News and Trends—August 2010

| August 23, 2010

New Data Shows Investigational Triple Antihypertensive Combination Therapy Significantly Lowers Blood Pressure in Hard-to-Treat Patients with Hypertension and Diabetes
PARSIPPANY, New Jersey—PRNewswire—Preliminary results of a prespecified subgroup study analysis of patients with diabetes and hypertension demonstrated that the investigational triple combination therapy of olmesartan medoxomil/amlodipine/hydrochlorothiazide (40/10/25mg) resulted in a statistically significant greater Least Squares (LS) mean reduction in blood pressure from baseline at Week 12 as compared to corresponding dual-combination therapy [olmesartan medoxomil (40mg)/amlodipine (10mg); olmesartan medoxomil (40mg)/hydrochlorothiazide (25mg); or amlodipine (10mg) and hydrochlorothiazide (25mg)]. These findings were presented during a poster presentation June 25–29, 2010 at the American Diabetes Association 70th Annual Scientific Sessions in Orlando, Florida.

This analysis of the TRINITY study (Triple Therapy with Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide in Hypertensive Patients Study) also demonstrated that the investigational triple combination therapy enabled more patients with hypertension and diabetes to achieve blood pressure goal of <130/80mmHg at Week 12 as compared to corresponding dual-combination therapies. The triple combination therapy (40/10/25mg) also demonstrated superior efficacy in the nondiabetes cohort with 68.6 percent of patients achieving goal compared to 39.0 to 52.8 percent in the dual combination therapy groups (P<0.0001). For more information on Daiichi Sankyo, Inc., visit www.dsi.com.

Metabolex and Sanofi-Aventis Enter Into An Agreement for Novel Type 2 Diabetes Treatment
HAYWARD, California—PRNewswire—Metabolex and Sanofi-Aventis announced that they have entered into a global license and development agreement for the research, development, manufacture, and commercialization of small molecules that modulate the G-protein coupled receptor 119 (GPR119), a receptor in the gut and pancreas that interacts with bioactive lipids to stimulate glucose-dependent incretin and insulin secretion. Agonists of GPR119 represent a first-in-class oral treatment for type 2 diabetes that function through a unique dual mechanism of action. First, they act directly on the pancreatic beta cell to increase insulin secretion. In addition, they stimulate release of the incretin GLP-1 from the intestines. This unique dual action may offer improved glucose homeostasis over existing diabetes therapies, with the potential for weight loss and improved islet health.

The agreement includes MBX-2982, a potent selective orally active GPR119 agonist discovered by Metabolex. MBX-2982 has completed three Phase 1 clinical studies and has consistently shown clinically meaningful glucose reductions in healthy volunteers and subjects with impaired glucose tolerance. In all of these studies, MBX-2982 was found to be safe and well tolerated. MBX-2982 is currently in a multinational, 28-day, Phase 2, clinical study in patients with type 2 diabetes.
For additional information about Metabolex and its development pipeline, visit www.metabolex.com.

Novo Nordisk re-initiates phase 3 development of liraglutide for obesity
Bagsvaerd, Denmark—Global healthcare company Novo Nordisk announced the decision to re-initiate the global Phase 3 development program of liraglutide for the treatment of obesity.

Based on the feedback from the FDA, Novo Nordisk now plans to re-initiate the global phase 3 program in the first half of 2011 in clinical trials comprising approximately 5,000 patients. The re-initiation of liraglutide obesity trials underlines Novo Nordisk’s dedication to the development of the liraglutide portfolio, that is the cardiovascular outcomes trial for Victoza®, the obesity program, the fixed-ratio combination of insulin degludec and liraglutide, and finally a once-weekly version of liraglutide.

Novo Nordisk remains committed to the development of a longer-acting GLP-1 analogue and now expects to outline the clinical development strategy for semaglutide, a once-weekly GLP-1 analogue, and the once-weekly version of liraglutide in the second half of 2011.

The trial will compare liraglutide added to standard of care with standard of care alone in people with type 2 diabetes.
For more information, visit www.novonordisk.com

VIVUS Comments on FDA Advisory Committee Panel Meeting on Qnexa (phentermine/topiramate) Controlled-Release Capsules for the Treatment of Obesity

MOUNTAIN VIEW, California—PRNewswire-FirstCall—VIVUS, Inc. announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the United States. Food and Drug Administration (FDA) voted against the following question: “Based on the current available data, do you believe the overall benefit-risk assessment of PHEN/TPM (QNEXA) is favorable to support its approval for the treatment of obesity in individuals with a BMI>30kg/m2 or >27kg/m2 with weight-related comorbidities?” The three comorbidities included hypertension, diabetes, and dyslipidemia.

The vote from the Endocrinologic and Metabolic Drugs Advisory Committee is a recommendation. The FDA will take the Committee’s recommendation into consideration during its review of the current application and will make a determination. The FDA may or may not follow the Committee’s recommendation.

“We appreciate the Advisory Committee’s recognition of obesity as a significant health crisis, and the challenges associated with the treatment of this disease,” stated Leland Wilson, chief executive officer, VIVUS. “We are disappointed with the Advisory Committee’s vote. While the final vote was close, and we are encouraged that the Committee recognized the efficacy demonstrated in the QNEXA clinical trials, we will work closely with the FDA leading up to our October 28, 2010 PDUFA date to address the labeling and safety questions raised during today’s proceedings. We remain committed to patients living with obesity and weight-related disease.”

Aragon Surgical Announces Successful First Cases with the Lektrafuse CAIMAN in Bariatric Surgery
PALO ALTO, California—Business Wire—Aragon Surgical, Inc. announced the successful completion of the first 100 bariatric surgical procedures with its Lektrafuse CAIMAN System. Lektrafuse is used during sleeve gastrectomy to cut and seal the short gastric vessels and omentum.

Founded in 2005, Aragon Surgical, Inc. is a venture-backed medical device company headquartered in Palo Alto, California. Its proprietary Lektrafuse System is designed to help surgeons in the performance of bariatric, robotic, and open procedures. Aragon Surgical is dedicated to pioneering the utilization of Lektrafuse in applications unmet by current RF devices.

Tags:

Category: News and Trends, Past Articles

Comments are closed.