The challenges of ‘orphan’: can drug development cope with rare diseases?

Thursday, June 9th, 2011

Scarcely a day goes by that the Clinuvel team is not contacted regarding the latest conference: everything from monitoring to manufacturing to marketing is analysed, discussed and disputed across the globe in conference form. It’s impossible – and unwise – for small companies to try to attend all these forums, but it is equally impossible to work in the space without looking outside the office door: there is much to be learned from what others have done or not done to succeed in an industry fraught with failure.

And indeed there was much to take on at the recent World Orphan Drug Summit, held in Frankfurt last week. (more…)

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A clinical success: study retention rates

Thursday, February 10th, 2011

We were delighted this week to be able to announce the successful completion of our first Phase II study conducted in the US, a placebo controlled, randomised trial of SCENESSE® (afamelanotide) for patients diagnosed with erythropoietic protoporphyria (EPP) (CUV030). (more…)

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Vitiligo, light therapy and stem cells: a new webcast online

Wednesday, January 12th, 2011
Vitiligo Narrowband UVB treatment

Vitiligo Narrowband UVB treatment

Today we’ve released our first new video webcast for the year, explaining the theory of repigmentation in vitiligo with narrowband UVB (NB-UVB) phototherapy in greater detail. You can view the new video on our website or on Youtube.

(more…)

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A new program for SCENESSE®: nonsegmental vitiligo

Wednesday, August 25th, 2010

A patient with vitiliginous lesions on their fingers and hands

Today Clinuvel has announced that it will be commencing a new program for SCENESSE® in the common pigmentary disorder vitiligo. While this is an exciting development for Clinuvel – increasing the potential for SCENESSE® as a therapy – we feel it is vital to provide as much in-depth information on our program as is feasible to ensure our stakeholders are aware of what we anticipate will and will not be achieved with SCENESSE® as a repigmentation therapy. (more…)

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Under your skin: Sunscreen and skin cancer this summer

Thursday, June 24th, 2010

With the northern Hemisphere officially creeping into summer, the first arguments of this season’s sun and skin debate have arisen

Anti cancer councils and organisations akin to Australia’s Sunsmart are continuing their awareness-raising campaigns, educating the public about the issue, and most importantly the practice of sun protective behaviour; although significant investment and persistence are required, well executed and long running campaigns can make significant progress, albeit on a regional scale. But a vocal group of skeptics are continuing to question whether a central element, sunscreen, might just be part of the problem.

(more…)

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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.

(more…)

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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.

(more…)

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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.

(more…)

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The fear of what lay ahead

Wednesday, February 10th, 2010

“The fear of what lay ahead” is our latest webcast exploring the impact of EPP upon individuals, their families and loved ones.

Wendy and Ralph are the proud parents of two daughters, who were both diagnosed with Erythropoietic Protoporphyria (EPP), although their first daughter suffered for almost three years before the correct diagnosis of EPP was arrived at.

In this short film they discuss the fear, confusion and distress they endured as a result of grappling with EPP’s severity, invisibility and often unknown and misunderstood nature, all the while unable to treat or protect their children.

Clinuvel would like to extend its thanks and appreciation to Ralph, Wendy, Angela and Lyndal for allowing us to share their story.

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Talking off the label – part three

Friday, November 6th, 2009

offlabel_3Allergan’s lawsuit filed against the FDA presents a relatively novel case in addressing the requirements of drug developers in relation to off-label use of drugs by physicians.

Allergan may be one of the many companies to follow suit in time. Allergan’s concern is the FDA’s stance – prohibiting communication to the medical community in regards to the common off-label uses of Allergan’s lead product – poses a violation of the first amendment rights under the US constitution. A pharmaceutical company should be able to exercise its rights under freedom of speech to provide truthful and relevant information to its users: physicians.

(more…)

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