About CLINUVEL

CLINUVEL TO TAKE 100% OWNERSHIP OF VALLAURIX

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 Singapore

Melbourne, 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 Lab Singapore Pte Ltd (BLS). With this transaction CLINUVEL will gain 100% ownership of VALLAURIX in Singapore.

CLINUVEL will issue 33,559 ordinary shares of CLINUVEL (ASX: CUV) representing an implied value (based on the one-month volume weighted average price of CLINUVEL shares as of 27 April 2018) of SGD$10.727 per CLINUVEL share, equating to a total of SGD$360,000 for the 18% equity stake currently held by BLS in VALLAURIX. All VALLAURIX staff will be retained following the acquisition.

VALLAURIX was established in 2014 to diversify the CLINUVEL Group’s in-house work and develop topical products complementary to CLINUVEL’s lead pharmaceutical product, SCENESSE® (afamelanotide 16mg). The joint venture aimed to exploit CLINUVEL’s scientific expertise in melanocortins in combination with the operational oversight of a local partner, allowing for a proportionate sharing of financial risks along with potential commercial upside. SCENESSE® is the world’s first systemic photoprotective therapy prescribed to adult patients diagnosed with erythropoietic protoporphyria (EPP), and the first ever melanocortin receptor 1 (MC1R) agonist approved by regulatory authorities.1

CLINUVEL continues to invest in its R&D operations in Singapore with a view to further expand and develop its portfolio of products, particularly focussing on the family of melanocortins to which SCENESSE® belongs. The Company is in the process of expanding its laboratory facilities to support R&D work. The integration of VALLAURIX with CLINUVEL’s South-East Asian operations brings it in line with all other Group subsidiaries which are wholly-owned by the Australian parent entity, CLINUVEL PHARMACEUTICALS LTD.

COMMENTARY
“Today’s value of CLINUVEL is largely based on the successful development, approval, and commercialisation of SCENESSE®,” CLINUVEL’s Chief Financial Officer, Darren Keamy said. “This would not have been possible without the persistence and expert knowledge of the entire CLINUVEL team. Expanding our facilities and developing new products seeks to leverage this expertise and allows us to expand further.”

“We will have all of CLINUVEL’s Singaporean activities under one roof, resulting in a simplified business structure. By leveraging the Company’s knowledge base across its global offices, the purchase of the minority interest in VALLAURIX allows the Group to have full operational and financial control of its global activities. The existing senior management of VALLAURIX will remain, allowing us to retain regional knowledge and continuity of business, and preserve important Company knowhow. We intend to be one of the few integrated pharmaceutical companies with a development hub out of Singapore to develop first-in-class pharmaceutical and over-the-counter products,” Mr Keamy said.

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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.

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 product, 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
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Forward-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, 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 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; 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 2017 Annual 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


Level 6, 15 Queen Street       T +61 3 9660 4900      www.clinuvel.com
Melbourne, Victoria 3000       F +61 3 9660 4999
Australia

Additional Info

  • customtext: CLINUVEL PHARMACEUTICALS LTD today announced that it has entered into an agreement to acquire 18% of the joint venture established in 2014 between CLINUVEL and Biotech Lab Singapore Pte Ltd