Millennium wants to rival top 10 drugmakers in oncology

Deborah Dunsire, CEO

Millennium has broken into the big leagues of oncology players over the past several years with its top-selling cancer drug Velcade. Now Millennium, a unit of the global pharma group Takeda, aims to become one of the top several cancer drug companies on the planet by the end of the decade, Millennium CEO Deborah Dunsire told FierceBiotech during an interview at the BIO meeting in Boston on Monday.

Millennium (known formally as Millennium: The Takeda Oncology Company) has expanded in size and global reach since Takeda, Japan's largest drugmaker, bought the Cambridge, MA-based group in 2008 for $8.8 billion. During that time, Millennium has more than doubled the number of experimental drugs in its pipeline to 20 molecules--including three drugs in late-stage trials led by its promising anti-prostate-cancer drug TAK-700. And the company has swelled its ranks by roughly 50% during the past four years, Dunsire says, with many of the hires made to beef up the company's development group.

In pharma, scale matters. Millennium now has the ability within its own ranks and via Takeda's commercial organization to handle sales of drugs around the world without needing another pharma partner to pick up the slack, Dunsire says. Take, for example, the fact that Millennium needed to tie up with Johnson & Johnson ($JNJ) to handle sales of the blood cancer drug Velcade outside of the United States because the company had lacked the bandwidth to launch the drug in Europe and other foreign markets.

Millennium now ranks No. 12 among cancer drugmakers worldwide, and improving its standing on the global oncology stage will take "a combination of growth in the current products" such as Velcade and the lymphoma drug Adcetris, Dunsire says, as well as drugs in late-stage clinical trials for a variety of tumor types.

In terms of the late-stage experimental drugs, Dunsire has high hopes for TAK-700, MLN8237, an Aurora A kinase inhibitor for lymphoma, and MLN9708, an oral proteasome inhibitor in development for multiple myeloma. TAK-700, which was discovered in Takeda's labs, is the most advanced of those contenders and could be on the market by 2014 for treating advanced prostate cancer, the CEO says.

TAK-700 (known chemically as orteronel) is the leading example of the company's increased emphasis on developing drugs against solid tumors, an area in which there's both plenty of competition and opportunity for business growth. In the prostate cancer arena, the orally administered TAK-700 faces potential rivals such as Johnson & Johnson's antitumor pill Zytiga, approved for the U.S. market last year, and Medivation's ($MDVN) late-stage candidate enzalutamide.

Millennium/Takeda's drug, which stymies the synthesis of male hormones that fuel prostate tumor cells, is being tested as a treatment for men with metastatic castration-resistant prostate cancer before and after they are treated with chemotherapy. Dunsire notes that a Phase II study presented at ASCO showed that the drug could be given without side-effect-causing steroids, and there's reason to believe that the compound could eventually be used to combat prostate cancer at an earlier disease stage and therefore address a larger market.

Dunsire, a physician by training and former Novartis ($NVS) oncology exec, owes much of her success at Millennium to expanding the market for Velcade. The injected proteasome inhibitor was initially approved in 2003 as a second-line treatment for multiple myeloma, a cancer of plasma cells in bone marrow. Since Dunsire joined Millennium in 2005, the company aggressively expanded the label for the drug to include mantle cell lymphoma in 2006 and first-line multiple myeloma in 2008. Velcade, which brought in $692.7 million in sales last year, has become one of the top-selling brands in oncology.

With the recent approval of Velcade for subcutaneous injection, Dunsire says, the drug could be used even more widely as patients take advantage of the quicker duration of dosing and lower risks of peripheral neuropathy than in patients who get infusions of the treatment.

Next up is Adcetris, a new drug for rare lymphomas that Millennium licensed from Seattle Genetics ($SGEN) for markets outside of North America. In the second half of this year, Millennium hopes that European regulators follow suit with the FDA, which approved the drug for the U.S. market in August, and green-light the drug for use in EU countries. The drug, which targets a tumor receptor known as CD30, has the potential to be used to kill additional cancers that express CD30. Millennium also aims to develop a companion diagnostic to identify patients with CD30-expressing tumors that would be used prior to treatment.

"My goal is not only to build a great oncology presence for Takeda, it's also to build a strong Takeda," Dunsire says.

To make good on this mission, Millennium has become laser focused on oncology over the past 4 years, though the company has continued to support development of key compounds from its former inflammation pipeline. For instance, Takeda has recently been touting positive Phase III data from studies of a former Millennium antibody known as vedolizumab in treating inflammatory disorders such as Crohn's disease and colitis. Millennium kept a development role in the program after it became part of Takeda.

So Takeda has felt the impact of the Millennium purchase outside of oncology, as vedolizumab could become an important new drug for the Japan-based company. And Takeda, which faces generic competition to its best-selling diabetes drug Actos, needs some new drugs to hit the market over the next several years to make up for the decline in Actos sales.

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