Can you outline your key management goals for Millennium over the next three years. What will the organization look like
then, as a consequence of your leadership?
Protopapas: I am very optimistic about growing the business by delivering on our pipeline of new products, where we have 15 candidates,
nine of which are at the final Phase-III stage of testing. Millennium Takeda is emphatically no longer a one product company.
MLN 9708 [ixazomib], the first all oral combination treatment for treatment of relapsed and previously untreated multiple
myeloma, is performing extremely well in three Phase III trials, in relapsed/refractory multiple myeloma, relapsed/refractory
amyloidosis; and previously untreated multiple myeloma. It stands out as a worthy complement to Velcade and promises to extend our myeloma franchise well into the next decade. Hence I see a successful launch here in the US and
other key international markets as a critical milestone for us. Overall, taking the success of Adcetris for Hodgkins lymphoma into account, Millennium will continue to have a dominant market position in treating hematological
malignancies. And I expect that Adcetris will deliver additional indications as it is taken up in the market, just like Velcade.
A second priority for me is to motivate and energize our commercial teams through ever closer engagement with Millennium's
R&D operation. One of our key assets is the clarity and focus that we place on our science, where we seek leadership in medicines
aimed at the biological pathways cancerous tumor cells rely on to survive and multiply. It's a commitment easily understood.
And that commitment will not change.
Finally, partnerships remain a central element in our growth plan. Takeda as more than 20 such tie-ins underwahy, ranging
from the formal licensing of products and technologies to providing seed money to academic enterprises. There are fewer surprises
in store when you work with us; this is an important factor for the smaller biotechs and academia. Last year, we initiated
a very innovative collaboration called the Tri-Institutional Therapeutics Discovery Institute with three academic institutions
in New York – Memorial Sloan-Kettering Cancer Center, Rockefeller University, and the Weill Cornell Medical College. The focus
is to investigate early stage compounds to produce useful "proof of concept" studies that will identify specific biologic
pathways and favorably alter the course of a disease, not just for cancer but other conditions as well. Takeda is sending
some of our best chemists in Japan to work with the biologists around this very open-ended agenda, one that minimizes all
the legal pre-conditions, paperwork and reporting that usually permeates these arrangements.
Are there potential "disruptive innovations" that pose a threat to the business plan and might require a change of course?
Protopapas: The science behind cancer is progressing rapidly. The more we know, the more complex are the challenges facing our researchers.
Keeping pace will demand a significant augmentation of resources, both human and financial. That is something that keeps me
up at night. Nevertheless, it is a truly exciting time to be in this business. There are byproducts from the expanding knowledge
of biologic pathways to cancer, such as protein homeostasis, where controlling protein replication in the cell can inhibit
malignancies. Immunotherapy is another promising field, with progress occurring after many years of dead ends. Our studies
on Adcetris have sparked interest in toxin-conjugated antibodies and other highly targeted therapies linked to individual mutations.
Whether any of these initiatives will yield that "silver bullet" is unclear right now, but with commitment and a lot of luck
the scenario could change dramatically.
Millennium is driven by the search for innovative new treatments. What message do you have for governments and regulators
in helping you to better deliver on this mission?
Protopapas: Two messages stand out. First, innovation begins with the basic research conducted at the major academic teaching institutions.
Academic research is vital to oncology because so little is understood on how cancer cells grow and mutate to where they become
resistant to current therapeutic interventions. The goal post in cancer is always moving. Research has to keep pace. Second,
patient access to new treatments depends heavily on the commercialization of basic research. Society must be sensitive to
the incentives that compensate for the cost of moving compounds forward to the point where they can be certified as safe and
effective for human use. Appropriate reimbursement prices facilitate access to patients, which in turn generates evidence
that can demonstrate a positive health outcome. If it is not economically feasible for companies to invest in this process,
innovation will dry up.
There is a difference of opinion on what is "economically feasible." How do you overcome the views of some stakeholders that
pharma companies are profiteering at the expense of payers and patients?
Protopapas: My response is to return to the fundamental premise of our business mission – to evidence better outcomes for patients. Our
robust development program that generated Velcades's approved label has a tangible, justifiable impact on the patient: who could say Velcade is not worth paying for? Conversely, if a company brings to market a fifth in class medicine that carries no evidence of a
differentiated value proposition, then I think it appropriate to ask why it deserves a premium price.
William Looney is Pharmaceutical Executive's editor. He can be reached at firstname.lastname@example.org