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The FDA has granted ‘breakthrough status’ this year on 15 potential drugs, mostly for cancer and rare diseases The US Food and Drug Administration already has numerous ways it can speed up the market authorisation of new medicines, ranging from 'accelerated approvals' to 'priority reviews' to its fast-track program. Even so, sometimes the existing mechanisms for speeding drugs to market, which typically require data from the traditional three phases of drug development, still take considerable amounts of time. The so-called 'breakthrough therapy' designation introduction may be a signal that the FDA will approve exceptional drugs more quickly with this new regulatory pathway. Ultimately, a breakthrough drug may be approved by the FDA without completing all three phases of clinical trials…
CUV has successfully raised AUD6.3mn via a private placement to international institutional and professional investors. The Placement was conducted at price of AUD2.136 per share, representing a 4.3% premium to the 20-day volume weighted average price on April 29 and 15.1% to the closing price on April 30.
Clinuvel filed its MAA for afamelanotide 16mg implant on 6 February 2012 for the preventative treatment of the orphan light intolerance disorder erythropoietic protoporphyria (EPP).
1H13 - awaiting EMA registration decision Anchor themes We continue to believe that there is a very high possibility of CUV getting afamelanotide to the market. This points to cashflow from sales, and sooner than for most other biotechnology companies Download the PDF to access the full report.
Wednesday, 19 December 2012 17:52

Nomura update "Statistically significant results - will progress to a Phase IIb"

CUV announced successful, statistically significant results from its US Phase IIa pilot study (CUV102) of its afamelanotide 16mg implant in the pigmentation disorder Vitiligo.
Tuesday, 16 October 2012 15:19
Preliminary observations from CUV’s open-label Phase IIa US pilot trial of its drug, afamelanotide, in four patients with Vitiligo (a de-pigmenting skin disease) have been published in the journal Archives of Dermatology. In total, 56 patients are participating in the trial, with results from the six-month treatment period expected to be released before the end of CY12.
Thursday, 30 August 2012 02:23

Nomura Update "F12 - good progress, expect a F13 EMA decision"

Vitiligo market is underserved in our view - CUV’s potential product addresses this.
Wednesday, 08 August 2012 18:43

Nomura Update "Funds to be used for further clinical development"

CUV raised AUD6.0mn via a placement at a price of AUD1.75 per share. Management state that the funds raised in the placement will be used for: 1) a US Phase III clinical trial in erythropoietic protoporphyria (EPP); 2) a global clinical trial program in patients with Vitiligo; and 3) working capital during the evaluation of the Marketing Authorisation Application (MAA) for afamelanotide for the prophylactic treatment of adult patients with EPP by the European Medicine Agency (EMA).
Wednesday, 23 May 2012 14:48

Nomura Quick Note: "Launches US Phase III trial for EPP treatment"

Clinuvel Pharmaceuticals (CUV) has started its confirmatory Phase III US study of the novel drug afamelanotide, for the treatment of erythropoietic protoporphyria (EPP), a rare light intolerance disorder. The Phase III trial protocol has been designed in close consultation with the US Food and Drug Administration (FDA).
CUV announced that their afamelanotide product has been accepted by two health insurers in Switzerland for full reimbursement for the prophylactic treatment of patients with erythropoietic protoporphyria (EPP), a rare genetic disease causing extreme intolerance of skin to light.
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07 November 2017

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30 October 2017

Melbourne, Australia, and Leatherhead, UK, 30 October 2017 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY), a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe and therapeutically unmet genetic disorders today announced its Appendix 4C – Quarterly Cashflow report for the period ended 30 September 2017.The cash balance as at 30 September 2017 was $26,180,000, an increase of $2,428,000 from the 30 June 2017 cash balance. This follows a $4,981,000 increase in the overall cash balance reported in the previous Appendix 4C report.Cash receipts for the quarter were $5,638,000 compared to $6,247,000 for the previous quarter. The level of cash receipts reflects the seasonal demand for CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) in the northern hemisphere when erythropoietic protoporphyria (EPP) patients are at a heightened risk of phototoxic reactions in the warmer months. Receipts are expected to reduce in the next two quarters as demand for SCENESSE® tapers off in the colder winter months.Net operating payments for the quarter were $3,269,000 compared to $2,248,000 for the previous quarter. The increase in net operating payments from the previous quarter was primarily due to spending on product operating costs and working capital along with annual remuneration related payments which traditionally occur in the July to September period. The combination of cash receipts and expenditures contributed to a net operating activity cash inflow result of $2,470,000 for the quarter ended 30 September 2017.Overall, for the 12 months to 30 September 2017 the Company reports an increase in cash balances of $8,915,000, from $17,265,000 on 01 October 2016, to $26,180,000 on 30 September 2017. The increase in cash is primarily generated from its operations, reflecting the Company’s first full year in generating revenues from launching a novel, orphan drug in a new therapeutic area and whilst also containing its overall cost base. - End -About SCENESSE® (afamelanotide 16mg)SCENESSE® (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 an 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.comAbout CLINUVEL PHARMACEUTICALS LIMITEDCLINUVEL 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 and skin disorders. As pioneers in 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 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 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, Switzerland, the US and Singapore.For more information go to http://www.clinuvel.com.SCENESSE® is a registered trademark of CLINUVEL PHARMACEUTICALS LTD.Media enquiriesLachlan Hay, CLINUVEL (UK) LTD. +44 1372 860 765 This email address is being protected from spambots. You need JavaScript enabled to view it.r This email address is being protected from spambots. You need JavaScript enabled to view it. Forward-Looking StatementsThis 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 6, 15 Queen Street            T +61 3 9660 4900        www.clinuvel.comMelbourne, Victoria 3000            F +61 3 9660 4999Australia CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY), a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic and skin disorders announced today its Appendix 4C – Quarterly Cashflow report for the period ended 31 March 2017. The cash balance as at 31 March 2017 was $18,772,000, a decrease of $788,000 from the end of the previous quarter. Cash receipts for the quarter were $1,597,000 compared to $4,352,000 for the previous quarter. The expected decrease in receipts reflects the seasonal supply cycles of SCENESSE® in Europe whereby treatment for erythropoietic protopophyria is expected to increase in the spring and summer months. Payments (net of GST refunds) for the quarter were $2,040,000, compared to $2,329,000 for the previous quarter. The combination of cash receipts and lower expenditures contributed to a net operating cash outflow result of $379,000 for the quarter ended 31 March 2017. - End - About SCENESSE® (afamelanotide 16mg) SCENESSE® (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 an 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 About 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 and skin disorders. As pioneers in 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 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 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, 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. 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 6, 15 Queen Street T +61 3 9660 4900 www.clinuvel.com Melbourne, Victoria 3000 F +61 3 9660 4999 Australia

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27 October 2017

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