Takeda Pharmaceutical Co has filed its new diabetes treatment alogliptin with US regulators in a bid to reduce its reliance on Actos and start making up ground on Merck & Co’s dipeptidyl peptidase-4 inhibitor Januvia.

The Japanese drugmaker has submitted a New Drug Application to the US Food and Drug Administration for SYR-322 (alogliptin), a DPP-4 inhibitor for the once-daily treatment of type 2 diabetes. DPP-4 inhibitors are a new class of oral agents that target the incretin system and it is thought that they reduce glucose more effectively without producing the side effects of present treatments.

The NDA submission was supported by six Phase III trials involving over 2,000 patients in 220 centers worldwide. The safety and efficacy of alogliptin was studied as a once-daily monotherapy adjunct to diet and exercise and as an add-on therapy to other medications including sulfonylureas, insulin metformin and thiazolidinediones,such as Takeda’s big-earning Actos (pioglitazone). In the studies, alogliptin was associated with statistically significant reductions in haemoglobin A1c, which reflects average blood glucose concentration over the previous two to three months. It was generally well-tolerated and weight neutral and there was no increase in hypoglycaemia compared to placebo.

The Osaka-based firm’s president Yasuchika Hasegawa said that the NDA submission is a significant milestone for Takeda “as it has the potential to position us as one of the global leaders in diabetes treatment". He added that the company’s continued growth, “now and in the future, will be based on our ability to focus and have success in this therapeutic area”.

If approved, a launch for alogliptin could take place in early 2009, and analysts believe it could bring in $2 billion a year. However it will have a lot of ground to make up on Merck’s Januvia (sitagliptin) which has already been available in the USA since October 2006, while Novartis will be hoping the FDA finally look favourably on its DPP-4 inhibitor Galvus (vildagliptin) before Takeda’s product hits the market.

Moving into this new area of diabetes treatment is also important for Takeda given that Actos will be hit by patent expiries in the USA in 2011. The drug, despite receiving stronger label warnings recently, brought in around $2.86 billion in the last fiscal year, more than 25% of the firm’s total revenues.

TAK-390MR also filed
Separately, TAP Pharmaceutical Products, Takeda's US joint venture with Abbott Laboratories, said it has submitted an NDA to the FDA for TAK-390MR, a proton pump inhibitor to treat diseases caused by stomach acid, including reflux.

"This compound and its novel delivery system is a promising next step in the management of erosive and non-erosive esophagitis," said Nancy Joseph Ridge, vice president of R&D at TAP.