Takeda halted development of an investigational drug, TAK-475 (lapaquistat), for the treatment of high cholesterol, based on efficacy and safety data, the company announced March 28.

The news is not too surprising, given that the Osaka-based company said last October that FDA had recommended suspending clinical trials evaluating higher doses of the drug.

Takeda had been planning to submit the squalene synthase inhibitor in the first quarter, but after elevated transaminase levels were seen in some patients taking higher doses, FDA requested additional clinical data prior to submission (¹ Also see "Takeda Cholesterol Drug Filing Set Back Due To Liver Enzyme Data" - Pink Sheet, 29 October, 2007.).

"Takeda has made the decision to discontinue development of TAK-475 based on judgment that the profile of the compound is not superior to existing marketed drugs from both efficacy and safety viewpoints," the firm said. The decision comes after a thorough analysis of clinical data, including Phase II clinical trial results in Japan, the company added.

In the near-term, Takeda said it will focus R&D efforts on "lifestyle-related or metabolic diseases," as well as other core therapeutic areas.

The firm currently has two NDAs under review at FDA: dipeptidyl peptidase-4 inhibitor SYR-322 (alogliptin) and Prevacid follow-on TAK-390MR for acid-related diseases and gastro esophageal reflux disease.

Takeda submitted SYR-322 for type 2 diabetes in December, potentially positioning the drug as the second DDP-4 to reach the market after Merck's Januvia (² Also see "Takeda Files DPP-4 Inhibitor NDA, Poised To Best Bristol/AstraZeneca, Novartis In Race For Second To Market" - Pink Sheet, 4 January, 2008.).

The NDA for TAK-390MR was filed in December by TAP Pharmaceuticals, the 50/50 joint venture between Takeda and Abbott, which Takeda announced plans to acquire full rights to earlier in March.

As part of the deal, Takeda said it would establish Takeda America Holdings and integrate TAP into its existing U.S. subsidiaries, Takeda Pharmaceuticals North America and Takeda Global Research & Development Center (³ Also see "Takeda Buys Abbott’s Stake In TAP Joint Venture" - Pink Sheet, 19 March, 2008.).

Takeda also said it is focusing on late-stage pipeline programs, including Hematide for chronic kidney disease and cancer related anemia. The novel peptide-based erythropoiesis-stimulating agent is in Phase III development with partner Affymax.

-Jessica Merrill (j.merrill@elsevier.com)

Takeda Discontinues Development Of Cholesterol Compound

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