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

German Porphyria Expert Centres to start distribution of SCENESSE® (afamelanotide 16mg) Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced an update on the company’s post-authorisation distribution of SCENESSE® (afamelanotide 16mg) across Europe for adult patients with the rare disorder erythropoietic protoporphyria (EPP).1 SCENESSE® in EPP SCENESSE® is the first approved treatment for EPP, a genetic disorder characterised by acute phototoxic reactions (anaphylactoid reactions and burns) and forced withdrawal from exposure to all forms of visible light. Clinuvel conducted clinical trials of SCENESSE® in EPP from 2006 to 2013. During this time the company evaluated the treatment in 352 EPP patients. After completion of the clinical trial program, approximately 130 patients across eight countries (Australia, Austria, France, Germany, Italy, Sweden, Switzerland and The Netherlands) received SCENESSE® free of charge. In total 601 implant injections were provided to patients free of charge under compassionate use schemes. The development program and the following compassionate use program was supported entirely by equity funding. Subsidised access to SCENESSE® treatment, prior to the drug’s formal commercial approval, was made possible in both Italy and Switzerland from 2010 and 2012 respectively. These two programs enabled 115 EPP patients to benefit from treatment with SCENESSE® totalling more than 200 patient years of cumulative care. Clinuvel is no longer in the position to provide access to SCENESSE® on a subsidised basis. Regulatory and clinical obligations prior to SCENESSE® distribution The European Medicines Agency (EMA) granted SCENESSE® marketing authorisation under a strict risk management plan, comprising a Post-Authorisation Safety Study (PASS) as well as a Retrospective Chart Review (RCR) to follow up those who do not consent to participate in the PASS. The process of regulatory drug release and approval of the pharmacovigilance systems required a further 18 months of in-depth discussion with the EMA. The EMA’s pharmacovigilance subcommittee (PRAC) formally endorsed the last of these protocols on April 14, 2016. The final regulatory and clinical steps prior to the start of the treatment are a review of the PASS and RCR protocols by some of the local ethics committees and the approval of patient and physician educational materials by various National Competent Authorities. SCENESSE® as High Specialty Care in Porphyria Expert Centres SCENESSE® is only being made available to EPP patients through Porphyria Expert Centres, which require training and accreditation by Clinuvel.In Germany it is anticipated that the first year three Porphyria Expert Centres – in Berlin, Chemnitz, and Düsseldorf – will be able to prescribe the treatment. The German national authorities have released their first assessment of the use of SCENESSE® in EPP. In parallel, 13 German insurance firms have agreed to make SCENESSE® available to EPP patients. It is the company’s expectation for a uniform commercial price to be in place across Europe. Discussions are underway with authorities in nine countries to make SCENESSE® available, with further submissions anticipated in 2016. Supporting rare diseases online Recognising the disparate nature of information on rare diseases online, Clinuvel is launching a new website – in beta version by May 31 and live by July 1 – focusing on the clinical aspects of EPP and research into the disease. The site will also serve to connect patients with Porphyria Expert Centres and diagnostic labs. Commentary ”The long term success of SCENESSE® lies in the safety profile of the product for EPP patients and, hence, our and regulators’ focus on pharmacovigilance,” Clinuvel’s chair, Mr Stan McLiesh said. “Now we look forward to the release of the photoprotective product by the various ethics committees to finally make the wishes of EPP patients a reality.” “After years of subsidising the treatment and providing it free of charge, Clinuvel needs to move towards the next stage of development: investing in a treatment for children with EPP. It has long been our desire to bring light to these children. Both decision makers and the medical community agree that Clinuvel should provide a pharmaceutical answer to EPP children,” Mr McLiesh said. - End - 1SCENESSE® (afamelanotide 16mg) is approved in Europe as an orphan medicinal product for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with EPP. The innovative nature of the therapy in the orphan disorder, the lack of available scientific instruments to adequately measure the therapy, ethical considerations and the drug’s positive safety profile were some of the factors which led to the European marketing authorisation of SCENESSE®. Information on the product can be found on Clinuvel’s website at www.clinuvel.com. 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. 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 (anaphylactoid reactions and burns) 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. 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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 2016-05-18

NICE’s technical team invited stakeholders with an interest in the treatment of erythropoietic protoporphyria (EPP) Executive summary SCENESSE® evaluated as part of the Highly Specialised Technologies Programme (HST) in UK HST Programme review of relatively high cost - low volume technology Evaluation of the drug as an innovative therapy for unmet clinical need in a rare disorder SCENESSE® to be available in trained and accredited expert EPP centres in the UK EPP patients acknowledged to be impaired due to light deprivation and isolation Clinuvel Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced that the National Institute for Health and Care Excellence (NICE) has held a public workshop to scope the benefits and costs of SCENESSE® (afamelanotide 16mg) in the treatment of adult patients with the rare disorder erythropoietic protoporphyria (EPP).1 This workshop is one of the last steps prior to national commissioning of the treatment by the National Health Service (NHS) England. The company was invited, alongside representatives of the EPP patient community and clinical experts and scientists to discuss the benefits of Clinuvel’s drug SCENESSE® and its characterisation as a Highly Specialised Technology (HST) in England. The meeting included a review of the specific burden of EPP (on patients’ lives), the number of treatment centres in the UK, patients eligible for treatment, and the lack of a standard of care.National Institute for Health and Care Excellence (NICE)NICE is the authority in England responsible for evaluating reimbursement of new treatments to be made available under the NHS, and its function is to provide a brief and recommendation to the Department of Health. The objective of the meeting was to agree on the remit and characterisation of the relatively high cost - low volume treatment as an innovative and specialised technology to be introduced in England. SCENESSE® is being proposed for review as a HST, consistent with its use in a rare genetic disorder and limited to distribution in trained and accredited expert EPP centres. NICE’s HST team will use feedback from the workshop to finalise a remit for final assessment by the Department of Health.2Relevant to the meeting is that ministers in the UK have to formally refer selected health topics and new treatments back to NICE for evaluation under the Highly Specialised Technology Programme. This makes the reimbursement process in the UK different from most European countries.Commentary“It has been refreshing to experience how NICE is involving all relevant stakeholders in the reimbursement discussion for SCENESSE® as a therapy for EPP,” Clinuvel’s CEO, Dr Philippe Wolgen said. “We left the meeting with a feeling of confidence that the technology advisors and executive management of NICE had done ample diligence on disease burden and therapeutic effectiveness, which are essential considerations for decisions on reimbursement.“Patients and expert physicians were animated and spoke uninhibited about their ordeal and the clinical effect of the SCENESSE® treatment.” Dr Wolgen said. - End -1 SCENESSE® (afamelanotide 16mg) is approved in Europe as an orphan medicinal product for the prevention of phototoxicity in adult patients with EPP. Information on the product can be found on Clinuvel’s website at www.clinuvel.com. 2 More information on the HST process can be found at https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-highly-specialised-technologies-guidance. 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. 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 (anaphylactoid reactions and burns) 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. 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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 2016-03-23

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 2016-03-18
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