Brand Building - Brand Institute, inc.



			Brand Building 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 approves Levaquin as short-course treatment of acute bacterial sinusitis The Food and Drug Administration approved a new five-day treatment regimen for Ortho-McNeil Inc.'s Levaquin (levofloxacin) tablets, indicated for the treatment of acute bacterial sinusitis. The new regimen is the first and only short-course fluoroquinolone regimen approved for this indication, according to Ortho. The approval was based on a randomized, double-blind trial that assessed 780 adult outpatients diagnosed with acute bacterial sinusitis. In the trial, researchers compared a dosage of Levaquin 750 mg given once daily for five days and the previously approved dosage of Levaquin 500 mg given over the course of 10 days. The primary outcome was the "complete or partial resolution of the signs and symptoms of acute bacterial sinusitis to the degree that no further antibiotic treatment was necessary." A clinical success rate of 91.4 percent was observed among those who received 750 mg for five days compared with a rate of 88.6 percent among those who received 500 mg for 10 days. "This means that the high-dose, short-course regimen delivered comparable efficacy in half the treatment time," Ortho said. "More importantly, these high rates of clinical success were maintained at one month." The company noted that no new or unexpected adverse events were observed during the study in either group. Levaquin is approved for treatment in adults with acute bacterial sinusitis caused by Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis. The short-course regimen is also approved to treat adults with community-acquired pneumonia caused by certain bacterial agents. Brand Building Pozen submits NDA for Trexima as potential migraine treatment Pozen Inc. submitted a New Drug Application to the Food and Drug Administration for Trexima (sumatriptan succinate/naproxen sodium) as an acute treatment for migraine. Pozen licensed Trexima's U.S. commercialization rights to GlaxoSmithKline Plc and will receive a $20 million milestone payment from GSK when the FDA accepts the NDA filing. "We are pleased to submit the Trexima NDA ahead of schedule and within four months from the database lock on the last pivotal clinical study for the NDA," said Dr. Marshall Reese, executive vice president of product development at Pozen. "This has been a well-executed development program with good collaborative efforts put forth by team members from both GSK and Pozen." Last Friday, Pozen said it will discontinue development of its other migraine candidate, MT 100 (naproxen sodium/metoclopramide hydrochloride), after an FDA advisory committee said the drug needed to demonstrate greater improvement than it had so far in current studies. Instead, the company said it intends to focus on Trexima, which "has already demonstrated greater efficacy without the metoclopramide risk associated with MT 100," according to Dr. John Plachetka, Pozen's chief executive officer. Metoclopramide has been associated with a potential risk of developing tardive dyskinsia. Brand Building Inflazyme to use patient-reported outcomes as primary endpoints in Phase III trials of potential asthma therapy Inflazyme Pharmaceuticals Ltd. and the Food and Drug Administration's pulmonary drug division have reached an agreement whereby Inflazyme will continue to develop IPL512,602 as a potential asthma treatment using quality-of-life measures and other patient-reported outcomes. Last summer, the product failed to improve forced expiratory volume in one second (FEV1) in a Phase IIa study. While certain secondary endpoints showed improvement in asthma symptoms, they did not reach pre-established product profile criteria. However, the secondary endpoints in quality-of life measures and the need for rescue medication demonstrated statistically significant improvements in those who received IPL512,602 as compared with placebo-treated patients. In April, Inflazyme stated its intention to further advance the product by targeting the underlying inflammation that leads to better asthma control. After the firm discussed with the FDA the acceptability of patient-reported endpoints, the agency said it would consider the use of quality-of-life measures and other patient-reported outcomes among the primary endpoints for Phase III trials. "There has been increasing recognition among asthma physicians that there is not a direct correlation between measures of airflow obstruction, such as FEV1, and asthma control, with increasing emphasis on the need to control asthma symptoms and improve the quality of life," said Dr. Kevin Mullane, Inflazyme's chief executive officer. "Consequently, we are very pleased that the FDA recognizes the importance of patient-reported outcomes among the endpoints suitable for the development of new asthma products." Manufacturing of the product will begin this quarter, and a Phase IIb study is scheduled to start in the first quarter of next year. The firm is also looking for a development and commercialization partner with which it can bring the compound to market. Brand Building Results show Schwarz's lacosamide may reduce diabetic neuropathic pain Schwarz Pharma AG's lacosamide significantly reduced diabetic neuropathic pain at a 400 mg dose in a Phase III trial, but it failed to show a difference from placebo in a European trial. For the first double-blind trial, 370 patients with painful diabetic neuropathy received either 200 mg, 400 mg or 600 mg of lacosamide or placebo daily for up to 20 weeks. The participants rated their perception of pain twice daily on a 10-point Likert scale. At the 400 mg dose, lacosamide showed statistical significance on the primary efficacy variable of change in pain from baseline to treatment end. When compared over the entire titration period, 12-week maintenance period and treatment period overall, lacosamide and placebo demonstrated statistically significant differences. Additionally, lacosamide provided significant results on patients' global impression of change in pain. "We are now in the final stage of the Phase III program. We are striving for its completion in the first half of 2006 in order to have the marketing applications prepared as soon as possible," said Dr. Iris Loew-Friedrich, a member of Schwarz Pharma's executive board. However, another double-blind study that included 357 patients who had painful diabetic neuropathy provided somewhat different findings. For up to 20 weeks, they received 400 mg/day or 600 mg/d of lacosamide or placebo. While the data demonstrated a "separation" between the lacosamide and placebo arms in terms of the primary and secondary efficacy variables, the primary variable of change in pain from baseline to treatment end did not achieve significance. Lacosamide-treated patients did report lower average pain scores that remained stable throughout the entire maintenance period. Also, differences between the treatment groups were statistically significant during the titration period, 12-week maintenance period and overall treatment. So far, 90 percent of patients have decided to continue therapy with lacosamide in open-label follow-on trials, Schwarz said. Other trial results using lacosamide for diabetic neuropathy and for epilepsy are expected in the second quarter of next year. Brand Building Singulair not inferior to fluticasone at increasing rescue-free days in children with mild asthma, study shows Merck & Co. Inc.'s Singulair (montelukast sodium), taken orally, was shown not to be inferior to fluticasone propionate, a commonly used inhaled asthma treatment, at increasing the percentage of asthma rescue-free days (RFDs) in patients aged 6 to 14 years, according to a new study. However, patients who received Singulair had more asthma attacks (32.2 percent) and required more systemic corticosteroids (17.8 percent) than did patients who received fluticasone (25.6 percent and 10.5 percent, respectively). After a four-week placebo run-in period, patients with mild asthma (median age, 9 years) were randomized to receive Singulair (5 mg or 10 mg, depending on age) at bedtime or fluticasone (2 puffs, 50 mcg each) in the morning and evening. If needed, patients could take systemic corticosteroids or other controller treatments. A total of 482 patients in the Singulair group and 484 in the fluticasone group were included in the intention-to-treat analysis; 459 patients who took Singulair and 466 who took fluticasone completed the 12-month trial. In the Singulair group, the mean percentage of RFDs was 84 percent; in the fluticasone group, the mean percentage of RFDs was 86.7 percent. This represents a difference of less than one day per month, the researchers noted. Fluticasone performed significantly better than did Singulair with regard to the trial's secondary endpoints: the percentage of predicted forced expiratory volume in one second (an increase from 88.9 percent at baseline to 91.7 percent at month 12 in the fluticasone group vs. an increase from 88.1 percent to 89 percent for the Singulair group); the percentage of days with beta receptor agonist use (12.8 percent for fluticasone vs. 15.4 percent for Singulair); and quality of life, as measured by a pediatric asthma-related quality-of-life score (an increase from 5.3 to 6.4 in the fluticasone group vs. an increase from 5.4 to 6.3 in the Singulair group). Both therapies were well tolerated, and no patients in either group experienced a serious clinical drug-related adverse event. The study appeared in the August issue of the journal Pediatrics. Brand Building Bayer drug demonstrates effectiveness in preventing venous thromboembolism after orthopedic surgery; plans begin for Phase III program Promising results from two Phase II studies of Bayer HealthCare AG's BAY 59-7939, also referred to as Factor Xa inhibitor, have prompted the firm to make plans for initiating a Phase III program later this year. Data from two prospective, dose-finding studies conducted in more than 1,300 patients were presented in Sydney, Australia, at the 20th Congress of The International Society of Thrombosis & Haemostasis. During the trials, Factor Xa was administered twice daily in tablet form (2.5 mg to 10 mg). Sanofi-aventis Group's Lovenox (enoxaparin), the current gold standard for this indication, is administered by injection. In addition to achieving the endpoint of testing optimal dosing to be used for future studies, Factor Xa showed safety and efficacy similar to that of Lovenox at preventing the incidence of venous thromboembolism (VTE) in patients who were undergoing knee or hip replacement surgery. Across Factor Xa's dose range, no differences were observed between Factor Xa and Lovenox in the frequency of post-operative bleeding. So far, no evidence suggests that liver monitoring is necessary with the use of this product. "The results are extremely encouraging for patients and for Bayer HealthCare. Therefore, we are planning to initiate our Phase III program before the year's end," said Wolfgang Plischke, president of Bayer HealthCare's pharmaceuticals division. "We feel confident that we will be able to offer a safe and effective thrombosis prophylaxis that may be taken orally, thus providing greater flexibility for patients. Analysts believe the drug could generate sales of more than $1.26 billion each year, Reuters reported. Bayer anticipates filing for approval of Factor Xa as a treatment to prevent thromboembolism in orthopedic surgery by the end of 2007. A Phase IIb is already under way to assess the safety and efficacy of once-daily Factor Xa for preventing VTE after elective total hip replacement surgery. Factor Xa is also being investigated to treat VTE and prevent stroke in patients with atrial fibrillation. An ongoing Phase II dose-finding study is evaluating once- and twice-daily dosing of Factor Xa for this indication, and Bayer expects to file for approval to market the drug for this use in 2009. Brand Building Brand Building Eli Lilly and Co. Eli Lilly and Co. and Isis Pharmaceuticals Inc. extended their antisense drug discovery collaboration for approximately 24 months. During the extended period, the companies will continue their work to identify new antisense drug candidates while further developing the drugs and associated technologies already identified during their initial four-year collaboration. The companies also agreed to add a second-generation antisense inhibitor to Lilly's oncology drug discovery and development portfolio, a protein referred to as Signal Transducer and Activator of Transcription 3 (STAT-3) that "regulates cell division and growth, and prevents cell death." Isis may receive milestone and royalty payments as this drug is developed. Brand Building Brand Building Merck KGaA Merck KGaA opened a new generics unit in New York, called Genpharm LP, to give the company greater access to U.S. customers, increase its U.S. presence and further establish its position as the No. 3 generics company worldwide, according to Merck. Robert Mauro, former president and chief operating officer of Able Laboratories Inc., is serving as president of Genpharm. Brand Building Brand Building TorreyPines Therapeutics TorreyPines Therapeutics initiated a Phase I trial of its investigational Alzheimer's disease treatment, NGX267, an M1 receptor agonist. The single-dose trial will enroll approximately 55 healthy volunteers and will assess the drug's safety, tolerance and pharmacokinetics. An additional Phase I trial in an age-appropriate population that better represents patients with AD will follow if the first trial is successful. Brand Building Brand Building Quest Diagnostics Inc. Quest Diagnostics Inc. agreed to acquire LabOne Inc., a company that provides insurance companies with services such as health screening and risk assessment. The agreement states that Quest will purchase all of LabOne's outstanding common stock for $43.90 per share; the total transaction is valued at $934 million, including $132 million in convertible debt, which Quest will assume from LabOne. Quest anticipates savings of approximately $30 million per year after the two companies have fully integrated their operations sometime late in 2007. The acquisition is expected to be finalized before the end of the year. LabOne shares closed at $42.82, up $5.18, or 13.8 percent, in heavy trading on the Nasdaq, while Quest shares closed at $49.21, up $1.71, or 3.6 percent, in heavy trading on the New York Stock Exchange. Brand Building Brand Building


	- advertising slogan - b2b branding - best company names - brand architecture - brand association - brand awareness - brand building - brand communication - brand communications - brand creation - brand essence - brand evaluation - brand experience - brand extension - brand extensions - brand id - brand identification - brand image - brand management - brand marketing - brand name generator - brand name product - brand name search - brand personality - brand planning - brand position - brand positioning - brand products - brand profile - brand repositioning - brand revitalization - brand strategist - brand valuation - brand value - brand values - brand vision - branded media - branding a product - branding advertising - branding campaign - branding consultancy - branding consultant - branding consulting - branding design - branding expert - branding experts - branding firm - branding firms - branding guidelines - branding ideas - branding identity - branding logos - branding process - branding products - branding research - branding strategies - branding strategy - branding tools - brandname - brandnames - business branding - business naming - business slogan - catchy slogan - change company name - changing company name - co branding - cobranding - companies name - companies names - company logo - company logos - company name change - company name creator - company name finder - company name generator - company name ideas - company name registration - company name suggestions - company taglines - company titles - conjoint analysis - consumer market research - consumer panels - consumer research - consumer survey - cool company names - corporate identity - corporate identity design - corporate internet branding - corporate logo - corporate name change - corporate name generator - corporation name - corporation names - create a company name - create company name - creating a company name - creative company names - design branding - design company names - digital branding - drug safety - fda approval - fda regulations - find company name - food package design - global branding - global market research - global panel - global survey - good company name - good company names - great company names - healthcare market research - how to choose a company name - how to name a product - how to name your company - ideas for company names - identity branding - image branding - internal branding - international market research - internet branding - internet market research - internet panel - internet poll - internet surveys - law firm names - line extension - logo branding - logo companies - logo company - logo creation - logo design - logo designer - logo designers - logo research - market research panels - market research tools - marketing branding - marketing slogan - name a company - name company - name creation - name development - name generation - name research - names for companies - naming a business - naming a company - naming a product - naming business - naming consultants - naming products - naming service - naming services - naming software - naming standards - naming strategy - naming tools - naming your business - naming your company - new company name - new company names - online market research - package designs - pharmaceutical consultants - physician survey - product brand - product launches - qualitative research - real branding - rebrand - rebranding - register a company name - register company name - registered company names - registering company name - registering company names - research panel - research panels - slogan - slogans - strategic branding - strategic name development - survey panel - survey tool - survey tools - tagline - tagline generator - trade name search - trademark - trademark search - trademark searches - trademark searching - trademarks - unique company names - visual branding - your company name


			Austin / Chicago / Geneva / London / Los Angeles / Miami / New York / Ottawa / Raleigh Durham / Rockville / San francisco / Tokyo