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			USAN INN 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 NDA for Biovail's Tramadol ER pain drug The Food and Drug Administration approved Biovail Corp.'s New Drug Application for Tramadol ER, an extended release, once-daily formulation of tramadol hydrochloride, for 100 mg, 200 mg and 300 mg dosage strengths for treating moderate to moderately severe chronic pain. The company said it is actively in negotiations with a "strategic marketing partner" related to the commercialization of Tramadol ER, whose trade name is still being finalized, and expects the commercial launch of the drug in early 2006. Biovail said it was the only company to submit an NDA for, and receive approval of, a once-daily formulation of the product. "The timing of the approval gives Biovail a significant competitive advantage, and allows us to further diversify our revenue base," said Dr. Douglas Squires, chief executive officer of Biovail. "The conditions of the approval by the FDA for Tramadol ER support three years of exclusivity for the indication and doses approved." Biovail also markets an orally disintegrating form of the drug, Tramadol ODT. Biovail shares closed at $22.58, up $4.31, or 23.6 percent, in heavy trading on the New York Stock Exchange. USAN INN Merck, BMS' Pargluva recommended for approval by FDA advisory committee A Food and Drug Administration advisory committee voted 8-1 in favor of approving Bristol-Myers Squibb Co. and Merck & Co. Inc.'s oral Pargluva (muraglitazar) as a monotherapy for treating type 2 diabetes, Dow Jones Newswires reported. The panel also voted 7-2 in favor of the drug being used in combination with metformin, but voted 6-3 against its use in combination with sulfonylurea drugs. The Endocrinologic and Metabolic Drugs Advisory Committee was convened to discuss potential cardiovascular risks associated with the drug, which, if approved, would be the first in a new class of drugs called glitazars. Pargluva studies were conducted in more than 3,000 patients and nine cardiovascular deaths were observed, Dow Jones reported, adding that an FDA reviewer said "the agency could not conclude the deaths were linked to the drug." Panel member Dr. Thomas Aoki, an endocrinologist at the University of California at Davis, said he thought the potential risks could be monitored and managed, according to Dow Jones. An example he gave was that if patients rapidly gained weight as a result of fluid retention, they should call their physician and be taken off the drug. Additionally, the FDA noted that just having diabetes increases a person's risk for cardiovascular problems and that other peroxisome proliferator-activated receptor drugs for diabetes are also associated with "dose-related fluid retention ... edema and congestive heart failure," according to Dow Jones. If Pargluva is approved, Merck and BMS plan to conduct additional studies on the potential cardiovascular risks, Dow Jones stated. USAN INN Pain Therapeutics reports positive Phase III trial results for abuse-resistant, long-acting form of oxycodone Pain Therapeutics Inc. reported positive Phase III data for pain-relieving therapy Remoxy, an abuse-resistant oral formulation of long-acting oxycodone. In the double-blind study designed to evaluate the safety and efficacy of Remoxy, 209 osteoarthritic patients with moderate to severe chronic pain were randomized to Remoxy 20 mg or placebo twice daily for a four-week study period. The primary endpoint was the percent decrease in pain scores from baseline to the final study visit, as measured with a standard Likert Pain Scale. Results indicated a statistically significant difference between Remoxy and placebo in this endpoint, the firm said. In addition, the study found statistically significant differences between Remoxy and placebo in each component of the Western Ontario and MacMaster Universities' Osteoarthritis Index, in physical function measured by a standard Short Form 12 Health Survey and in patients' self-reported Quality of Analgesia. No drug-related safety issues were reported in this study. "As expected, opioid-related adverse events were higher in the Remoxy arm compared to the placebo arm," the company noted. By the end of 2005, the company expects to initiate a large, pivotal Phase III registration study of Remoxy to support a New Drug Application. Based on Durect Corp.'s Oradur technology, Remoxy is being developed by Pain Therapeutics through a license from Durect. USAN INN Early treatment with Avonex may be cost effective in patients with MS who experience single demyelinating event Biogen Idec Inc.'s Avonex (interferon beta-1a) is a reasonably cost-effective treatment for patients with multiple sclerosis who experience a single demyelinating event, according to data from a recent study. Furthermore, the overall incremental cost-effectiveness profile of Avonex improves if treatment is initiated before clinically definite multiple sclerosis, the authors added. The study, which was published in the October issue of the journal Multiple Sclerosis, consisted of a cost-effectiveness analysis (CEA) and cost-utility analysis (CUA) performed from Canadian Ministry of Health (MoH) and societal perspectives. Costs are reported based on the exchange rate between Canadian and U.S. dollars on Dec. 31, 2002. In the CEA from a societal perspective, the cost-effectiveness ratio for Avonex was approximately $42,736 per monosymptomatic life year (MLY) gained compared with approximately $47,764 per MLY gained for the current treatment. Thus, the incremental cost of Avonex was approximately $28,356 per MLY gained. "Since the incremental cost [of Avonex] was lower than the average cost per MLY gained of current treatment, it was considered cost effective," the authors noted. In the CUA, the incremental cost of Avonex per quality-adjusted MLY gained (QAMLY) was approximately $144,085 per QAMLY and $119,836 per QAMLY from MoH and societal perspectives, respectively. Additionally, "[r]esults of the multivariate analyses from the societal perspective suggested that more than 87 percent of the scenarios would result in an incremental cost per MLY gained lower than the cost per MLY gained of current treatment," the authors noted. They added that the cost effectiveness and cost utility of Avonex, when compared with current therapy, improved, so that "the longer the model the greater the improvement in the cost-effectiveness profiles." The results of the study suggest that treatment with Avonex following a single demyelinating event "could not only provide decreased morbidity and improved quality of life to the patient in the immediate time frame, but also suggest a relative cost effectiveness for Avonex over a 12-year period," the authors concluded. USAN INN Novartis' Starlix plus metformin may be safer initial combination therapy than glyburide plus metformin among drug-naove type 2 diabetes patients Novartis AG's Starlix (nateglinide) plus metformin may be a safer initial combination therapy than glyburide plus metformin among drug-naove patients with type 2 diabetes, according to study results published in the September issue of Diabetes Care. In a double-masked, two-year study, researchers randomized 428 drug-naove patients with type 2 diabetes to either 120 mg of Starlix before meals or 1.25 mg of glyburide daily in addition to 500 mg of open-label, daily metformin for the initial four weeks. During a subsequent 12-week titration period, investigators increased glyburide and metformin by 1.25-mg and 500-mg increments to maximum daily doses of 10 mg and 2,000 mg, respectively, if a subject's fasting plasma glucose (FPG) was at least 6.7 mmol/L biweekly. Starlix was not titrated. Researchers maintained blinding by using matching placebo for Starlix and glyburide. During a subsequent 88-week monitoring period, researchers measured hemoglobin A1C, FPG and postprandial glucose excursions (PPGEs) during an oral glucose tolerance test. Average HbA1C levels were approximately the same for both groups at baseline (8.4 percent for the Starlix arm vs. 8.3 percent for the other treatment group) and at week 104 (6.9 percent for the Starlix group vs. 6.8 percent for the glyburide arm). Results indicated that both treatments achieved similar efficacy with differential effects on FPG versus PPGE. However, hypoglycemia occurred in 8.2 percent and 17.7 percent of patients treated with Starlix/metformin and glyburide/metformin, respectively. More than 90 percent of patients in both treatment groups experienced one or more adverse events (AEs); most were mild or moderate. Aside from gastrointestinal symptoms and those typically linked to falling glucose, the AE profile mirrored common ailments observed in the general population, the study authors said. "Similar good glycemic control can be maintained for two years with either treatment regimen, but [Starlix]/metformin may represent a safer approach to initial combination therapy," the authors concluded. USAN INN Researchers report encouraging, mixed findings regarding prescription of hypertension drugs upon discharge after acute ischemic cerebrovascular events Findings from a study of representative California hospitals suggest that a majority of patients hospitalized with acute ischemic cerebrovascular events are discharged with a prescription for one or more hypertension medications, but that there is still "considerable room for improvement." "A potential bridge for the antihypertensive knowledge-treatment divide could be the systematic and appropriate prescription of antihypertensives before the patient leaves the hospital or after admission for an acute ischemic stroke or transient ischemic attack (TIA)," wrote the researchers. "This strategy is attractive because it can be safe, studies suggest that in-hospital behavior strongly influences postdischarge community practice and moderate reductions in blood pressure during the first week after hospital admission have been associated with improved short-term functional outcome in patients with acute ischemic stroke." According to the authors, no studies have evaluated the frequency and patterns of discharge prescription for hypertension drugs in patients who experienced acute ischemic cerebrovascular events. To address this issue, the investigators analyzed the California Acute Stroke Prototype Registry, which prospectively collected data on acute stroke care for individuals with stroke or TIA at 11 representative hospitals in the state. Study periods were from Nov. 1, 2002, through Jan. 31, 2003, and from Nov. 1, 2003, through Jan. 31, 2004. The current analysis focused on all patients with a discharge diagnosis of ischemic stroke or TIA admitted during either study period. Subjects included 764 patients (average age, 70.4 years), of whom 53.4 percent were women. Overall, 69.4 percent received a discharge prescription for any hypertension medication; 2.2 percent were discharged on four or more medications, 7.9 percent were discharged on three medications, 23.2 percent were discharged on two medications and 36.1 percent were discharged on one medication. Rates were significantly heterogeneous among hospitals, ranging from 55 percent to 100 percent. In multivariate analysis, independent predictors of receiving hypertension drugs at discharge included history of hypertension, diabetes and older age. "At first glance, the fact that a majority of hospitalized ischemic stroke and TIA patients are discharged on at least one antihypertensive drug may seem encouraging," the investigators noted. "However, the evidence that large numbers of stroke survivors with hypertension remain poorly controlled suggests there is either ineffective implementation or suboptimal long-term maintenance of these therapies." This study appeared in the Sept. 1 issue of the journal Stroke. USAN INN USAN INN Merck & Co. Inc. Merck & Co. Inc. plans to defend itself against every Vioxx (rofecoxib)-related lawsuit and has no plans to settle, Dow Jones Newswires reported. Although recent reports suggested Merck may consider settling some cases after losing the first Vioxx case, Kenneth Frazier, senior vice president and general counsel at Merck, reiterated in a phone call to reporters that the company does not intend "to enter into any kind of global settlement." In August, a jury awarded $253.4 million to the widow of a Texas man who once took Vioxx. In Friday's conference call, Frazier said he believes Merck has "strong grounds for appeal," and that the company plans to do so. USAN INN USAN INN Abbott Abbott signed an agreement with German biotech company Biovision AG to collaborate on research concerning the discovery of new biomarkers for lung cancer. Biovision said it will analyze biological samples provided by Abbott "to discover tumor biomarkers." Under the agreement, Biovision will receive research payments, as well milestone and royalty payments if the firm is successful. USAN INN USAN INN TAP Pharmaceutical Products Inc. TAP Pharmaceutical Products Inc. signed a license agreement with Il-Yang Pharmaceutical Co. Ltd. for the development and distribution of ilaprazole, an investigational proton pump inhibitor. TAP holds the worldwide rights to ilaprazole--which will enter Phase II studies next year--with the exception of South Korea and China. TAP, a joint venture between Abbott and Takeda Pharmaceuticals North America Inc., recently said that it is initiating Phase III studies of TAK-390MR, the successor to TAP's ulcer treatment, Prevacid (lansoprazole). USAN INN USAN INN Medicare Today Medicare Today released a report using U.S. Census Bureau data and other sources to estimate potential savings from the new Medicare law. Under the new prescription coverage, all beneficiaries could save $700 annually on average in out-of-pocket spending, according to the report, but for beneficiaries who earn 150 percent of the federal poverty level or less, out-of-pocket drug spending will fall from $1,657 to $180 per year. Medicare Today noted that PricewaterhouseCoopers LLP prepared the data. USAN INN USAN INN


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