Eisai will look to China and India for investment opportunities after establishing a strong oncology presence in the U.S.

Following the acquisition of MGI Pharma at the end of January, Eisai's assets were ¥1,238 trillion ($11.97 billion), Eisai Executive VP Hideaki Matsui told investors and analysts during a March 4 meeting in Woodcliff Lake, New Jersey, the company's new U.S. headquarters.

Eisai, based in Tokyo, launched its "Dramatic Leap Program" in 2001 under which it began an aggressive strategy of acquiring oncology-oriented products and companies to strengthen its global presence.

The company plans to have headquarters in each of five regions: Japan; the U.S.; the European Union; China; and Asia/Oceania/the Middle East. In January, Eisai moved its Asian headquarters, excluding China, to Singapore, CEO Naruo Naito told investors. He said the company would also have different growth strategies for each region.

Different Strategies For Different Regions

"When DLP started we had one growth strategy that could be applied worldwide; that was the idea that we had back then," Naito said. "But of late, there have been rapid changes in the environment as well as regulations. We realize that we need a different growth strategy for each of the regions … and that's why we've set up regional headquarters in five regions."

In Japan, Eisai has consolidated its operations to focus on prevention, intervention and innovation. Dispensing pharmacies have become more important in Japan, he said, so this regional approach will support the strategy in Japan.

In the U.S., the company is focusing on oncology. Eisai purchased MGI Pharma in January and Morphotek in March 2007, and the firm gained four oncology products from Ligand Pharmaceuticals in October 2006 (Also see "Eisai Strengthens Oncology Position With $3.9 Billion MGI Pharma Acquisition" - Scrip, 11 December, 2007.).

The Morphotek and MGI acquisitions opened the U.S. oncology market to the Japanese company, and it already has roughly 1,000 marketing reps in the U.S., Naito said.

Bolstered by its oncology pipeline, the company is now splitting its U.S. operations into two business units: Oncology and Institutional Care; and Primary Care and Specialty, Eisai U.S. subsidiary President and COO Lonnel Coats told investors. He said the firm is expanding its North Carolina plant to include a parenteral-use facility, "which will be the global supplier of parenteral products in the area of oncology for Eisai."

Now that the company has established a strong oncology presence, the next area for investment will be China and India, Naito said.

"Among the Japanese companies, we are the first to make such investments. We are already ahead in making investments and, as we have made investments, we realized that in these two markets the disease structures are different," Naito said, noting that the dominant diseases in Asia are infectious diseases and gastrointestinal diseases.

He added that because these diseases generally affect lower-income populations, pricing in India and China will need to be in the mid to low range.

Supportive Care Products Taking Larger Market Share

Eisai saw strong sales with its flagship supportive care product antiemetic Aloxi (palonosetum), which gained a U.S. indication Feb. 29 for post-operative nausea and vomiting (Also see "Eisai Wins U.S. FDA Post-Operative Indication For Antiemetic Aloxi" - Scrip, 4 March, 2008.). Eisai acquired North American rights to Aloxi when it purchased MGI Pharma.

"We don't see Aloxi just as a brand name but as an entire franchise," Eisai North America Chairman Lonnie Moulder told analysts. "Aloxi injection is a best-in-class product for chemotherapy-induced nausea and vomiting," which is "one of the most feared side effects of cancer chemotherapy."

Aloxi has a 40 percent market share, and Eisai sees opportunities to expand that share because other products in the same category, such as GlaxoSmithKline's Zofran (odansetron), have gone off-patent and are no longer promoted, Moulder said.

"The three other first generation 5-HT3 antagonists [5-hydroxytryptamine-3 receptor antagonist] that do have this indication, no longer have the support that we are applying to Aloxi in the field - marketing support and medical support. So that's why we anticipate additional share growth."

"In the head-to-head Phase III pivotal trial, compared to odansetron - or Zofran- Aloxi performed well on day one and on the two to five-day period. Pharmacologically, Aloxi has a longer plasma life," Moulder said, "40 hours compared to four to eight hours with the older agents."

An oral capsule formulation is also under review by U.S. FDA with an Aug. 22 action date.

Another franchise product acquired from MGI Pharma is Dacogen (cytosine). It is approved in the U.S. for a broad range of myelodysplastic syndromes, and Eisai is conducting roughly 30 clinical trials investigating the compound in other hematological areas, including a Phase III survival trial in acute myeloid leukemia.

"The launch of Dacogen has actually doubled the dollar size of this marketplace, having now achieved a 50 percent share," Moulder said.

A pro-drug of propofol, sedative agent Aquavan (fospropofol) is under review at U.S. FDA for use in brief therapeutic and diagnostic procedures. It has a July 26 user fee date.

With Eisai's Morphotek acquisition, it also is focusing on creating global biomarkers and antibodies and growing its biologics pipeline.

Eisai also said it recently had discussions with U.S. FDA regarding its next-generation Alzheimer's drug E2012. The company hopes E2012 will replace its blockbuster Aricept (donepezil), which goes off-patent in 2010. A gamma-secretase modulator, E2012 began Phase I trials in 2006 in the U.S., but Eisai suspended the trials in 2007 after concomitant trials in rats indicated that E2012 could cause clouding of the eyes (PharmAsia News, Nov. 6, 2007).

Eisai has conducted additional animal studies and discovered that the eye problem developed because E2012 caused blood cholesterol levels to fall too far. The tests also found that using E2012 in a lower dose kept the blood cholesterol levels from declining too much. Eisai hopes to resume clinical trials in 2008 after finding a blood marker that can be used to monitor safety.

- Tamra Sami (t.sami@elsevier.com)

China And India Next Targets For Eisai’s Global Plan&nbsp;

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China And India Next Targets For Eisai’s Global Plan