B&M: What strategic opportunities exist for Diurnal? What kinds of partnerships are you going to make in the next 2 years?

MW: We know our products intimately which have been developed to treat a very clear, defined unmet clinical patient need. We also have advantages around orphan drug designation which means a strong exclusivity position to supplement our patent portfolio.

First we need to achieve market authorisation of our lead products. Thereafter, the ambition is to broaden the product portfolio. We also have an early stage product portfolio, which includes an exciting new testosterone product coming into the clinic this year. We are also going to progress Tri4Combi, a treatment for hypothyroidism, to get that close to clinic this year.

We do come across opportunities in the wider endocrine space, and we carefully evaluate their merits in each case. There is definitely an opportunity to accelerate our commercial ambitions. As long as it ts in our area of expertise, we would be happy to add to our existing portfolio.

B&M: We interviewed Jim Phillips of Midatech last year, who was brave enough to put a figure on that level of ambition for his business. He mentioned a 3 billion dollar valuation. Do you have a figure in mind as to your ultimate level of ambition for Diurnal?

MW: It’s certainly too early to comment on a 3 billion figure, but the ambition is to become the world’s leading endocrine company. Those are multi-billion dollar market opportunities. Once we’ve progressed our first product to market and are generating revenues, there is a real opportunity for Diurnal to expand into other endocrine areas.

B&M: What will be your major aims in the coming 12 months or so?

MW: We have key milestones to hit over the next 12 months. But it’s also about understanding patient needs. We are in regular contact with patient advocacy groups and charities, so that we can we sure our products will provide a holistic solution for patients.

Working in this orphan drug area affords us this opportunity, because we’re very close to patients. In areas such as diabetes, a pharmaceutical company may be quite far removed from patients.

IA: The commercial side will be an interesting challenge as well. The typical model of the UK biotech sector is to develop a product and sell the asset. We have ambitions beyond that. We will transition from being a small UK company to embrace the world, starting off with Europe and the US, and through the process to achieve all the required pricing and reimbursement arrangements in different countries.

The first steps have been taken this year with the recruitment of the core of the commercial team. We’ve been able to recruit people with from larger pharmaceutical companies with direct and relevant experience.

B&M: You’ve obviously got a strong management team and board. You have also brought in a lot of specialist input from the field of endocrinology to help you achieve your aims.

MW: That’s right. We have a number of endocrinologists, including our CSO, Professor Richard Ross, founder of the company. We’ve recently recruited the core of our commercial team. Part of that team is an experienced industry paediatric endocrinologist, Dr John Porter, again bringing a wide range of expertise in the paediatric and commercial areas.

B&M: It’s interesting you say many UK companies look for that exit rather than build it out. Why do you think the UK industry is more in favour of exit rather than building the scale of the business like you see in the US?

IA: Probably a variety of reasons. Good science will end up appealing to people with deep pockets, and those pockets tend to be overseas. And then there’s that concept of making the jump from academia and research into the commercial world. The stereotype is that the US is more focused on the commercial than the UK.

MW: We have some great research going on in the UK, like at the Crick Centre in St Pancras and at the various universities. That tends to be early stage activity. The next stage in UK company development will be pushing through these ideas to a marketed product.

With Diurnal, choosing a niche area affords us the chance to be one of the first to do that. There aren’t too many people who have done that before in the UK. Shire is probably the best known example, starting off with a small specialist product, taking it to market, and growing by acquisition over the years.

That’s exactly the model we are using. Endocrinology is a specialist area. To commercialise your own product isn’t right for every company. For us we though it’s the right thing. We know who our prescribers are. They’re concentrated around specialist hospital centres in the UK, Europe and US. That therefore gives us an opportunity to target those specialist centres with a very modest sales force, very similar to the model Shire used in the early days.

With rare diseases, the patient and prescribing community is quite small. We’re in contact with the clinicians who treat the patients. A lot are coming to us asking how trials are progressing, wanting to take part in clinical trials.

We are well known in the endocrine space and we believe people will give us the opportunity to commercialise these products.

B&M: I guess the orphan market itself is taking a bit of a lead from the US at the moment, with support from Martin Shkreli and Hilary Clinton. Does your pipeline purely exist in the orphan designation area?

IA: No we very much see ourselves as the endocrinology company. We are starting off with an orphan disease, and one we know very well, but we have a broader pipeline looking at diseases such as hypogonadism (testosterone de ciency) and hypothyroidism (thyroid hormone deficiency), which is a very common endocrine disease, more prevalent particularly in older women. These are both large chronic endocrine diseases rather than orphan diseases.

B&M: What’s keeping you both awake at night at the moment? It could be a challenge or an opportunity.

IA: There is so much going on at the moment. We’ve come out of the back of a very heavy Q4 in terms of the IPO project.

There’s plenty to keep us busy, and certainly keeping me busy in terms of trying to get that company transitioned into all the process and procedures that a newly listed company needs.

So if the brain is buzzing, it’s buzzing with all the things we need to do, rather than what we haven’t done. I’m sleeping well.

MW: With regards to our product development moving into com- mercial, there’s nothing keeping me awake at night. We have a
very experienced management team that has taken many products through to market already. I think one of the key strengths of Diurnal is we’ve recruited the core commercial team already, so that’s well ahead of schedule. So we’re now setting down our plans for a commercial piece well ahead of most companies probably would be doing. We are going out, speaking to key opinion leaders, seeing how the market lies, and really developing the strategy as to how to tackle these markets.

For me it’s an exciting year ahead. We can make those plans on the commercial side work and that will coincide with us completing our clinical trials and launching our first product.

Martin Whitaker has overall responsibility for delivering the Group’s commercial objectives and joined the Group in January 2008, supporting Fusion’s investment. Martin has over 18 years’ experience in the pharmaceutical industry and has led the Diurnal team to progress the Company’s lead products, Chronocort® and Infacort®, into pivotal Phase III clinical trials.

Diurnal is a specialty pharmaceutical company dedicated to developing high-quality hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including Congenital Adrenal Hyperplasia, Adrenal Insufficiency, Hypogonadism and Hypothyroidism. The company has a strong, multi-skilled entrepreneurial management team with extensive pharmaceutical product development experience in endocrinology.