Takeda's Oncology Taskmaster

Feb 01, 2014



With a freshly minted brand identity bound tightly to its formidable Japanese parent, Millennium: The Takeda Oncology Company is shedding its reputation as a "one drug wonder." That drug, Velcade [bortezomib] is the first FDA-approved proteasome inhibitor and the first approved 21st century treatment for multiple myeloma; with its multiple expanded indications, the blockbuster has, for many patients, turned what was once seen as a death sentence on diagnosis into something resembling a chronic disease. There are a few more spins on the cycle to come from Velcade, and Millennium now has its second marketed product, Adcetris, for relapsed Hodgkin lymphoma. The capstone is what looks like a new drug pipeline of steady, solid performers, all centered on oncologic applications, and with roughly half of the candidates now being tested at an advanced Phase III level. A globalized organizational model, the positive R&D buzz, the scale and deeper pockets afforded by the combination with Takeda – all this suggests Millennium may finally be moving up the ranks in the cancer league play. It's a view expressed with sunny, Greek-style confidence by Millennium's new President, Anna Protopapas, in an interview last month with Pharm Exec.

PE: Millennium Takeda's singular focus on oncology avoids the frequent strategic R&D repositioning that characterizes the more diversified big Pharma players. But there are risks, too, in depending on what is now seen as a crowded, highly competitive sector, where the science is challenging and pricing pressures are intense. How does Millennium maintain its therapeutic advantage in this environment? Is the overriding commitment to oncology products a hard fact for investors going forward?

Protopapas: Contributing to the fight against cancer has always been Millennium's mark of distinction. This was reaffirmed and accentuated by our merger with Takeda in 2008, where we now serve as the company's global "center of excellence" in oncology research, product development and commercialization. This commitment remains firm. In fact, we do not believe that oncology products bind us too narrowly in serving patients. Cancer is a complex condition; it affects patients in different ways. It is now accepted that cancer is a highly heterogeneous collection of diseases. Understanding these at the genetic and molecular level helps us discover new medicines.

PE: Oncology is not only at the frontier of science, it is the focal point for change in the practice of medicine as well as in the way new therapies are promoted to the provider and payer communities. The business model for oncology specialists is under significant financial pressure, while proactive patient education has become essential to a successful launch strategy. What is Millennium Takeda doing to address these structural transformations in the marketplace?

Protopapas: Our response to transition in the marketplace is very simple. It is to generate the right data and evidence to support our products' value proposition to clinicians, payers and patients. The starting point is the clinical trial, which we design and position not as an end in itself but as part of a research continuum that will extend well into the Phase IV post-marketing work that oncology stakeholders are coming to regard as even more important than the data submitted to secure initial FDA authorization. In fact, the differentiating factor in success is how well this evidence relates to the real-world clinical setting after registration. We build a strong data trail designed to support additional indications, to guide physicians in deciding among choice of therapy, to demonstrate compliance with relevant treatment protocols, to establish cost-effectiveness against the current standard of care, and to set proper expectations for the patient in terms of outcomes. Our data is increasingly targeted to this latter objective, because, as more cancer therapies are introduced, the patient experience is now the dominant thread driving treatment eligibility decisions.



With greater choice, we face an equally important obligation to help patients and their provider decide what is best for their condition. This is precisely what we did with Velcade, where strong trial data put us in the fortunate position as the only approved FDA treatment for myeloma with a demonstrated survival benefit in its label. We were able to leverage this evidence very quickly to ensure physicians took it into account in prescribing decisions.

Another example is the truly compelling evidence compiled on Adcetris, the treatment recently approved for patients with relapsed-refactory Hodgkin lymphoma. This cancer strikes young adults disproportionately and the drug is indicated for those who have exhausted other drug options – so the stakes for the eligible patient are very high. Trial data we presented with our partner, Seattle Genetics, at the December 2013 American Society of Hematology conference, yielded a median survival curve of 40.5 months – more than three years – for trial patients, most of whom, based on historical controls, typically would not be expected to do very well.

In our view, the strength of this data leads immediately to a conversation about value – no convincing is needed. We want products that advance the discussion beyond incremental benefit; our ultimate aim is to produce a cure. I think that attitude filters back to positively influence our relationship with providers and – obviously – patients.