Takeda is taking back marketing rights to type 2 diabetes treatment Actos (pioglitazone) from Eli Lilly in Canada and six other countries as early as this year, according to the two companies.

Lilly Spokesman Scott Macgregor told PharmAsia News the agreement between the two was reached last year, and the transfer of rights will be finalized later this year.

Macgregor downplayed the rights roll back as a transfer that "has been planned." He added that this is a continuation of a process that has been ongoing for several years. The seven targeted countries for marketing approval are Canada, Demark, Belgium, Norway, Sweden, Turkey and Luxembourg.

Takeda Spokesman Seizo Masuda told PharmAsia News that the transfer is very important for the company "in the sense that Takeda is now trying to expand geographic coverage on its own." Masuda added that Takeda went through "friendly discussions" with Lilly to regain the marketing rights.

Lilly obtained the marketing rights from Takeda in 1999 for Actos in markets outside the U.S. Lilly reported Actos sales in 2007 totaling $370.6 million, with sales of $150.8 million in the U.S. and $219.8 million outside the U.S. The combined sales grew by 51 percent compared to 2006. In 2008, Takeda's third-quarter results reported worldwide sales for Actos from April to December at ¥297.7 billion ($2.97 billion) and Japanese domestic sales of ¥37.6 billion ($375 million).

"In 1999, we granted exclusive rights to Eli Lilly to regions [where] we did not have direct sales channels," Masuda said. Now the company has an increasingly larger presence in both Europe and North America. On March 31, Takeda opened a sales office in Spain and expanded marketing operations in Ireland, after establishing six wholey owned branches in France, UK, Germany, Italy, Austria and Switzerland. On the same day, Takeda announced a reorganization of its corporate structure in a quest to become a global pharmaceutical company with highly integrated global operations (Also see "Takeda Starts Japanese Fiscal Year With Global Reorganization" - Scrip, 2 April, 2009.).

Masuda noted that Actos sales have suffered both in the U.S. and Japan. He attributed the drop to the U.S. economic downturn and the drug price reductions every two years introduced by the Japanese government in 2008.

Like other major Japanese drug makers, Takeda's best-selling drug faces a patent expiration in 2011. Takeda's solution: apply for approval of DPP-4 inhibitor alogliptin. However the application has been held up at U.S. FDA because Takeda's data did not meet new FDA standards related to cardiovascular risk assessment for type 2 diabetes drugs (PharmAsia News, March 9, 2009).

It is also reported that to compensate Lilly for reclaimed sales rights, Takeda plans to cut royalty payments and wholesale prices, which Masuda called "speculation" as it was not formally disclosed by the company.

- Brian Yang (pharmasia@elsevier.com)

Takeda Takes Back Actos Rights from Eli Lilly, Sets Course For Own Geographic Expansion

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