TOKYO - Takeda, like most Japanese pharma, is hoping to counter the ongoing trend of patent expirations and yen appreciation by looking outward. Pushing beyond their comfort zones of Japan and U.S. markets, Japan's top pharma are pushing to gain ground in Europe and Asia. Similarly, these companies are looking outside of their own staff for expertise in these new regions.

The 2009 patent loss of Prevacid (lansoprazole) continues to impact Takeda's sales. First quarter net sales decreased 6.4 percent to ¥354.7 billion ($4.08 billion) from the same period last year. The drop in net sales comes regardless of new product launches in Japan, including DPP-4 inhibitor Nesina (alogliptin), hypertension combo Unisia (candesartan/amlodipine), and anti-cancer mAb Vectibix (panitumumab). Prescription drug sales increased 1.1 percent - or ¥1.5 billion - for the quarter, but overseas sales decreased ¥24.3 billion from the same period last year.

Asked about Nesina's potential in the Japanese market - where it is the third DPP-4 introduced in the market, behind two sitagliptin entries from Merck and Ono Pharmaceutical - Senior VP Masato Iwasaki said that DPP-4 inhibitors appear to be particularly effective for the Japanese population compared to Western populations, which enhances the DPP-4 market. "The diabetic franchise has been very strong and we are very positive in making good progress in sales on Nesina," Iwasaki said.

But this all comes as expected, and the company is maintaining the decreased fiscal 2010 forecast it published in May 2010 (Also see "Takeda Cuts Jobs And Pushes Oncology After Patent Losses Nudge 2009 Sales Down 4.7%" - Scrip, 14 May, 2010.). The appreciation of the yen against the dollar continues to be a struggle for all Japanese companies, but now the financial crisis in Europe is weighing in as well. Takeda changed its assumption of the euro exchange rate from ¥130 to ¥110 for €1, which the company expects to have a negative impact on sales.

Takeda Looks To External Products, Leadership For Growth

Regardless, the company is hoping to gain ground in Europe. In April, Takeda and AMAG Pharmaceuticals teamed up to commercialize AMAG's intravenous iron drug Feraheme (ferumoxytol). For an upfront $60 million and up to $220 million in milestones, Takeda will sell Ferahame in Europe, Canada, Turkey, the Commonwealth of Independent States and Asia Pacific - excluding Taiwan, China and Japan. 3SBio owns rights to the drug in China, and AMAG has said Feraheme would have trouble competing at its price in Japan (Also see "AMAG Pharmaceuticals Irons Out Ex-US Deal With Takeda For Feraheme" - Scrip, 2 April, 2010.).

Marketing authorization for Feraheme was submitted to the European Medicines Agency in June for iron deficiency anemia in chronic kidney disease patients, and Takeda expects marketing approval in fiscal 2011.

"We anticipate that Feraheme can be differentiated from existing drugs because while other approved IV iron formulations typically require five to 10 administrations given over multiple weeks to receive a standard one gram course of therapy, Feraheme needs [two doses]," Takeda Chief Scientific Officer Shigenori Ohkawa told analysts, adding, "We expect that Feraheme can provide physicians a new treatment paradigm for patients with iron deficiency anemia."

Feraheme is also currently undergoing Phase III clinical trials for IDA treatment regardless of underlying cause.

Takeda is also taking strides to revise its approach to its international operations leadership, and recently announced the appointment of two senior executives that came from outside of the company. Japanese media has focused on the external hires, a somewhat surprising move in a country where companies usually promote from within their own ranks.

Noxxon Pharma CEO Frank Morich is to succeed Alan MacKenzie, who is scheduled to retire Oct. 1 as executive VP of international operations, Americas/Europe. Haruhiko Hirate was brought in from GlaxoSmithKline to serve as senior VP of international operations, Asia.

Takeda is seen to be shifting some resources from the U.S. to Asia. After announcing a 10 percent cut of its jobs in the U.S., Takeda said it will finally launch its own commercial presence in neighboring South Korea, and has stressed the importance of type 2 diabetes treatment Actos (pioglitazone) in the company's emerging markets growth strategy, particularly in China (Also see "Takeda Takes Global Expansion Next Door To South Korea" - Scrip, 24 June, 2010.).

Of course, not everyone is impressed with Takeda's message. "Judging from the 1Q results conference call, the company lacks fresh themes so we await fresh developments with its new drug pipeline," Credit Suisse analyst Fumiyoshi Sakai said in a July 30 note.

- Daniel Poppy (d.poppy@elsevier.com)

Takeda Continues Post-patent Prevacid Hit, Looks Externally For Innovation And Leadership

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