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			Image Branding 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 SANOFI-AVENTIS' ADACEL WHOOPING COUGH VACCINE APPROVED BY FDA ------------------------------------------------------------------------------- Sanofi-aventis Group's Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap]) was granted approval from the Food and Drug Administration for treating pertussis, or whooping cough, among patients aged 11 to 64 years. The FDA said the therapy is the first vaccine approved by the regulatory agency to boost immunity in adults. Pertussis vaccines are routine among U.S. children but experts in the field believe immunity to the disease tapers by adolescence, Reuters reported. They hope that vaccinating adolescents and adults will reduce the number of infections in such age groups and prevent the disease from spreading to infants. In May, the FDA approved GlaxoSmithKline Plc's Boostrix (Tdap) vaccine to protect adolescents aged 10 to 18 years against tetanus, diphtheria and pertussis. -=- CERTAIN NSAIDS MAY INCREASE RISK OF HEART ATTACK, RESEARCHERS FIND ------------------------------------------------------------------------------- New research suggests that certain nonsteroidal anti-inflammatory drugs, including Merck & Co. Inc.'s COX-2 inhibitor, Vioxx (rofecoxib), are associated with an increased risk of myocardial infarction. Researchers conducted a nested case-control study of 9,218 cases with a first-ever diagnosis of myocardial infarction between 2000 and 2004. The cases were identified in 367 general practices that contribute to the United Kingdom's QResearch database. More than 85,000 controls were matched for age, calendar year, sex and practice. The findings were adjusted for other risk factors and for whether a patient had pre-existing coronary heart disease or was taking aspirin. The results suggest that Vioxx, diclofenac and ibuprofen are associated with a significantly increased risk of myocardial infarction. Researchers also found increased risk associated with other NSAIDs, including naproxen, but these risks were not as significant. No significant interactions were found between any of the NSAIDs and aspirin or coronary heart disease. In addition, no evidence pointed to a reduced risk of myocardial infarction associated with the current use of naproxen, as had been suggested by other researchers. "This is an observational study and may be subject to residual confounding that we cannot fully correct for," the study authors cautioned. "However, we think that enough concerns exist to warrant a reconsideration of the cardiovascular safety of all NSAIDs." The study was published in the June 11 edition of the British Medical Journal. -=- HUMIRA PLUS METHOTREXATE SUPERIOR TO EITHER DRUG ALONE IN METHOTREXATE-NAïVE PATIENTS WITH EARLY RA ------------------------------------------------------------------------------- Abbott Laboratories' Humira (adalimumab) in combination with methotrexate is superior to Humira or methotrexate alone for achieving and sustaining significant clinical outcomes and inhibiting structural damage in methotrexate-naïve patients with early (less than three years) active rheumatoid arthritis, according to two-year data presented at the European League Against Rheumatism's annual meeting in Vienna, Austria. The double-blind, Phase III study randomized 799 patients to 40 mg of Humira every other week, methotrexate that was rapidly escalated to 20 mg/week or a combination of the two. The co-primary endpoints at 52 weeks were response to the American College of Rheumatology 50 (ACR50) and the average change in total Sharp score (TSS). Overall, 68 percent of patients completed the study; a larger proportion of these patients (76 percent) were from the combination arm than from either of the other two arms. At 52 weeks, the rates of ACR50 response were 62 percent for combination treatment, 42 percent for Humira alone and 46 percent for methotrexate alone. These significant response rates were sustained at two years (59 percent, 37 percent and 43 percent, respectively). In terms of TSS, the combination-treated patients demonstrated only an average 1.3 change at 52 weeks compared with a change of 3 for Humira alone and 5.7 for methotrexate alone. The combination arm also showed a significantly stronger suppression of damage at two years: average TSS changes were 1.9, 5.5 and 10.4 for the combination, Humira alone and methotrexate alone groups, respectively. Indeed, at two years, approximately twice as many combination-treated patients revealed no radiographic progression as compared with methotrexate-treated patients. The rate of clinical remission, defined as a Disease Activity Score 28 of less than 2.6, was also higher with the combination therapy at both time points; specifically, at two years, 49 percent of the combination group achieved clinical remission versus a 25 percent clinical remission rate for each of the monotherapies. Based on a sustained clinical remission and major clinical response, the combination treatment resulted in approximately 50 percent of patients achieving remission at two years. Abbott submitted a supplemental Biologics License Application to the Food and Drug Administration in December 2004 seeking approval for Humira to treat early RA. -=- TWO-YEAR DATA SHOW REMICADE'S LONG-TERM EFFICACY IN TREATING ACTIVE PSORIATIC ARTHRITIS ------------------------------------------------------------------------------- Centocor Inc.'s Remicade (infliximab) confers a long-term benefit for treating the symptoms of arthritis, psoriasis, dactylitis and enthesopathy in patients with active psoriatic arthritis, according to two-year data presented at the European League Against Rheumatism's annual congress in Vienna, Austria. The study was an extension of IMPACT, which included 104 patients with active psoriatic arthritis. Patients were randomized to receive Remicade 5 mg/kg of body weight or placebo at weeks zero, two, six and 14. Patients in the Remicade group continued maintenance treatments every eight weeks. At week 16, placebo recipients received an induction regimen of Remicade followed by maintenance treatment every eight weeks. In the second year, patients received Remicade infusions every 8 weeks from week 54 through 94; final assessments were conducted at week 98. Two-year results showed that 62 percent of Remicade-treated patients (n=78) achieved at least a 20 percent improvement in arthritis symptoms, as measured by American College of Rheumatology scoring criteria (ACR20). Remicade recipients also displayed sustained improvement in psoriasis symptoms during year two. At week 98, 64 percent of patients with a baseline Psoriasis Area and Severity Index (PASI) score of at least 2.5 achieved a PASI 75 response, indicating a significant and sustained improvement in skin disease. "Inflammatory diseases such as psoriatic arthritis can severely impact patients' abilities to function and lead normal, everyday lives," said Dr. Arthur Kavanaugh, director of the Center for Innovative Therapy, Division of Rheumatology, Allergy and Immunology, at the University of California at San Diego. "These results demonstrate that treatment with [Remicade] provides a significant clinical benefit, which may lead to a positive effect on patients' physical and emotional well-being," he added. -=- RESEARCH MISCONDUCT COMMON AMONG U.S. SCIENTISTS, SURVEY FINDS ------------------------------------------------------------------------------- A recent survey found that approximately one-third of U.S. scientists admit to research misconduct in the last three years. The HealthPartners Research Foundation mailed an anonymous survey to 3,600 mid-career scientists and 4,160 early-career scientists who received support from the National Institutes of Health. Of the 3,247 researchers who responded, 33 percent said they had engaged in at least one of the survey's top 10 contentious behaviors during the previous three years. Less than half of 1 percent said they had falsified data, and less than 1.5 percent said they had plagiarized. However, 15.5 percent said they had changed a study's design, methodology or results because of pressure from a funding source. Furthermore, 12.5 percent admitted they had overlooked the use of flawed data by others, 7.6 percent said they had skirted minor aspects regarding human-subject requirements and 6 percent said they had failed to present data contradicting their previous research. In response to questions about other behaviors, more than a quarter of respondents (27.5 percent) said they had kept inadequate records of research projects. Another 15.3 percent said they had omitted observations or data points from analyses "based on a gut feeling that they were inaccurate." "Our findings suggest that U.S. scientists engage in a range of behaviors extending far beyond [fabrication, falsification or plagiarism (FFP)] that can damage the integrity of science," the study authors stated. "Attempts to foster integrity that focus only on FFP therefore miss a great deal. "It is now time for the scientific community to consider what aspects of this environment are most salient to research integrity," they continued, "which aspects are most amenable to change and what changes are likely to be the most fruitful in ensuring integrity in science." The study and an accompanying commentary were published in the June 9 edition of the journal Nature. -=- PRELIMINARY DATA ON 2006 HMO RATES DEMONSTRATE LOWEST RATE INCREASE IN FIVE YEARS ------------------------------------------------------------------------------- A new report indicates that HMO plan rates may only increase approximately 12.4 percent on average in 2006, which represents the lowest rate of increase in more than five years. Hewitt Associates LLC evaluated data from Hewitt Health Resource, an Internet-based record of HMO rate information for approximately 160 large companies with a total of more than 1 million employees and annual premiums of nearly $4 billion. According to the preliminary figures, national HMO plan rates are anticipated to increase by 12.4 percent in 2006 compared with a 13.7 percent increase expected at the same time last year. After plan changes, negotiations and terminations, HMO rates rose by 9 percent on average in 2005. Hewitt said after negotiations are complete in 2006, the expected increase should be in the 8 to 9 percent range. "The positive impact of employee cost sharing on utilization rates, stabilization in the frequency of hospital visits and the increased focus of companies on health management programs are playing a major role in ongoing cost moderation," said Paul Harris, Hewitt's senior health care strategist. Although the rate of increase may be lower overall, the East is expected to experience a rate hike of 15.8 percent in 2006 compared with 14.6 percent at this time last year; the Southwest is expected to experience an increase of 13.5 percent in 2006 compared with 13.4 percent last year. Hewitt said the regional variances may be a result of differences in demographics, provider costs and common plan designs and coverage. Despite these positive preliminary predictions, employers are still adjusting plan designs to allow for more cost sharing. In 2004, 16 percent of firms offered $20 office visit copayments. In 2005, the number rose to 25 percent of firms. In contrast, the number of companies offering $10 office visit copayments was 22 percent in 2005 compared with 29 percent in 2004. "[I]t's important to remember that growth in health care costs continues to well outpace inflation. The longer-term challenge for employers and health plans is to bring cost increases down closer to the rate of salary increases," Harris added. -=- Image Branding BRISTOL-MYERS SQUIBB CO. ------------------------------------------------------------------------------- Bristol-Myers Squibb Co. informed health care professionals of revisions to the label of HIV drug Sustiva (efavirenz). According to a BMS letter, the revisions stem from four retrospective reports of neutral tube defects in infants born to women with first-trimester exposure to Sustiva. Because Sustiva may cause fetal harm when given to a pregnant woman during the first trimester, women receiving Sustiva should avoid pregnancy. BMS added that an antiretroviral pregnancy registry has been created to monitor fetal outcomes of pregnant women exposed to Sustiva. In combination with other antiretroviral agents, Sustiva is indicated for the treatment of HIV-1 infection. -=- Image Branding ELI LILLY AND CO. ------------------------------------------------------------------------------- Eli Lilly and Co. reached an agreement to settle approximately 75 percent of the outstanding lawsuits against the firm associated with its atypical antipsychotic, Zyprexa (olanzapine). Terms of the agreement provide that Lilly establish a fund of up to $690 million for plaintiffs who agree to settle their claims. A majority of the lawsuits claimed that before September 2003, information on Zyprexa's warning label conveying the risk of hyperglycemia and diabetes as "an infrequent adverse event since 1996" was inadequately displayed. However, in September 2003, the Food and Drug Administration required label changes on all atypical antipsychotics to reflect such a risk. -=- Image Branding SENATE FINANCE COMMITTEE ------------------------------------------------------------------------------- Senate Finance Committee Chair Charles Grassley, R-Iowa, and the committee's highest-ranking democrat, Max Baucus, D-Mont., sent a letter to more than two dozen drug companies asking them to explain their policies for awarding educational grants, Reuters reported. The senators are requesting the information to make sure that grants are not "a backdoor way to funnel money to doctors and other individuals who can influence prescribing and purchasing of particular prescription medications." Recipients of the letter include Pfizer Inc., GlaxoSmithKline Plc and Merck & Co. Inc. -=- Image Branding INSMED INC. ------------------------------------------------------------------------------- Insmed Inc. said the Food and Drug Administration has extended the deadline for completing a priority review of the New Drug Application for SomatoKine (mecasermin rinfabate), a treatment for growth hormone insensitivity syndrome. The anticipated date of completion is now Oct. 3, 2005, which is three months later than the original user fee goal date. "The extension is a result of the [FDA] classifying responses to questions about the NDA as a major amendment to the NDA," Insmed said. The company also said it was not made aware of any "specific deficiencies" regarding the application, and that it has responded to the agency's questions "thoroughly and comprehensively." Insmed shares closed at $0.97, down $0.25, or 20.5 percent, in heavy trading on the Nasdaq. -=- Image Branding MCKESSON CORP. ------------------------------------------------------------------------------- McKesson Corp. agreed to sell its McKesson BioServices division to Fisher Scientific International Inc. for approximately $60 million. McKesson expects the sale to generate an after-tax gain of approximately $13 million to $15 million for its second quarter, which will end Sept. 30, 2005. The transaction is subject to certain adjustments after it closes. For the first quarter ending June 30, McKesson will report financial results for the division as a discontinued operation. -=- Image Branding


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