Shire as a whole has grown dramatically in the past twelve years, going from approximately 400 to more than 5,000 employees worldwide in 2013. Shire’s presence in Canada grew as well: in less than a decade, we launched seven products in the country. And there are yet others to come in the short to medium term.
When I became country manager in 2004, we were just establishing ourselves in the area of attention deficit hyperactivity disorder (ADHD), namely with the launch of ADDERALL XR®, one of the first long-acting ADHD medication launched in Canada. In 2010, Shire launched VYVANSE®, the company’s second entry into the ADHD marketplace and earning the title of the industry’s “Best product launch” in 2010. Today, Shire holds 23 percent of the ADHD market share in Canada with these two products combined. Now that we have a definite footprint in the ADHD community in Canada, our goal is to continue to strengthen our leadership position in that area day after day.
Another important milestone for Shire in Canada has been establishing itself in the area of rare diseases, mainly in lysosomal storage disorders such as Hunter syndrome (MPS II) as well as Gaucher and Fabry disease. We have active partnerships with medical and patient associations across the country with the end goal to help improve patients’ lives, as well as their families, either by working closely with stakeholders to improve access to our medications, investing in better tools for accurate diagnosis and patient care support.
Another interest for Shire in Canada has been in the area of ulcerative colitis, with the launch of MEZAVANT® in 2008 (marketed as LIALDA® in the US), as well as end-stage kidney disease with the launch of non-calcium phosphate binder FOSRENOL® in 2007.
We are proud of what we have accomplished so far in Canada and our focus is to continue to build and grow on these solid foundations.
What is the perception of ADHD in Canada?
It is difficult to say with certainty; it depends where you sit in the room! Overall, I believe that the vast majority of Canadian healthcare professionals recognize that ADHD is a genuine and serious medical condition. ADHD management requires medical experts that have the appropriate training and tools to properly diagnose and treat the condition. We have wonderful ADHD experts in Canada and their number is growing. However, there is still room for more to be able to answer the needs of the population. Shire tries to support the community, namely by investing in continuing medical education initiatives for physicians and by supporting patient initiatives to raise awareness and education about the condition.
According to the Canadian ADHD Resource Alliance (CADDRA), there is an indication that the rate of ADHD among adolescents has increased dramatically in the last decade. What is the source of this sudden increase?
I think a combination of factors contributes to explain the increase. Although the overall prevalence of ADHD has remained stable over the years, the tools and knowledge to diagnose ADHD have improved significantly during the last decade. The science of ADHD continues to evolve still to this day – for example, there is clear and documented evidence on which areas of the brain are affected that we didn’t have just a few years back. This leads to more education more physicians who treat ADHD. Considering the long waiting lists for access to a specialist, even a modest increase in the number of treaters can have an impact on number of diagnosis. These are just a few potential explanations; I would defer to CADDRA for a final say on the matter.
Russell Williams of Rx&D mentioned that one of the biggest challenges of the industry at the moment was for people to comprehend the value of innovative products. How can Shire, as an innovative company, be a champion of that cause?
Shire can be a champion by focusing on bringing innovative medicines to the market that add value to physicians, patients and society as a whole.
For example, Shire provides innovative therapies for rare diseases, an area where incidence and prevalence rates are very low but need for treatments very high.
Another example is DERMAGRAFT®, a skin substitute newly introduced in Canada to treat diabetic foot ulcers (DFUs), a complication of diabetes. The societal and financial impacts of DFUs on the Canadian healthcare system are huge, to the extent where Canada’s political leaders identified DFUs as one of the country’s most pressing health issues. Here again, Shire is present in an area of high, unmet need.
What is the potential of regenerative medicine as part of Shire Canada’s portfolio with the launch of a product like DERMAGRAFT?
DERMAGRAFT is the first product to come out of Shire Regenerative Medicine’s team. Right now, we are focused on bringing DERMAGRAFT to market in Canada and ensure the best access possible to patients who need it.
Mary DiMarzio of Shire Nordics emphasized the importance of companies to provide strong evidence as to why their product should be sold and reimbursed at a certain price. How does Shire Canada manage to demonstrate the efficacy of its products?
As mentioned, Shire focuses on bringing innovative medicines to the market that add value to physicians, patients and society as a whole; the point being that it is much easier to demonstrate the value of a product when it is clearly differentiated. Where I think pharmaceutical companies need to improve is quality of their evidence, namely via head to head trials and real-life outcome data. I’m glad to say that Shire has already improved its approach in that sense and will continue to do so moving forward.
The first quarter of 2013 for Shire delivered strong results, with sales of USD $1,117 million. What is the strategic importance of Canada for the organization as a whole?
Canada plays an important role in Shire’s success outside the United States, and increasingly so in recent years due to the challenges the industry has been facing in Europe. The Canadian affiliate has doubled its revenue in the last three years, from around CDN $70 million in 2009 to more than CDN $140 million last year. Our aspiration is to continue being a significant contributor to Shire’s commercial success.
Inorganic growth has played an important role in the development of Shire over the years; most recently SARCode in California and PremaCure in Sweden. To what extent does Shire Canada actively look for local companies to merge with?
Shire has a dedicated team that focuses on assessing business opportunities across the world, including Canada. In fact, Shire’s presence here followed the acquisition of Roberts Pharmaceuticals followed by Laval (Québec)-based BioChem Pharma in 2001. As local experts of our market, we will of course proactively share any relevant leads or opportunities that come to our attention.
Shire Canada is actively involved with a number of social initiatives, including the United Way campaign, the Shire ADHD Scholarship Program as well as being contributions to the SickKids and Montreal Children’s Hospital Foundations. Looking at 2013, what can we expect from Shire Canada in terms of social initiatives?
On a local level, Shire has been an active player and contributor to the United Way campaign in the Greater Montreal region. Shire is also a partner to two of Canada’s most important pediatric hospital foundations: the Montreal Children’s Hospital Foundation and the Hospital for Sick Children Foundation in Toronto. We have also developed and implemented Shire-owned initiatives, such as the Shire Brave Awards to support caregivers as well as the Shire ADHD Scholarship Program meant to support individuals with ADHD pursue post-secondary studies. The program provides financial support to help pay for tuition, but also coaching services from the Edge Foundation for one full academic year.
If we were to return to Canada in another three to four years, what is your vision for the affiliate by that point?
I would like Shire to have a strong presence in Canada in all five therapeutic areas: Neuroscience, Rare Diseases, Gastroenterology, Internal Medicine and Regenerative Medicine. The Company has two well-established ADHD products available in Canada. I hope the ongoing clinical trials for other uses of VYVANSE, namely for major depression and binge-eating disorder, come to fruition so we can make it available to Canadians. Essentially, I would like to be able to say that everything that Shire can currently offer is available in Canada.
What keeps you motivated to come to work every day?
I have been working in the industry for 30 years, the last 12 at Shire. At the time, Shire was just a small company relying heavily on the success of ADDERALL XR in the United States. Today, after seven successful product launches in Canada, many of which are market leaders, our Canadian affiliate plays a significant role in Shire’s overall success. Since Canada is often second to launch after the US, the feedback we get from patients benefiting from our products remains most gratifying. You feel that your entrepreneurial skills and initiatives are appreciated and you can see the outcome of those initiatives in different countries. Another powerful source of motivation is the unprompted feedback we receive, stories about how one of our products helped change the life of a patient for the best. I never get tired of hearing those and it’s the reason I go to work every day.
What is your final message to the readers of Pharmaceutical Executive?
Canada remains a very interesting market for research and development, provided that the country continues to fight for very competitive IP protection. At the moment, Canada is trying to align on data protection and patent-term restoration, as part of our free trade discussions with Europe, similar to what is seen in the best jurisdictions around the world. Shire, as all other pharmaceuticals in the country, needs to continue to show the value of what it brings to market. Innovative medications need to been seen as what they are: an investment in our healthcare systems, not a cost. This integration of innovation into the healthcare system should lead to improve health outcomes and efficient use of resources. As for Shire, we will continue to focus on bringing innovative medicines to the market that add value to physicians, patients and society as a whole in areas of high unmet need.
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