Clinuvel Pharmaceuticals Accelerates Offshore Expansion
Global biopharmaceutical company, Clinuvel Pharmaceuticals, has announced that it will be expanding its facilities in Singapore to be equipped with state-of-the-art laboratories due to open on 01 July 2020. The Singapore Economic Development Board (EDB) has awarded research & development grant to the firm’s wholly-owned subsidiary Vallaurix Pte Limited, which will be expanded through both an analytical and biological laboratory. Additionally, both labs will work operate under Good Laboratory Practice (GLP) and ISO 17025 specifications.
Headquartered in Melbourne, Clinuvel is satisfied with the support it has received regarding its expansion plans. The plans are also in line with the government's plans in assisting corporations to develop research capacity, further advancing high valued technologies. The award is up to $547,000 over three years.
The firm has also witnessed a surge in company value to that of $2.2 billion after massive buying triggered by US Food & Drug Administration’s (FDA) decision. The federal agency has given the green light for the company’s drug, Scenesse to be used on patients in the vast US market. Scenesse is a slow-release implant approximately the size of a grain of rice that initiates the production of melanin – human’s natural shield against ultra-violet light.
Specifically, the primary purpose of the drug seeks to treat adult patients who have been diagnosed with the rare metabolic disorder known as Erythropoietic Protoporphyria (EPP). More importantly, Scenesse will also aim to increase pain-free light exposure in adult EPP patients who have a track record of phototoxicity.
In light of the outbreak of the deadly coronavirus, Clinuvel has reached out to assure customers that the supply of its Scenesse remains unaffected. More notably, the synthetic peptide, which is the key active ingredient in the drug, continues to be manufactured under good manufacturing practice (GMP) conditions within the European Union. Measures surrounding quality control of the drug have also been put in place where further laboratory tests are conducted before it is released and distributed to patients and hospitals.
The FDA has also confirmed on 03rd March 2020 that it has confirmed the date where discussions surrounding the North American development program for Scenesse for the pigment loss disorder vitiligo would occur. Presently, the meeting is due to take place on 29 April 2020 and expects to witness the attendance of global vitiligo professionals.
2019 was a significant milestone for Clinuvel as it was the year where the firm made it to the ASX 200. The firm now has a similar value to telecommunication Vocus Communications and property group, Charter Hall. More broadly speaking, the FDA’s approval is deemed momentous given that the regulatory path to approval spanned across a decade, starting with Europe back in 2006. Likewise, the firm’s achievements were reflected in its results for the half-year ended 31 December 2019 where net profits came in at $1.059 million – Clinuvel’s eighth consecutive half-year profit.
By Caroline Wong
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