Mary Di Marzio has been General Manager of Nordics for Shire Inc for nearly 2 years now. Today she shares with Pharmaboardroom the progress of Shire’s relatively new branch in Scandinavia. She continues to give insights into the balancing act between pricing versus reimbursement and how they are raising awareness for conditions such as ADHD.

Since May 1st, Shire has a new chief executive who in his short time on the job has already reorganized the company into five business units.  To begin, could you please provide an overview of how Shire is structured today?

Interestingly enough, our new CEO is actually Danish – the team here is very proud of that fact.  He came on board in the latter half of last year and started as CEO on May 1st.  He had about 4 months to work with the existing leadership team, ask questions, and find out about our business, which is great, on top of his previous experience managing and directing other large pharmaceutical companies. We were looking forward to his first announcement. I was expecting him to make announcements very early, and sure enough on May 2 he announced the re-structuring into five business units. 

Previously we were essentially three “sister companies” of Specialty Pharma, HGT (human genetics or rare diseases), and Regenerative Medicines which was originally Advance Bio-Healing.  The models were a bit different as were the types of products and strategies and we continued to work in separate silos.  In some areas that’s fine, but we are not a huge company.  There were a lot of opportunities for synergies and some of our target audiences were very similar.  For example we could leverage congress opportunities and positions.  The restructuring was kind of expected for us, but what it would actually look like was revealed in the five business units.  

Our areas of focus are rare diseases; neuroscience, which includes mainly our ADHD products; GI products; a regenerative medicine line; and our internal medicine line, products that in some markets have gone through the life cycle, but have yet to be launched in others as we continue to expand geographically.  Across the five business units we still specialize in responding to very specific unmet needs with our patients.  That common thread exists and now it’s really a matter of how we align.  So the next thing is what it now means to work this way.  The “one Shire” theme is not a new theme.  I had in my office in Canada a little train that said “all aboard, one Shire.”  And now we’re back to that.  So it’s interesting how some things come around full circle.  But it makes sense as there are synergies that we need to transition to.  

Flemming Ornskov has been very clear that we are focusing on “in line” products and “pipeline” products.  These together will increase our revenues and we have to move our pipeline products so we continue to have that sustained growth.  Revenue growth is his main focus right now.  

So to sum up: five business units, one Shire while trying to create synergies and leverage each others’ strengths, focusing on existing in line products, what’s coming down the pipeline, and creating growth.  The common thread is the type of patient and the type of business model which is very much based on specialists.

 

In terms of revenue growth, Flemming Ornskov emphasized his focus on Asia and Latin America.  Where does that leave the Nordics? 

We just opened up an office in Japan earlier this year. The Nordics is the second newest local operating company (LOC) to be opened.  Before 2011, our HGT division was here but the other Shire products were being managed through the distributor model, via a team known as the export team who manages the products through distributors in any countries or markets where we don’t have offices set up with our own people promoting the products. 

The SP products were introduced here in the middle of 2011.  The Nordics really came to be by looking at the products that we had already, but also at looking down the line of what was coming.  Products for ADHD are a huge part of our business and identity and we were looking at the ADHD market in the Nordics.  The ADHD market here is very well developed in terms of the diagnosis and treatment of patients.  There are guidelines, and the competitive products were doing very well.  Because ADHD is such a big part of what we do, we wanted a strategy to launch our products, particularly Elvanse, the product that we recently launched this year.  What do we want to do with our flagship product?  In that sense, the Nordics became even more desirable.  We were generating important revenues with our internal medicine products and the rare diseases had already been doing extremely well here.  Through them we were able to learn a lot about the regulatory processes, the environment, and looking at the potential for ADHD.  We were looking at growing the GI business at the same time and there is a very favorable market for them here. There were certain indicators that showed that it was now the time for us to come into the Nordic market.

 

We have been to countries where the main point of focus has been raising awareness especially around diseases such as ADHD that carry social stigmas and a need for education.  This is a well developed market in ADHD, so what is the value added for Shire in the Nordics?

If we look at the competitive market in ADHD, all of our competitors have been doing some really great work.  We come with a package of a different type of product.  You have probably heard that if you have seen one ADHD patient, then you have seen one ADHD patient because everyone is different and needs to be treated as an individual.  By Shire coming into this market and bringing the first long acting amphetamine stimulant, we are bringing a pipeline of products and experience that we have been able to garner through what we have been doing in the US and other markets.  We also took over from UCB a product called Equasym – essentially a product that we felt fit in very well with that menu of medications that the patients and doctors need to work with to better treat their patients.  You will need a methylphenidate, you will need an amphetamine and you will need a non-stimulant.  We have all three types of products, either existing or soon to be launched in the Nordics.  We have Equasym in Europe.  We are now introducing Elvanse in Europe having launched it in the UK and Denmark earlier this year.  Denmark is actually the second market in all of Europe to have Elvanse launched and we are now preparing for Sweden in the next few months. 

The company has put a lot of emphasis and priority on responding to ADHD patients in the Nordic countries.  We also have in our pipeline, which is available in the US, Intuniv, which is a non-stimulant.  So we really offer a full menu of products as well as experience and services that we can continue to bring to physicians and patients in the Nordics.This is one area through innovation and collaboration where we can continue to support ADHD patients.

 

One topic that has divided the industry is how innovation is rewarded in the Nordics.  One pool says that the focus is too much on price and not enough on innovation.  Others say that the Nordics is the best place to launch a product because it is where you get very fast market access for innovation.  What is your opinion?

I have to say that I am very familiar with the challenges of obtaining reimbursement.  And a product can’t get accepted into a market unless it has a significant level of reimbursement.  In Denmark we launched our GI product last year and we launched Elvanse very recently on April 15.  In Denmark you post the price that you want to be reimbursed at – and then a decision is made on the level of reimbursement you achieve.  I believe that’s probably a bit too extreme. I think a company needs to be able to show value for their product.  We put together a very extensive value dossier for Elvanse which we are using for our pricing and reimbursement negotiations here in the Nordics. We worked with local consultants to build this dossier to make sure it’s appropriate for Nordic markets and many say that it’s incredible data that we have – that we  have done the clinical trials that show that we can compare to other products.  I think that’s what a company needs to do.  We of course have to be cost conscious along the way.  Ultimately you and I are consumers as well.  We are selling products, but on the other end our families are also consuming products.  It’s incumbent upon pharmaceutical companies to be able to provide the studies to show why their product should be able to achieve a certain price and level of reimbursement.

 

Shire has just acquired Swedish company Premacure. What makes home grown innovation in the Nordics so successful compared to a country such as France, for example, which has not had much innovation in recent years?

A country like Sweden provides an environment, whereby, unlike perhaps other countries, the government and authorities have allowed companies to really be innovative and be rewarded with such things as incentives and favorable taxation.  Let’s not forget that the Nobel Prizes comes from here.  So that’s at the core of what the Nordic countries are encouraged to do and are rewarded for doing.  We have not acquired that many companies or products, but for Shire to be able to partner with Premacure, which is Swedish, I think is phenomenal.  It really speaks to the viability of the biotechnology here and how people here are encouraged to innovate.  Before Premacure was part of Shire, they were surrounded by an environment that allowed them to invest, explore and discover, which we then found was a good fit for us to be involved with.  So it’s not just Shire, it’s Premacure itself existing and being able to bring and develop these types of technologies and products which I think needs to be highlighted.

 

You have been here for 18 months now.  What is the one lesson that you could tell a fellow expat general manager coming to the Nordics?

I always joke around that the team accepted me very well here because I have extensive experience with Shire.  After 16 years with Shire, I could really help this new Nordic LOC.I knew a lot about Shire.  I wasn’t here when we first set up the Team, but I come with a lot of experience as to what is Shire and what the processes are here.  So this was a quick way for us to get the Nordic team up and running, by having someone who can connect them within Shire.  On the flip side, what I needed to do was be very mindful of the culture of the people.  We didn’t want to come in here and change the Nordic team.  We wanted to make sure that the Nordic team was heard.  When I first met the team we had dinner that night and they asked me what the biggest challenge the Nordic team will face.  And I said, the same challenge that any team has within Shire – to do what is right for Shire Nordics.  Not just Shire, but Shire Nordics.  It means to not just respect the rules and the regulations, but also the culture and the way people act and respond to things in this country.  We were not coming here with a broad stroke and wiping everything out.  The issue was how to make sure that we continue to respond to the needs of the patients, physicians and authorities here. 

When I first came on board they accepted me because they first tried to scare me by saying that it’s very cold here!  But I told them that I’m from Montreal where it’s just as cold in the winter!  So I think they accepted me very readily because of: Canada, Nordics, cold weather, and very similar family values and how we see the work environment.  So it was a good fit from the beginning.  But I’ve also had to learn a few things and bite my tongue at times.  But that comes to the point that this is not Canada.  You’re in the Nordics and you have to be mindful of that.

 

If we come back in five years, what would you like to be your legacy, having started the Shire specialty pharma team here?

I think the legacy will always be some of the growing pains that we experienced.  Even though the HGT group had been here before, we were bringing on more employees and business infrastructure which brought on a whole new business model while having to get everybody up and running in the processes.  I would like to see us establishing ourselves as a credible partner with a long-term vision of how we continue to work to improve the quality of life of patients in the Nordics.  I’m usually known as the trouble shooter.  I come in, face the problems, fix it all, walk away and allow the next person to claim that all is good and well.  So I’d like to be back and watch the revenues grow and track the continued growth of what we started to build here, as well as the enthusiasm that the Shire Nordic team has with regards to the work and the passion that they continue to bring.  This team has already won awards within Shire for innovative ideas and ways to approach the customers and physicians.  I want to continue to see the Nordics stand out as the team who did and succeeded at X, Y, and Z things for the first time.

 

Would this be your final message to our readers?

Anywhere you go in Shire – any affiliate – when you meet the doctors, after they’ve gotten to know people who have worked at Shire for a while they say that there’s something different about the people who work here.  I know that’s why I continue to work here at Shire – because it’s a company that grows quickly, changes, and adapts to its environment.  There’s something about all the people that you meet at Shire.  It’s something that I think the Nordics can fully embrace now, can make their own, and continue to grow among the team.