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.
Summary of today’s announcements
Wednesday, July 14th, 2010Jack Wood discusses Clinuvel’s manufacturing partner for SCENESSE®
Friday, July 9th, 2010Clinuvel Non-Executive Director Jack Wood discusses the selection of SurModics Inc as Clinuvel’s first commercial manufacturing partner for SCENESSE®. Click here to listen.
Necessary innovation: the vital role of manufacturing in pharmaceutical development
Thursday, July 8th, 2010
This morning Clinuvel announced a significant milestone in its development program for SCENESSE®: the signing of the first manufacturing agreement for the final drug product with SurModics, Inc., a leading provider of drug delivery technologies to the healthcare industry. It has taken over eight years for Clinuvel to reach this milestone. In this time, the company has refined SCENESSE’s active ingredient – afamelanotide – and arrived at a final injectable drug product which controls its release to achieve an optimal photoprotective response in patients.
Orphan drug development legislation and regulation landscape
Monday, May 17th, 2010
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.
Broader implications of a landmark announcement
Monday, May 17th, 2010
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.
Unexpected news for afamelanotide from Italy
Monday, May 17th, 2010
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.
Introduction to the melanocortin system
Wednesday, February 24th, 2010
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.
The Clinuvel technology series; in-depth discussion
Friday, February 5th, 2010As 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.
The Clinuvel AGM
Tuesday, November 24th, 2009
As many of you may know, this week saw Clinuvel hold its Annual General Meeting in the Melbourne Town Hall. As managing director I welcome these opportunities where I am able to meet and talk to the people whom Clinuvel considers integral to the company and its existence; the Board of Directors sees Clinuvel’s investors as unique. In Clinuvel, an investor has to fundamentally believe in the premise of offering pharmaceutical photoprotection, a novel option, an innovative approach to skin disorders.
In a meeting that would be considered short by international standards I was both excited and proud to present some of the achievements and milestones our team has reached this year, and lay out our plans for the next 12 months.
A brief history of afamelanotide
Friday, October 9th, 2009
The research that underpins afamelanotide began over 20 years ago in the US. At that time the dramatic increase in incidence of skin cancer and its impacts were beginning to be discovered and new solutions sought. The National Cancer Institute (NCI) sponsored researchers to explore applications for various peptides as part of its melanoma prevention strategy.
This study led them to investigate peptides that acted on melanocyte receptors. The rationale behind this being that increased melanin leads to more efficient photoprotection, as melanin is a highly successful and naturally occurring UV quencher and filter. By consistently increasing melanin in the skin, skin damage from light and UV radiation can be lessened.
