Archimedes, Inc. and FDA : Collaboration to Evaluate the Clinical Risks and Benefits of Weight Loss Medications

January 20, 2011 - Clinical Trial Simulation Will Model Obesity Interventions — Archimedes Inc., a healthcare modeling company, announced that it has entered into a Research Collaboration Agreement with the U.S. Food and Drug Administration (FDA) to develop a computer model of clinical trials evaluating weight loss medications. The model will be used to obtain a better understanding of the benefits of weight loss against the long-term risks of cardiovascular outcomes in patients treated with weight loss drugs.

The computer model will attempt to reproduce the results of the Sibutramine Cardiovascular Outcome Trial (SCOUT), which showed that patients receiving sibutramine were 16 percent more likely to suffer serious cardiac events than those who received a placebo. The model is expected to provide insight into the relationship between patient outcomes and cardiovascular risk factors such as blood pressure, heart rate and cholesterol. The model will then be used to explore outcomes over a 10-year simulated extension of the SCOUT trial.

"We are excited about the collaborative work we are conducting with the FDA to further understand the effects of weight loss medications in a population of 'virtual' patients... Archimedes' Press Release -

GlaxoSmithKline : non-core OTC products to be divested

Thursday 14 April 2011 - GSK identified the non-core OTC brands that it intends to divest as the company focuses its Consumer Healthcare business around a portfolio of fast-growing priority brands and the emerging markets. GSK’s intention to divest its non-core Consumer assets was announced at the company’s fourth quarter 2010 results on 3rd February 2011.
The products to be divested, which are primarily sold in Europe and the United States, had sales in 2010 of approximately £500 million, 10% of GSK’s total Consumer Healthcare turnover. They include analgesics: Solpadeine, BC and Goody’s; vitamin and supplement product Abtei; feminine hygiene treatment Lactacyd; and alli for weight management.
Individually, the brands to be divested have strong heritage and good prospects, but GSK has lacked sufficient critical mass in some product categories and certain brands have lacked focus due to other global priorities. GSK therefore believes that other companies are better placed to maximise the potential they offer... GSK 's Press Release -

SATIETY’S TOGA SYSTEM : TOP MEDICAL INNOVATION

November 10, 2010 - Satiety, Inc. announced that its TOGA® System which enables an incision-free weight loss procedure was named one of the Top 10 Medical Innovations for 2011 by a group of 60 experts from the Cleveland Clinic. The TOGA System was the only therapeutic medical device named to the list among a field of innovative drugs, diagnostics, vaccines and monitoring equipment. One of the selection criteria was that “the innovation had to have significant clinical impact and offer significant patient benefit in comparison to current practices.” The TOGA System was noted as potentially making a weight loss procedure more accessible “for patients who want to lose weight and improve their health but without undergoing major surgery.” In the U.S., there are approximately 22 million surgical candidates by BMI, but only about 1% of these patients undergo surgery each year. According to Company market research, one of the primary reasons many of these patients do not choose surgery is because of their concerns about surgical complications. The TOGA Procedure may be an attractive option for some of these patients who are currently not opting for surgery... Satiety's Press Release -

ARROWHEAD RESEARCH INCREASES OWNERSHIP IN ABLARIS TO 64%

April 6, 2011 - Ablaris Secures $2.9 Million to Enter Phase I Trial in Second Half 2011 — Arrowhead Research Corporation (NASDAQ: ARWR), a nanomedicine company with development programs in oncology, obesity and regenerative medicine, announced that majority-owned subsidiary Ablaris Therapeutics, Inc. has completed a second closing of its Series A financing round for gross proceeds of $1.2 million, with aggregate gross proceeds of $2.9 million to date. Arrowhead invested $1.3 million in the offering and holds a 64% stake in the obesity company post closing. Use of proceeds includes upfront licensing payments and expenses associated with preparation for a Phase I clinical trial, expected in the second half of 2011.
"The offering achieved our goal of securing outside capital for Ablaris' license and operations, and provides for incidental costs as we make our way to the clinic," said Arrowhead President and CEO Dr. Chris Anzalone. Direct costs for a Phase 1 clinical trial of Ablaris' first compound are expected to be borne by licensor MD Anderson Cancer Center.

"Preclinical studies of Ablaris' technology have demonstrated considerable promise as a novel way to treat the growing problem of obesity," continued Dr. Anzalone. "While much attention has been given to various anti-obesity therapeutic candidates, the FDA has not approved a new anti-obesity drug in over a decade, leaving a large underserved market in search of a safe and effective treatment. We believe Ablaris’ unique technology that directly targets blood vessels feeding white fat tissue presents a significant advantage as we look to enter the clinic with Ablaris' first drug candidate later this year."
Arrowhead launched Ablaris in December 2010 to commercialize the innovative technology platform developed by Drs. Wadih Arap and Renata Pasqualini at MD Anderson Cancer Center for use in weight loss and obesity-related metabolic conditions... Arrowhead Research's Press Release -

UK Surgeons Perform Europe's First Incisionless POSE Procedures Using USGI Medical's Incisionless Operating Platform™ (IOP)

September 15, 2010 - SCAR-FREE PROCEDURE DESIGNED TO REDUCE STOMACH SIZE IN OVERWEIGHT AND OBESE PATIENTS - USGI Medical, Inc. the Incisionless Surgery Company, announced that surgeons in the UK are the first in Europe to offer POSE (Primary Obesity Surgery, Endolumenal) to patients for weight loss. The surgeons used USGI's Incisionless Operating Platform™ (IOP), to perform the scar-free procedure designed to reduce the size of the stomach helping patients feel full after consuming less food.

Surgeons Mr. James Byrne and Mr. Jamie Kelly performed Europe's first POSE procedures on six patients at a private hospital in Southampton on August 26. The patients who underwent the procedure returned to work or normal activities within 2-3 days.

"Given the lack of long-term success patients experience with diets and weight loss drugs, we're very proud to be the first in Europe to offer this incisionless procedure to help overweight and obese patients feel full and eat less," Mr. Jamie Kelly said. "This discreet outpatient procedure should result in less pain, shorter hospitalisation, less risk of infection and no visible scars compared to traditional surgeries performed through the abdomen. Our first patients were back at their jobs without any bandages or signs of surgery within two to three days."... USGI Medical's Press Release -