As snow begins to fall around Clinuvel’s European office, the team in Australia is preparing for a long hot summer. The seasons are at the forefront of our minds at Clinuvel, since our lead drug SCENESSE® appears to have a dramatic impact on the ability of patients to expose themselves to sun. We try to test the drug under the most extreme conditions, meaning trials must be conducted in spring and summer. As the seasons change, we begin to see more requests and enquiries from the southern hemisphere, in particular from patients with erythropoietic protoporphyria (EPP), seeking access to the drug outside of formal trial programs. (more…)
Compassionate use – navigating the regulatory landscape to ‘do good’
Friday, December 3rd, 2010The effects of photosensitivity disorders on patient quality of life
Friday, October 22nd, 2010
A new study from the University of Manchester has uncovered some of the impacts that photosensitivity disorders have upon individual and family quality of life. While several research papers have illustrated the trend towards reduced psychological health in this group, this is the first to compare specific aspects of lifestyle in photosensitive and healthy individuals. (more…)
Mikey’s story – EPP
Tuesday, September 7th, 2010
Today Clinuvel presents the first in a series of webcast videos featuring 44 year-old Mikey, an Australian man with the severe light intolerance disorder Erythropoietic Protoporphyria (EPP).
EPP is a rare, inherited, metabolic disorder characterised by extreme phototoxicity; toxic reactions to UV and visible light, particularly blue light. The symptoms of this photosensitivity may include those which are not visible to the naked eye, including itching, burning, prickling and most notably, intense pain. (more…)
Orphan drug development legislation and regulation landscape
Monday, May 17th, 2010Previously we have discussed the shifts which take place in the regulatory centers of the world specifically London and Maryland, which present an opportunity to the industry to respond to expressed need. Perhaps the greatest concern of every individual is access to health and quality of life.
This implies a strong directive for drug developers to respond to the identified needs of the patients and patient communities. But amongst those with therapeutic needs are some with more unaddressed medical requirements: patients with ‘orphan’ diseases.
Orphan diseases are rare and frequently untreated diseases. The previously referred shift towards patient driven drug development made a few voices heard and legislators in the European Community and United States started to act on behalf of the population. Here the legislators and regulators provided incentives to drug developers by reducing fees, providing exemptions and protection from competitors.









