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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Summary of today’s announcements

Wednesday, July 14th, 2010

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.

(more…)

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Jack Wood discusses Clinuvel’s manufacturing partner for SCENESSE®

Friday, July 9th, 2010

Clinuvel Non-Executive Director Jack Wood discusses the selection of SurModics Inc as Clinuvel’s first commercial manufacturing partner for SCENESSE®. Click here to listen.

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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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The Melanocortin-1 Receptor (MC1R) and allelic variations

Thursday, July 1st, 2010

Red Hair from  derekGavey

Yesterday, Clinuvel announced the grant of a new patent from the USPTO – allowing the company exclusive protection for the use of afamelanotide (SCENESSE®) and any molecule belonging to the family of melanocortins for UV-protection of individuals who are at high risk of skin cancers. This patent, granting protection until 2024, refers specifically to individuals with defects (allelic variations) seen in the melanocortin-1 receptor (MC1R). The MC1R plays a key role in the pigmentary response and defensive mechanism to UV.

The MC1R is vital in regulating the quantity of melanin in skin and an individual’s pigmentary response; one’s ability to activate the protective dark pigment eumelanin in skin after UV induced skin damage (also known as the ‘tanning response’ after erythema).Allelic variations of the MC1R – of which there are over 80 identified in medical literature – are considered highly prevalent in fair skinned populations of European descent, with reports of up to 75% prevalence in Ireland. In red haired coloured (RHC) individuals single or multiple variations are seen in 93% of people tested. Conversely, variations are not seen in African populations, rather a wild type MC1R is referred to in those with darker skin. (more…)

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Online updates and more digital development

Tuesday, June 1st, 2010

Although we’ve been a little quiet this week on the blog, a number of updates have been made to the main site as part of our ongoing commitment to improving our online presence.

We’ve added a new, expanded article on melanoma, improved our article on skin cancer and organ transplant patients to include information on vitamin D deficiency.

We’ve also produced two short educational videos on the topics of skin and skin types. These now form a key part of the articles on Skin and the Function of Skin Pigment sections on our new website.

In the coming months we will produce and release more of these videos explaining the science, technology and concepts that  influence, underpin and drive Clinuvel and our proprietary first-in-class medicinal photoprotective drug, Scenesse.

You may also have noticed that we have updated the visual design of the blog, making it more engaging, easy to use and also easier to share and interact with us on Twitter and Facebook.

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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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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.

(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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