FDA online regulation

Monday, January 17th, 2011

Effective communication is demanded more than ever in present-day drug development. I’ve blogged before about the role of patients in this process and the importance of acknowledging patient driven drug development. In a time of advanced technologies and communications it is my intention that Clinuvel be at the forefront of any developments in this area and that the company seeks new ways to discuss our program, online and off.

We also work in a highly regulated environment: very little of what the company does is without scrutiny from this perspective, either from our own regulatory team or from external organizations established for this purpose. Despite the hightened reviews, there remains a discord in the communications realm, with a lack of regulation surrounding tools referred to broadly as ‘social media’. (more…)

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Time to look forward

Monday, December 20th, 2010

Many of you who follow the company closely will notice the increase in communications in recent weeks. As our clinical and regulatory workload increases behind the scenes, it is our intention to keep our numerous stakeholders abreast of relevant updates in the field and with Clinuvel’s work.

While it is commonplace to review the year past during the festive season, I take this time to indulge in the progress and challenges that lie ahead for Clinuvel. (more…)

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Compassionate use – navigating the regulatory landscape to ‘do good’

Friday, December 3rd, 2010

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…)

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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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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.

(more…)

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News from Italy and the launch of our brand

Tuesday, May 18th, 2010

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.

(more…)

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Changing the rules in pharmaceutical development: wider significance of Clinuvel’s progressive communication channels

Monday, May 17th, 2010

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.

(more…)

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Patient driven drug development

Monday, May 17th, 2010

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.

(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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Unique UV development

Monday, December 21st, 2009

skin_blocksToday’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.

(more…)

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