Takeda plans to file six new chemical entities by 2010 as part of an effort to shore up its portfolio ahead of patent expiry for its biggest product, diabetes drug Actos (pioglitazone), in 2011.

The Japanese pharma has tried to bolster its pipeline to guard against patent expiries and unexpected product development snags, such as the recent setback with cholesterol drug TAK-475, but has not "been able to do this as well as we would like to," Takeda President Yasuchika Hasegawa said during a Nov. 5 second quarter earnings call.

The firm is adopting a strategy of "overall re-examination" of TAK-475 (lapaquistat) after FDA asked it to halt clinical trials of a higher dose of the squalene synthase inhibitor. The agency's request came after elevated transaminase levels were seen in some patients taking the higher dose (¹ Also see "Takeda Cholesterol Drug Filing Set Back Due To Liver Enzyme Data" - Pink Sheet, 29 October, 2007.).

The company had planned to file TAK-475 in first quarter 2008.

While Takeda is talking with FDA about the drug's path forward, the firm plans to file several other products soon.

The company will submit an NDA for dipeptidyl peptidase-4 inhibitor SYR-322 (alogliptin) in the first three months of 2008, Hasegawa stated, noting there appear to be "no issues of concern" with the product.

In addition to TAK-475 and SYR-322, Takeda has four other in-house drugs in Phase III, including TAK-242 for severe sepsis and TAK-491 for hypertension.

Actos has been the major driver of growth at Takeda. The firm reported consolidated net sales up 10.3 percent to ¥708.5 billion ($6.2 billion) in the second quarter, "mainly due to the significant sales growth of Actos."

U.S. sales of the drug jumped 23.8 percent to $1.4 billion in the period.

Consolidated net income soared 37 percent to ¥218 million ($1.9 million). For the fiscal year ending March 31, the firm forecast net income up 17.6 percent, to ¥395 million ($3.45 million).

-Brooke McManus (b.mcmanus@elsevier.com)

[Editor's note: Additional coverage of Asian markets is provided at ² PharmAsia News, F-D-C Reports' new beta site for Asian biotech and pharmaceutical news. To register for complimentary e-mail updates, visit ³ www.pharmasianews.com.]

Takeda Shores Up Pipeline Ahead Of Actos Patent Expiry

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