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Survey ToolBrand 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 DRUG SALES INCREASE, BUT GROWTH IS LOWER THAN BEFORE, IMS HEALTH REPORTS ___________________________________________________________________________ Drug sales through retail pharmacies rose 7 percent to $340 billion in 13 key countries from October 2004 to September 2004, IMS Health Inc. reported in its Drug Monitor.This was a slight decrease from sales reported in a previous survey done by IMS Health. Sales of drugs in the cardiovascular and central nervous system therapeutic areas were highest, rising 8 percent at constant exchange to $66.9 billion and 12 percent to $63.3 billion, respectively. However, growth in sales was highest for blood agents (21 percent in U.S. dollars) and musculoskeletal drugs (19 percent in U.S. dollars), which each demonstrated 14 percent growth at constant exchange. The best selling drug was again Pfizer Inc.'s cholesterol-lowering therapy Lipitor (atorvastatin calcium) valued at more than $10.2 billion. Following Lipitor, the 4 other top-selling drugs were Merck & Co. Inc.'s cholesterol drug Zocor (simvastatin), AstraZeneca Plc's gastrointestinal drug Nexium (esomeprazole magnesium), Pfizer's hypertension drug Norvasc (amlodipine besylate) and Bristol-Myers Squibb and Co. and the sanofi-aventis Group's thrombosis drug Plavix (clopidogrel bisulfate), which showed the most growth (34.4 percent). The five leading pharmaceutical corporations included Pfizer, GlaxoSmithKline Plc, Merck, AstraZeneca and Novartis AG. The United States posted a 9 percent growth at constant exchange to nearly $172 billion in sales. In North America, where sales increased 10 percent to $181 billion, the central nervous system remained the key therapeutic growth area at 14 percent at constant exchange. BIOVAIL SHARES SINK ON ANDA FILING FOR WELLBUTRIN ___________________________________________________________________________ Biovail Corp. received notification that an Abbreviated New Drug Application has been submitted to the Food and Drug Administration for 150 mg and 300 mg generic formulations of Wellbutrin XL (bupropion hydrochloride), pushing Biovail shares down 9 percent. Biovail said in a press release that it does not know whether the submission, filed by Anchen Pharmaceuticals Inc., has been accepted for review by the FDA. Biovail has 45 days to analyze the submission and determine if it believes its intellectual property has been infringed. "We are confident in the strength of our intellectual property rights as they relate to Wellbutrin XL and will defend these vigorously," said Chief Executive Officer Dr. Douglas Squires in the press release. Wellbutrin XL is a once-daily norepinephrine dopamine reuptake inhibitor approved for the treatment of depression in adults. Biovail developed Wellbutrin XL and licensed worldwide sales and distribution rights to GlaxoSmithKline Plc, excluding Canada. During the third quarter of this year, Biovail accrued $203.5 million in sales, $86.4 million of which came from Wellbutrin XL. USB Securities Canada analyst Dimi Ntantoulis said Wellbutrin XL accounts for approximately 30 percent of the investment firm's 2005 sales estimate for Biovail and 60 percent of its earnings-per-share estimate, according to Canada's Globe and Mail. He added, however, that the generic filing would be of more concern if it were filed by an established generic company. Ntantoulis said it does not appear that Anchen has commercialized any products to date. Biovail is currently developing a new formulation of Wellbutrin XL. The firm aims to initiate relevant studies during the first half of next year, which could lead to an FDA submission in the second half of the year. Biovail shares closed at $15.70, down $1.55, in heavy trading on the New York Stock Exchange. MOST PARENTS RELUCTANT TO ALLOW CHILDREN TO PARTICIPATE IN CLINICAL STUDIES, SURVEY SHOWS ___________________________________________________________________________ Although two-thirds of U.S. adults believe pediatric research studies are necessary to advance the treatment of diseases that affect children, only 25 percent would definitely consider allowing their own child to participate in a clinical trial, according to a survey conducted by Harris Interactive Inc. The survey was conducted online between May 6 and May 17 of this year among 5,822 adults in the United States, including 3,220 who have at least one child. Results showed 67 percent of respondents believe clinical pediatric studies are necessary, while 4 percent do not believe they are necessary and 29 percent are not sure. However, when asked if they would consider allowing their own child to participate, only 25 percent said yes, while 30 percent said no and 45 percent were not sure. Several factors were identified through the survey that would make a parent or guardian "more likely" to consider allowing a child to participate. Among them, 73 percent of parents said they would be more likely to consider participation if their child had a terminal illness, and 70 percent would be more likely if their child's current treatment options were no longer effective. Other factors included the belief that the study drug would cure the child (75 percent) and the belief that the child would get an active drug instead of a placebo (47 percent). Data showed the likelihood of child participation is inversely correlated with the likelihood of receiving a placebo. Among the 1,687 respondents who said they would consider allowing their child to participate, 80 percent said they would be "somewhat likely" or "very likely" to allow participation if there were no chance of receiving a placebo, while only 62 percent would be likely to allow participation if there were a 50 percent chance of getting a placebo. The survey also examined the impact of monetary compensation and physician support, showing that 68 percent of parents would be more likely to let their child participate if their child's physician recommended participation, while 58 percent would be more likely to participate if the treatment were free and 37 percent would be more likely if they received additional financial compensation. MAJORITY OF AMERICANS DISSATISFIED WITH QUALITY OF HEALTH CARE; APPROXIMATELY ONE-THIRD REPORTED MEDICAL ERROR ___________________________________________________________________________ More than one-half (55 percent) of U.S. residents say they are not satisfied with the quality of health care in this country, according to results from a survey by the Henry J. Kaiser Family Foundation, the U.S. Agency for Healthcare Research and Quality (AHRQ) and the Harvard School of Public Health. On the same survey conducted four years ago, 44 percent of residents reported being dissatisfied with health care quality. Between July 7 and Sept. 5, 2004, a telephone survey was conducted in a randomly selected, nationally representative sample of 2,012 adults. Prior to answering any questions, respondents were read a common definition of medical errors. A greater proportion of people (40 percent) said the quality of health care has gotten worse in the past five years rather than getting better or staying the same (17 percent and 38 percent). Nearly half of the residents reported they are concerned about the safety of the medical care that they and their families receive. Half of patients with chronic conditions said that they or a family member have experienced a medical error as compared with only 30 percent of patients without chronic illnesses. Nearly one-quarter of Americans said a medical error caused "serious health consequences," including death, long-term disability or severe pain; of these individuals, 14 percent, or 3 percent of all Americans, said that they or their family filed a malpractice lawsuit due to the error. "Many steps have been taken to improve patient safety and the greater use of health information technology is one of the most promising developments in this area," said Dr. Carolyn Clancy, director of AHRQ. "Our challenge is to show the connection between these kinds of changes and improving the care patients receive, while at the same time expanding and accelerating those efforts." Most Americans said the reporting of serious medical errors should be required and released publicly. They were most likely to cite workload and stress, inadequate staffing and poor communication among health care providers as the causes of medical errors. Doctors spending more time with patients, hospitals being required to develop systems for avoiding medical errors, better training of health professionals and more use of computerized rather than paper medical records for ordering drugs were cited as "very effective" solutions for reducing preventable medical errors. These results come just one day after The Leapfrog Group, a coalition of companies, released results from its Leapfrog Hospital Quality and Safety Survey. A total of 1,019 hospitals responded to the survey about their knowledge, ability and action on 30 safety practices endorsed by the National Quality Forum. Only 21 percent of hospitals have complied with 27 of the safety practices related to safe drug use and ensuring patients understand procedure risks. MOST EMPLOYEES WILLING TO TAKE GREATER ROLE IN HEALTH CARE DECISION-MAKING, SURVEY SHOWS; BETTER EMPLOYER COMMUNICATION NEEDED ___________________________________________________________________________ More than 90 percent of employees surveyed by Hewitt Associates said they would be comfortable assuming more responsibility for decisions pertaining to their health care, but at present, most do not actively engage in informed health care decision-making. The Hewitt survey included more than 39,000 U.S. employees and showed that 93 percent would be comfortable taking more responsibility for their own health care. However, more than 80 percent of respondents said they currently do not estimate their annual health care expenses and 79 percent do not believe they can personally take action to control their health care costs. Furthermore, 57 percent said they have never researched provider costs or quality, 24 percent have never asked about their prescription drug options and less than half believe they do a great job of adhering to preventive medicine recommendations (including preventive drugs, screening tests and immunizations). While many employers now offer services that can help workers make informed health care decisions, a large number of workers are unaware these services exist. The Hewitt poll showed more than 50 percent of participants do not know if they have access to prescription, hospital or physician cost and quality data through their employer, and 60 percent do not know if they have online access to disease-management tools, medical expense estimators or general and company-specific information on rising health care costs. "Ironically, many companies are offering this kind of information and support today, so clearly there is a disconnect," said Jennifer Murphy, health care communication leader at Hewitt. "However, this is something that can be fixed through aggressive and targeted communication." The Hewitt survey also showed employees feel the government should take a more active role in helping individuals become buyers of health care by requiring providers to report quality data (90 percent) and physician fees (67 percent), and by passing legislation to hold down malpractice awards (66 percent) and to allow consumers to purchase prescription drugs from foreign countries (62 percent). AVANDIA MAY REDUCE RESTENOSIS RATE IN PATIENTS WITH DIABETES FOLLOWING CORONARY STENT IMPLANTATION, NEW FINDINGS DEMONSTRATE ___________________________________________________________________________ Patients with type 2 diabetes undergoing coronary stent implantation may be protected against restenosis when treated by GlaxoSmithKline Plc's Avandia (rosiglitazone maleate), new research suggests. In the prospective trial, 95 patients with type 2 diabetes who had recent acute myocardial infarction and underwent coronary stent implantation were randomized to a treatment group that received Avandia (n=47) or a control group (n=48) that received only conventional antidiabetic therapy. Clinical follow-up was performed at one, three and six months, and follow-up angiography was performed at six months. The rate of restenosis was 17.6 percent in the Avandia group compared with 38.2 percent in the control group. Furthermore, Avandia treatment was related to a significant reduction in the diameter stenosis after six months compared with the control group. More control patients (n=9) underwent target lesion revascularization versus Avandia-treated patients (n=4), although this difference was not statistically significant. Results also indicated a reduction in fasting insulin concentration and the high-sensitivity C-reactive protein concentration as a result of six-month Avandia therapy. However, the baseline and follow-up glucose and lipid concentrations did not differ between the groups. The researchers noted that the effect of Avandia is partly due to its anti-inflammatory properties. "This effect of rosiglitazone for preventing in-stent restenosis . . . may present an important modality for inhibiting any undiscovered and diffuse atherosclerotic processes observed in diabetic patients," they concluded. The study was published in the November issue of Diabetes Care. Survey Tool PFIZER INC. ___________________________________________________________________________ Pfizer Inc.'s injectable contraceptive Depo-Provera (medroxyprogesterone acetate) will now carry a black box warning on its label, indicating long-term use of the product may result in loss of bone density. The Food and Drug Administration said the bone density loss increases as the length of treatment increases and may not be completely reversible upon discontinuation of therapy. The warning states women should only use Depo-Provera as a long-term birth control method (for example, longer than two years) if other methods are inadequate. Survey Tool THE IMMUNE RESPONSE CORP. ___________________________________________________________________________ The Immune Response Corp. presented preliminary data from an ongoing Italian Phase II study of Remune (HIV-1 immunogen) in HIV-positive, antiretroviral-naive patients. The analysis, which included data from 37 patients in the 51-patient study, showed trends toward stabilization of total CD4+ T-cell counts, increased HIV-specific CD8+ memory T-cells and decreased levels of activated CD38+ T-cells with Remune therapy. The data were presented in Glasgow, Scotland, at the 7th International Congress on Drug Therapy in HIV Infection. The final analysis is expected by year-end. Shares of Immune Response closed at $1.13, up $0.18, or 19 percent, in heavy trading on the Nasdaq. Survey Tool CV THERAPEUTICS INC. ___________________________________________________________________________ CV Therapeutics Inc. completed enrollment in a late-stage trial of Ranexa (ranolazine) ahead of schedule. The company said it now expects data from the placebo-controlled, 500-patient study in the second quarter of 2005. The study was designed under a special protocol assessment agreement with the Food and Drug Administration and could support the angina drug's approval, if successful. If granted marketing clearance, Ranexa would be the first approved drug in a new class of angina therapy in more than 25 years, the firm said. Shares of CV Therapeutics closed at $21.62, up $1.32, or 6.5 percent, in heavy Nasdaq trading. Survey Tool GUILFORD PHARMACEUTICALS INC. ___________________________________________________________________________ Guilford Pharmaceuticals Inc. appointed Dean J. Mitchell president and chief executive officer, effective Dec. 1. Mitchell will succeed Dr. Craig R. Smith, who is retiring, the company said. Mitchell most recently served as vice president of strategy for Bristol-Myers Squibb Co. He worked for GlaxoSmithKline Plc and its predecessor companies from 1987 to 2001. Survey Tool
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