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Inside Clinuvel: effective drug development

Tuesday, July 31st, 2012

Take ten years, half a billion dollars and countless man hours from some of the most highly trained, intelligent individuals on the globe. You still stand a 90% chance of failure, some of which is totally out of your control. This is the apparent reality of modern drug development.

With the odds so stacked against it, it’s little wonder that the drug development sector is one requiring constant evolution in rethinking how to survive. In addition to the ‘regular’ risks of drug development, turmoil in global markets since 2007 has seen risk adverse investors shun drug development and biotechnology stocks for blue chip companies which are perceived as safer. The pressure to perform has increased for those companies who continue to work in the space.

In short, it’s forced even greater creativity to ensure survival and prosperity. (more…)

Return to core pharma values

Monday, July 9th, 2012

Several recent stories have caught the industry’s attention and set media imaginations alight, but none moreso than last week’s record-breaking US$3B marketing settlement between pharma giant GlaxoSmithKline and the US government. In short, GSK plead guilty to withholding safety data and illegal marketing practices related to three drugs and agreed to pay US$1B in criminal fines and US$2B to resolve civil complaints with the federal and several state governments. (more…)

Delivering a therapy for those who need it most: EPP in Switzerland

Thursday, April 26th, 2012

Earlier today we announced that two health insurers in Switzerland had agreed to reimburse SCENESSE® (afamelanotide) for the rare disease erythropoietic protoporphyria (EPP). While this is an encouraging step forward for the program and for Swiss patients, I felt it appropriate to take a moment to discuss the important role that Switzerland has played, and continues to play, in our EPP program.

In 2006 Clinuvel announced that it would commence a new clinical trial program focused on an unknown disease in a small open label study. At the time I noted that our aim was to “provide a prophylactic treatment for [a] debilitating and incurable skin disorder”. (more…)

MAA: a moment in Clinuvel’s EPP story

Thursday, February 9th, 2012

Those who have taken an interest in Clinuvel will have learned with joy that, on Monday February 6th, the company announced its first official filing for SCENESSE® (afamelanotide) with the European Medicines Agency. It has taken our teams around six years to arrive at this point. Benchmarked against peer companies, it is a relatively swift development path for a first-in-class drug; we first publicly announced our erythropoietic protoporphyria (EPP) program in September 2006. It is an opportune moment to reflect briefly on how we reached this milestone and then discuss the steps that must be taken from here. (more…)

EPP results and clinical relevance

Friday, November 4th, 2011

A protoporphyrin IX molecule

Over recent months I have written several times of the need for Clinuvel to prove clinical relevance in our trials with the use of SCENESSE® (afamelanotide) in erythropoietic protoporphyria (EPP). In orphan populations the need to demonstrate how a novel drug assists in their daily activities and improve their lives is at the forefront of the regulators’ minds. And so it should be, after all the objective of the pharmaceutical industry is to develop drugs which address either disease or symptoms adequately and safely. The results the company released yesterday from our Phase II US study of the drug in EPP (CUV030) have given us important data towards demonstrating clinically relevant improvement of patients’ lives. (more…)

Clinical relevance – the value of patient experiences

Friday, September 30th, 2011

Since 2006 Clinuvel has trialed SCENESSE® in a truly unique group of individuals: patients living with erythropoietic protoporphyria (EPP), a rare genetic blood disorder which causes an absolute intolerance to light.

EPP prevents patients from leading ‘normal’ lives, especially outdoors. It is one of the few diseases that manifest clinically with initially invisible symptoms which cause severe dermal pain for several days. This not only presents a challenge for diagnosis and treatment, but also for generating meaningful clinical trial results – those which are measurable numerically and are used by regulatory authorities to evaluate the efficacy of a drug in a patient population. Here, real life patient experiences during a trial can play an important role in providing clinical relevance and analysing hard data. (more…)

Porphyrias: a disease grouping by cause, not symptoms

Monday, April 18th, 2011

Held biennially, the Porphyrins & Porphyrias conference (P&P) is the world’s largest gathering on the porphyrias – a group of metabolic disorders causing biochemical disruptions in the pathway of the body which synthesizes haem (heme).

As a result of each of these disruptions, the body presents with unique symptoms ranging from skin symptoms and phototoxicity – as those seen in erythropoietic protoporphyria and congenital erythropoietic porphyria – through to acute attacks of abdominal pain, seen most commonly in acute intermittent porphyria. In short, no two porphyrias are clinically identical yet they are discussed as a single group of disorders with a similar cause. As a matter of fact, there are eight variations of porphyrias, each with a specific clinical manifestation of disease. (more…)

Mikey’s story part three – EPP

Tuesday, April 12th, 2011

As part of an ongoing series, Clinuvel has released its third video featuring Mikey, an Australian man with erythropoietic protoporphyria (EPP). EPP is a rare disorder in which a chemical, called protoporphyrin IX, accumulates in the skin. When exposed to UV and visible light, the protoporphyrin IX molecules in the skin undergo a chemical reaction which results in swelling scarring and can leave those with EPP in considerable pain. (more…)

Allergic to the sun?

Monday, February 21st, 2011

As the Northern Hemisphere approaches the end of winter, we are beginning to see more mentions of ‘sun allergies’ in popular press, online and in social media.

Most people are not actually ‘allergic’ to the sun, but rather are suffering the first symptoms of seasonal or light-induced skin disorders, known medically as photodermatoses. Photodermatoses cause a person’s skin to react to even the briefest sunlight exposure by burning, swelling or developing a rash. Most distressingly, these diseases can have sudden onset where people, who may have never experienced them before, see symptoms following their first day in the spring sun. (more…)

How I explain EPP to the world

Friday, February 18th, 2011

As part of our ongoing focus on erythropoietic protoporphyria (EPP), we’ve invited Victoria to share her experiences with EPP as a guest blogger. You can read Victoria’s first post here.

When I was first diagnosed with EPP there was a huge sense of relief: someone had actually listened to me and believed that something wasn’t quite right.

That said, I am not overjoyed at having the condition as it restricts my life so much. When Spring starts to approach I get anxious as I dread having a reaction; my freedom to go out feels more restricted. (more…)

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