ASX Share rice
Sat 15 May 2021 - 03:46:am (Sydney)

CUV Share Price

CLINUVEL PHARMACEUTICALS LIMITEDCUVPharmaceuticals, Biotechnology & Life Sciences

CUV Company Information

Name:

Clinuvel Pharmaceuticals Limited

Sector:

Healthcare

Industry:

Biotechnology

GIC Industry:

Biotechnology

GIC Sub Industry:

Biotechnology

Address:

535 Bourke Street Melbourne VIC Australia 3000

Phone:

61 3 9660 4900

CEO, MD & Director:

Dr. Philippe Jacques Wolgen M.B.A., MBA, M.D.

CFO & Company Sec.:

Mr. Darren M. Keamy

Chief Scientific Officer:

Dr. Dennis J. Wright

Head of Investor Relations:

Mr. Malcolm Bull

Gen. Mang. of Europe:

Lachlan Hay

Company Overview:

Clinuvel Pharmaceuticals Limited, a biopharmaceutical company, focuses on developing and delivering drugs for the treatment of patients with severe genetic and skin disorders worldwide. Its lead drug candidate is SCENESSE, a photoprotective drug for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). The company's pipeline products include CUV9900, an alpha-melanocyte stimulating hormone analogue; Parvysmelanotide (VLRX001), an addition to the family of melanocortin analogues, which provoke increased and prolonged cellular activity; and PRÉNUMBRA, a liquid injectable formulation of afamelanotide. Clinuvel Pharmaceuticals Limited has a collaboration agreement with HK Winhealth Pharma Group Co. Limited for launching SCENESSE under a named patient program for the treatment of patients with EPP in the People's Republic of China. The company was founded in 1987 and is headquartered in Melbourne, Australia.

CUV Share Price Information

Shares Issued:

49.41M

Market Capitalisation:

$1.40B

Dividend per Share:

$0.025

Ex Dividend Date:

2020-09-03

Dividend Yield:

0.09%

Revenue (TTM):

$38.34M

Revenue Per Share (TTM):

$0.78

Earnings per Share:

$0.446

Profit Margin:

0.5875

Operating Margin (TTM):

$0.45

Return On Assets (TTM):

$0.14

Return On Equity (TTM):

$0.33

Quarterly Revenue Growth (YOY):

0.579

Gross Profit(TTM):

$30.39M

Diluted Earnings Per Share (TTM):

$0.446

QuarterlyEarnings Growth(YOY):

9.583

CUV CashFlow Statement

CashFlow Date:

2020-06-30

Investments:

$-888,826

Change To Liabilities:

$-2,444,733

Total Cashflow From Investing Activities:

$-888,826

Net Borrowings:

$-243,341

Net Income:

$16.65M

Total Cash From Operating Activities:

$14.19M

Depreciation:

$427.63K

Dividends Paid:

$-1,224,021

Change To Inventory:

$848.17K

Change To Account Receivables:

$-2,456,468

Capital Expenditures:

$888.83K

CUV Income Statement

Income Date:

2020-06-30

Income Before Tax:

$13.14M

Net Income:

$16.65M

Gross Profit:

$22.94M

Operating Income:

$12.51M

Other Operating Expenses:

$750.12K

Interest Expense:

$25.89K

Income Tax Expense:

$-3,510,388

Total Revenue:

$33.13M

Cost Of Revenue:

$9.63M

CUV Balance Sheet

Balance Sheet Date:

2020-06-30

Total Liabilities:

$7.87M

Total Stockholder Equity:

$73.67M

Other Current Liabilities:

$3.34M

Total Assets:

$81.54M

Common Stock:

$151.85M

Retained Earnings:

$-80,037,286

Other Liabilities:

$105.73K

Good Will:

$185.03K

Other Assets:

$3.81M

Cash:

$66.75M

Total Current Liabilities:

$6.66M

Property - Plant & Equipment:

$2.39M

Net Tangible Assets:

$73.48M

Total Current Assets:

$75.16M

Net Receivables:

$6.61M

Short-Term Investments:

$6.39M

Inventory:

$1.29M

Accounts Payable:

$1.43M

Short-Term Investments:

$6.39

Non Current Liabilities Total:

$1.21M

CUV Share Price History

CUV News

07 Apr, 2021
Like a puppy chasing its tail, some new investors often chase 'the next big thing', even if that means buying 'story...
24 Mar, 2021
SCENESSE® (afamelanotide 16mg) to be evaluated in xeroderma pigmentosum variant (XP-V) MELBOURNE, Australia, March 24, 2021 (GLOBE NEWSWIRE) -- CLINUVEL has expanded its clinical program to evaluate the DNA reparative potential of afamelanotide in skin cells which have been damaged by ultraviolet (UV) and sun exposure. The program now includes patients with the rare disorders XP-V and XP-C. Having reached agreement with clinical and academic experts, CLINUVEL will generate clinical data on the safety and efficacy of SCENESSE® (afamelanotide 16mg). “XP patients are at extreme risk of skin cancer – up to 10,000 times that of the general population – due to their inability to repair damage caused by UV and sunlight, known as photodamage,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “Afamelanotide has been shown to protect skin from UV and light, and repair photodamage. We are now working to confirm this concept in clinical trials with both XP patients and healthy volunteers.” UV radiation penetrates into the nucleus of skin cells and causes defects of the DNA helix known as photoproducts. If left unrepaired, these chemical changes to DNA may replicate as mutations, leading to irreversible damage (photoaging) and may further progress to skin cancer, including melanoma. Human biology contains complex mechanisms to protect itself from UV damage and restore cellular DNA to its original state. Due to genetic defects, XP patients have impaired DNA repair processes, leading to an extreme risk of skin cancer from an early age and a life expectancy of around 30 years. Afamelanotide, the active ingredient in SCENESSE®, improves the function of skin cells which have incurred photodamage and assists these cells to repair DNA through several mechanisms, including nucleotide excision repair (NER). CLINUVEL is conducting clinical trials in XP-C and XP-V patients, as well as healthy volunteers, to evaluate the safety and efficacy of afamelanotide as a DNA regenerative therapy. “Up to two billion individuals of fair-skinned complexion are known to have defects in UV protective and DNA repair processes, including NER, increasing their long-term risk of skin cancer,” Dr Wright said. “XP patients are at the most extreme risk and serve as a model for what happens if UV-induced damage is left unrepaired. “I am pleased that we have been able to reach agreement with global XP experts to expand the DNA Repair Program and evaluate SCENESSE® in XP-V patients and look forward to first results – pending the COVID-19 pandemic – in 2021,” Dr Wright said. ABOUT XERODERMA PIGMENTOSUM XP is a group of eight rare disorders causing extreme UV sensitivity leading to skin cancers, defects in development and neural disease. Compared to the general population, XP patients have been shown to have a 1,000 to 10,000-fold increased risk of developing skin cancer(s). XP-C results from a defect in one of the genes (chromosome 3p25.1) responsible for replicating proteins involved in a DNA repair process known as nucleotide excision repair (NER). Inefficient NER causes the accumulation and replication of UV-induced DNA lesions (photoproducts) in skin, leading to aggressive and recurrent skin cancers. Due to the frequency and spread of skin cancers during adulthood, XP-C patients have a median survival of 30 years. A small subset of XP-C patients develop neurological disorders, leading to developmental delay and sensory loss. XP-V is caused by a defect of the POLH gene (chromosome 6p21.1-6p12) causing a disturbance in DNA translesion synthesis of UV-induced pyrimidine dimers (photoproducts). Pyrimidine dimers are molecular lesions formed within the DNA strands. The disease is autosomal recessive in nature (the patient carrying two copies of the affected gene). XP-V patients typically develop skin cancer(s) during late adolescence and adulthood. In this variant, patients have a dysfunction or malfunction of polymerase (pol)eta, an enzyme required to ensure DNA translesion synthesis of skin cells, a process required after sun exposures and sunburns. Further resources – DNA Damage and Repair CLINUVEL has published an in-depth video on DNA damage and repair and the eight XP complementation groups. For more details see: https://www.youtube.com/watch?v=9kZgZ0_Ip-M. CLINUVEL’s Scientific Communiqué Series provides an extensive overview of DNA damage and repair, with Communiqué VIII focused on DNA Repair Mechanisms and Communiqué IX looking at the role of the Melanocortin-1 Receptor (MC1R) in DNA Repair. About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) is a global and diversified biopharmaceutical company focused on developing and commercialising treatments for patients with genetic, metabolic, and life-threatening disorders, as well as healthcare solutions for the general population. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, DNA repair and acute or life-threatening conditions. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014, the US Food and Drug Administration in 2019 and the Australian Therapeutic Goods Administration in 2020 for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). More information on EPP can be found at http://www.epp.care. Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore and the USA. For more information please go to http://www.clinuvel.com. SCENESSE® and PRÉNUMBRA® are registered trademarks of CLINUVEL PHARMACEUTICALS LTD. Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD Media enquiriesMonsoon CommunicationsMr Rudi Michelson, 61 411 402 737, rudim@monsoon.com.au Head of Investor Relations Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD Investor Enquiries https://www.clinuvel.com/investors/contact-us Forward-Looking StatementsSee CLINUVEL’s website for details. www.clinuvel.com.
02 Mar, 2021
As you might know, Clinuvel Pharmaceuticals Limited ( ASX:CUV ) last week released its latest interim, and things did...
03 Feb, 2021
Most readers would already know that Clinuvel Pharmaceuticals' (ASX:CUV) stock increased by 8.2% over the past three...
20 Dec, 2020
The big shareholder groups in Clinuvel Pharmaceuticals Limited ( ASX:CUV ) have power over the company. Institutions...
09 Nov, 2020
It might be of some concern to shareholders to see the Clinuvel Pharmaceuticals Limited (ASX:CUV) share price down 14...
27 Oct, 2020
Acute Ischaemic Stroke A clot in the brain vessel of a stroke patient leads to instant death of brain tissue closest to the clot, shown in dark pink. The larger area surrounding the core (shaded) is characterised as the penumbra, tissue which can still be rescued.MELBOURNE, Australia, Oct. 28, 2020 (GLOBE NEWSWIRE) -- The drug afamelanotide will be used for the first time in patients with acute stroke. The study will evaluate the safety and efficacy of afamelanotide, developed by Australian company CLINUVEL, in arterial ischaemic stroke (AIS). The aim is to offer a treatment for patients suffering a stroke who are unable to receive treatment to dissolve or remove the underlying blood clot. AIS accounts for approximately 85% of the 15 million strokes suffered worldwide each year.“Stroke is most commonly caused by a clot in a patient’s brain which starves surrounding tissue of blood and essential oxygen, causing the destruction of brain cells,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “This brain damage can have an irreversible effect on a patient’s ability to speak, move, and function, and tragically leads to an early death for more than 5.5 million people per annum. It is our aim to show that treatment with afamelanotide can safely reduce and prevent brain damage in the majority of stroke patients who cannot be offered standard therapy.”Strokes cause death of brain tissue at the site of the clot and lead to a shortage of oxygen in a larger area of the brain, known as the penumbra, which is salvageable brain tissue if treated quickly. The longer the delay in a stroke patient receiving treatment, the greater the potential threat to their life and overall prognosis as tissue within the penumbra becomes irreversibly damaged.Current stroke therapies rely on early intervention to restore blood flow to the brain by either chemically dissolving or physically removing the clot. In Europe, no treatment can be offered to over 85% AIS patients due to a critical delay between the start of the stroke and presentation of the patient to a hospital. Additionally, the location of the clot within the artery is also an important factor impacting the possibility to offer treatment.Research has indicated that afamelanotide – which is approved in Europe and the USA for patients with a rare metabolic disorder called EPP1 – may rapidly exert its effects to protect brain tissue, act on blood vessels to optimise blood flow, and reduce the size of swelling in the brain following a stroke. More than 10,000 doses of afamelanotide have been administered to over 1,400 individuals during its development and use across a period of nearly two decades.The pilot Phase IIa clinical study (CUV801) will be conducted at a single expert neurological emergency centre, assessing the safety and effectiveness of an injectable controlled-release implant formulation of afamelanotide (SCENESSE®) in AIS patients. Six adult patients with clots located in the higher segments of the brain and who are ineligible for alternative treatments will be enrolled in the study and evaluated for six weeks.CUV801 will assess patients’ brain injury with computed tomography (CT) scans and magnetic resonance imaging (MRI), as well as using recognised methods of clinical evaluation to measure changes in patients’ neurological and cognitive function following treatment.“The objective of intervention with afamelanotide is to safely assist the restoration of blood flow and oxygen supply to the brain while minimising the traumatic damage and fluid accumulation. For our team, the ultimate aim is to reduce the overall damage stroke does to those patients,” Dr Wright said.“Having monitored the real-world use of SCENESSE® in patients in Europe and the USA, we have now collected sufficient safety data to further our clinical programs in life threatening disorders. We look forward to the first study results in the first half of 2021, but also depending on the capacity of hospitals due to the COVID pandemic,” Dr Wright said.Media enquiries Monsoon Communications Mr Rudi Michelson, 61 411 402 737, rudim@monsoon.com.auNotes to editors: A longer technical release has been issued to the Australian Securities Exchange and is available on CLINUVEL’s website www.clinuvel.com.1 SCENESSE® (afamelanotide 16mg) is approved in the European Union and Australia as an orphan medicinal product and the world’s first systemic photoprotective pharmaceutical 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 can be found on CLINUVEL’s website at www.clinuvel.com.Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTDAbout CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) is a global and diversified biopharmaceutical company focused on developing and commercialising treatments for patients with genetic, metabolic, and life-threatening disorders, as well as healthcare solutions for the general population. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, DNA repair and acute or life-threatening conditions. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014 and the US Food and Drug Administration in 2019 for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). More information on EPP can be found at http://www.epp.care. Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore and the USA. For more information please go to http://www.clinuvel.com.SCENESSE® and PRÉNUMBRA® are two of several registered trademarks of CLINUVEL PHARMACEUTICALS LTD.Head of Investor Relations Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTDInvestor enquiries https://www.clinuvel.com/investors/contact-usForward-Looking Statements This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Please see the CLINUVEL website for the full disclaimer – www.clinuvel.com.A photo accompanying this announcement is available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/fcd23834-07a7-4914-91b7-12969f6472b7
02 Oct, 2020
Does the October share price for Clinuvel Pharmaceuticals Limited (ASX:CUV) reflect what it's really worth? Today, we...
15 Sep, 2020
SCENESSE® DNA Repair Program – studies 2020/21 Figure 2: SCENESSE® DNA Repair Program – studies 2020/21 The worldwide incidence of xeroderma pigmentosum Figure 1 The worldwide incidence of xeroderma pigmentosum (XP)MELBOURNE, Australia, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Xeroderma pigmentosum (XP) patient receives SCENESSE® treatmentNote to editors: CLINUVEL is releasing in-depth infographics and a video explaining the mechanisms of action in XP and the overall DNA repair process. For updates, follow: Twitter | Facebook | Instagram | LinkedInIn the search for a preventative treatment of skin cancers, including melanoma, it is imperative to understand and treat DNA damage caused by ultraviolet (UV) radiation. Following the treatment of a patient suffering from xeroderma pigmentosum (XP), a disease characterised by an inborn insufficiency to repair DNA damaged by sun exposure, Australian based CLINUVEL PHARMACEUTICALS is the first company worldwide to use a systemic therapy to repair DNA. CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) belongs to a group of hormones which have been shown to reduce UV-induced damage to DNA (photoproducts) and assist in DNA regeneration.1 The Company is running a staged clinical program to confirm the ability of SCENESSE® to repair the DNA in skin cells, focusing initially on XP.SCENESSE® IN XERODERMA PIGMENTOSUM XP is a genetic disease which has served as a human model for studying the insufficiency of human DNA repair. Patients develop frequent skin cancers from an early age – most experience their first malignancy before adolescence – and must avoid all forms of UV exposure. The disease has a high mortality rate, with a median life expectancy of thirty years. XP treatment is limited to management of symptoms, in particular regular surgery to remove cancerous lesions. An estimated 1 in 450,000 individuals in Europe suffer from XP.Today CLINUVEL announced that SCENESSE® has been administered for the first time to a patient diagnosed with XP under a Special Access Program, whereby the patient’s safety will be evaluated over six weeks of treatment. Following confirmation of safety of the drug product in this patient, CLINUVEL will conduct two further studies as part of the DNA Repair Program. Both studies – an open-label Phase II study involving six XP-C patients (CUV150) and a control study enrolling 10 healthy volunteers (CUV151) – will evaluate the impact of treatment with SCENESSE® on DNA damage and restoration.Commentary “We seek to provide meaningful benefit to XP patients, and these results will serve a wider population of fair-skinned individuals at risk of developing skin cancers,” CLINUVEL’s Clinical Operations Manager, Dr Pilar Bilbao said. “The next 12 months will be exciting for many patients, their families, the clinical experts and our own teams.”CLINUVEL is developing a range of products based on its very targeted research with SCENESSE®, including topical formulations of its proprietary drugs and over-the-counter products, and has recently opened a new Research and Development Centre in Singapore to accelerate this work. First results from the use of SCENESSE® in XP patients are expected in 2021. The scientific data from SCENESSE® has led to further products for general use.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 can be found on CLINUVEL’s website at www.clinuvel.com.Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTDAbout CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) is a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic, skin, and systemic disorders. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development initially has led to innovative treatments for patient populations with a clinical need for photoprotection and repigmentation. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014 and the US Food and Drug Administration in 2019 for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). More information on EPP can be found at http://www.epp.care. CLINUVEL is advancing its portfolio of melanocortins, among which is PRÉNUMBRA® for the treatment of several critical disorders. Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information please go to http://www.clinuvel.com.SCENESSE® and PRÉNUMBRA® are registered trademarks of CLINUVEL PHARMACEUTICALS LTD.Media enquiries Monsoon Communications Mr Rudi Michelson, 61 411 402 737, rudim@monsoon.com.au Level 39, 55 Collins Street, Melbourne, Victoria, Australia 3000Head of Investor Relations Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTDInvestor enquiries https://www.clinuvel.com/investors/contact-usForward-Looking Statements This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Statements may involve a number of known and unknown risks that could cause our future results, performance or achievements to differ significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialise pharmaceutical products, the COVID-19 pandemic affecting the supply chain for a protracted period of time, including our ability to develop, manufacture, market and sell biopharmaceutical products; competition for our products, especially SCENESSE® (afamelanotide 16mg); our ability to achieve expected safety and efficacy results through our innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, China and Japan of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE® which may lead to it being unable to supply its commercial markets and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; any failure to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry and related industries; potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 2019 Annual Report and 2020 Preliminary Final Report. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation, outside of those required under applicable laws or relevant listing rules of the Australian Securities Exchange, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. More information on the forecasts and estimates is available on request. Past performance is not an indicator of future performance.  www.clinuvel.com  Level 11T +61 3 9660 4900 535 Bourke StreetF +61 3 9660 4999 Melbourne  Victoria, Australia, 3000 Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/e162ca4b-27bb-4716-97e5-49a603bbebda https://www.globenewswire.com/NewsRoom/AttachmentNg/0d2e4b7a-f3b5-4efc-9d67-58ae0b7d3810
10 Sep, 2020
Drug tested to protect skin and regenerate DNA, firstly in XP patients at 10,000-fold skin cancer risk Figure 1: SCENESSE® connects the dots CLINUVEL’s DNA Repair Program aims to confirm that intervention with SCENESSE® causes elimination of DNA damage (photoproducts) and regeneration of DNA. The diagram shows that SCENESSE® has been proven to protect skin from light (photoprotection) and shown to repair DNA damage. Since photoprotection and regeneration are necessary to reduce the risk of skin cancer, the role of SCENESSE® is obvious. In the diagram, “P” stands for probability. Figure 2: SCENESSE® repairs DNA damage caused by UV and lowers risks of skin cancers The exact biochemical and cellular mechanisms of UV-induced cellular damage and repair by SCENESSE® are explained in technical terms.MELBOURNE, Australia, Sept. 10, 2020 (GLOBE NEWSWIRE) -- CLINUVEL PHARMACEUTICALS LTD today announced the progression of its drug SCENESSE® (afamelanotide 16mg) to treat the disease xeroderma pigmentosum (XP). The aim of the development program is to confirm the drug’s ability to regenerate DNA of skin exposed to ultraviolet (UV) damage.1 Skin incurs DNA damage following UV exposure. Non-ionising light penetrates the nucleus of skin cells and causes distortions to the DNA helix known as photoproducts. If left unrepaired, these chemical changes to DNA may replicate as mutations, leading to irreversible damage (photoaging) and further progress to skin cancer, including melanoma.Human biology contains complex mechanisms to protect itself from UV damage and restore cellular DNA to its original state. People of fair-skinned complexion are known to have defects in these UV protective and DNA regenerative processes, increasing their long-term risk of skin cancer.Having commercialised SCENESSE® in Europe and the USA for the rare genetic disorder porphyria (EPP), CLINUVEL is expanding its clinical research, aiming to confirm how intervention with the drug enhances elimination of photoproducts and regeneration of DNA.“In SCENESSE® we have a hormone acting on various organs and receptors, but most of all known to protect human DNA,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “Our task is to confirm how DNA regeneration occurs within genetically affected patients and healthy subjects.”Following decades of clinical experience with SCENESSE®, CLINUVEL is now accelerating a comprehensive DNA Repair Program by first treating patients with the rare genetic disorder xeroderma pigmentosum (XP) who have the most extreme deficiencies in their DNA repair processes, leading to a 10,000-fold increase in their risk of skin cancer.“Tragically, XP provides an extreme model of what happens to our skin if UV-induced damage is left unrepaired,” Dr Wright said. “From a young age, XP patients are incapable of responding to DNA damage caused by UV exposure and experience disfiguring and aggressive skin cancers.“After two decades of clinical research, I’m delighted that our team can now focus on the XP patients who are severely affected by UV radiation leaving them a short life expectancy. We will facilitate treatment for the first patient in the next few weeks,” Dr Wright said.The first clinical results from the DNA repair program are expected to be reported in 2021.1 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 can be found on CLINUVEL’s website at www.clinuvel.com.Note to editors: a technical release has been lodged with the ASX. CLINUVEL CEO Dr Philippe Wolgen is available for interview through Monsoon Communications.Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTDAbout CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) is a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic, skin, and systemic disorders. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development initially has led to innovative treatments for patient populations with a clinical need for photoprotection and repigmentation. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014 and the US Food and Drug Administration in 2019 for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). More information on EPP can be found at http://www.epp.care. CLINUVEL is advancing its portfolio of melanocortins, among which is PRÉNUMBRA® for the treatment of several critical disorders. Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information please go to http://www.clinuvel.com.SCENESSE® and PRÉNUMBRA® are registered trademarks of CLINUVEL PHARMACEUTICALS LTD.Media enquiries Monsoon Communications Mr Rudi Michelson, 61 411 402 737, rudim@monsoon.com.au Level 39, 55 Collins Street, Melbourne, Victoria, Australia 3000Head of Investor Relations Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTDInvestor enquiries https://www.clinuvel.com/investors/contact-usForward-Looking Statements This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Statements may involve a number of known and unknown risks that could cause our future results, performance or achievements to differ significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialise pharmaceutical products, the COVID-19 pandemic affecting the supply chain for a protracted period of time, including our ability to develop, manufacture, market and sell biopharmaceutical products; competition for our products, especially SCENESSE® (afamelanotide 16mg); our ability to achieve expected safety and efficacy results through our innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, China and Japan of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE® which may lead to it being unable to supply its commercial markets and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; any failure to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry and related industries; potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 2019 Annual Report and 2020 Preliminary Final Report. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation, outside of those required under applicable laws or relevant listing rules of the Australian Securities Exchange, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. More information on the forecasts and estimates is available on request. Past performance is not an indicator of future performance.www.clinuvel.com  Level 11T +61 3 9660 4900 535 Bourke StreetF +61 3 9660 4999 Melbourne  Victoria, Australia, 3000  Photos accompanying this announcement are available at: https://www.globenewswire.com/NewsRoom/AttachmentNg/2a299a29-422f-4851-b440-b41ca9d5d419 https://www.globenewswire.com/NewsRoom/AttachmentNg/10d8f419-bef2-40a6-a81d-0acc1485ee0b
31 Aug, 2020
Bespoke Research & Development Centre to advance innovative pharmaceutical and OTC products Entranceway to the newly opened VALLAURIX Research & Development Centre CLINUVEL has opened its bespoke Research & Development Centre at Singaporean subsidiary VALLAURIX to advance innovative pharmaceutical and OTC productsMELBOURNE, Australia and SINGAPORE, Aug. 31, 2020 (GLOBE NEWSWIRE) -- The CLINUVEL Group today announced the opening of its state-of-the-art centralised Research & Development Centre in Singapore, operated by CLINUVEL subsidiary VALLAURIX PTE Ltd.The extensive bespoke analytical and biological laboratories and offices will house and advance CLINUVEL’s innovative R&D projects, expanding capacities in molecular profiling, peptide chemistry, and polymer and formulation sciences, as well as the capability to conduct ex vivo experiments and bioassays, and studies on fresh biological and tissue cultures.CLINUVEL is focused on innovative areas of medicine with VALLAURIX developing drugs from the family of melanocortins and complementary over-the-counter (OTC) consumer products. In July the Company announced the first novel products from the VALLAURIX laboratories, liquid injectable formulations known as PRÉNUMBRA®.“In recent years CLINUVEL has controlled its investments in new product development, building dedicated scientific teams worldwide and now opening its purpose-built facility in Singapore to expedite our research,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said.“Our research work with melanocortins – which target cells across the body and are known to have protective, anti-inflammatory and vasoactive effects, amongst others – focuses on translating our new molecules into safe, effective and clinically accepted pharmaceutical drugs for unmet patient needs. With CLINUVEL’s first product already approved and being used to treat patients in Europe and the USA, the VALLAURIX teams are working on second-generation melanocortins, as well as OTC products which leverage our expertise in related fields. The new facilities will enable VALLAURIX to conduct a greater diversity of work in-house, faster and more efficiently,” Dr Wright said.In April 2020, the Singapore Economic Development Board (EDB) reviewed VALLAURIX’s scientific results and progress and decided to award up to S$500,000 under their Research Incentive Scheme for Companies (RISC). This award is offered by the Singaporean government to incentivize CLINUVEL to base its research on high values technologies in Singapore. The new facility replaces the previous laboratory which opened in 2014. Construction of the new facility commenced in 2019 but was delayed by four months due to government restrictions put in place to limit the spread of the corona virus. Final inspection and certification will see the facility operating under ISO 17025 and conforming to Good Laboratory Practice.Singapore was chosen as CLINUVEL’s main research centre due its geographical location, excellent infrastructure and public safety, but most of all because of the superior education system and access to scientific talent.“It is a privilege to see the planning of facilities coming to fruition, akin to scientific research projects becoming clinical reality,” Head of the VALLAURIX Research & Development Centre, Dr Uma Rai said. “VALLAURIX can only achieve its scientific goals because we attracted and retained the right talent and faculty, who come together in a truly interdependent team knowing that speed of progress rests on each member; here at VALLAURIX we have been given the opportunity to build this team. Our scientists in Singapore have come to realise that being part of the CLINUVEL Group is not only exciting but maybe a once in a lifetime opportunity for those who aim to translate research into commercial pharmaceutical products.”Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTDAbout CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) is a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic, skin, and systemic disorders. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development initially has led to innovative treatments for patient populations with a clinical need for photoprotection and repigmentation. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014 and the US Food and Drug Administration in 2019 for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). More information on EPP can be found at http://www.epp.care. CLINUVEL is advancing its portfolio of melanocortins, among which is PRÉNUMBRA® for the treatment of several critical disorders. Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information please go to http://www.clinuvel.com.SCENESSE® and PRÉNUMBRA® are registered trademarks of CLINUVEL PHARMACEUTICALS LTD. 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 can be found on CLINUVEL’s website at www.clinuvel.com.Head of Investor Relations Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTDInvestor enquiries https://www.clinuvel.com/investors/contact-usForward-Looking Statements This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Statements may involve a number of known and unknown risks that could cause our future results, performance or achievements to differ significantly from those expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialise pharmaceutical products, the COVID-19 pandemic affecting the supply chain for a protracted period of time, including our ability to develop, manufacture, market and sell biopharmaceutical products; competition for our products, especially SCENESSE® (afamelanotide 16mg); our ability to achieve expected safety and efficacy results through our innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, China and Japan of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE® which may lead to it being unable to supply its commercial markets and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; any failure to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry and related industries; potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 2019 Annual Report and 2020 Preliminary Final Report. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation, outside of those required under applicable laws or relevant listing rules of the Australian Securities Exchange, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. More information on the forecasts and estimates is available on request. Past performance is not an indicator of future performance.  www.clinuvel.com Level 11T +61 3 9660 4900  535 Bourke Street F +61 3 9660 4999  Melbourne Victoria, Australia, 3000   A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/93396e8e-8ff6-4bc1-8a3c-aca6f4b9fe70
28 Aug, 2020
With its stock down 8.5% over the past three months, it is easy to disregard Clinuvel Pharmaceuticals (ASX:CUV...
13 Jul, 2020
MELBOURNE, Australia and SINGAPORE, July 13, 2020 -- CLINUVEL PHARMACEUTICALS today revealed PRÉNUMBRA®, the Company’s second afamelanotide product in development. PRÉNUMBRA®.

CUV Dividend Payments

EX-Date Dividend Amount
2018-09-21$0.0200
2019-09-04$0.0250
2020-09-03$0.0250