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			The Brand Institute 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 FDA requests label updates for Advair, Serevent, Foradil The Food and Drug Administration requested that GlaxoSmithKline Plc's Advair (fluticasone propionate/salmeterol xinafoate) diskus and Serevent (salmeterol xinafoate) diskus, and Novartis AG's Foradil (formoterol fumarate) aerolizer product labels be updated to include new warnings and a medication guide for patients to warn health care professionals and patients that these drugs could increase the chance of severe asthma episodes, and death when those episodes occur. According to the FDA, Advair, Serevent and Foradil all contain long-acting beta 2-adrenergic agonists (LABAs). LABAs decrease the occurrence of asthma episodes; however, when these episodes do occur, the drugs can make them more severe. The FDA cited a study in which an increased number of patients who took a LABA plus their usual asthma care died from their asthma as compared with patients who took placebo plus their usual care, although the FDA noted that the number of deaths from asthma was small. The FDA recommends the following about use of a LABA drug to treat asthma: LABAs should not be the first drug used to treat asthma, patients should not stop using their prescribed LABA until they have discussed with their health care provider whether or not to continue treatment, patients should not use a LABA to treat wheezing that is getting worse and LABAs do not relieve sudden wheezing. GSK disagrees with the FDA's proposed label changes for Serevent and Advair "because they are inconsistent with established [National Institutes of Health] treatment guidelines and the standard of care for asthma treatment, which could put many patients at risk of uncontrolled asthma." GSK said the FDA's proposed label changes are not in agreement with outcomes of a July 2005 FDA advisory committee meeting that reinforced the "favorable" benefit-to-risk profile of both drugs. The committee supported the use of LABAs in combination with inhaled corticosteroids. Since then, there has not been any new data that suggest that salmeterol used alone or in combination with ICSs are not safe or efficacious, according to GSK. "These proposed labeling changes would reserve the most effective asthma treatment--the combination of ICSs and LABAs--until after a patient has failed on other treatment options and therefore may be at risk for severe outcomes, such as exacerbations and potentially death," said Dr. Kathy Rickard, GSK's vice president of clinical development and medical affairs, respiratory medicine in the United States. GSK believes that these products' labels already include adequate safety information. However, they plan to work with the FDA to resolve the difference of opinion. The Brand Institute Tamiflu not responsible for deaths of Japanese children, FDA advisory committee says The Food and Drug Administration's Pediatric Advisory Committee said it saw no evidence that F. Hoffmann-La Roche Ltd.'s influenza drug Tamiflu (oseltamivir phosphate) caused the deaths of 12 children in Japan. Since 2001, 12 of the 11.6 million children in Japan who have taken Tamiflu have died, according to Roche. The firm noted that "a relationship to Tamiflu was difficult to assess because of the use of other medications and/or presence of other medical conditions." The advisory committee, which also was scheduled to discuss adverse events reports that were received for seven other drugs during the year after they had been granted pediatric exclusivity, heard an in-depth presentation on Tamiflu. "The committee does not think, based on the data presented, that there's any evidence Tamiflu played a role in the deaths," Robert Nelson, panel chairman, said in a Reuters report. Documents released ahead of the meeting on the FDA's Web site suggested that these deaths may have been seen only in Japanese children since Japan uses the majority of the world's Tamiflu supply and has different methods of adverse event reporting. "It is possible that some of these events might be observed in the U.S. population if the use of Tamiflu increases substantially," the agency said. The advisory committee recommended that the FDA continue to monitor the drug's safety in children and report back after data are available from another flu season, according to Reuters. Also, the committee advised that the agency add new information to the drug's label to warn about serious skin reactions, which are already listed on the label, Reuters noted. "Roche intends to work with the FDA to change the drug's labeling based on adverse skin events that have occurred in a small number of patients, mostly in Japan," the firm said, adding that the FDA will report back to the committee in two years. The Brand Institute FDA approves updated label for Lexiva The Food and Drug Administration approved GlaxoSmithKline Plc's application to add clinical data to the prescribing information for Lexiva (fosamprenavir calcium), an HIV protease inhibitor. Lexiva is co-marketed by GSK and Vertex Pharmaceuticals Inc. The updated prescribing information indicates that blood levels of the drug are not lowered when combined with AstraZeneca Plc's Nexium (esomeprazole). "Drug interactions that result in lower protease inhibitor blood levels may increase the risk for virologic failure in patients treated with HIV protease inhibitors," according to GSK. The newly added information is based on a study that showed blood levels of Lexiva remained unchanged when patients took Lexiva and 20 mg of Nexium once-daily simultaneously. The randomized, open-label, crossover study included 48 healthy adults. For seven days, patients received 20 mg of Nexium alone. Researchers then added 1,400 mg of Lexiva twice daily or 700 mg of Lexiva boosted with 100 mg Abbott's Norvir (ritonavir) twice daily for 14 days at the same time with their dose of Nexium. The regimen was followed by a 21-day to 28-day washout period. Patients then received unboosted or boosted Lexiva for 14 days. The study's results showed that blood levels of Lexiva when taken simultaneously with Nexium were unchanged when compared to Lexiva administered alone. Study data also showed that blood levels of Nexium were increased by 55 percent when taken with 1,400 mg of Lexiva twice daily. Lexiva is indicated to treat HIV infection in adults in combination with other antiretroviral drugs. The companies warned that "the protease inhibitor-experienced patient study was not large enough to reach a definitive conclusion that Lexiva [plus Norvir] and [Abbott's Kaletra] (lopinavir/ritonavir) are clinically equivalent. Once-daily administration of Lexiva plus [Norvir] is not recommended for protease inhibitor-experienced patients. Lexiva is the first protease inhibitor to offer flexible dosing options with no food or fluid restrictions." The Brand Institute Abbott's Meridia should be paired with exercise for best weight loss, study finds Combining Abbott's Meridia (sibutramine hydrochloride), a weight-loss medication, with lifestyle modifications, such as a low-fat diet and increased exercise, results in more weight loss than treatment with either Meridia or lifestyle modifications alone, according to a study published in the Nov. 17 issue of The New England Journal of Medicine. A total of 224 obese adults (body mass index between 30 kg/m2 and 45 kg/m2) were randomized to receive Meridia 15 mg/day alone (delivered by a primary care provider in eight visits of 10 to 15 minutes each), lifestyle-modification counseling alone (delivered in 30 group sessions), combined therapy of Meridia plus 30 group sessions of lifestyle-modification counseling or Meridia plus brief lifestyle-modification counseling (delivered by a primary care provider in eight visits of 10 to 15 minutes). All patients were prescribed the same exercise regimen and were required to follow a 1,200 to 1,500 calorie per day diet. Patients who received combined therapy lost an average of 12.1 kg at one year compared with an average loss of 5 kg for patients who received Meridia alone, 6.7 kg for patients who received lifestyle-modification counseling alone and 7.5 kg for patients who received Meridia plus brief counseling. A total of 73 percent of the patients in the combined therapy group lost 5 percent or more of their initial weight compared with 56 percent of patients who received Meridia plus brief counseling, 53 percent of patients who received lifestyle modification alone and 42 percent of patients who received Meridia alone. Furthermore, the percentage of patients who received combination therapy who lost 10 percent or more of their initial weight was nearly double that of any other treatment group. Additionally, the researchers found that patients who received combined therapy who frequently recorded their food intake lost significantly more weight than did those who recorded food intake infrequently. "Our findings strongly suggest that the best weight-loss results will be obtained when medication is used as an adjunct to a comprehensive program of diet, exercise and behavior therapy," the authors concluded. The Brand Institute Lidoderm patch may be effective treatment option for patients with low back pain at risk for cardiovascular, GI adverse events Data from a 12-week, open-label, parallel-group study that compared the efficacy and safety of Endo Pharmaceuticals Inc.'s Lidoderm (lidocaine patch 5%) with that of Pfizer Inc.'s Celebrex (celecoxib) in patients with axial low back pain with or without radiation showed no statistically significant differences between the two treatments. Patients included in the study underwent a two-week washout period prior to randomization. Of the 97 patients who were randomized to receive Lidoderm (n=41; two patches applied once every 24 hours) or Celebrex (n=38; 200 mg daily), 76 were included in the efficacy analysis. The mean change from baseline in average pain intensity at week four, which was the study's primary efficacy measure, was similar for both treatments. Likewise, no significant differences between the two groups were observed at week four in scores on the Brief Pain Index (BPI) subscales, in Oswestry Disability Index data, in quality-of-life measures or in the responder analysis, when defined as at least a 30 percent or at least a 50 percent reduction in BPI average pain scores. Global impression of change (patient and investigator) and global assessments of treatment satisfaction at the end of the study also were similar between the two treatment groups. According to the study authors, both treatments were well tolerated and all adverse events were mild or moderate in severity. Sixteen treatment-emergent adverse events occurred in the Lidoderm group (32.7 percent) compared with 20 in the Celebrex group (42.6 percent). Because of safety concerns regarding COX-2 inhibitors, the study was stopped in November 2004 before enrollment was completed. The researchers used treatment group means in place of missing scores for patients who had not completed treatment when the study was halted. The authors concluded that patients experienced similar degrees of pain relief regardless of which treatment they received, and that either therapy can increase patient functionality. Hence, they suggested that Lidoderm may be of particular benefit to patients who have inherent risk factors for cardiovascular or gastrointestinal disease, as well as for those who are at risk for interactions regarding concomitantly prescribed drugs. Lidoderm is approved for relief of pain associated with post-herpetic neuralgia. These data were presented as a poster at the American College of Rheumatology's annual scientific meeting in San Diego. The Brand Institute Gilead's Truvada more effectively suppresses HIV virus than GSK's Combivir, preliminary data suggest Gilead Sciences Inc. reported preliminary trial data that showed treatment-experienced HIV-infected patients who switched from GlaxoSmithKline Plc's Combivir (lamivudine/zidovudine) to Gilead's Truvada (emtricitabine/tenofovir disoproxil fumarate) had a significantly lower virus concentration after week 24 than before the switch. Patients also demonstrated significantly increased levels of hemoglobin and reported greater satisfaction with their treatment regimen. The trial included 411 virologically suppressed HIV-infected patients who were treatment experienced. Data from 198 patients were used for this analysis. At study entry, patients had received Combivir twice daily and Bristol-Myers Squibb Co.'s Sustiva (efavirenz) once daily for at least eight weeks. Patients then switched to treatment with Truvada and Sustiva once daily. Results showed that 76 percent of the patients achieved a viral load of less than 50 copies/mL compared with 59 percent at baseline. Ninety-four percent of patients maintained a viral load of less than 400 copies/mL. Data also showed that hemoglobin levels increased significantly from baseline. A total of 32 percent of patients experienced at least a 1 g/dL increase in hemoglobin levels. Truvada, a combination of Gilead's Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate), is indicated for the treatment of HIV-1 infection in adults in combination with other antiretroviral agents. The data "could facilitate Truvada access to the lucrative but challenging Combivir patient market," said Deutsche Bank analyst Jennifer Chao, Reuters reported. The preliminary data were presented in Dublin, Ireland, at the 10th European AIDS Conference. The Brand Institute The Brand Institute Eisai Medical Research Inc. -------------------------------------------------------------------------------- Eisai Medical Research Inc. resubmitted the New Drug Application for rufinamide, an anti-epilepsy agent. The company withdrew the original NDA in early November and has supplemented the application to include electronic copies of some of the data from the original NDA. Rufinamide is intended to be an adjunctive treatment for partial-onset seizures in adult and adolescent patients and an adjunctive treatment for seizures associated with Lennox-Gastaut Syndrome in children. The Brand Institute The Brand Institute Ligand Pharmaceuticals Inc. Ligand Pharmaceuticals Inc. is initiating "an external process to explore strategic alternatives to enhance shareholder value." The firm has retained UBS Investment Bank as its financial advisor. Ligand also said it filed audited results for fiscal year 2004, restated audited results for fiscal years 2003 and 2002 and restated results for selected financial data from fiscal years 2001 and 2000. "Now that the financial reporting normalization is proceeding toward completion, the company, with UBS, intends to build on the work done over the past months and move forward with a robust process to carefully explore all strategic alternatives to enhance shareholder value," said David Robinson, Ligand's chief executive officer. The Brand Institute The Brand Institute Inex Pharmaceuticals Corp. Inex Pharmaceuticals Corp.'s board of directors approved a reorganization that would spin-off the company's targeted immunotherapy technology and product candidates into a new company. If the firm's shareholders and the Supreme Court of British Columbia approve the plan, most shares of the new public company would be distributed among Inex shareholders. The spin-off would allow the new company to raise capital necessary to advance the immunotherapy technology. The Brand Institute The Brand Institute Tibotec Pharmaceuticals Ltd. Tibotec Pharmaceuticals Ltd. began its pivotal Phase III trial program for TMC125, its investigational non-nucleoside reverse transcriptase inhibitor (NNRTI). The program will include two randomized, placebo-controlled, 600-patient trials in treatment-experienced adults with HIV-1 and documented resistance to NNRTI. Patients must also have at least three primary protease mutations. These trials, which will also use the company's TMC114 as a background protease inhibitor, will be the first to study two new investigational antiretrovirals together in "heavily treatment-experienced patients," Tibotec said. TMC125 has been granted fast track status by the Food and Drug Administration. The Brand Institute


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