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Trade NamesBrand 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 TYSABRI APPROVED FOR MS; ANALYSTS SAY DRUG COULD EXCEED $2 BILLION IN ANNUAL SALES OVER NEXT TWO YEARSThe Food and Drug Administration approved Biogen Idec and Elan Corp. Plc's Tysabri (natalizumab), formally known as Antegren, which is the first humanized monoclonal antibody approved for treating multiple sclerosis. Analysts believe the drug can generate more than $2 billion in annual sales over the next two years, The Wall Street Journal reported. Tysabri can be intravenously administered once a month for treating relapsing forms of MS to reduce the frequency of clinical relapses. As part of the accelerated approval, which was based on one-year data from two Phase III trials, the companies agreed to continue the studies for another year. They anticipate two-year results from the studies to be available in the first half of 2005. In the AFFIRM study, 942 patients were randomized to Tysabri or placebo. Those who received Tysabri had a 66 percent reduced rate of clinical relapse at one year as compared with patients who received placebo. The SENTINEL trial included 1,171 patients who were taking Biogen Idec's Avonex (interferon beta-1a), but who continued to experience disease activity. Tysabri or placebo was added to their usual regimen. Adding Tysabri to Avonex reduced the rate of clinical relapses by 54 percent over the effect of Avonex alone. These results could convince some physicians to prescribe both drugs, but the combination would probably exceed $30,000, the Journal reported. However, most insurers are expected to cover the cost of Tysabri. Eric Ende, a biotech analyst for Merrill Lynch, said they expect Tysabri to allow Biogen Idec to achieve a long-term 19 percent growth rate, TheStreet.com reported. "We believe Tysabri will rapidly capture a significant portion of 100,000 patients in the U.S. and Europe [who] are not currently on existing therapy due to intolerance or lack of efficacy and the 60,000 patients...ho] are currently on treatment but are not receiving adequate benefit and/or are intolerant of therapy," Ende said in a research report Wednesday. Tysabri inhibits adhesion molecules on immune cell surfaces, thus preventing the cells from migrating from the bloodstream and into the brain, where they can cause inflammation and damage. The drug is also being studied for use in Crohn's disease and rheumatoid arthritis. Shares of Biogen Idec closed at $58.59, up $1.16, or 2 percent, in heavy trading on the Nasdaq, while shares of Elan closed at $27.27, down $0.03, or 0.1 percent, in heavy trading on the New York Stock Exchange. FDA REJECTS CONNETICS' SKIN TREATMENT EXTINA The Food and Drug Administration issued Connetics Corp. a non-approvable letter for Extina (ketoconazole 2%) in the treatment of seborrheic dermatitis. The federal agency determined that Extina is not effective for seborrheic dermatitis because it was not superior to placebo foam in a Phase III trial, according to a Connetics press release. In the Phase III study, Extina demonstrated non-inferiority to Johnson & Johnson's Nizoral Cream (ketoconazole 2%). "The FDA's decision is disappointing and surprising," said Connetics Chief Executive Officer Thomas Wiggans. "Based on discussions with the FDA regarding the requirements for the Phase III trial, we believe Extina met the study endpoints and that the New Drug Application was approvable." Wiggans added that he expects any potential lost revenue for Extina in 2005 will be offset by expense savings since the company will not incur the planned commercialization costs for Extina. However, as a result of the FDA letter, Connetics now expects its fourth-quarter revenue and earnings per share to be at the low end of its previous guidance ranges. The firm had projected revenue of $43 million to $46 million and earnings of $0.16 to $0.18 per diluted share. Seborrheic dermatitis is a skin condition characterized by loose, greasy or dry scales, with or without associated reddened skin. Shares of Connetics closed at $21.72, down $4.63, or 17.6 percent, in heavy trading on the Nasdaq. AGGRESSIVE, FOCUSED STATIN THERAPY MANAGEMENT STRATEGY MAY BE SUPERIOR TO USUAL CARE IN PATIENTS WITH CHD "The ALLIANCE study breaks ground by showing the incremental benefit attributable to an aggressive, focused clinical strategy compared with usual care in predefined groups of coronary heart disease (CHD) patients with equal access to health care resources," authors of a recently published report stated. As part of the Aggressive Lipid-Lowering Initiation Abates New Cardiac Events study, 2,442 CHD patients with hyperlipidemia were randomized to an aggressive treatment arm with Pfizer Inc.'s Lipitor (atorvastatin) or usual care (defined as any lipid-lowering treatment deemed appropriate by their regular physician). All subjects were receiving care through one of 16 different HMOs or Veterans Administration centers. Average follow-up was 51.5 months. Subjects in the Lipitor group were started on the drug at a dose of 10 mg/day. This dosage was doubled every four weeks until either an LDL level of less than 80 mg/dL or a maximum dose of 80 mg/d was achieved. The average dose of Lipitor received by patients over the course of the study was 40.5 mg/d. Overall, 958 subjects in the Lipitor group and 941 subjects in the usual-care group completed end point assessments. The primary efficacy end point was time to first cardiovascular event (cardiac death, non-fatal myocardial infarction [MI], resuscitated cardiac arrest, cardiac revascularization or unstable angina requiring hospitalization). Two hundred eighty-nine patients (23.7 percent) in the Lipitor group experienced a primary outcome compared with 333 patients (27.7 percent) in the usual-care group. The reduction in morbidity appeared to be due primarily to fewer non-fatal myocardial infarctions in the Lipitor group (4.3 percent vs. 7.7 percent in the usual-care group). In addition, subjects in the Lipitor group showed a greater reduction in LDL cholesterol compared with the usual-care group. Those in the Lipitor group were also more likely to meet National Cholesterol Education Program goals of LDL cholesterol less than 100 mg/dL by the end-of-study visits (72.4 percent vs. 40 percent). Patients in the Lipitor group had an average of an additional 16 mg/dL reduction in LDL cholesterol beyond that of patients in the usual-care group. Serious adverse events were similar between the groups with the most common serious events being chest pain, atrial fibrillation, pneumonia, cellulitis and gastrointestinal hemorrhage. The study investigators acknowledged both the advantages and limitations of a "real-world" study such as the ALLIANCE trial but felt that the data solidly demonstrated the benefits of lipid-lowering therapy. "The ALLIANCE study adds important safety information about the use of high-dose statin therapy," the authors stated. "It is reassuring that patients treated aggressively achieved their goals with a low risk of adverse drug effects." "The ALLIANCE study results further support a growing body of evidence to suggest that LDL cholesterol treatment goals below current guidelines are desirable for appropriate patients," they concluded. The study appeared in the Nov. 2 edition of the Journal of the American College of Cardiology. IMITREX NASAL SPRAY WELL TOLERATED DURING LONG-TERM USE IN ADOLESCENT MIGRAINE PATIENTS, STUDY SUGGESTS GlaxoSmithKline Plc's Imitrex (sumatriptan) nasal spray is generally well tolerated during long-term use by adolescent patients with migraine, suggest findings from a prospective open-label study. In this study, adolescents aged 12 to 17 years were allowed to treat an unlimited number of migraines on an outpatient basis with Imitrex nasal spray for up to one year. Participants could treat migraines regardless of pain intensity (i.e., mild, moderate, or severe). The initial Imitrex dose was 20 mg; at the discretion of the investigator, the dose could be adjusted downward to 5 mg to optimize therapy. In total, 484 adolescents (mean age, 14.2 years; 60 percent female; 85 percent white) treated 4,676 migraines with Imitrex nasal spray 20 mg during the study period (3,593 migraines during the first six months and 1,083 during the second six months). A total of 3,940 migraines were treated with one 20 mg dose, while 699 were treated with two 20 mg doses (37 migraines were treated with three 20 mg doses within a 24-hour period, in violation of study protocol). As only 10 patients used the 5 mg dose of Imitrex nasal spray (having treated 42 migraines), the researchers focused only on migraines treated with the 20 mg dose. Overall, the proportion of migraines treated with Imitrex nasal spray (one to three doses) with at least one drug-related adverse event was 19 percent. Aside from unpleasant taste, reported in 17 percent of migraines, there were no other drug-related adverse events reported in more than 1 percent of migraines during the study period. After excluding unpleasant taste from the calculation of overall incidence of adverse events, the percentage of migraines with at least one drug-related adverse event declined to between 3 and 4 percent. No patient had drug-related changes in 12-lead ECGs, vital signs or nasal assessments, nor were there any clinically meaningful changes in clinical laboratory values. Considering all 4,334 migraines with evaluable efficacy data, headache relief was reported in 43 percent after one hour and in 59 percent at two hours. Of the 2,561 migraines in which headache relief was reported at two hours pos-dose, headache recurred within 24 hours of initial dosing in 7 percent. There was no variance in efficacy or tolerability as a function of time in the study (i.e., first six months vs. second six months). "[Imitrex] nasal spray has now been studied in the adolescent population in both crossover and parallel-group placebo-controlled trials as well as two one-year, open-label studies," the authors concluded. "Considered in aggregate, the data show that [Imitrex] nasal spray is well tolerated in doses up to 20 mg in adolescent patients. The current study extends previous work by providing additional data supporting the tolerability and efficacy of the 20 mg dose of [Imitrex] nasal spray with long-term use." This study can be found in the November issue of Headache. ENBREL SAFE, EFFECTIVE TREATMENT FOR ANKYLOSING SPONDYLITIS Amgen Inc. and Wyeth's Enbrel (etanercept) appears to be safe and effective in reducing the clinical symptoms and signs of ankylosing spondylitis (AS). In a multicenter trial, adult patients with AS were randomized to receive 25 mg injections of Enbrel (n=45) or placebo (n=39) twice per week for 12 weeks. The primary endpoint was an improvement of at least 20 percent in patient-reported symptoms, as measured by the Assessments in Ankylosing Spondylitis (ASAS 20). Secondary endpoints included the percentage of patients improving by 50 percent or more (ASAS 50) and the percentage of patients improving by 70 percent (ASAS 70) or more at any visit. Secondary endpoints included improved scores on the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), acute phase reactants and spinal mobility tests. The investigators found that significantly more patients assigned to Enbrel than placebo responded at the ASAS 20 level as early as week two. By week 12, significantly more Enbrel-treated patients than placebo-treated patients were ASAS 20 responders (60 percent vs. 23 percent). Furthermore, the results showed significantly more responders in the Enbrel arm at the ASAS 50 level at all visits and at the ASAS 70 level at weeks two, four and eight. Scores on the BASDAI composite index and the BASDAI fatigue component improved by 44 percent among those receiving Enbrel as compared with those treated with placebo. A significant decrease was noted in acute phase reactants, C-reactive protein and erythrocyte sedimentation rate in those assigned to Enbrel. Spinal flexion also improved more among the subjects in the treatment group. Although other measures of spinal mobility were improved in the treatment group, the between-group differences were not significant. Adverse events were primarily mild to moderate, and no discontinuations occurred for safety reasons. However, significantly more subjects undergoing treatment with Enbrel experienced injection site reactions. This study appeared in the December issue of Annals of the Rheumatic Diseases. CAMPTOSTAR GIVEN ONCE EVERY THREE WEEKS MAY COST MORE THAN ONCE WEEKLY REGIMEN, BUT MAY YIELD LOWER TOXICITY Treating colorectal cancer patients with Pfizer Inc.'s Camptostar (irinotecan) once every three weeks versus once weekly is more costly but achieves lower toxicity, which results in modestly improved utility, researchers suggest. They prospectively evaluated resource utilization data from a previously reported Phase III study. The participants had 5-fluorouracil-refractory metastatic colorectal carcinoma and had been randomized to receive Camptostar either at 125 mg/m2 weekly for four weeks followed by a two-week break (n=95) or 350 mg/m2 (300 mg/m2 in certain patients) once every three weeks (n=196). The two dosing schedules had similar efficacy. In the current analysis, the researchers found a significantly greater proportion of patients in the weekly group requiring dose reduction, which allowed delivery of only 75 percent of the planned doses compared with 97 percent of the planned doses in the three-week regimen. Drug costs were $4,977 higher for the three-week regimen than with the once-weekly schedule. However, combined with lower toxicity and fewer hospital days, the three-week regimen reduced hospital costs by $518 and ancillary drug costs by $550. Overall, the cost difference between the two regimens was $1,362. The every-three-weeks arm was related to less of a decline in utility during the trial, which resulted in a saving of 6.3 quality-adjusted days. Relating the cost differences to the difference in utilities, the three-week schedule was associated with a cost-utility ratio of $78,627 per quality-adjusted life year. However, this ratio was very sensitive to the cost of Camptostar. "Although the cost rises rapidly if offsetting savings are not realized in clinical practice, it likely will become increasingly attractive if the cost of [Camptostar] comes down in the future," the authors wrote. The economic review appeared in the Dec. 1 edition of the journal Cancer. Trade Names EXPRESS SCRIPTS INC. Express Scripts Inc. said Wednesday that it expects to post 2005 earnings per diluted share in the range of $4.50 to $4.65. Analysts polled by Thomson First Call had been expecting earnings of $4.61 per share in fiscal 2005, according to The Associated Press. Earlier this month, Express Scripts reported third-quarter earnings per share of $1.00, excluding charges, and projected its full-year 2004 earnings (excluding charges) would be in the range of $3.86 to $3.88 per share. Shares of Express Scripts closed at $69.65, down $2.60, or 3.6 percent, in heavy trading on the Nasdaq. Trade Names UNITED THERAPEUTICS CORP. United Therapeutics Corp. received Food and Drug Administration approval to market an intravenous formulation of Remodulin (treprostinil sodium). The approval was based on data establishing the IV formulation's bioequivalence with the company's previously approved subcutaneous formulation of Remodulin. Remodulin is indicated for the treatment of pulmonary arterial hypertension in patients with New York Heart Association Class II, III or IV symptoms. Shares of United Therapeutics closed at $41.54, up $6.21, or 17.6 percent, in heavy trading on the Nasdaq. Trade Names REGENERX BIOPHARMACEUTICALS INC. RegeneRx Biopharmaceuticals Inc. shares climbed 71.4 percent Wednesday on positive results from a preclinical study of Thymosin beta 4. The trial showed Thymosin beta 4, a naturally occurring peptide, significantly reduced tissue damage, ventricular scarring and dilation, and markedly improved cardiac function in laboratory animals when administered immediately following an induced heart attack. The data were published in the Nov. 25 issue of Nature. Shares of RegeneRx closed at $4.80, up $2.00, in heavy trading on the OTC Bulletin Board. Trade Names EURAND AND TRIGEN LTD. Eurand and Trigen Ltd. entered into a collaboration to develop controlled-release formulations of Trigen's oral anticoagulant TGN 167. Trigen has already completed a Phase I dose-escalation study of TGN 167 using a classical rapid-release tablet formulation. Trigen will retain all commercialization and development rights for TGN 167. Trade Names THE CENTERS FOR DISEASE CONTROL AND PREVENTION The Centers for Disease Control and Prevention falsely stated in March that obesity contributed to the preventable death of 400,000 Americans in 2000, up 33 percent from 300,000 in 1990, according to a Wall Street Journal report. Documents reviewed by the Journal indicate mathematical errors may have inflated the obesity-related death toll in 2000 by approximately 80,000, meaning the growth in obesity-related deaths was actually less than 10 percent. The CDC is conducting an internal review of the study to determine the extent of the errors. A correction is expected to be printed in JAMA, which published the study in March, once the review is completed. Trade Names
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