Biopharmaceuticals: creating the new and the different

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But what are the rationales for these biopharmaceutical companies to go global rather than take a potentially less burdensome route and fully out-license their innovative assets? What challenges do they face in establishing international operations and what sort of people does it take to actually make it all happen? Just as importantly, are there lessons learned for other companies looking to follow in their footsteps?

Why go global? Steve Aselage, Executive Vice President and Chief Business Officer at Novato, Calif.-headquartered BioMarin, says of their decision to go global: “Our original intent was to outlicense Naglazyme [an enzyme replacement therapy for the rare genetic disease MPS VI)], ex-USA. We set up our own operation in the EU when it became clear that we were not going to get a deal done that fairly valued the product. Interestingly, we went through the exact same process before expanding into Latin America. It was not clear-cut at the time but it is very clear now that we made the right decision.” Conversely for Gillian Ivers-Read, who was one of the founding executives of Pharmion (acquired by Celgene in 2007 for $2.9 billion), and who with former Pharmion CEO Pat Mahaffy is part of the leadership team at Clovis Oncology (she is Executive Vice President, Technical Operations and Chief Regulatory Officer), the decision to develop an international footprint at Pharmion and second time around at Clovis—was a nobrainer. “We were clear from the outset that we wanted to commercialise in the US and Europe. It’s quite simple—we want to be in control of our products and the community of physicians/KOLs we need to engage with is of such a size that we know from past experience that we can establish EU operations in a cost-efficient and effective way.” Dr. Thierry Darcis, the Vice President and General Manager of ViroPharma’s European operations, (which he helped create in 2007), echoes the ‘value’ argument and goes further: “It made sense financially of course but there was something more. We felt that we could bring the passion to the patient. It is the difference between another product that a distributor or partner adds to their portfolio and something into which all of our collective energies are channelled.”

It made sense financially of course but there was something more. We felt that we could bring the passion to the patient. It is the difference between another product that a distributor or partner adds to their portfolio and something into which all of our collective energies are channelled.

Barry Labinger, Chief Commercial Officer at Human Genome Sciences which partnered GlaxoSmithKline in developing and launching Benlysta (the first new treatment for Lupus in 50 years) offers a slightly different

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