Takeda and Millennium's combined oncology unit has 13 molecules in clinical development, six of which are in Phase II or III, including potential first-in-class opportunities.

Takeda outlined the strategy for its Millennium oncology unit during an investor meeting March 25, marking the first detailed overview the Japanese pharma has laid out for the business since acquiring the Velcade marketer last year.

Building on the 13 oncology compounds in clinical development, Millennium also aims to bring three to four new investigational new drugs to the pipeline each year, both small and large molecules, focusing on best-in-class or first-in-class opportunities

When Takeda announced the $8.8 billion acquisition last April, the company said it would maintain Cambridge, Mass.-based Millennium as a stand-alone business unit responsible for Takeda's global oncology (Also see "Takeda’s Bid For Millennium May Face Several Hurdles – Pharma Analyst" - Scrip, 11 April, 2008.).

Now that Takeda's oncology program has been transferred to Millennium, management has prioritized the pipeline and is re-evaluating its strategic goals. At the time of the acquisition, Takeda said it aimed to become a top-three player in oncology by 2020, but President Yasuchika Hasegawa threw a splash of cold water on that goal during the latest update.

Citing recent consolidation in the industry - the Pfizer/Wyeth and Merck/Schering-Plough mergers among them - Hasegawa said the company is re-evaluating that aspiration. Nonetheless, Takeda has not altered its overall goal of becoming a leading oncology company, he said.

Takeda and Millennium's combined oncology-related revenues are expected to be $1.5 billion for fiscal 2008 (ending March 31), ranking the company behind the top 10 players in the field. Revenues include Millennium's Velcade (bortezomib), indicated for multiple myeloma and mantle cell lymphoma and partnered with Johnson & Johnson, and Takeda's Lupron (leuprolide), a gonadotropin-releasing hormone agonist for prostate cancer patients. Under the dissolution of Takeda's TAP joint venture with Abbott, however, Abbott gained full rights to Lupron while Takeda took rights to Prevacid (Also see "Takeda Buys Abbott’s Stake In TAP Joint Venture" - Pink Sheet, 19 March, 2008.).

"When we think about leadership, we think about it in multiple dimensions," Millennium CEO Deborah Dunsire said. "Of course, there is always the metric of revenue leadership ... but leaders are not only about revenue. They are also about having a pipeline of differentiated therapies that will deliver launches out into the future."

High Priorities For Motesanib, Aurora A Kinase Inhibitor

While Millennium continues to study Velcade in new indications, including in follicular, frontline mantle cell and diffuse large B-cell lymphomas, the R&D focus is on creating a portfolio of drugs around the flagship product. Among the compounds in the pipeline is a next generation proteasome inhibitor, MLN9708, which could be dosed orally and potentially be more effective than Velcade, Exec VP Christophe Bianchi said.

MLN9708 is still in early development, but a late-stage opportunity is motesanib, which is currently in development with partner Amgen in non-small cell lung cancer patients. A Phase III trial of the oral vascular endothelial growth factor inhibitor is now set to re-start after being halted last year due to cases of severe bleeding, based upon the recommendation of the study's independent data monitoring committee (Also see "DMC Recommends Resuming Phase III Takeda, Millennium, Amgen MONET1 Trial" - Scrip, 12 February, 2009.).

Another high priority program is MLN8237, an aurora A kinase inhibitor with the potential to disrupt tumor cell growth and survival, discovered at Millennium with the potential to be a first-in-class drug. The company is studying MLN8237 in two Phase II trials in leukemia and lymphoma and a third will start in ovarian cancer patients.

Millennium is also looking to build on Takeda's foundation in prostate cancer with Lupron, a drug developed by the Japanese pharma.

"There continues to be a large unmet medical need for prostate cancer patients, and so we want to build on the strength of Takeda with two molecules that are now in clinical development," Chief Medical Officer Nancy Simonian said.

One is TAK-700, a 17, 20 lyase inhibitor that targets a key enzyme in the synthesis of testosterone. A Phase I/II study is ongoing. The second program is TAK-683 and TAK-448, gonadotropin releasing hormone receptor modulators that reduce testosterone levels. Both are in Phase I trials and Millennium expects to make a decision later this year on which to move forward in clinical development.

Among the biggest challenges Millennium has faced in combining the businesses is transitioning from a small nimble biotech into a global enterprise, as well as cultural differences combining with a Japanese pharma, Dunsire acknowledged.

On the flip side, Takeda's broader resources have proved useful, she said, noting that funding from Takeda allowed for the expansion of the Velcade sales force and marketing programs.

Takeda also recently announced the approval of its monocolonal antobody Vectibix (panitumumab) in Japan for treating colorectal cancer (PharmAsia News, March 27, 2009).

-Jessica Merrill (j.merrill@elsevier.com)

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