Takeda Pharmaceutical Co has pulled development of an experimental cholesterol drug lapaquistat as it is not safer or more efficacious than currently-sold treatments.
The Japanese firm is discontinuing work on lapaquistat, also known as TAK-475, for the treatment of hypercholesterolaemia following a “thorough review of the clinical data available to date” including Phase II trial results in Japan “and discussions with the relevant regulatory authorities. Last October, the US Food and Drug Administration requested additional data prior to submission of a New Drug Application for TAK-475 and recommended the suspension of clinical studies with higher doses. That news caused Takeda’s stock to slide to a 20-year low.
The decision to scrap the development programme for TAK-475, a squalene synthase inhibitor, is based on a “judgment that the profile of the compound is not superior to existing marketed drugs from both efficacy and safety viewpoints”, the Osaka-based company said.
Takeda added that it will continue to make “strategic investments aiming for [the] earliest possible launch” of the type 2 diabetes drug SYR-322 (alogliptin), which belongs to the new class of dipeptidyl peptidase-4 inhibitors. The latter has already been filed with the FDA, as has the proton pump inhibitor TAK-390MR (dexlansoprazole).
The firm concluded by noting that it is looking to submit NDAs soon for Hematide, a peptide-based anaemia drug being developed with Affymax, and the mood and anxiety disorder treatment Lu AA21004, partnered with Lundbeck.
The failure of TAK-475 is a major disappointment for Takeda which has not launched a product in the USA for three-and-a-half years, the last being Rozerem (ramelteon) for sleeping disorders. The firm badly needs new products to fill the space that will be left once the diabetes blockbuster Actos (pioglitazone) gets hit by patent expiries in 2011.
