About CLINUVEL

Corporate News & Publications

CLINUVEL's company releases, including archives.

NICE MAINTAINS ITS POSITION NOT TO RECOMMEND SCENESSE® FOR REIMBURSEMENTCLINUVEL TO APPEAL NICE DECISION IN ENGLANDMelbourne, Australia, and Leatherhead, UK, 23 May 2018 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced that the English National Institute of Health and Care Excellence (NICE) maintained its position not to recommend CLINUVEL’s drug SCENESSE® (afamelanotide 16mg) for reimbursement in England (see ASX announcement 21 December 2017). In its evaluation of novel medicinal therapies NICE advises the English National Health Service (NHS) whether a proposed therapy meets its economic criteria for reimbursement or not. CLINUVEL will now proceed to…
CLINUVEL REGULATORY UPDATE EUROPEAN SAFETY DATA ADDS TO US FDA FILING (NDA) European Annual and Periodic Reports show positive benefit-risk and safety profile maintained SCENESSE® implants administered globally to date: >5,100 (>4,000 to EPP patients) >99% treatment compliance rate in European EPP population maintained >85% of European patients on treatment consented to inclusion in disease registry Confirmation that no off-label use of SCENESSE® has taken place Individual Swiss patients have received >50 SCENESSE® implants over 12 years of treatment EU data reviewed by EMA support US New Drug Application, expected to be filed with FDA before 1 July 2018Melbourne, Australia,…
CLINUVEL TO TAKE 100% OWNERSHIP OF VALLAURIX Full control to be taken of subsidiary focused on novel R&D and new product development CLINUVEL Group to acquire 18% of Singaporean joint venture VALLAURIX PTE LTD from Biotech Lab Singapore Pte Ltd for 33,559 CLINUVEL ordinary shares VALLAURIX PTE LTD will continue to focus on R&D CLINUVEL to expand its research facilities in SingaporeMelbourne, Australia, 01 May 2018 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY) today announced that it has entered into an agreement to acquire 18% of the joint venture established in 2014 between CLINUVEL and Biotech…
Appendix 4CMelbourne, Australia and Leatherhead, UK, 30 April 2018 CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; XETRA-DAX: UR9; NASDAQ INTERNATIONAL DESIGNATION: CLVLY), a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic disorders, today announced its Appendix 4C – Quarterly Cashflow report for the period 01 January to 31 March 2018. All figures are reported in Australian dollars. Cash receipts from customers for the quarter were $3,480,000, a 118% increase compared to the same quarter last year ($1,597,000 for the January to March 2017 quarter). Orders received from European Erythropoietic Protoporphyria (EPP) Expert Centres…
Positive catalysts for ongoing M&A activity in the pharma sectorWe believe there are a number of positive catalysts for ongoing pharma/biotech M&A activity in the near term. These include: 1) increasing cost of pharma R&D associated with fewer new drug successes per dollar of R&D spent; and 2) recent US tax reform, leading to increased CY18 cash for big pharma. If history is any guide, then some of these increased cash balances will be used for pharma/biotech M&A. We have looked at Australian pharma/biotech companies that have the potential to operate globally should their technology be proven or if already proven, be transferred to additional geographies. These companies include: CLINUVEL; Ellex; Medical Developments; Mesoblast; Nanosonics, Osprey; Pro Medicus and Telix.See…
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