Clinuvel Pharma (CUV.AX) (CLVLY.PK): Corporate Interview Print E-mail
By Mike Rabe   
Monday, 24 August 2009 11:35

Clinuvel Pharma CUV.AX) (CLVLY.PK) is an Australia-based pharmaceutical company focused on the development and registration of afamelanotide as a photoprotective drug. Afamelanotide has various modes of actions but primarily acts by increasing the levels of melanin (pigmentation) in the skin; the drug shields against UV radiation (UVR) and sunlight. Afamelanotide is delivered via a subcutaneous dissolving implant approximately the size of a grain of rice. Increased pigmentation of the skin appears after 2 days and lasts up to 2 months.

 

Clinuvel is currently trialing afamelanotide in a range of light and UV related skin disorders (photodermatoses). It is proposed that afamelanotide will provide prophylactic treatment to patients suffering from these disorders.

Afamelanotide is in Phase III trials in both Europe and Australia, its lead indications are:

- Erythropoietic Protoporphyria (EPP) - absolute sun/light intolerance, intolerable pain suffered when exposed to light.

- Solar Urticaria (SU) - acute allergic reaction to UV and sun.

- Photodynamic Therapy (PDT) - phototoxicity following cancer treatment.

- Polymorphous Light Eruption (PLE/PMLE) - which is likened to sun poisoning.

- Actinic Keratosis (AK)/Squamous Cell Carcinoma (SCC) - chronic damage of the skin due to sun and UV leading to skin malignancy. Clinuvel is testing afamelanotide in hypersensitive organ transplant recipient (OTR) patients.

Clinuvel Q + A

By Mike Rabe (MR)

MR:  In a corporate video that is available at Clinuvel.com, non-Executive Director Jack Wood mentions that the company will need to decide how it plans to commercialize afamelanotide through partnerships. 

In this video Mr. Wood discusses the possibilities, such as licensing out a particular territory to a partner(s) or licensing out one or more of afamelanotide's medical indications to a partner(s).  

Is the Company getting closer to deciding on its commercialization strategy with prospective partners? 

A. Clinuvel:

Commercialization of afamelanotide is the objective of the company. The strategy is based on various routes to market, and whether the company does this alone and/or in partnership will be decided shortly.

MR:  In January, the company announced the FDA had granted an Investigative Drug Status (IND) for your photoprotective drug, afamelanotide.   A media release on January 29th stated "Clinuvel can now commence trials in the US, the world's largest pharmaceutical market." 

In an Open Briefing interview in January, Clinuvel CEO Dr. Wolgen said, "Getting Clinuvel's trials in the US underway will be a major milestone for us in 2009."

As of August, Clinuvel still has not started a trial for afamelanotide in the US.  Can you provide an update with the status of the US trial(s)?   Has there been a change of plans for the US market?

A. Clinuvel:

The US markets are important to Clinuvel, but the road to obtain registration in the US is complex and also depends on the results and progress of the European trials. In other words, the European data have an influence on our US strategy. Nothing has changed in this respect. Our aim is to mirror the US trials to the European clinical program and this will be under way shortly.

MR:  At the last AGM in November of 2008, the company mentioned in the CEO presentation that it planned on initiating a pediatric trial for Erythropoietic Protoporphyria (EPP) in the next 12 months.   Does the company still plan on doing a pediatric trial for any of afamelanotide's indications?

A. Clinuvel:

In EPP, we have found that children are severely affected, and it would be wonderful if we could start treating the pediatric population. EU and US regulators are currently looking at this, and the clinical program will need to be initiated when all regulators approve the clinical need. Subsequently, the company will decide on regimen, dose etc. For now registration of afamelanotide for adults is our principal objective. At the end of the day, all requests and plans need to be supported by strong data.

MR: In October of 2005, when the Company was under its previous management team, a patent was filed for a topical lotion version of the drug.  During that same month, a topical trial of the drug began in London. 

Since then, it appears the Company has dropped plans for a topical lotion version of the drug.  While the afamelanotide implant has been successful thus far in clinical trials, it would seem to be commercially beneficial to also continue studies on the lotion.  Can you explain why the decision was made to stop the topical lotion trials?

A. Clinuvel:

We can't comment for plans and intentions of previous managements.

In general, this management is focusing on the current controlled-release formulation and does not venture out to plans courted in the past.

The question alludes to commercial benefit, but the author does not fully appreciate the pharmacology nor the regulatory process. Afamelanotide is a pharmaceutical, a hormone, not a food supplement.

MR: What is the current timetable for how soon afamelanotide might receive a trade name by Clinuvel?

A. Clinuvel:

We will release a trade name at the appropriate time, not before.  It will be a step to be taken before MAA filing. We will make the appropriate announcement as part of our marketing strategy.

MR:  Is Clinuvel still anticipating that Phase III EPP study results will be released in Q4 2009 as was mentioned in the European Road Show in May? 

A. Clinuvel:

We're on track to complete this study by Q4 2009, that is the goal. So far everything seems to be according to plans in our trial and we have not heard any news of delay from our trial centers. If the results are good, and if the safety of afamelanotide is satisfactory, the decision will be made to file in EU first. An additional factor is how the EMEA will assess the adequacy and caliber of our dossier.

Modern drug development is very complex and highly uncertain, and it needs to be stressed that the progress that Clinuvel has made in 4 years is extra-ordinary compared to most teams developing novel drugs. Most of these compounds never reach Phase III, let alone the filing stage. So we all keep our fingers crossed.

MR: Is there anything else you would like to add?

A. Clinuvel:

For most investors unfamiliar with pharmaceutical development, this area of lifesciences is a confusing, often frustrating process which appears lengthy and unclear. Our entire team is aware of this, but would rather have an active dialogue with investors whereby appreciation of each step in a treacherous regulatory environment is seen as a step closer to the ultimate goal. Perhaps, it would be good to look at other one-drug companies and survival rate at 4 years.

Clinuvel is a very unique and special company, as this management has taken on the task to do something that has been achieved in 15 years: commercial registration of a melanocortin. We need all the positivism and support to succeed in this attempt, every positive voice will assist us in bringing this drug to market. Board member Mr Jack Wood summed it well in the webcast video you've mentioned: "you're going where no one has gone before". It is exciting to be innovative and imagine if this venture would succeed. The company would be revered globally.

The process of getting support from regulators in 4 different continents with their own specific set of rules, physicians with differing views on therapies and need for their patients, patients and their willingness and ability to be in lengthy trials, investors with various motives and expected returns, banks and ability to support the listing of the company, patients support groups, local governments, and management trying to implement a uniform strategy in a changing environment. All these factors are very unique to Clinuvel attempting to achieve a world's first. 

As Clinuvel progresses closer to market with afamelanotide we'll be sharing more on each step, through the blog, webcasts and other mediums to help investors better understand where we're heading and why.

MR: Thank you very much for your time.

Clinuvel is a publicly listed company on the ASX (CUV), XETRA-DAX (UR9), and in the US as a Level 1 ADR (CLVLY).

For more information:

http://www.clinuvel.com/ All about the company

http://photoprotection.clinuvel.com/ Clinuvel's resource library

http://www.clinuvel.com/en/blog/  Clinuvel's blog for insight and discussion

Disclosure:  Long Clinuvel




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