Furiex Pharmaceuticals Confirms Takeda Launches LIOVEL® LD and LIOVEL® HD, a Fixed Dose Combination of NESINA® and ACTOS® for Type 2 Diabetes in Japan

September 20, 2011 - Furiex Pharmaceuticals, Inc. (Nasdaq: FURX) confirmed that Takeda Pharmaceutical Company Limited ("Takeda") has launched two dosages of LIOVEL®, a fixed dose combination tablet of NESINA® (alogliptin) and ACTOS® (pioglitazone HCL), in Japan for the treatment of Type 2 diabetes.

Furiex developed NESINA, which is a member of the dipeptidyl peptidase IV (DPP-4) inhibitor class, in collaboration with Takeda's wholly-owned subsidiary, Takeda San Diego, Inc. LIOVEL LD and LIOVEL HD contain 25 mg alogliptin/15 mg pioglitazone and 25 mg alogliptin/30 mg pioglitazone, respectively.

"We are very pleased with Takeda's launch of LIOVEL in Japan, a new product using the drug NESINA," said June Almenoff, M.D., Ph.D., president and chief medical officer of Furiex. "This launch adds to Furiex's revenue stream and confirms our strategy of partnering drug candidates in return for royalty payments." 

Under Furiex's agreement with Takeda, this launch does not trigger a milestone payment to Furiex. However, Furiex is entitled to receive royalty payments on sales of LIOVEL... Furiex Pharmaceuticals' Press Release - Takeda Pharmaceutical's Press Release -

Takeda : New Drug Application in the U.S. for Alogliptin (SYR-322) / ACTOS(R) (pioglitazone HCl) for the Treatment of Type 2 Diabetes

September 24, 2008 - Takeda Pharmaceutical Company Limited (Takeda) announced that its wholly owned subsidiary, Takeda Global Research & Development Center Inc. (U.S.), submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of alogliptin (SYR-322) and ACTOS^® (pioglitazone HCl) (“alogliptin/ACTOS”) in a single tablet for the treatment of type 2 diabetes.

Alogliptin was discovered by Takeda’s wholly owned subsidiary, Takeda San Diego, Inc. and is a member of the DPP-4 inhibitors class, which are newer oral agents for the treatment of type 2 diabetes. DPP-4 inihibitors slow the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide). The incretins play a major role in regulating blood glucose levels and have the potential to improve pancreatic beta-cell function. GLP-1 and GIP are produced by the digestive tract in response to food and regulate glucose balance, primarily by stimulating glucose-dependent insulin secretion. In addition, GLP-1 suppresses pancreatic glucagon secretion and subsequent liver glucose production, enhances glucose disposal, slows gastric emptying, and elicits satiety, a feeling of fullness. Takeda is the originator of the thiazolidinedione (TZD) class of oral anti-diabetes medications. ACTOS is a TZD that directly targets insulin resistance, a condition in which the body does not efficiently use the insulin it produces to control blood glucose levels... Takeda's Press Release -

Takeda : Voglibose (BASEN) for the prevention of type 2 diabetes mellitus

May 26, 2008 - Takeda Pharmaceutical Company Limited (“Takeda”) announced that, on May 24 at the 51st Annual Meeting of the Japan Diabetes Society, the data from a phase 3 clinical study to evaluate the effects of BASEN^® (generic name: voglibose) on prevention of onset of type 2 diabetes mellitus in subjects with impaired glucose tolerance (“IGT”) was presented. The data represents the first clinical evidence with Japanese subjects that showed preventive effects by medicinal treatment of type 2 diabetes, when being added on the dietary treatment and/or exercise therapy.
BASEN was launched in 1994 in Japan as an improving agent for postprandial hyperglycemia in diabetes mellitus. Based on the data presented this time, Takeda submitted on December 18, 2007 an application to the Ministry of Health, Labour and Welfare in Japan for an additional indication of “BASEN^® Tablets 0.2” and “BASEN^® OD Tablets 0.2” for prevention of onset of type 2 diabetes in patients with IGT... Takeda's Press Release -

Takeda : ACTOS® (pioglitazone HCl) Prevented Progression of Atherosclerotic Plaque Volume in Patients with Type 2 Diabetes

March 31, 2008 – New data from a clinical trial using intravascular ultrasound (IVUS) technology found that in patients living with type 2 diabetes, ACTOS^® (pioglitazone HCl) reduced the atherosclerotic burden in the coronary arteries compared to glimepiride, and prevented progression compared to baseline. These data stem from the PERISCOPE (Pioglitazone Effect on Regression of Intravascular Sonographic Coronary Obstruction Prospective Evaluation) trial.

The PERISCOPE trial was presented today as a late breaker at the 57th Annual Scientific Session of the American College of Cardiology in Chicago. This trial adds to the body of cardiovascular data for ACTOS. ACTOS studies, conducted over the past 10 years in more than 16,000 patients, including short- and long-term trials, as well as prospective and observational studies, have shown no evidence that ACTOS is associated with an increased risk of heart attack, stroke, or death... Takeda's Press Release -

PPD, Takeda's NDA Filing of Alogliptin with U.S. Food and Drug Administration

February 28, 2008 - PPD, Inc. (Nasdaq: PPDI) confirmed that Takeda Pharmaceutical Company Limited's new drug application (NDA) for alogliptin, a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, has been accepted for filing by the U.S. Food and Drug Administration. PPD partnered with Takeda to develop the compound.Under PPD's agreement with Takeda, the FDA's acceptance of the NDA filing triggers a $15 million milestone payment to PPD. This milestone payment was included in PPD's previously issued 2008 financial guidance... PPD's Press Release -