Response to increasing US investor interest

CLINUVEL Pharmaceuticals Limited (ASX: CUV; XETRA-DAX: UR9; ADR: CLVLY) today announced the inclusion of its Sponsored Level 1 American Depository Receipt (ADR) program in Nasdaq’s International Designation, a new visibility offering available to non-US companies. CLINUVEL is the first life science company to be selected for this initiative, first launched by Nasdaq on 9 December 2015.

CLINUVEL’s US Investor Base and Level 1 ADR (CLVLY) Program

CLINUVEL’s Level I ADRs (CLVLY) have traded on the over-the-counter market since 2004. The Bank of New York Mellon is the depository bank and one ADR represents one ASX-listed ordinary share.

The International Designation will provide CLINUVEL with access to Nasdaq’s visibility assets. Nasdaq will distribute the company’s news through its press release distribution service, reaching both investor and financial news and online services. Nasdaq is one of the world’s leading electronic stock markets, attracting many companies who focus on innovation.

The International Designation is not a listing. The companies who participate in this initiative are not subject to the same listing or qualification standards applicable to securities listed on an exchange. There are no additional regulatory or compliance requirements to what is in place for Level I ADRs.

“CLINUVEL’s progress against its corporate objectives has seen in recent months an increase in interest from the US as seen through our ADR program,” CLINUVEL’s Chief Financial Officer, Darren Keamy said.

“As CLINUVEL’s US activities expand, and the company eyes the relatively large US therapeutic market, it is natural for us to consider broadening our appeal to US investors, with a US listing a viable option for continued growth. In an uncertain US macroeconomic environment where pharmaceutical companies are being re-rated, we approach this topic methodically. It is our expectation Nasdaq’s International Designation will provide a benefit to the company’s visibility in the US and to its Level I ADR program.

“An assessment of the benefits and effectiveness of the International Designation will be made by the Board in due course. In parallel management continues to prepare the company for a number of options to broaden its appeal in the US.” Mr Keamy said.

Media enquiries

Lachlan Hay, CLINUVEL (UK) Ltd. +44 1372 860 765

Nick Miles, Cabinet Privé de Conseils s.a. +41 22 321 4540

Ted Agne, The Communications Strategy Group Inc. +1 718 631 3117

Investor enquiries

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

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.

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