Canada: Smaller Market Entrants with Big Plans

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Several smaller pharmaceutical companies – Taiho, Valneva, Mallinckrodt, Théa and Intercept Pharma – have chosen to set up operations in Canada very recently, recognizing the potential for product launches and development or taking back their out-licensed portfolio.

“The establishment of the Canadian affiliate had always been part of our global expansion plan”

Ross Glover, Taiho

Pride and high motivation characterize the approach of recent entrants to the Canadian market. Company heads are looking confidently at the future of their operations, some already heavily advocating for increased responsibilities and investment into research for instance. Having only opened operations in 2017, Taiho’s flagship oncology drug Lonsurf® received fast-track review and approval from Health Canada andTaiho plans to become an important player in oncology in Canada. Ross Glover, general manager, says, “the establishment of the Canadian affiliate had always been part of our global expansion plan, whereby the intention was to establish a strong presence in the US first, before venturing across the border.” And it has proven a success – Glover admits that the company’s venture has paid off: “ we have been very successful in hitting objectives in the first year”.

The Canadian affiliate of Valneva, a smaller vaccine-specialized French company started out in 2015 but “already contributes 20 percent to global revenues,” according to its general manager Greig Estabrooks. “For a new and emerging company, we are punching above our weight and will continue to do so in the years to come,” posits Estabrooks. Like many CEOs of newly founded operations, he follows a clear path to ensure the successful development of the subsidiary. Estabrooks confides: “I have a mantra: ‘Practice like you have never won and perform like you have never lost.’ For a relatively new company, this is very important across our entire Canadian Organization and something I try to instil in all employees.”

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As many new entrants do not set-up full functions immediately, they leverage shared services from their companies’ US operations. Taiho and Mallinckrodt both profit from the close proximity to the US and have been able to drive efficiency as a result; Glover noting that there is a complementary aspect in the collaboration, and highlighting how the Canadian affiliate was able to refer to the US team’s experience with the launch of their flagship oncology product Lonsurf® three years prior to its introduction to Canada. Mallinckrodt’s general manager Robin Hunter however also underlines that one of the “most difficult aspects lies in correcting the assumption that a product launch in Canada can be successfully executed by a US-based brand team.” Canada is not just the 51st state to replicate a schema in the expansion of a company but requires a targeted strategy. He adds, “Mallinckrodt Canada today is not yet the company we aspire to become. I think people should keep their eyes on us through our transitional period, and in 2020, those who did not will say ‘I wish I had known that company before. I would have liked to work there.’”

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The French ophthalmic company Théa chose to enter Canada in form of a joint venture with local Labtician. The new company, Labtician Théa, launched in November 2017 is “a very natural fit” and the collaboration of “two pretty amazing companies that are very well aligned culturally and both have a rich history in innovation,” according to its president Mark Smithyes. He sees “Théa’s rich pipeline of preservative-free treatments, which are already the standard of care in Europe, [combined] with Labtician’s proven sales, distribution and service expertise truly representing a major win for Canadian eyecare professionals and their patients. We have set out to leverage the strengths of both organizations to be the leader and essential partner for optometrists and ophthalmologists in Canada.” Not only does Smithyes aim for leadership with Labtician Théa, he considers that Canada itself has enormous potential “to be a leader. All the building blocks for a robust life sciences sector are here; an innovation mindset, great science and scientists, world class universities and research, entrepreneurs and a growing investment community.”

Other new entrants are including a research dimension in their activities from the start: several affiliates were established precisely because of the potential for conducting research in decisive therapeutic areas in Canada. Intercept Pharma came to Canada in 2015, and immediately started heavily relying on research conducted in Canada in its efforts to bring its drug for PBC (primary biliary cholangitis, a non-viral liver disease and the number one reason for liver transplants among women in Canada) to the Canadian market. Its general manager Brian Canestraro recalls: “I was actually impressed by the number of Canadian sites that are part of our clinical programs. We had number of sites participating in early PBC research; as well as a significant number of sites in long-term extension studies as part of our post approval commitments. We also have a number of sites participating in our NASH (nonalcoholic steatohepatitis) registration studies and are very optimistic that this will continue to be the case as we explore potential further research in PSC (primary sclerosing cholangitis).” “Overall,” he continues, “I have found that there are sometimes limitations in relying solely on translating data from abroad into the Canadian environment in a way that is meaningful. This underscores the importance of incorporating Canadian-specific epidemiology and disease outcomes data into planning, which ultimately supports stakeholders and healthcare professionals to make better decisions.”

Taiho also has an already operational R&D site in Canada and “intends to further capitalize on the rich R&D landscape here,” according to Glover. He continues, “when I came on board at Taiho Pharma Canada, I noticed that we lacked research activity in Canada, and there was tremendous scope to ramp up and expand operations. I am excited that we have started a new level of colorectal research and cholangiocarcinoma research in Canada. Indeed, Canada should not be overlooked for R&D operations due to its global connectivity. We offer a more affordable environment than other major countries like Germany, the US or the UK. We have excellent facilities and the best academic minds in the world.”

Other new players have yet to start their R&D activity in Canada but are already heavily advocating for projects to reach Canadian ground. Lobbying for “more research investment to come to Canada is one of my key responsibilities, to take advantage of the exceptional quality of research centers Canada offers,” says Hunter of Mallinckrodt. He is echoed by Valneva’s Estabrooks who is a strong proponent “for clinical trials to be conducted in Canada for the company’s pipeline vaccine candidates – given the available talent and resources for vaccine research in Canada,” especially in an area such as Lyme disease, which is becoming more and more prominent in Canada.

Writer: Anna-Luisa Vogt

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