Takeda Halts Development Of Diabetes Agent TAK-379
This article was originally published in PharmAsia News
Executive Summary
Takeda announced April 21 it would discontinue clinical development of diabetes agent TAK-379 because it did not meet internal criteria to support further development. An insulin sensitizer, TAK-379 was in Phase II trials in the U.S. and Europe and in Phase I in Japan
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Takeda announced April 21 it would discontinue clinical development of diabetes agent TAK-379 because it did not meet internal criteria to support further development. An insulin sensitizer, TAK-379 was in Phase II trials in the U.S. and Europe and in Phase I in Japan. Takeda Spokeswoman Ayako Iwamuro told PharmAsia News that the company would not disclose specifics, but said the impact of the discontinuation would be minimal since TAK-379 is considered an early-stage compound. The halt came after U.S. FDA told Takeda in March that it would apply its December 2008 guidelines on cardiovascular risk assessment for type 2 diabetes drugs in its review of Takeda's DPP-4 inhibitor alogliptin (SYR-22), despite the fact that the company submitted its NDA prior to the published guidance. The agency informed Takeda that the amount of existing alogliptin clinical data was not sufficient to meet statistical requirements in the new guidance. Alogliptin is Takeda's most promising diabetic drug candidate to take the place of its best-selling type 2 diabetes drug Actos (pioglitazone), which is facing patent expiration (Also see "More data needed for Takeda’s alogliptin" - Pink Sheet, 9 Mar, 2009.). According to FDA's "Orange Book," the primary active ingredient patent for Actos expires Jan. 17, 2011. Nine "method of use" patents also are listed, expiring in 2016. Takeda submitted its NDA for alogliptin to U.S. FDA in Dec. 2007, and applied for approval in Japan in September 2008. The company also applied for approval with FDA for alogliptin's combo with Actos in September 2008. As the top-selling drug for Takeda, Actos alone achieved ¥297.7 billion ($3.02 billion) in sales in the third fiscal quarter ending Dec. 31, accounting for nearly one-fourth of the company's total sales of ¥1,202.8 billion. Takeda places a high expectation for a quick approval for alogliptin. The company disclosed in its third-quarter statement that the fiscal year priority is a prompt approval of SYR-322 and peptic ulcer treatment TAK-3900MR (dexlansoprazole) "to maximize each product's market potential, by leveraging the company's established U.S. franchises for Actos and Prevacid (lansoprazole)" Takeda announced earlier this month it was taking back marketing rights to Actos from Eli Lilly in Canada, Demark, Belgium, Norway, Sweden, Turkey and Luxembourg. Takeda Spokesman Seizo Masuda told PharmAsia News that the transfer is very important for the company to expand geographic coverage on its own (Also see "Takeda Takes Back Actos Rights from Eli Lilly, Sets Course For Own Geographic Expansion" - Scrip, 12 Apr, 2009.). The delayed U.S. approvals have caused the largest Japanese drug maker to re-think its strategies. Takeda President Yasuchika Hasegawa said that structural differences in pharmaceutical companies in different countries, including Japan, are causing the delays. Takeda said it plans to discuss approval timelines with FDA (PharmAsia News April 22 2009). Takeda unveiled an ambitious plan March 31 to reorganize 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 Apr, 2009.) Takeda's Iwamuro noted that the company has four other diabetes products in clinical development: DDP-4 inhibitor SYR-472 is in Phase II trials in the U.S. and Europe, and Phase I in Japan; diabetic neuropath agent TAK-428 is in Phase II in the U.S. and Europe; glucose dependent insulin secretagogue TAK-875 is in Phase II in Japan, and in Phase I in the U.S. and Europe; and DPP-4 inhibitor TAK-100 is in Phase I in Japan. Takeda is scheduled to announce financial results for fiscal year 2008 on May 11. Japanese media estimate that the company's profit will decrease by 31 percent to ¥290 billion ($2.95 billion), revised from ¥270 billion ($2.74 billion). The company is also expected to reduce market research expenses and advertising due to the delays in the U.S. for SYR-322 approval. However, the company will increase dividends by ¥8 to ¥176 per share as planned. - Brian Yang ([email protected]) |