The CLINUVEL Group today announced the opening of its state-of-the-art centralised Research& Development Centre in Singapore, operated by CLINUVEL subsidiary VALLAURIX PTE Ltd. The extensive bespoke analytical and biological laboratories and offices will house and advance CLINUVEL’s innovative R&D projects, expanding capacities in molecular profiling, peptide chemistry, and polymer and formulation sciences, as well as the capability to conduct ex vivoexperiments and bioassays, and studies on fresh biological and tissue cultures.
CLINUVEL is focused on innovative areas of medicine with VALLAURIX developing drugs from the family of melanocortins and complementary over-the-counter (OTC) consumer products. In July the Company announced the first novel products from the VALLAURIX laboratories, liquid injectable formulations known as PRÉNUMBRA®.
“In recent years CLINUVEL has controlled its investments in new product development, building dedicated scientific teams worldwide and now opening its purpose-built facility in Singapore to expedite our research,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said.
“Our research work with melanocortins – which target cells across the body and are known to have protective, antiinflammatory and vasoactive effects, amongst others – focuses on translating our new molecules into safe, effective and clinically accepted pharmaceutical drugs for unmet patient needs. With CLINUVEL’s first product already approved and being used to treat patients in Europe and the USA, the VALLAURIX teams are working on secondgeneration melanocortins, as well as OTC products which leverage our expertise in related fields. The new facilities will enable VALLAURIX to conduct a greater diversity of work inhouse, faster and more efficiently,” Dr Wright said.
In April 2020, the Singapore Economic Development Board (EDB) reviewed VALLAURIX’s scientific results and progress and decided to award up to S$500,000 under their Research Incentive Scheme for Companies (RISC). This award is offered by the Singaporean government to incentivize
CLINUVEL to base its research on high values technologies in Singapore.
The new facility replaces the previous laboratory which opened in 2014. Construction of the new facility commenced in 2019 but was delayed by four months due to government restrictions put in place to limit the spread of the corona virus. Final inspection and certification will see the facility operating under ISO 17025 and conforming to Good Laboratory Practice.
Singapore was chosen as CLINUVEL’s main research centre due its geographical location, excellent infrastructure and public safety, but most of all because of the superior education system and access to scientific talent.
“It is a privilege to see the planning of facilities coming to fruition, akin to scientific research projects becoming clinical reality,” Head of the VALLAURIX Research & Development Centre, Dr Uma Rai said. “VALLAURIX can only achieve its scientific goals because we attracted and retained the right
talent and faculty, who come together in a truly interdependent team knowing that speed of progress rests on each member; here at VALLAURIX we have been given the opportunity to build this team. Our scientists in Singapore have come to realise that being part of the CLINUVEL Group is not only exciting but maybe a once in a lifetime opportunity for those who aim to translate research into commercial pharmaceutical products.”
Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD
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,
skin, and systemic disorders. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development initially 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 and the US Food and Drug Administration in 2019 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. CLINUVEL is advancing its portfolio of melanocortins, among which is PRÉNUMBRA® for the treatment of several critical disorders. Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information please go to http://www.clinuvel.com.
SCENESSE® and PRÉNUMBRA® are registered trademarks of CLINUVEL PHARMACEUTICALS LTD. SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase “pain- free” light exposure in adult EPP patients with a history of phototoxicity. Information on the product can be found on CLINUVEL’s website at www.clinuvel.com.
Head of Investor Relations Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD
Investor enquiries
https://www.clinuvel.com/investors/contact-us
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, the COVID-19 pandemic affecting the supply chain for a protracted period of time, 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, China 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; that the Company may incur unexpected delays in the outsourced manufacturing of SCENESSE® which may lead to it being unable to supply its commercial markets and/or clinical trial programs; any failures to comply with any government payment system (i.e.Concentric growth of CLINUVEL’s research & clinical focus. 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 2019 Annual Report and 2020 Preliminary Final 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 and estimates is available on request. Past performance is not an indicator of future performance.
www.clinuvel.com
Level 11 T +61 3 9660 4900
535 Bourke Street F +61 3 9660 4999
Melbourne
Victoria, Australia, 3000