HY A0023, ALOGLIPTIN BENZOATE, NESINA, SYR 322

Takeda Receives FDA Approval For Three New Type 2 Diabetes Therapies

Furiex Pharmaceuticals Inc. Friday 25 jan 2013,confirmed that Takeda Pharmaceutical Company Limited  has received approval from the U.S. Food and Drug Administration of three new type 2 diabetes therapies, NESINA (alogliptin) and the fixed-dose combination therapies, OSENI (alogliptin and pioglitazone) and KAZANO (alogliptin and metformin HCl), for the treatment of type 2 diabetes in adults as adjuncts to diet and exercise.

Under its agreement with Takeda, Furiex is entitled to receive a $25 million milestone payment as a result of this approval, as well as royalties on sales in the United States and potential sales-based milestones. Furiex has already been receiving royalty payments from Takeda for the sale of NESINA and LIOVEL in Japan.

“Receiving regulatory approvals for NESINA, OSENI and KAZANO in the U.S. marks an important milestone for Furiex,” said Fred Eshelman, chairman of Furiex.

“These approvals should enable Takeda to build on the success of NESINA in Japan and leverage its more than 20 years of clinical and patient experience in the type 2 diabetes therapeutic area.”

Type 2 diabetes is the most common form of diabetes and has reached epidemic proportions globally. The global health care expenditures to treat and prevent diabetes and its complications were estimated at $471 billion in 2012. In addition to diet and exercise, patients often need to take multiple medications to help manage blood glucose. Because of the chronic nature of this disease, combination therapy is often required to maintain diabetic control over many years of therapy.

NESINA is a DPP-4 inhibitor for the treatment of type 2 diabetes as an adjunct to diet and exercise. DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide).

OSENI is a fixed dose combination therapy that combines alogliptin and pioglitazone in a single tablet for the treatment of type 2 diabetes in adults as an adjunct to diet and exercise. Pioglitazone is a thiazolidinedione that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels. It is currently approved for use in adults for the treatment of type 2 diabetes as an adjunct to diet and exercise.

KAZANO is a fixed dose combination therapy for the treatment of type 2 diabetes that combines alogliptin and metformin in a single tablet. Metformin is a widely-used diabetes medication that acts primarily by reducing the amount of glucose produced by the liver. These medications work in combination to help patients with type 2 diabetes manage their blood glucose levels.

Nesina^® (alogliptin) is a member of a new class of drugs for the oral treatment of type 2 diabetes (T2D). Nesina is being developed and marketed by Takeda Pharmaceuticals. In April 2010, Takeda received regulatory approval from Japan’s Ministry of Health, Labour and Welfare for Nesina and it is now being sold in Japan.

Takeda has resubmitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA), and has submitted a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA).

As a result of their collaboration, Furiex has rights to royalties and sales-based milestones from Takeda for the sale of Nesina in Japan. Furiex will be entitled to receive regulatory milestones, royalties and sales-based milestones upon marketing approval of Nesina in other countries.

Alogliptin is a DPP-4 inhibitor that slows the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide), which play a major role in regulating blood glucose levels and have the potential to improve pancreatic beta-cell function.

Alogliptin has been studied in 12 Phase III trials including more than 8,000 patients. Pivotal trials demonstrated alogliptin was well-tolerated and it significantly improved glycemic control in T2D patients without raising the incidence of hypoglycemia. Additionally, alogliptin has been shown to enhance glycemic control when used in combination with other commonly prescribed diabetes drugs.

Alogliptin was tested in 329 drug-naive patients with inadequately controlled T2D in a double-blind, placebo-controlled, multicenter study. Patients were randomized to once-daily treatment with 12.5 mg or 25 mg alogliptin or placebo for 26 weeks. The primary efficacy end point was HbA(1c). Alogliptin was well-tolerated and significantly improved glycemic control in these patients with T2D without raising the incidence of hypoglycemia.

DR ANTHONY CRASTO, PhD, ICT Organic chemistry, Currently working with GLENMARK GENERICS LTD research centre as Principal Scientist, process research (bulk actives) at Mahape, Navi Mumbai, India, helping millions, million hits on google on all organic chemistry websites, Hands on experience in developing novel routes for drug molecules and implementation on commercial scale. several international patents published.pushing boundaries, one lakh connections on all networking sites