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			Pharma Names 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 EMEA rejects GTC's ATryn due to insufficient data The European Medicines Agency rejected GTC Biotherapeutics' market authorization application for ATryn, a recombinant form of human antithrombin, based on an "insufficient number of surgical patients enrolled" in recent tests to warrant approval. The application sought approval of ATryn to be used as a prophylaxis for deep vein thrombosis and other thromboembolic events during high-risk procedures, such as surgery and childbirth, in patients who have hereditary deficiency indications and are prone to developing blood clots. ATryn would have been the first approved drug to be produced in the milk of genetically engineered animals, according to The New York Times. GTC said using animal milk is a less expensive way to produce biotechnology drugs. The EMEA's decision was based on a trial that included 14 people who were undergoing surgery or giving birth. The agency rejected the application due to an insufficient number of surgical patients, as well as concerns about sufficient immunologic data and lack of data about ATryn produced with an additional filtration step. The company said it would appeal the decision. GTC's Chief Executive Officer Geoffrey Cox added that the company will continue seeking approval for a Biologics License Application in the United States because "the United States remains a major long-term opportunity for ATryn in a range of hereditary and acquired deficiency indications." Pharma Names Health care spending to rise faster than GDP does through 2015, new report indicates Health care spending in the United States is expected to increase 7.2 percent per year on average through 2015, a pace that is faster than that of the U.S. gross domestic product, according to an updated outlook by researchers from the Centers for Medicare & Medicaid Services Office of the Actuary. For 2005, growth in national health care spending is expected to increase 7.4 percent compared with increases of 7.9 percent in 2004 and 9.1 percent in 2002. Health care spending is expected to increase 7.3 percent in 2006. The researchers noted that the growth in spending during the next 10 years is 2.1 percentage points faster than the projected average GDP annual growth. In 2004, health care spending accounted for approximately 16 percent of the GDP, but by 2015, the share will increase to 20 percent, according to the report. Overall, health care expenses totaled $1.88 trillion in 2004 and are anticipated to reach $2.02 trillion in 2005. By 2015, the expenses are expected to total more than $4 trillion based on the data. Spending for prescription drugs is expected to increase 8 percent in 2005 and by an average of 8.2 percent per year until 2015, which represents a lower rate of increase as compared with recent years. In 2002, the growth rate was 13.4 percent. According to the researchers, this slowdown was driven by lower drug use, as privately insured adults had higher cost sharing in the form of greater drug copayments, thus causing more cautious drug use. Furthermore, the report took into account the effects of larger discounts and rebates than originally expected from Medicare Part D. Private health insurance spending in 2005 is expected to grow at a rate of 6.8 percent for premiums compared with a growth rate of 8.4 percent in 2004. The study showed that Medicare spending is expected to increase by 25.2 percent in 2006 due to the drug benefit and average 7.5 percent annual growth between 2008 and 2015. Medicaid spending is projected to increase by 7.7 percent in 2005 and grow an average of 8.6 percent per year through 2015. Lastly, the study authors said in 2005, hospital spending is expected to increase by 7.9 percent, nursing home spending by 5.6 percent and home health spending by 13.2 percent. The report was published by the journal Health Affairs as a Feb. 22 Web exclusive. Pharma Names Most prescribers adhere to black box warnings, but concerns remain Although violations of black box warnings occurred in less than 1 percent of prescriptions written by physicians in 2002, "the absolute number of outpatients at risk is substantial," the authors of an observational study concluded. The researchers examined 2002 data from the electronic health records of 51 outpatient practices to measure the frequency with which physicians prescribed drugs in violation of black box warnings for drug-drug, drug-laboratory and/or drug-disease interactions. In that year, 324,548 outpatients aged 18 years or older (mean age, 61 years) received a prescription drug. Of this total, 33,778 patients received a prescription that contained a black box warning. Of this subpopulation, 2,354 patients, or 7 percent, received a prescription that violated the warning. This amount represented 0.7 percent of all outpatients included in the study. The researchers then performed a record review on a sample of 575 of the patients who received a prescription in violation of a black box warning. They estimated that of this sample, 16 patients, or less than 1 percent, had an adverse drug event resulting from the violation; another approximately one in six patients had a potential adverse drug event, while approximately one in four patients had a medication error. After multivariate adjustment, patients who were 75 years or older, female or white individuals were significantly more likely to have received a prescription in violation of a black box warning than were younger, male nonwhite patients who took fewer drugs. The number of drugs a patient took, the number of medical problems a patient experienced and the type of care facility also affected the likelihood of receiving a prescription that violated a black box warning. The authors noted that other studies have shown that black box violations occur more frequently than what was seen in their trial. Despite the relatively small numbers of violations observed in this study, the authors cautioned that the issue remains a problem and recommended that warnings "be clarified, simplified and made consistent with commonly used practice guidelines." The study appeared in the Feb. 13 issue of the Archives of Internal Medicine. Pharma Names Merger-related costs slash Sanofi-Aventis' Q4 profit Sanofi-Aventis Group reported a substantial decrease in its fourth-quarter 2005 net profit related to costs associated with the company's merger with Aventis in August 2004. Net profit for the quarter was approximately $543.7 million compared with approximately $1.42 billion adjusted pro forma income for the fourth quarter of 2004. Excluding $1.18 billion in merger-related charges, net profit increased 21 percent to approximately $1.72 billion in the fourth quarter of 2005. Adjusted earnings per share increased 20 percent from approximately $1.07 per share in the fourth quarter of 2004 to approximately $1.29 per share in the latest quarter. Net sales for the fourth quarter reached approximately $8.35 billion, an increase of 7 percent from approximately $7.81 billion for the same quarter a year ago. For the full year, net income was approximately $2.68 billion, or $2.01 per share, including approximately $4.84 billion in charges. Excluding the charges, full-year earnings increased to approximately $7.52 billion, or $5.63 per share, compared with approximately $5.97 billion, or approximately $4.48 per share, in 2004. The 26 percent increase in adjusted earnings per share narrowly beat Sanofi-Aventis' 25 percent forecast. Net sales for the year totaled approximately $32.43 billion compared with $29.92 billion in 2004. For 2006, the company forecasts an adjusted earnings-per-share growth of 10 percent. Sanofi-Aventis said it hopes to launch its weight-loss drug, Acomplia (rimonabant), in the second half of 2006. Last week, the company received an approvable letter from the Food and Drug Administration's Division of Metabolism and Endocrinology Products for Acomplia as a treatment for weight management; however, it also received a non-approvable letter from the Division of Anesthesia, Analgesia and Rheumatology Products for Acomplia as a treatment for smoking cessation. Shares of Sanofi-Aventis closed at $43.22, up $0.53, or 1.2 percent, in heavy trading on the New York Stock Exchange. Pharma Names SkinMedica's Desonate HydroGel shows positive results in pediatric patients with atopic dermatitis SkinMedica Inc.'s Desonate (desonide) HydroGel 0.05%, an investigational, low-potency, topical steroid treatment for atopic dermatitis, yielded positive results in two Phase III clinical trials. The double-blind Phase III studies assessed the efficacy of Desonate HydroGel in 582 patients aged 3 months to 18 years with mild to moderate atopic dermatitis. Patients were randomized to treatment with Desonate HydroGel or vehicle gel twice a day for four weeks. The results demonstrated a "highly statistically significant treatment effect" for Desonate HydroGel compared with placebo in both primary and secondary endpoints. These included the Investigator Global Severity Assessment, which was the primary endpoint, and the alleviation of signs and symptoms of atopic dermatitis, such as erythema, induration/papulation and scaling. Specifically, in the group of patients who received the active treatment in the first trial, 44 percent experienced treatment success based on the IGSA compared with 14 percent of the placebo group. In the second trial, the success rates for the same endpoint were 28 percent and 6 percent for Desonate HydroGel and placebo, respectively. The company said it will seek approval of the drug in the United States. SkinMedica licensed the drug-delivery technology used in developing Desonate HydroGel from Dow Pharmaceutical Sciences. The company said its product differs from conventional steroid formulations in that it does not contain alcohol, an ingredient that can be irritating to patients with atopic dermatitis. Pharma Names Glucosamine/chondroitin sulfate combination may decrease knee pain, according to trial results Data from two clinical trials show that glucosamine hydrochloride/sodium chondroitin sulfate combination therapy may improve knee pain. The Glucosamine/chondroitin Arthritis Intervention Trial (GAIT), a double-blind, 24-week trial funded by the National Institutes of Health, was the first study of its kind to evaluate the safety and effectiveness of glucosamine hydrochloride (1,500 mg/day) and chondroitin sulfate (1,200 mg/d), individually and in combination. Researchers randomized 1,583 patients with symptomatic knee osteoarthritis to one of five treatment groups, based on the severity of the patients' knee pain. The groups received 1,500 mg/day of glucosamine, 1,200 mg/d of chondroitin, a combination of glucosamine and chondroitin at the same dosages, 200 mg/d of Pfizer Inc.'s Celebrex (celecoxib) or placebo. The primary endpoint of the study was a 20 percent reduction in knee pain from baseline to week 24. Patients were also evaluated at weeks four, eight and 16. The results showed that, overall, glucosamine and chondroitin, either in combination or as monotherapy, did not achieve the endpoint statistically significantly better than placebo did. Treatment with Celebrex, however, did yield statistically significantly superior results in terms of the endpoint when compared with placebo. Among the patients with moderate to severe knee pain at baseline (22 percent of the total trial population), the combination of glucosamine and chondroitin did lead to a significantly higher rate of response than did placebo (79.2 percent vs. 54.3 percent, respectively). By comparison, patients in this subcategory who were treated with Celebrex experienced a response rate of 69.4 percent. In these patients, Celebrex, glucosamine alone and chondroitin alone did not yield significantly superior results in terms of the primary endpoint as compared with placebo. The researchers reported that adverse events were mild and were similar among the treatment groups. Details of the study were published in the Feb. 23 issue of The New England Journal of Medicine. Pharma Names Pharma Names Merck & Co. Inc. Merck & Co. Inc. said the Food and Drug Administration extended the review period for the Biologics License Application for Zostavax (zoster vaccine live), an investigational shingles vaccine. The FDA told Merck it expects to complete its review of the application by May 25. The company submitted the BLA in April 2005. Pharma Names Pharma Names GlaxoSmithKline Inc. GlaxoSmithKline Plc was granted a temporary restraining order blocking the shipment and sales of fluticasone, a generic competitor of GSK's Flonase nasal spray for allergies. The Food and Drug Administration approved Roxane Laboratories Inc.'s fluticasone propionate nasal spray last Wednesday. Par Pharmaceutical Companies Inc. also has a generic version of Flonase, which GSK authorized. A federal judge granted the 10-day restraining order after GSK claimed the FDA failed to adhere to its own regulations in approving the generic formulation and failed to apply the same quality standards. According to The Associated Press, the FDA has rejected GSK's allegations. Pharma Names Pharma Names Baxter International Inc. Baxter International Inc.'s European subsidiary received a contract from the United Kingdom's National Health Service to supply 2 million doses of candidate H5N1 influenza vaccine based on an avian strain. The company said the stockpile will be delivered to the NHS before the end of the year. In addition, Baxter is collaborating with the National Institute of Allergy and Infectious Diseases to develop a cell culture-based H5N1 candidate pandemic influenza vaccine. According to Baxter, clinical testing of the vaccine is expected to begin this year. Pharma Names Pharma Names The Centers for Disease Control and Prevention The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices voted to expand the recommended age of routine influenza vaccination for children. The new recommendation advises giving influenza vaccinations to children aged 6 months to 5 years, whereas the previous recommendation was limited to children aged 6 months to 23 months. The committee also voted to recommend influenza vaccinations for household contacts and caregivers of children aged 6 months to 59 months. Pharma Names


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