email address is being protected from spambots. You need JavaScript enabled to view it. Forward-Looking Statements This release to the Australian Securities Exchange and to press may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause Clinuvel’s actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: that the FDA may require additional studies beyond the studies planned for product candidates or may not provide regulatory clearances, including for SCENESSE®; that the FDA may not provide regulatory approval for any use of SCENESSE® or that the approval may be limited; that Clinuvel may never file an NDA for SCENESSE® regulatory approval in the US; that the Company may not be able to access adequate capital to advance its vitiligo programs; that the Company may not be able to retain its current pharmaceutical and biotechnology key personnel and knowhow for further development of its product candidates or may not reach favourable agreements with potential pricing and reimbursement agencies in Europe and the US. Level 5, 160 Queen Street  T +61 3 9660 4900             www.clinuvel.com Melbourne, Victoria 3000 F +61 3 9660 4999 Australia  

Read More
 2015-12-02
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