Clinuvel Pharmaceuticals - light, skin, UV and photoprotection blog

Who wins from pharma cost-cutting?

September 23rd, 2011

Earlier this month Sanofi, the world’s fourth largest pharmaceutical company by revenues, announced that it would go on a cost-cutting spree, trimming its expenditure by $US2.9billion annually and cutting many thousands of jobs in the process. Amidst the upheaval, Sanofi stated its key goal for 2012 onwards was ‘generating sustainable growth’ for shareholders (the complete presentation can be viewed here). One of the key targets for its cuts was R&D costs, both in terms of overall spend and employee headcount. Read the rest of this entry »

‘Off-Label’ Drugs: Regulations and Policies

September 20th, 2011

As we recently discussed, a number pharmaceutical companies have been fined for promoting off-label uses of their drugs. These practices are difficult to control and the monetary penalties seem to have had little effect on manufacturers, as the number of off-label breaches being reported continues to grow.

In the world of contemporary medicine, off-label prescribing plays a fundamental role in providing the best available standard of care for several health problems. In some areas of practice, including oncology, pediatrics and obstetrics, off-label prescribing provides some of the best known interventions for patients. Yet, off-label prescriptions can also threaten the safety of the patients if they are not supported by legitimate scientific evidence. Hence, promoting such uses of drugs is not encouraged by the regulatory authorities with a view to safeguard the health of patients (a key regulatory role). Read the rest of this entry »

British Skin Foundation scratches the surface

September 16th, 2011

In a striking new campaign, the British Skin Foundation have teamed up with photographer Rankin to try and visualise the physical and emotional impact that skin diseases can have on individuals.

Launched earlier this week at London’s National Portrait Gallery, the works posted online feature models crawling with bugs, with cracked and dried skin and covered in barbed wire. For many living with skin disorders such sensations can feel all too familiar, although the symptoms aren’t always visible. Read the rest of this entry »

The mystery of melanin

August 30th, 2011

The brown-coloured pigment melanin is present in many different species – from humans, to birds, to microbes. It is well known that melanin affords these organisms some protection from the damaging effects of UV radiation, however the latest research indicates that melanin may also be providing a defense against ionising radiation (such as x-rays and gamma rays). Read the rest of this entry »

Study: pharma ads failing FDA guidelines

August 25th, 2011

The marketing model for US prescription pharmaceuticals is often debated for its direct-to-consumer (DTC) advertising as the United States is one of the few jurisdictions globally which allows this type of marketing. Yet equally debated is promotion directly to physicians, key decision makers in the prescription process. Physician promotion comes in many forms, ranging from one on one visits with sales representatives to educational sponsorship to the ubiquitous branded pen. Read the rest of this entry »

A coffee a day keeps skin cancer at bay? Look a little deeper…

August 18th, 2011

We tweeted it earlier this week and it’s been run across numerous news sites: new research has suggested that coffee – or more specifically caffeine – can help reduce the risk of skin cancer. It’s a fascinating story and one which deserves further review.

The research, conducted across multiple US sites and supported by National Institutes of Health grants, sought to expand upon an existing understanding of the correlation between the intake of caffeinated beverages and a decrease in the incidence of non-melanoma skin cancers. Read the rest of this entry »

Can Vitamin D Prevent Diabetes?

August 5th, 2011

Recently, Vitamin D has gained a lot of interest for its potential to prevent chronic diseases. The latest article released this year by Mitri et al., linking the risk of diabetes to low levels of vitamin D in the body, has created media speculation about the potential of vitamin D to help prevent diabetes.

Read the rest of this entry »

The importance of clinical relevance

August 2nd, 2011

Development of novel drugs is truly like no other business: one attempts to address questions that may have never been previously posed – let alone answered – in the pursuit of improving the lives and quality of life of patients. As I eluded to in my recent letter to shareholders, the team is now well into the analysis of results from our erythropoietic protoporphyria (EPP) program; two studies from the US and Europe. This is a complex and time consuming task that requires one to collate and make sense of thousands of data points to answer a seemingly straight forward question: does this trial show that the drug is safe and effective?

Obtaining an answer needs to be understood from the concept of clinical relevance. Put simply, results don’t just need to show that a treatment or intervention has an effect on a disease. Rather, they need to indicate that that effect is relevant to the current clinical understanding, treatment and care for the disease or indication. They need to show that the drug’s effect is having a positive, meaningful impact upon a patient’s prognosis and care. This is a crucial point to consider in the development of protocols and in the careful analysis of results, as it is how regulators will review the results. Read the rest of this entry »

‘Off-Label’ Drugs: Promotions and Promises

July 27th, 2011

Use of drugs in patient populations for purposes which are not approved by the regulatory authorities is termed ‘off-label’ use. As the regulatory authorities do not have specific power over doctors’ prescribing habits (provided that the doctor assumes the medical risk), it is a common practice to prescribe drugs for purposes which have not been authorised by the regulators. While it is legal for doctors to prescribe off-label drugs, it is illegal for companies to market the use of these drugs. Read the rest of this entry »

Afamelanotide: an analogue of α-MSH designed to assist in vitiligo repigmentation

July 25th, 2011

Vitiligo is a common skin depigmentation disorder in which the melanocytes, the skin cells which produce melanin pigment, are progressively lost. Despite this, melanocyte stem cells, or immature melanocytes, are preserved in a special region within hair follicles called the bulge, or niche. Often these cells are able to be stimulated with narrowband ultraviolet B (NB-UVB) phototherapy to mature into fully functional melanocytes which migrate to the epidermis to replace the lost or damaged cells. Upon further exposure to UVB radiation, skin cells (keratinocytes) manufacture a hormone called alpha-melanocyte-stimulating hormone, or α-MSH. Alpha-MSH binds to receptors on the newly formed melanocytes and activates melanin production to repigment areas of skin affected by vitiligo. Read the rest of this entry »