Naming a Product - Brand Institute, inc.



			Naming a Product Brand Institute is the premier full-service branding agency dedicated to strategic and innovative brand naming and identity solutions. We strive to exceed the expectations of every client by combining leading-edge market research with the highest levels of client service, integrity and brand management Guidelines introduced for treating diabetes-related pain The American Society of Pain Educators (ASPE) released its first consensus guidelines for the treatment of diabetic peripheral neuropathic pain. Diabetes-related pain has been "underdiagnosed" and "undertreated," according to the ASPE. And although most patients who have diabetic peripheral neuropathy are asymptomatic, 11 percent have chronic, painful symptoms that may impair quality of life, lead to sleep disruptions and trigger depression. In response to the growing condition, leading pain management specialists met in June for a two-day conference to develop formal recommendations. "In the absence of guidelines, physicians have relied on a combination of antidepressants, anticonvulsants and various analgesics based on their experience and comfort level," commented Dr. B. Eliot Cole, ASPE's executive director. At the conference, specialists evaluated randomized clinical trial outcomes as well as real-world experience regarding various patient treatment situations. As a result, treatment options were ranked as first-tier and second-tier based on efficacy. First-tier drugs, which had strong clinical support for the relief of diabetic peripheral neuropathic pain, were identified as Eli Lilly and Co.'s Cymbalta (duloxetine hydrochloride), Pfizer Inc.'s Lyrica (pregabalin), controlled-release oxycodone and all tricyclic antidepressants. Cymbalta and Lyrica are the only agents formally approved by the Food and Drug Administration for diabetic peripheral neuropathy. Second-tier agents included the anticonvulsants gabapentin and GlaxoSmithKline Plc's Lamictal (lamotrigine) as well as Wyeth's antidepressant Effexor XR (venlafaxine, extended-release). These were classified as second-tier options because data showed they relieve other types of nerve damage pain but did not show they relieve diabetes-related pain. The guidelines were developed through an educational grant from Lilly and were jointly sponsored by The Johns Hopkins University School of Medicine and the ASPE. They appeared as a Continuing Medical Education supplement of the April issue of the journal Mayo Clinic Proceedings. Naming a Product Mirapex improves symptoms of restless legs syndrome, studies show Boehringer Ingelheim Pharmaceuticals Inc.'s Mirapex (pramipexole dihydrochloride) significantly improved the symptoms of restless legs syndrome (RLS) in two clinical trials that included nearly 500 patients, according to data presented at the 58th Annual Meeting of the American Academy of Neurology. A total of four posters from the two studies were presented at the meeting. In one of the studies, a double-blind, placebo-controlled trial that involved 344 patients with RLS, participants were randomly assigned to receive placebo or one of three doses of Mirapex (0.25 mg, 0.50 mg or 0.75 mg). Over a 12-week period, all doses of the drug produced statistically significant improvements on patient- and clinician-rated RLS improvement scales as compared with placebo. Another presentation of data from the same study found that patients treated with Mirapex exhibited a 56 percent quality-of-life improvement as compared with placebo, one of the secondary endpoints of the study. The second trial was a double-blind, placebo-controlled withdrawal study of 150 patients with RLS who had previously completed a six-month, open-label run-in with Mirapex. Patients were randomized to receive three months of treatment with placebo or Mirapex. At the end of this trial, treatment with the drug was associated with sustained improvement of RLS symptoms, while withdrawal of Mirapex (i.e., the placebo group) resulted in significant worsening of symptoms. "These studies provide evidence that supports the efficacy and safety of [Mirapex] for RLS across a range of symptoms which were sustained over time," said Dr. John Winkelman, the lead investigator of the first study. Mirapex is currently approved for treatment of the signs and symptoms of idiopathic Parkinson's disease and is co-promoted in the United States for this indication by Boehringer and Pfizer Inc. Naming a Product Takeda's Rozerem reduces sleep latency in adults with chronic insomnia, data suggest Takeda Global Research & Development Inc.'s Rozerem (ramelteon) significantly reduces latency to persistent sleep (LPS) in adults with chronic insomnia, suggest findings from a subanalysis of Phase III data reported by Newswise. As part of a double-blind study, 269 patients were randomized to receive Rozerem 8 mg (n=138) or placebo (n=131) for five weeks of nightly treatment. The primary endpoint was the percentage of patients who achieved a reduction in LPS by 50 percent or more. Outcomes were assessed at weeks one, three and five. After the treatment period, Rozerem was replaced by placebo for two nights so investigators could evaluate the presence of rebound insomnia or withdrawal effects. During week one, LPS decreased by 50 percent or more in 63 percent of Rozerem-treated patients compared with 40 percent of placebo-treated patients. These results were sustained at weeks three (63 percent vs. 41 percent) and five (66 percent vs. 48 percent). There was no evidence of rebound insomnia or withdrawal effects among patients taking Rozerem. The incidence of adverse events was similar between the treatment groups and comparable to rates observed in previous trials, the investigators noted. Headache, fatigue and somnolence were the only adverse events reported by 5 percent of patients in either group. These findings were presented in San Diego at the annual meeting of the American Academy of Neurology. Naming a Product U.S. health care system performs poorly from patient perspective, study shows Despite spending more per capita on health care than any other country, the United States' health care system performs poorly from the patient perspective, according to a study by The Commonwealth Fund. This finding is based on two surveys of patients conducted in 2004 and 2005. The first survey included a nationally representative sample of adults from Australia, Canada, New Zealand, the United Kingdom and the United States. The second survey included participants from the same five countries plus Germany. Patient responses were organized into six categories based on the Institute of Medicine's framework for quality, and each country's score on these items was ranked from lowest to highest. The six areas were patient safety, effectiveness, patient-centeredness, timeliness, efficiency and equity. Although the U.S. system ranked first on effectiveness and third on timeliness, it ranked last on patient safety, patient-centeredness, efficiency and equity. The report highlighted some specific problem areas. For example, among sicker adults, Americans had the highest rate of receiving the wrong drug or dose during the two years prior to the survey, and Americans who had undergone lab tests were the most likely to receive incorrect results. Additionally, sicker adults in the United States were more likely to say they had gone to the emergency room for a problem that could have been treated by a regular physician if one were available. Many also reported that their records or test results failed to reach their physician's office prior to an appointment. Even though Americans, along with Germans, reported the least difficulty waiting to see a specialist or to have elective or non-emergency surgery, Americans and Canadians were more likely than others to wait six days or more for an appointment with a physician or to have trouble receiving care at night and on weekends. The United States also had the greatest disparities between access to care for people who have below-average incomes compared with those who have above-average incomes. The study authors noted that while their rankings are based on patients' perspectives, reports from the World Health Organization that compare health care system performance using more objective measures also indicate "the U.S. achieves the least for its population among these six countries." title="branding company" "These findings suggest that, if the health care system is to perform according to patients' expectations, the [United States] will need to remove financial barriers to care and improve the delivery of care. Disparities in terms of access to services signal the need to expand insurance to cover the uninsured and to ensure that the system works well for all Americans," the authors concluded. Naming a Product Study finds use of type 2 diabetes drugs doubled among children in four years A study of prescription claims for people aged 5 to 19 years revealed a four-year doubling in the prevalence of children using drugs to treat or prevent type 2 diabetes. Usage increased from approximately 0.3 children per one thousand in 2002 to 0.6 per thousand in 2005. Express Scripts Inc. performed the study, known as "2002-2005 Trends in the Prevalence of Use of Antidiabetic Agents in Children: 5 to 19 Years." title="branding company" It included the review of prescription records for 3.7 million children in the United States each year. The study revealed that the prevalence of patients receiving type 2 diabetes treatments increased most significantly (106 percent) in those aged 10 to 14 years. Overall use of drugs to treat diabetes was highest among those aged 15 to 19 years. That group experienced usage growth from 0.6 children per thousand to 1.2 per thousand. The study did not investigate the causes of the increase in type 2 diabetes treatment, but Express Scripts noted that childhood obesity may be a primary factor. The 1999-2002 National Health and Nutrition Examination Survey revealed that 16 percent of children aged 6 to 19 years were overweight, while the 1988-1994 survey estimated that only 11 percent of children in that age group were overweight. Express Scripts further noted that research indicates overweight and obese children are approximately two times more likely to develop type 2 diabetes than normal-weight children. Naming a Product Discovery Labs' investigational RDS treatment receives second approvable letter Discovery Laboratories Inc. received its second approvable letter from the Food and Drug Administration for Surfaxin (lucinactant), an investigational treatment for respiratory distress syndrome (RDS) in premature infants. The FDA requested information focused on the chemistry, manufacturing and controls section of the application. The FDA does not have concerns regarding clinical or statistical data, the company said. A clinical study, known as SELECT, demonstrated Surfaxin was significantly more effective than other surfactants at preventing RDS and improving survival, according to the company. RDS is a life-threatening breathing disorder that impacts tens of thousands of premature infants each year in the United States. The only current treatments for the disease are animal-derived surfactants. Discovery shares closed at $5.02, down $2.07, or 29.2 percent, in heavy trading on the Nasdaq. Naming a Product Naming a Product Pro-Pharmaceuticals Inc. Pro-Pharmaceuticals Inc. will begin enrolling patients in a Phase III trial of Davanat, a colorectal cancer treatment. The randomized trial is designed to evaluate the safety and efficacy of Davanat with 5-fluorouracil and leucovorin in combination with Pfizer Inc.'s Camptosar (irinotecan) and Sanofi-Aventis Group's Eloxatin (oxaliplatin) as second-line therapy for patients with metastatic colorectal cancer. The decision to proceed with the Phase III trial was based on preliminary data from a Phase II study that showed an objective tumor response in patients. Naming a Product Naming a Product SuperGen Inc. SuperGen Inc. completed the acquisition of Montigen Pharmaceuticals Inc. in an effort to broaden and balance its oncology and hematology product line. SuperGen acquired all outstanding Montigen capital stock for $9 million in cash plus $9 million of SuperGen common stock. Additionally, SuperGen could pay Montigen stockholders another $22 million in SuperGen common stock based on milestone achievement. "Montigen's products and product candidates should benefit our product portfolio both near- and long-term, while we continue to consider clinical candidates for potential in-licensure during 2006," title="branding company" said James Manuso, chief executive officer of SuperGen. Naming a Product Naming a Product TeGenero AG TeGenero AG's investigational monoclonal antibody TGN1412, which caused serious adverse events in six people during a clinical trial last month, was reviewed by the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) to determine the cause of the events. The agency concluded "that an unpredicted biological action of the drug in humans is the most likely cause of the adverse reactions in trial patients." title="branding company" The MHRA further noted that the incidence raises important questions regarding the potential risks associated with this type of drug and how to proceed from pre-clinical testing to trials in humans. All six patients who were treated with TGN1412 experienced life-threatening incidents of cytokine release syndrome, which occurs when the substance released by activated T-cells yields a systemic inflammatory response. Naming a Product Naming a Product Baxa Corp. Baxa Corp.'s U.K. subsidiary, Baxa Ltd., is relocating its sales and marketing operations to a new 10,000-square foot facility in Bracknell, Berkshire. Baxa said its sales revenue has tripled since 2000 and its staff has doubled. The new facility will house the sales, marketing, customer service, operations, finance, human resources and quality departments. Naming a Product


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