Rhythm Pharmaceuticals : RM-493 Reverses Obesity and Insulin Resistance in Obese Primates

June 21, 2010— Rhythm, a biotechnology company developing peptide therapeutics for metabolic diseases, announced a study of obese primates treated with RM-493 showing a reversal of obesity and insulin resistance, and improvement in both heart rate and blood pressure. RM-493 is a novel peptide agonist targeting the melanocortin 4 receptor (MC4R) that is a clinical candidate for the treatment of obesity and diabetes. The study, “A Novel MC4R Agonist Reduces Body Weight and Improves Glucose Homeostasis in High Fat Diet-Induced Obese Rhesus Macaques,” was presented at the 92nd annual meeting of the Endocrine Society (ENDO 2010) in San Diego.

“The goal of this study was to determine the effects of RM-493 on food intake, weight, and cardiovascular function, as well as to evaluate safety with long-term treatment,”... Rhythm's Press Release -

Abbott : Statement on the FDA Advisory Committee Recommendation on Sibutramine

September 15, 2010 — The U.S. Food and Drug Administration (FDA) held an Endocrinologic and Metabolic Drugs Advisory Committee to review the results of SCOUT (Sibutramine Cardiovascular OUTcome Trial) and the weight loss medication sibutramine (sold as Meridia® in the United States). In response to the Advisory Committee's mixed vote, Abbott issued the following statement:

"Today's vote highlights the complexity of this scientific debate," said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott. "We continue to believe that there are appropriate and identifiable patients that derive benefit from sibutramine. Sibutramine is an important option for patients and physicians to treat a serious condition for which there are few treatment options currently available, and Abbott has proposed comprehensive risk management tools to ensure that physicians and patients have the most relevant information for the continued appropriate use of sibutramine."

"Sibutramine has been studied in more than 100 clinical trials involving more than 20,000 patients, in addition to those involved in the SCOUT study," said Sun. "SCOUT did not directly assess the risk/benefit profile of the medication in patients for whom it is specifically intended and its results cannot be readily extrapolated to the approved patient population, that is, patients who do not have a history of cardiovascular disease."

The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee will be considered by the FDA during its decision-making process for Meridia. Abbott intends to consult with the FDA on sibutramine moving forward.

Sibutramine is approved for weight loss in patients who are either obese or overweight, and have no previous history of cardiovascular disease. The approximately 10,000-patient, six-year SCOUT study was requested by European regulatory authorities as a post-marketing commitment. More than 90 percent of the patients studied in SCOUT had underlying cardiovascular disease or were otherwise ineligible to receive sibutramine under the current labeling and prescribing information... Abbott's Press Release -

Crospon : EndoFLIP® system presented at International Obesity Surgery Congress 2010

9th September 2010 - Crospon, an Irish medical device developer based in Galway, has announced results of a study presented at the 15th Annual Congress of the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO 2010), in Long Beach, CA.

The study which took place at the Speciality Surgery Center of Fort Worth, TX, a Center of the AIGB True Results clinical network, the largest gastric band placement network in the world, under the direction of Principal Investigator Dr. Robert G. Snow, demonstrated that 30% of the patients measured achieved greater than 30% excess weight loss in the 4-6 week period after surgery. Even though they had a band adjustment during surgery, no patient required their band to be loosened in the post-operative period.

Crospon develops leading edge minimally invasive medical devices for monitoring, diagnosis and therapy in the gastroenterology area. Earlier this year Crospon launched its EndoFLIP® product in the U.S. market at the 12th World Congress of Endoscopic Surgery in National Harbor, Washington DC. The EndoFLIP® product which received FDA clearance in December 2009 is the first product of its kind, which allows a bariatric surgeon to measure and set a consistent gastric band stoma size during surgery... Crospon's Press Release -

Orexigen Therapeutics and Takeda Pharmaceutical : Partnership to Commercialize Contrave® in North America

September 2, 2010 – Orexigen® Therapeutics, Inc. (Nasdaq: OREX) and Takeda Pharmaceutical Company Limited (TSE: 4502), announced that they have entered into an exclusive partnership to develop and commercialize Contrave® (naltrexone SR/bupropion SR), Orexigen’s investigational drug for the treatment of obesity, in the United States, Canada and Mexico.

Contrave is a combination therapy believed to address both biological and behavioral drivers of obesity. The central pathways targeted by this treatment are involved in controlling the balance of food intake and metabolism, and regulating reward-based eating behavior. Orexigen submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave on March 31, 2010 and the Prescription Drug User Fee Act (PDUFA) action date has been set for January 31, 2011.

Under the terms of the agreement, Orexigen will receive an upfront cash payment of $50 million from Takeda, and Takeda will obtain an exclusive marketing right from Orexigen in the United States, Mexico and Canada while Orexigen retains the right to co-promote with Takeda in the United States. Orexigen will be eligible to receive payments of over $1 billion upon achieving certain regulatory and sales-based milestones. Assuming Contrave is commercialized, Takeda will pay tiered double-digit royalty payments on net sales in the Territory.

Under the terms of the agreement, Orexigen and Takeda will work together on ongoing development of the product, with Orexigen leading pre-approval activities, and Takeda leading post-approval activities. The parties will share in the costs of any future development of the product.

“Takeda is an ideal partner for Contrave given its proven track record in commercializing innovative medicines and its commitment to the treatment of obesity,” ... Takeda Pharmaceutical's Press Release - Orexigen Therapeutics' Press Release -

NeuroSearch : Interim report for H1 2010 - Tesofensine – Obesity

25 August 2010 – The Board of Directors of NeuroSearch A/S (NEUR) considered and adopted the company’s interim report for the period 1 January to 30 June 2010.

The operating result for the period was a loss of DKK 168.0 million (a loss of DKK 204.1 million in the same period of 2009). The company’s capital resources totalled DKK 808.4 million at 30 June 2010 (DKK 488.9 at 30 June 2009), consisting primarily of highly liquid short-term bonds and guaranteed future payments from partners. Financial net income for the period positively affected net results by DKK 20.5 million.

Key business events and development in the second quarter of 2010 and the subsequent period:

Huntexil® (pridopidine) – Huntington’s disease...

[...]

Tesofensine – Obesity
– A new Phase III plan is in preparation and in this relation NeuroSearch is closely following the US regulatory authorities' evaluation of other drugs to treat obesity. A revised Phase III plan is expected to be ready for discussion with the US and the European regulatory authorities in the fourth quarter of 2010.
– NeuroSearch will continue the dialogue with potential partners with the aim of signing a licensing agreement before the initiation of Phase III... NeuroSearch's Press Release -