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EXCLUSIVE LIFE SCIENCE FEATURE leaders LIFESCIENCELEADER.COM JULY 2014 22 illennium itself found suc- cess — and some frustra- tion — with championing a new class of cancer drugs inspired by release of the first human genome maps. The prize, the company's proteasome inhibitor Velcade (bortezo- mib), won its initial FDA approval in 2003 for treatment of refractory multiple myeloma (MM) and was later approved elsewhere for MM and for mantle cell lymphoma. Velcade remains Millennium's sole original oncology franchise prod- uct, though it shares commercial rights with Seattle Genetics for Adcetris (bren- tuximab vedotin) for Hodgkin lympho- ma and systemic anaplastic large cell lymphoma (ALCL). In 2008, Millennium became "Millennium: The Takeda Oncology Company," when it was acquired by the Japan-based corporation as the keystone of an ambitious global expansion in the cancer area. Now in charge of all of oncol- ogy R&D; at Millennium and Takeda is Michael Vasconcelles, M.D., as global head, the Oncology Therapeutic Area Unit (OTAU). Vasconcelles helps put the com- pany's past, present, and future into the context of Takeda's oncology expansion. STRUCTURAL CLUES — TAKEDA & OTAU A continuum of integration seems to be developing among the many indus- try mergers, acquisitions, and business- unit swaps now transpiring. Typically, on one end, a large company will absorb the smaller one, harvesting the "synergies" and erasing all vestiges of the acquired entity. On the other end, the acquired organization becomes the dominant force in the merged company. Millennium's acquisition falls nearer the latter, continu- ing its former identity and contributing most of the operational support for the OTAU, which is the umbrella that cov- ers all of Takeda's oncology R&D.; Hence, Vasconcelles' remarks apply to the par- ent company's entire oncology program, including R&D; partnerships, yet they also draw from Millennium's achievement. "Millennium built a legacy that led to a transformation in treatment of a disease that not long ago had a very poor out- come," he says. "Velcade is a large reason the lives of patients with myeloma are looked at substantially different today. It is a foundation that still drives the way we think." Vasconcelles could be naturally skeptical of mergers, considering he joined his cur- rent company only two years ago, in March 2012, after coming from Genzyme follow- ing its purchase by Sanofi. The Takeda/ Millennium union had a four-year track record by then, however, and it offered continuity, especially in his area. "The company's commitment to the oncology space was unchanged, and that was actu- ally one of the challenges. We were in the midst of many late-stage programs and an early pipeline that has real potential. First and foremost, we needed to continue to prosecute those efforts as flawlessly as we could. But we also made a shift in strategic direction, which was to integrate the R&D; structure of legacy Millennium into the Takeda R&D; organization." In addition to realizing efficiencies from the integration, Vasconcelles says the company had the strategic goal of "a truly global footprint" for its R&D; beyond what a wholly owned subsidiary such as Millennium could achieve. "Operating rea- sonably independently, even at the scale of Millennium, would potentially pres- ent growing challenges as our portfolio matures and our footprint in oncology strengthens and deepens." According to Vasconcelles, another action that strengthened Takeda's glob- al R&D; footprint was its acquisition of Nycomed in September 2011. A long- time licensor and developer, Nycomed immediately increased the number of products in Takeda's product portfolio and pipeline, and it bolstered Takeda's presence in Europe and "high growth emerging markets." "Now we have all the key organizational ingredients for delivering medicines to patients truly in a global sense. But we also need to make sure we think about our opportunities in the context of variations in disease patterns that occur in cancer globally, and our thinking was strength- ened by the global integration." Have the downside effects of large-scale corporate change intruded into this global harmony? "I've seen many similarities M to the changes I went through at other times in my professional life. It is critical that leaders within the organization do everything possible to be clear in their communication and transparent in their actions — to paint a clear picture of the underlying reasons for the changes and their intended results. Because, I believe, we have done a good job in that respect, we now have a settled organization with a clear set of objectives, and we are as passionate and excited about our mission as ever." FROM FRONTIER TO FRONTIER Besides globalization, another challenge for Millenium and the OTAU has been moving beyond the legacy of Velcade in ways that reflect the scientific progress since the product entered the scene. The initial enthusiasm over genetic and molecular targeting has been tempered by experience — tumors quickly develop resistance to targeted drugs, and their remarkable heterogeneity defies applica- tion to broad patient populations. Though Vasconcelles might be expected to mount a rigorous defense of the targeting strat- egy, his response is quite nuanced. "There are certain malignancies with identifiable disease-driving mutations that have allowed us to sufficiently understand the biology and target our discovery efforts accordingly," he says. "But there are also large areas of human cancers where the genomic complexity obligates us, not necessarily to shift from M I C H A E L V A S C O N C E L L E S , M.D. Global Head, The Oncology Therapeutic Area Unit, Millennium: The Takeda Oncology Company We have all the ingredients here to take Takeda Oncology to even broader and deeper places than it's ever been before. MILLENNIUM CARRIES ON WITH THE TAKEDA ONCOLOGY EXPANSION By W. Koberstein 0 7 1 4 _ F e a t u r e _ T a k e d a . i n d d 3 0714_Feature_Takeda.indd 3 6 / 2 3 / 2 0 1 4 2 : 5 5 : 3 1 P M 6/23/2014 2:55:31 PM