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			Brand Image 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 Long-acting release formulation of Byetta improves diabetes outcomes, preliminary study results show Amylin Pharmaceuticals Inc., Eli Lilly and Co. and Alkermes Inc. reported that a once-weekly, long-acting release formulation of injectable Byetta (exenatide) may improve glycemic control and weight and be well tolerated among patients with type 2 diabetes. The companies conducted the Phase II study among 45 patients with type 2 diabetes who were unsuccessful in improving diabetes outcomes despite using diet and exercise with or without metformin, a sulfonylurea or both. Patients were randomized to receive a once-weekly, long-acting formulation of Byetta subcutaneously at one of two doses or placebo for 15 weeks. Byetta has been approved by the Food and Drug Administration as a twice-daily formulation, but the sustained-release injectable formulation has not been approved. Baseline hemoglobin (Hb) A1C levels averaged approximately 8.5 percent. Patients who received the high dose of the Byetta study formulation experienced an approximately 2 percent improvement in HbA1C levels at 15 weeks compared with placebo. Twelve of the 14 high-dose subjects whose baseline HbA1C measurements were greater than 7 percent achieved HbA1C levels of 7 percent or less by 15 weeks. However, none of the placebo-treated patients achieved this HbA1C target. The study also demonstrated a reduction in fasting blood glucose concentrations by approximately 50 mg/dL for those in the high-dose Byetta group compared with the placebo group. High-dose patients also averaged approximately 9 pounds in weight loss compared with patients who received placebo. The pharmaceutical firms noted that both doses of the new Byetta formulation were well tolerated, with the most common adverse effect being mild nausea. The study will continue for an additional 12 weeks for patient observation; the firms expect complete results to be presented at an upcoming scientific meeting. Amylin shares closed at $28.00, up $6.07, or 27.7 percent, while Alkermes shares closed at $17.67, up $1.84, or 11.6 percent, both in heavy trading on the Nasdaq. Lilly shares closed at $53.71, up $1.00, or 1.9 percent, in moderate trading on the New York Stock Exchange. Brand Image FDA approves expanded indication for Solvay, CV Therapeutics' Aceon The Food and Drug Administration approved Solvay Pharmaceuticals Inc. and CV Therapeutics Inc.'s ACE inhibitor, Aceon (perindopril erbumine) tablets, for the treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. The drug is also indicated for the treatment of patients with essential hypertension. The expanded indication is based on the EUROPA study, a randomized, double-blind, placebo-controlled trial that assessed Aceon's ability to reduce cardiovascular death, nonfatal MI or cardiac arrest in 12,218 patients with stable coronary disease and without heart failure. The study results indicated a 20 percent reduction in the combined endpoint of cardiovascular mortality, nonfatal MI and cardiac arrest compared with placebo, the companies said. "EUROPA demonstrated that [Aceon] can provide benefit in stable coronary artery disease patients with or without hypertension and in a broad range of younger and older patients, when used in combination with current conventional therapy," said Dr. Kim Fox, co-chairman of the study. "Because of this outcomes benefit, our conclusion was that [Aceon] should be considered in the management of patients with coronary heart disease." In December 2004, CV Therapeutics and Solvay entered into a co-promotion agreement for Aceon. In the United States, the firms will co-promote Aceon at least through 2010. CV Therapeutics is responsible for brand marketing activities; the firm has created a cardiovascular specialty sales force to promote Aceon. Also, Solvay manufactures and distributes the product and uses its primary care sales force to promote it. Solvay books Aceon sales and CV Therapeutics receives a share of sales above a pre-specified baseline. Brand Image FDA sends third warning letter to Boston Scientific for serious manufacturing problems The Food and Drug Administration sent a third warning letter to Boston Scientific Corp. regarding manufacturing problems with the company's Taxus drug-eluting stents, Vaxel ports and Symmetry catheters. The letters followed an inspection of the company's Quincy, Mass., shipping facility by the FDA earlier this year, which revealed "serious regulatory problems," including instances in which the company "on a number of occasions . . . shipped medical devices that were not considered acceptable for release." The FDA said Boston Scientific shipped units from a batch of Taxus Express 2 coronary stent systems that failed a kinetic drug-release test and had been placed in quarantine last year. Last year, the company recalled approximately 99,000 Taxus and other stents following complaints that the balloons used to insert the stents into arteries failed to deflate after the procedure, according to The Wall Street Journal. Furthermore, the FDA said the company distributed Vaxel ports, which are used to give chemotherapy drugs and other fluids to patients, from a batch that had been placed under quarantine last August after one report of port separation. The most recent letter also included a notice that the company had distributed Symmetry balloon catheters that did not undergo a so-called final release disposition. Charles Rudnick, a spokesman for Boston Scientific, acknowledged the problems and told Reuters that the company had already taken some corrective actions. "We do not dispute that some of these mistakes occurred," Rudnick said. "We're working on the process issues." He also added that no patients were harmed as a result of the problems. Rudnick told The Journal that the company had previously discovered the shipping errors and "retrieved the products." According to the FDA's letter, the company's response to the previous warning letters "does not identify how and when you plan to implement significant, broad-based corrective actions, nor does it provide sufficient evidence to establish that you have made real changes to your current quality system to ensure control over the release and distribution of your devices." Shares of Boston Scientific closed at $25.92, down $1.23, or 4.5 percent, in heavy trading on the New York Stock Exchange. Brand Image In patients with nonulcer dyspepsia, triple therapy with Aciphex for 10 days eradicates H. pylori at a higher rate than does seven-day treatment, study shows To eradicate Helicobacter pylori, seven- and 10-day triple therapy that includes Eisai Inc.'s Aciphex (rabeprazole sodium) appears to be equally effective in patients who have peptic ulcers, a new trial suggests, but 10-day therapy appears to be more effective than seven-day treatment in patients with nonulcer dyspepsia. The trial included 458 Spanish patients with either peptic ulcer or nonulcer dyspepsia according to endoscopy; histology, a rapid urease test or a urea breath test established H. pylori infection in these subjects. Along with 1 g of amoxicillin and 500 mg of clarithromycin twice daily, the trial participants were randomized to receive 20 mg of Aciphex twice daily for seven days (n=237) or 10 days (n=221). Also, for patients with a history of bleeding peptic ulcer, 300 mg/day of ranitidine was available after treatment and until H. pylori infection cure. The primary outcome was the eradication of H. pylori infection by either histology or a C-urea breath test at least two months after treatment. Analyses were performed as intention-to-treat (all patients in the study) and per-protocol (patients who underwent a valid posteradication assessment). With the seven- and 10-day regimens, 73.8 percent and 79.6 percent of the patients were cured, respectively, as measured by the intention-to-treat analysis. At the same time, the cure rates per-protocol were 81.8 percent with the seven-day therapy and 89.3 percent with the 10-day treatment. By patient, the subjects with peptic ulcers had similar cure rates in both treatment groups by both intention-to-treat and per-protocol analysis. In contrast, the nonulcer patients showed lower cure rates with the seven-day than with the 10-day regimen: by intention-to-treat, rates were 65.8 percent versus 77.2 percent, and by per-protocol, rates were 72.5 percent versus 91 percent, respectively. "Ten-day therapy seems, therefore, preferable for treating nonulcer patients," the research team noted. "However, even 10-day triple therapies achieve suboptimal intention-to-treat cure rates of below 80 percent." This study was published in the August issue of the American Journal of Gastroenterology. Brand Image Long-term use of aspirin, NSAIDs sharply reduces women's risk of colon cancer, results suggest Regular, long-term use of aspirin or non-aspirin nonsteroidal anti-inflammatory drugs was shown to reduce a woman's risk of developing colon cancer compared with those who did not regularly use these drugs, though the benefit does not appear until after more than a decade of use. The study, which examined data from a prospectively selected cohort of 82,911 women enrolled in the Nurses' Health Study, examined the influence of aspirin and NSAIDs in the prevention of colon cancer. Compared with women who did not use aspirin regularly, those who took two or more standard 325 mg tablets per week had their risk for colon cancer reduced by 23 percent. This benefit was observed to be related to dose, with a risk reduction of 11 percent for those taking two to five aspirin per week, 22 percent for those taking six to 14 aspirin per week and 32 percent for those taking more than 14 aspirin per week. The authors noted that women who took more than 14 aspirin per week for longer than 10 years in the past had their risk reduced by as much as 53 percent. This benefit was similarly found with regular, long-term NSAID use. However, the risk of developing colon cancer increased by 10 percent for women who took 0.5 to 1.5 aspirin per week. Furthermore, increased aspirin use was related by dose with incidence of gastrointestinal bleeding events. The data "suggest that use of aspirin at the highest-dose category compared with no use of aspirin would prevent one to two cases of colorectal cancer" per 10,000 person-years, though this would be offset by "an excess of eight episodes of major gastrointestinal bleeding . . . ," the authors added. The authors concluded by noting that "optimal chemoprevention may require substantially higher doses of aspirin than currently recommended for the prevention of cardiovascular disease." The study appeared in the Aug. 24/31 issue of JAMA. Brand Image Phase I oncology trials vastly underreported; valuable research results likely lost to scientific community, researchers report Results from Phase I oncology trials are seriously underreported, according to a study published online Aug. 22 ahead of print in the journal Cancer, suggesting that investigators and journals should revise the mechanisms in place for publishing such research. Investigators analyzed Phase I studies submitted to the 1997 annual meeting of the American Society of Clinical Oncology, including whether the study was novel (agents not approved by the Food and Drug Administration at the time of submission) or non-novel (at least one agent approved), and whether the study was ultimately published in a peer-reviewed journal and if not, why. Approximately 54 percent of the 275 studies submitted were selected for presentation at the ASCO meeting, with abstracts that reported novel agents significantly more likely to be selected for presentation compared with those that reported non-novel compounds. The overall publication rate was 67 percent at 7.5 years. Of the abstracts presented, 72 percent were subsequently published compared with 62 percent of those not presented. Presented abstracts were published significantly sooner than those not presented, the authors noted, with a median time to publication of 3.4 years. Only 12 percent of the studies were published within one year of the ASCO meeting. Of authors whose studies were not published, lack of time was the most common reason cited for nonpublication, followed by ongoing preparation of results and relocation of authors. Uninteresting results or incomplete data was cited as a contributing factor in only approximately one-third of the studies. "[C]linical trials can advance the practice of medicine only if their results are shared with the medical community," the authors noted, adding that "a median time to publication of more than three years is unacceptable for Phase I studies." The authors suggested journals adopt a uniform, specified format for publishing Phase I trials in a timely manner, similar to that used by some journals for null results. "Persistent underreporting of Phase I clinical trials hinders the dissemination of information to the medical community, delays scientific progress and may ultimately have an adverse effect on patient care," the authors concluded. Brand Image Brand Image GlaxoSmithKline Plc GlaxoSmithKline Plc is seeking a further indication for its antiviral drug Relenza (zanamivir), Dow Jones Newswires reported. The drug, which was initially launched in 1999 as the world's first influenza antiviral, is currently approved for the treatment of influenza, and GSK is reportedly in talks with the Food and Drug Administration and European regulators to extend this approval to the prevention of influenza, as well. The company said government interest in the drug has increased with the potential threat of a bird flu pandemic, and the German government placed an order for 1.7 million doses of the drug earlier this month. GSK is also looking to extend the drug's shelf life and is looking into different delivery methods, a company spokesman told Dow Jones. Brand Image Brand Image Neurobiological Technologies Inc. Neurobiological Technologies Inc. (NTI) and the Food and Drug Administration reached an agreement on the design of NTI's Phase III clinical trial for Viprinex (ancrod), an investigational acute ischemic stroke treatment. The FDA granted fast track status to the clinical protocol; the agency previously granted fast track status to the drug's overall development program. "We anticipate patient enrollment in the trial to begin within the next few weeks," said Paul Freiman, NTI's chief executive officer. "Our goal was to initiate the Phase III program in the third calendar quarter of 2005 and we fully expect to achieve that goal." NTI obtained worldwide rights to Viprinex in July 2004 when it acquired Empire Pharmaceuticals Inc. Brand Image Brand Image Nobex Corp. Nobex Corp. and Biocon Ltd. entered into an agreement to co-develop an oral brain-type natriuretic peptide (BNP) product for the treatment of cardiovascular disease. The companies will work closely in all aspects of the development process and will combine Nobex's proprietary oral peptide delivery technology with Biocon's peptide production capabilities. The companies plan to develop an oral BNP product for the chronic treatment of heart failure and other cardiovascular indications, and they hope to initiate an Investigational New Drug filing with the Food and Drug Administration and Indian regulatory officials in early 2007. Financial terms of the agreement were not disclosed. Brand Image Brand Image Lorus Therapeutics Inc. Lorus Therapeutics Inc. selected two molecules, ML-133 and LT-253, as lead candidates for further development as investigational cancer treatments. In the National Cancer Institute's in vitro cancer screening program, ML-133 demonstrated "potent activity against colon carcinoma, leukemia, non-small cell lung cancer and prostate cancer cell lines," Lorus said, adding that like ML-133, LT-253 has exhibited "potent growth inhibition in xenograft models of various human cancers, including colon carcinoma and non-small cell lung cancer." Lorus and researchers from the University of Toronto are developing formulations of the drug candidates to characterize pharmacokinetic properties. Brand Image Brand Image


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