Those who follow the company’s clinical announcements would be well aware of our recently announced vitiligo program. To provide a deeper understanding of the science and the concept of phototherapy, today we’ve released a second technology update focused on exploring narrowband UVB technology. See our main site:
Technology Update II: Afamelanotide as an adjunct to phototherapy
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…)
Today’s announcement of the results of CUV017 has brought with it a stream of updates from Clinuvel, on the website, YouTube and beyond.
In this post we summarise the days releases and developments.
Following two important announcements, we spoke yesterday with Clinuvel Non-Executive Director, Dr Roger Aston. We asked Dr Aston to draw upon his experiences within the international pharmaceutical and life sciences industries to provide context to the company’s news.
Listen to the entire webcast here
The human body functions and survives by maintaining a biological and physiological balance. Over tens of thousands of generations we have evolved numerous systems to care for and protect our health and well being at a cellular level.
As a response to damage, various cells are programmed to self-destruct. The process is known as apoptosis, and it works to ensure that defects to the nucleus of the cell arising from any damage are not replicated and passed on in subsequent generations of cells.
A second, and lesser known process, is the concept of senescence.
The market entry of afamelanotide as a first-in-class drug is the culmination of a decade long R&D program, and most of all signifies Clinuvel’s ability to focus.
It is most important to communicate afamelanotide’s novel pharmaceutical properties and its clinical effects. Here we worked for over 2 years with various groups and third parties and agencies to align all views, whereby clear product differentiation was key in our choices.
Previously 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.
Pharmaceutical development is undergoing a defining shift following the ever-increasing regulatory rigor in the process of evaluating a new product. Our recent announcement reflects the conservative view we hold on 21st century drug development.
During development the innovator often seeks to create a market for the new product, a common concept applicable to various industries. The same holds true for afamelanotide: we identified and developed our lead product in an under-served market of porphyria. Adaptation to chemistry and technology, novel communication platforms, deep knowledge and relationships with academia facilitated today’s entry to market.
I take a moment on this day to discuss a separate impact of the surprising development surrounding our photoprotective drug afamelanotide, despite this being a result where Clinuvel has not played any role other than making afamelanotide available to Italian patients.
Much as afamelanotide will assist and transform the lives of the population of Italian EPP patients, it also promises to evolve Clinuvel as a mature pharmaceutical company in Europe and the US.
An unprecedented and unexpected announcement over the weekend has lead to the company’s announcement this morning that afamelanotide will be first made available to Italian erythropoietic protoporphyria (EPP) patients prior to its formal approval anywhere else in the world.
A governmental publication in Italy has confirmed that Clinuvel’s afamelanotide implant formulation can now be prescribed for patients diagnosed with EPP under Law 648/96, while marketing authorisation for the European Community is being prepared.
CEO blog (31)Clinuvel News (36)Erythropoietic Protoporphyria (22)Guest Bloggers (18)Issues & Discourse (122)Light & Health (110)Mothers & Children (6)Pharma Development (31)Scenesse (25)Vitiligo (19) |
© Clinuvel Pharmaceuticals Ltd 2009 |
