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Q&A: SCENESSE® successful in Phase IIa vitiligo study

Wednesday, December 19th, 2012

We’ve just released the first results from our vitiligo program which you can view online here. Following their release, we expect a number of questions from the vitiligo community, some of which we hope to address below. If you have any other questions, feel free to contact us via Facebook or email.

What was the CUV102 study?

CUV102 was an open-label Phase IIa study conducted in three US expert centres (The Vitiligo & Pigmentation Institute of Southern California in Los Angeles, The Henry Ford Hospital in Detroit and Mount Sinai Hospital in New York). The trial was designed as a ‘proof-of-concept’: to explore the potential of SCENESSE® to repigment depigmented skin in vitiligo. In total, 54 patients enrolled in the study and 41 completed the full treatment course. All of these patients were of Fitzpatrick skin types III-VI, generally darker skin types. (more…)

Clinuvel Director recognised in the Women of Influence 2012 Awards

Wednesday, October 24th, 2012

Clinuvel Non-Executive Director Brenda Shanahan has been honoured at The Australian Financial Review and Westpac Group Woman of Influence 2012 Awards, being recognised as the second most influential woman in the category of Boards and Management from a field of over 350 nominees.

Mrs Shanahan has been a Director of Clinuvel since 2007, serving as Non-Executive Chair from late 2007 until July 2010. In addition to her role at Clinuvel Mrs. Shanahan is the Chair of the St Vincent’s Institute, an independent medical research institute in Melbourne, as well as a Non-Executive Director of Challenger Limited (ASX: CGF), Bell Financial Group (ASX: BFG) and DMP Asset Management. You can read Mrs. Shanahan’s full biography on Clinuvel’s website and more about the Women of Influence 2012 Awards at The Financial Review.

Inside Clinuvel: Vitiligo and treatment frustrations

Tuesday, August 14th, 2012

Since we publicly announced our vitiligo program in 2010, the entire Clinuvel team has aimed to gain a better understand this disease, its possible causes and how SCENESSE® (afamelanotide) may become a vital tool in a dermatologist’s arsenal for vitiligo.

We’ve also worked closely with the broader vitiligo community to better communicate the program’s goals and limitations (if you missed them, you can see the first two videos in a series of interviews between Mr Lee Thomas and our CEO here) as well as reaching out to individuals with vitiligo to better understand how this disease impacts upon lives. For me, one of the most prominent recurring topics in discussions, emails, phone calls and online is the lack of treatment for vitiligo and the frustrations of physicians and patients alike at treatment inconsistency. (more…)

Inside Clinuvel: SCENESSE® in acne?

Monday, August 6th, 2012

A new article was published last week looking at a small pilot study of SCENESSE® (afamelanotide) in acne vulgaris. Before discussing this piece specifically, I think it is relevant to briefly review melanocortins and their receptors.

The active ingredient in SCENESSE®, afamelanotide, has been the focus of over 80 peer reviewed journals (as well as being mentioned in at least 100 more) since the initial formulatory work with the drug began in the 1980s. In the last two years alone the drug and its actual or theoretical application in the clinic have been presented at least 20 times at various global scientific forums. This growing library of resources reflects the enthusiasm of the medical community to put a new compound through its paces, both in vitro and in vivo. (more…)

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…)

Inside Clinuvel

Tuesday, July 31st, 2012

The last five years have brought much change in the global pharmaceutical industry. As one of thousands of firms working in the space, we’ve taken a novel approach to try and overcome the challenges such change has presented.

This approach has taken us close to achieving what few of these firms will – proving that a new drug is safe and effective in its treatment of a disease and getting the product approved by the regulatory authorities. Every day the team and I have learnt something new that has helped us in this quest.

Over the next few months – coming from a different perspective as head of communications – I will try to share some of this knowledge with you via the blog; looking at how and why we do what we do, and trying to address some of the most common questions the company encounters on a day to day basis. I welcome your thoughts and feedback, either through comments on the blog, via Facebook, or directly via email to mail@clinuvel.com

- Lachlan Hay, Head of Global Network and Communications, Clinuvel

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…)

Online evolution

Thursday, December 15th, 2011

Earlier this week we unveiled a major update to our online presence with the release of our new-look website and the launch of Mothers & Children, a new site focusing on the pediatric and parental skincare.

Over the past five years the team has worked to continuously improve our online resources, expand into social media and build our presence on our Youtube channel (generating over 100,000 views in the process). The new site, Mothers & Children, is a direct response to what we saw as a key gap in online skincare information: up-to-date, accurate and concise information on caring for and protecting young and maternal skin. This is a new space for us and we’re excited to be able to compliment our extensive Science of Skin resources with this site.

We’re not standing still online. You will notice further changes in the coming months as they emerge from internal development and testing as well as new content being developed across the site.

Let us know your thoughts about our new site via Twitter, Facebook or email.

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