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With U.K. court decision, Teva one step closer to launching Symbicort equivalent in Europe

BY Michael Johnsen

JERUSALEM — Teva Pharmaceutical on Wednesday announced that a positive judgment has been given by the U.K. High Court in support of Teva's case against AstraZeneca relating to the validity of EP 1,085,877 covering the SMART (Single inhaler Maintenance And Reliever Therapy) indication for AstraZeneca's fixed dose formoterol/budesonide combination product, Symbicort.
 
The court agreed with Teva that AstraZeneca’s patent covering the SMART indication of Symbicort was obvious, and rejected AstraZeneca's proposed amendments to the patent on the basis that they added matter. The case was brought to facilitate Teva's European launch of its formoterol/budesonide fixed combination product, DuoResp Spiromax which utilizes Teva's Spiromax device technology.
 
“Our DuoResp Spiromax product brings effective treatment to the patient in a device that is intuitive and easy to use," stated Rob Koremans, president and CEO, Teva Global Specialty Medicines. “[This] judgment is a big step in enabling us to make a difference to people’s lives in the U.K. and all across Europe.”
 
This is the latest decision in Teva's favor in respect of AstraZeneca's fixed dose, formoterol/budesonide combination product, Teva reported. The Teva Group has previously successfully revoked patents EP 0,613,371 and also, EP 1,014,993, covering the use of the fixed dose combination in the treatment of asthma and in COPD respectively, and their national equivalents, before the European Patent Office and the Norwegian court.
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JAMA: Weight-loss differences between structured diet plans small; adherence is what matters

BY Michael Johnsen

CHICAGO — A diet by any other name is just as effective, according to a study in the Sept. 3 issue of JAMA. In an analysis of data from nearly 50 trials including about 7,300 individuals, significant weight loss was observed with any low-carbohydrate or low-fat diet, with weight loss differences between diet programs small, findings that support the practice of recommending any diet that a patient will adhere to in order to lose weight. 
 
Named or branded (trade-marked) weight-loss programs provide structured dietary and lifestyle recommendations via popular books and in-person or online behavioral support and represent a multibillion-dollar industry. Debate regarding the relative merit of the diets is accompanied by advertising claiming which macronutrient composition is superior, such as a low-carbohydrate or low-fat diet. Establishing which of the major named diets is most effective is important because overweight patients often want to know which diet results in the most effective weight loss, according to background information in the article. 
 
Bradley Johnston of the Hospital for Sick Children Research Institute, Toronto, and McMaster University, Hamilton, Ontario, and colleagues conducted a meta-analysis to assess the relative effectiveness of different popular diets in improving weight loss. The researchers conducted a search of the medical literature to identify studies in which overweight or obese adults (body mass index 25 or greater) were randomized to a popular self-administered named diet and reported weight or body mass index data at 3-month follow-up or longer.
 
The meta-analysis included 59 articles that reported 48 randomized clinical trials (7,286 individuals; median age, 46 years; median weight, 207.5 lbs.). In the diet-class analysis adjusted for exercise and behavioral support, all treatments were superior to no diet at 6-month follow-up. Compared with no diet, low-carbohydrate diets had a median difference in weight loss of 19.2 lbs. and low-fat diets had similar estimated effects in weight loss of 17.6 lbs. 
 
At 12-month follow-up, the estimated average weight losses of all diet classes compared with no diet were approximately 2.2 lbs. to 4.4 lbs. less than after 6-month follow-up. The diet classes of low fat (16 lbs.) and low carbohydrate (16 lbs.) continued to have the largest estimated treatment effects. 
 
Weight loss differences between individual diets were minimal. For example, the Atkins diet resulted in a 3.8 lbs. greater weight loss than the Zone diet at 6-month follow-up. “Although statistical differences existed among several of the diets, the differences were small and unlikely to be important to those seeking weight loss,” the authors noted. 
 
“Our findings should be reassuring to clinicians and the public that there is no need for a one-size-fits¬all approach to dieting because many different diets appear to offer considerable weight loss benefits. This is important because many patients have difficulties adhering to strict diets that may be particularly associated with cravings or be culturally challenging (such as low-carbohydrate diets)," the authors wrote. "Our findings suggest that patients may choose, among those associated with the largest weight loss, the diet that gives them the least challenges with adherence. Although our study did not examine switching between diets, such a strategy may offer patients greater choices as they attempt to adhere to diet and lifestyle changes.”
 
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Study: Low-carb diet more effective in weight loss and improving heart health than low-fat diet

BY Michael Johnsen

DENVER — The Annals of Internal Medicine just published results of a National Institutes of Health trial titled "Effects of low-carbohydrate and low-fat diets," in which a low-carbohydrate diet was found to be more effective both for weight loss and cardiovascular risk factor reduction than a low-fat diet, Atkins Nutritionals announced Tuesday.
 
Participants in this study were assigned to one of two groups: low carbohydrate and low fat. In the low carbohydrate group, participants were instructed to count "net carbs" of less than 40 grams/day, similar to the Atkins Diet. Researchers refer to this as digestible carbohydrate — total carbohydrate minus total fiber.
 
As with the Atkins approach, participants were not given a strict calorie limit, nor were they told they needed to pair with an exercise regimen to see results. Following these guidelines, the low-carbohydrate group saw greater improvements in measures of body composition, good cholesterol, cholesterol ratio, triglycerides and overall reduction in cardiovascular risk.
 
"Over the past fifteen years, over 20 randomized clinical trials compared low carbohydrate to the standard recommendation, a low fat diet. And consistently these trials show that carbohydrate restriction is the best approach for weight management," stated Jonathan Sackner-Bernstein, Atkins spokesman and former Food and Drug Administration executive. "The data from Bazzano and colleagues confirm that the low carbohydrate strategy yields significantly better weight loss than the standard recommendation of a low fat diet. This study extends prior observations by calculating the risk of a major cardiovascular event such as a heart attack. By using the Framingham Risk Calculator, they show that the low carbohydrate strategy significantly lowers the risk of cardiovascular events."
 
"I commend the researchers with Tulane University School of Public Health and Tropical Medicine for helping reduce confusion on this subject by crystalizing the message that dietary fat does not make people fat, and it also does not negatively impact heart health," added Colette Heimowitz, VP nutrition education for Atkins. "Though it should be noted that this study is not the first to do so, it simply adds to the bank of research over the past decade that continues to confirm that lower carb, higher fat eating can successfully lead both to weight loss and improvements in cardiometabolic measures."
 
Additionally, authors of the study make a call out to National Dietary Guidelines authorities, implying that dietary fat, and specifically saturated fat, has been unduly associated with heart disease outcomes, including metabolic syndrome. Metabolic syndrome is a group of risk factors including high blood pressure, high blood sugars, excess body fat and cholesterol levels that are notable precursors of diabetes, heart disease and stroke.
 
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