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
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.
Communication remains key, whereby content of news and material facts dominate over frequency of news flow. Here our adagium no news signifies focus and good news. A total devotion to this one project, and execution on clinical and regulatory development while finding a balance in available funds, are the core activities en route to commercialisation of afamelanotide.
The significance of communication is equally seen in the way regulators, patients and the medical community gain access to information, data and obtain feedback. Clinuvel is well aware of this and consistency in our operations helps to communicate its objectives.
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.
Evolving our communications channels, digital in particular, was an obvious and necessary next step. The launch today has provided us with a dynamic and flexible new platform from which we can continue to innovate online.
2010 is an important year for Clinuvel, as we progress afamelanotide in clinical trials across three continents.
A large part of our year is the refinement of our communications online. Feedback from many interested parties and stakeholders, and their constructive and excited responses have led us to develop digital communication opportunities and channels that:
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The body consists of cells which communicate with each other via signaling molecules to govern and determine a variety of physiological functions in the body. The action and effect of these signaling molecules is mediated by ‘receptors’ which are located on the surface of (plasma membrane), or inside a cell. A molecule that ‘binds’ with a receptor is known as a ligand and can be protein such as a hormone or drug and the role of the ligand is to activate, or inactivate a particular biological activity.
In some ways receptors can be likened to switches with on and off positions, and which in turn affect the cell’s internal functioning. The action or inaction of receptors is determined by the type of ligand with which they bind, i.e. receptors are activated when an agonising ligand, an ‘agonist’ binds and left inactive when an ‘antagonist’ in some way prevents the agonist from binding. The specific biological action is dependent upon which particular ligand binds with a receptor.
As part of a new series of updates on technology, and to complement on Clinuvel’s public news flow, Clinuvel is initiating a regular bulletin to provide its followers worldwide with the latest advances on relevant issues, such as environmental factors, skin and related biochemical issues.
These discussions aim to increase the understanding of the science and technology behind Clinuvel. Where the depth of information becomes too profound an attempt shall be made to summarise in easier terms. Basic take-aways will provide clarification throughout each bulletin.
The first issue, available here, discusses in detail the physiological “UV tanning response” and touches on the development of afamelanotide in relation to an evolving understanding of both the peptide itself and the physiology of UV and sun damage to skin and DNA.
Today’s EPP (porphyria) preliminary results mark a significant step in afamelanotide’s 19 years of development.
When we started developing afamelanotide as a medicinal photoprotective, the concept of providing skin protection “from within” by mimicking the biological mechanisms was unknown. However, there has always been a clear need for protection from UV and light.
Physicians treating EPP patients have not had access to an effective treatment, despite the knowledge gained on the underlying biochemical mechanism of disease symptoms and relation to light and UV.
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