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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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Latest Company Announcements


12 April 2017

Melbourne, Australia, April 12, 2017CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY) wishes to advise in accordance with the terms and conditions of issue that the following unquoted conditional performance rights have lapsed and forfeited: Class Number                    Exercise price              CUVAK Conditional Performance Rights subject to various performance milestones, issued various dates under the 2009 and 2014 Plans                                                           25,400   $Nil Consequently, there are now 1,882,260 unlisted conditional performance rights on issue.- End -For more information contact:Darren KeamyCompany SecretaryCLINUVEL PHARMACEUTICALS LIMITEDT: +61 3 9660 4900E: This email address is being protected from spambots. You need JavaScript enabled to view it.-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

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12 April 2017

Melbourne, Australia and Leatherhead, UK, US, 12 April 2017 CLINUVEL [ASX: CUV; Nasdaq International Designation ADR: CLVLY; Xetra-DAX: UR9] today announced that it had reached agreement with the German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband or GKV-SV) for the treatment of erythropoietic protoporphyria (EPP) patients with CLINUVEL’s drug SCENESSE® (afamelanotide 16mg).CLINUVEL had been in mandatory ‘negotiation’ with GKV-SV since August 2016. Under the German Pharmaceuticals Market Reorganisation Act (AMNOG) a pricing agreement was reached after an Arbitration Board was called. The outcome of the Arbitration Board is legally binding for all state insurers (‘Krankenkassen’) in Germany.aEPP TREATMENT WITH SCENESSE®SCENESSE® is a first-in-class therapy for the treatment of adults with EPP, a poorly characterised and an ultra-rare metabolic disorder which causes severe phototoxic and anaphylactoid reactions in patients. In Germany, the disease affects between 500 and 1,090 patients (based on disease prevalence).Reports from clinical studies and during conditions of use over the last decade have indicated that EPP patients treated with SCENESSE® obtain an ‘improved life’ by:(i) losing their prodromal reactions (‘warning signals’ triggered by accidental light exposure);(ii) losing their anxiety for burns and anaphylactoid reactions;(iii) being able to gradually expose their skin to light sources; and(iv) participating in daily activities which had been impossible prior to treatment.CLINUVEL monitors the ongoing use of SCENESSE® in EPP patients during its indefinite post-marketing authorisation program, which includes post authorisation safety study (PASS) protocols and a European EPP Disease Registry.UNIFORM EUROPEAN PRICINGCLINUVEL has adopted a uniform global pricing policy and provides its clear rationale, acknowledging the facts that patients are migrating across borders to seek treatment, expert physicians are associated through porphyria networks, and hospitals collaborate internationally to purchase pharmaceutical products for orphan diseases. The company bears the risk of foreign exchange fluctuation over a period of 24 months (as of 15 February 2017) and will not make inflationary adjustments to the uniform price.The annual costs of therapy with SCENESSE® range between €56,404 and €84,606 per EPP patient per annum. Figure 1. (below) highlights the main factors which were published by GKV-SV.FIGURE 1: ANNUAL COSTS OF THERAPY IN GERMANY – SCENESSE® IN EPP1¹Price of treatment depends on number of implant injections per annum²No alternative effective therapy exists for SCENESSE®³Price in Lauer-Taxe is published by IFA GmbHCOMMENTARY“The company is constrained as to the insight it can provide on the ‘negotiations’ and GKV-SV story,” CLINUVEL’s UK General Manager, Mr Lachlan Hay said. “It has been shown that SCENESSE® is priced uniformly in Europe, there is no alternative effective treatment for EPP, and as per EMA approval in 2014 there are no scientific instruments to quantify and measure the impact of disease or therapy.“In an era where pharmaceutical companies are scrutinised by media, the general public, and insurers, we intend to set an example through our uniform product pricing policy. We run the company in an open and simple manner and therefore we will not engage in any incentivisation programme with any party. There is not an exception to this principle.“This outcome is a well-deserved and long-awaited blessing for the German EPP patients and healthcare providers, who have been seeking clarity on pricing and supply conditions since the drug’s European approval in October 2014. CLINUVEL commends the German Arbitration Board and its judges for its professionalism, independence and clear mind in its ruling. I thank my team who have worked very hard over a long time to arrive at this justified result,” Mr Hay said.- End -Notesa According to Sozialgesetzbuch Fünftes Buch (SGB V) section 130b, available online (German only) at https://www.gesetze-im-internet.de/sgb_5/.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 

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24 February 2017

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