Millennium, After Takeda Takeover, Shows Off Cancer Drug Pipeline

About 11 months ago, Cambridge, MA-based Millennium Pharmaceuticals agreed to be acquired by Tokyo-based Takeda Pharmaceuticals for $8.8 billion. We’ve already written some about how this deal presented Millennium’s CEO, Deborah Dunsire, some special challenges in terms of language barriers, cultural barriers, taking control of Takeda’s entire cancer drug portfolio, and trying to fit her company’s fast-moving biotech management style into the context of a global concern.

Last night (actually 10 am Tokyo time/9 pm Boston), Millennium apparently felt confident enough to shed some more light on its game plan. Executives described some of the highlights of the company’s pipeline of cancer drugs in front of financial analysts at Takeda’s Tokyo headquarters, and at least a few in the media (like me) staying up late back home in the States.

The crown jewel of this deal obviously was, and remains, bortezomib (Velcade). Sales of this drug for multiple myeloma, a bone marrow cancer, grew by more than 40 percent last year, exceeding $1.1 billion worldwide. But as Dunsire explained to me last fall, Takeda also wanted Millennium’s in-house expertise in cancer drug development, and its pipeline. Millennium, she said last night, now has 13 drugs in development, with the goal of introducing three to four new drugs into clinical trials each year. The company aims to develop differentiated drugs that seek to hit targets on cells that have never been hit before, or novel compounds against targets that have been validated by other drugs.

The opportunity for developing new cancer drugs is vast and growing, because of improved understanding of the fundamental biology of what causes cells to become cancerous, Dunsire said. She showed one slide, citing data from Cowen & Co., that said the global market for cancer drugs, worth $66 billion in 2008, will grow to $84 billion by 2012. Another slide showed the world’s top makers of cancer drugs, ranked by revenue. Takeda was 11th, at $1.5 billion. Dunsire made it clear she wants to rise in those standings.

“We aspire to cure cancer,” Dunsire said. “I know and you know that hasn’t been done. We believe this will inspire us to bring forward extraordinary medicines.”

Here’s some of the highlights of what Millennium chose to present about what it considers its most promising candidates in the pipeline:

—MLN-9708. This is a proteasome inhibitor, like Velcade, except that it has been designed to be safer and have better absorption characteristics.It also might work against solid tumors as well as blood cancers like myeloma, and is given orally, instead of intravenously. This candidate is still in animal testing, but Millennium sees this as the logical extension when the Velcade patents expire in 2017 in the U.S., and 2019 in Europe and Japan, Dunsire said.

—MLN-8237. This drug is made to interfere with the cell cycle, by blocking the Aurora A kinase. Nancy Simonian, the company’s chief medical officer, shared an anecdotal case from early clinical studies in which a 52-year-old woman with a relapsed form of ovarian cancer had a partial response when taking this drug by itself—and it also appears to work well in tandem with standard chemotherapies. Many other companies are pursuing drugs to block forms of Aurora kinase, yet Simonian said, “this drug has an opportunity to be first-in-class.” It is expected to enter mid-stage trials this year.

—MLN-4924. This drug blocks a target called Nedd8 activating enzyme, a novel target discovered by Millennium scientists. This small-molecule drug is supposed to block pathways that are critical to cancer cell growth and survival. It is currently in early-stage clinical trials for solid tumors and blood cancers, and is expected to enter the second of three phases of clinical testing this year, Simonian said.

How much all of this is costing Takeda is a mystery, since executives ducked that question from one financial analyst, at least according to the English translation I heard on the call. Some of these questions were of the left-field variety that you wouldn’t expect from biotech analysts in the U.S., like whether Dunsire has a relationship with the incoming FDA commissioner. (She doesn’t, and patiently explained that doesn’t really matter, because the company deals mainly with staff in the oncology division.)

One question I did hear loud and clear was whether Dunsire would like to become the CEO of Takeda someday. “My Japanese would have to improve a lot,” she said, leaving it at that, as the room filled with laughter.

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