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			Company Taglines 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 ID Biomedical's Fluviral influenza vaccine granted fast track designation by FDA ID Biomedical Corp.'s Fluviral influenza vaccine was granted fast track status by the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER). In March, Fluviral was deemed eligible for accelerated approval and priority review by CBER. In addition, CBER and ID Biomedical created a clinical trial program that, depending on trial results, will facilitate the Canadian company's submission of a Biologics License Application by the end of 2005. "This designation along with our access to accelerated approval and priority review mechanisms clearly signal the importance of expanding flu vaccine availability in the United States," said Jane Halpern, ID Biomedical's vice president of regulatory affairs. The firm also said that the ongoing expansion and upgrading of its flu vaccine manufacturing facilities in Quebec is on schedule and will increase its production capacity from 50 million doses per year, as previously announced, to approximately 75 million doses annually in 2007. "[T]he expansion of our production capacity is right on track," said Dr. Anthony Holler, ID Biomedical's chief executive officer. "Once completed, ID Biomedical will be positioned as one of the largest flu vaccine manufacturers in the world." Once Fluviral is approved, ID Biomedical said it will be able to manufacture approximately 20 million to 25 million doses for the U.S. market in 2006 and approximately 40 million doses in 2007. It also plans to develop a preservative-free formulation of the vaccine for children. The company said its distribution partners, Henry Schein Inc., AmerisourceBergen Corp.'s Specialty Group and McKesson Corp., have agreed to purchase and distribute 38 million doses of the vaccine each year for the U.S. market, beginning in 2007. If the vaccine is approved by April 1, 2006, the agreement will apply to the 2006 season as well. ID Biomedical currently supplies approximately three-quarters of the Canadian government's influenza vaccine purchases. ID Biomedical shares closed at $19.04, up $1.44, or 8.2 percent, in heavy trading on the Nasdaq. Company Taglines Boehringer's Flomax outperforms Abbott's Hytrin in reducing symptoms of enlarged prostate, new data show Patients treated with Boehringer Ingelheim Pharmaceuticals Inc.'s Flomax (tamsulosin hydrochloride) had significantly greater improvement in symptoms associated with benign prostate hyperplasia, (enlarged prostate) after four days of treatment than patients treated with Abbott's Hytrin (terazosin hydrochloride), according to a study published in the summer issue of The Journal of Applied Research in Clinical and Experimental Therapeutics. The study included 1,993 patients with benign prostate hyperplasia who were randomized to receive either Flomax (0.4 mg/day) or Hytrin (5 mg/d, following titration). The study's primary endpoint was to compare patients' total American Urological Association Symptom Index (AUA-SI) score after four days of treatment. Flomax-treated patients experienced a statistically and clinically significant improvement (25.3 percent) in mean total AUA-SI score after four days of treatment compared with an 18.1 percent improvement in Hytrin-treated patients. Patients who received Flomax reported fewer incidences of dizziness and somnolence than patients treated with Hytrin. In addition, 4.3 percent of patients in the Flomax group stopped treatment due to adverse effects compared with 6.6 percent of the Hytrin group. "Unlike [Hytrin], [Flomax] does not have to be titrated and patients receive a therapeutically effective dose on day one," said Dr. Perinchery Narayan, director of the North Florida Urology Association and principal author of the study. "Because side effects, including dizziness and reduced blood pressure, were more common in men treated with [Hytrin], these findings also indicate that [Flomax] may be a more appropriate treatment option for men with [benign prostate hyperplasia] who might also be taking medications for hypertension." Reuters reported that Flomax was Boehringer's best-selling prescription drug last year, with sales of $896 million. Flomax is co-marketed by Boehringer and Astellas Pharma Inc. The study was funded by Boehringer. Company Taglines Avandia does not increase risk of hepatoxicity among diabetes patients with elevated baseline liver enzymes, research suggests New research suggests that diabetes patients with elevated baseline liver enzymes do not have a higher risk of hepatoxicity from GlaxoSmithKline Plc's Avandia (rosiglitazone maleate) than diabetes patients with normal enzymes. Investigators noted that thiazolidinediones such as Avandia are to be used cautiously in patients with diabetes with mild elevations in liver enzymes and are not to be used in patients with alanine aminotransferase greater than 2.5 the upper limit normal. The authors added that studies have not adequately examined if the risk of hepatoxicity with Avandia therapy is greater among diabetes patients with elevated liver enzymes than in those with normal liver enzymes. Two cohorts of patients--cohort 1 (diabetes patients with elevated baseline liver enzymes, n=210) and cohort 2 (diabetes patients with normal liver enzymes, n=628)--received Avandia. Increases in liver biochemistries during a 12-month period after initiating Avandia treatment were labeled as mild to moderate or severe elevations. In addition, the incidence of liver biochemistry elevations meeting the criteria of "Hy's rule" was assessed. Researchers found that compared with cohort 2, patients in cohort 1 did not have a higher incidence of mild to moderate and severe elevations in liver biochemistries. In addition, there was no statistical difference between the cohorts in the incidence of liver biochemistry abnormalities meeting Hy's rule. Also, the frequency of Avandia discontinuation during the follow-up was similar between the cohorts. The study findings were published in the June issue of The American Journal of Gastroenterology. Company Taglines Sustained treatment efficacy in rheumatoid arthritis, decrease in rate of radiographic progression observed with Enbrel, methotrexate Treatment with Amgen Inc. and Wyeth Pharmaceuticals' Enbrel (etanercept) or methotrexate provided sustained efficacy and reduced the rate of radiographic progression for up to five years in patients with early rheumatoid arthritis, according to new data. A total of 632 adult patients who had RA for no more than three years were enrolled in a double-blind efficacy study and were randomized to receive up to 20 mg of methotrexate per week or 10 mg or 20 mg of Enbrel twice weekly for one year. Those who completed this phase of the study continued open-label therapy with the originally assigned medication for up to two more years. Following this phase, 468 of the patients entered into an open-label extension during which they all received 25 mg of Enbrel twice each week. Of these patients, 293 have five years of efficacy data, and 77 percent are still being studied. Response scores, based on the American College of Rheumatology (ACR) criteria, stayed relatively constant from the beginning of the extension study through five years. At the fifth year, ACR 20, 50 and 70 responses were achieved by 65 percent, 52 percent and 37 percent, respectively, in patients who initiated treatment with methotrexate and then added Enbrel. Corresponding rates for the Enbrel 10 mg arm were 74 percent, 57 percent and 32 percent; for the Enbrel 25 mg group, the rates were 68 percent, 49 percent and 33 percent. This efficacy was maintained even among patients who decreased or discontinued their use of corticosteroids or methotrexate. Also, by year one, the median values for the number of swollen joints, C-reactive protein, Health Assessment Questionnaire score and C-reactive protein based on the evaluation of 28 joints showed rapid improvements among all treatment groups. These improvements continued to be observed through year five. Among the 297 patients for whom radiographic data were available through five years, 55 percent demonstrated no progression in Total Sharp Score from baseline to year five. On average, the annual rate of progression was less than one TSS unit per year in patients who received methotrexate and/or Enbrel 25 mg versus an annual progression of more than one TSS unit per year in patients who received Enbrel 10 mg. Moreover, 11 percent of patients demonstrated a negative change in TSS from baseline to year five. Even with long-term exposure to Enbrel, the rates of serious adverse events and serious infections did not increase. The two reported lymphomas reflected a higher rate than expected for the general population, but the study authors noted that patients with RA are known to have a higher incidence of lymphoma than that found among the general population. "It is noteworthy that a small group of patients actually showed negative rates of radiographic progression, suggesting that cessation of new erosions and repair of old erosions may be possible, and emphasizing the influence of early treatment with biological therapy in patients with early RA," the investigators concluded. The study was published in the July edition of The Journal of Rheumatology. Company Taglines Statin use does not decrease risk of dementia in elderly patients, findings suggest Statin therapy does not appear to be linked to a decreased risk of dementia in the elderly, according to results of a study published in the July issue of Archives of Neurology. This outcome differs from previous case-control studies, which found a possible association between statin use and dementia, the authors noted. The cohort study included 2,798 community-dwelling adults aged 65 years or older who were free of dementia at baseline. The authors estimated the risk of various types of dementia associated with the use of statins (characterized as current use, former use or ever use). The study included a one-year lag between exposure and outcome because dementia generally manifests in a gradual manner. Participants were checked annually to determine their health status, symptoms and medication use. The authors found no association between the use of statins (ever use) and the risk of all-cause dementia, Alzheimer's disease, mixed AD and vascular dementia or vascular dementia alone after considering other risk factors. They cited several reasons why statin use in this study did not seem to lower the risk of dementia, including the age of participants and length of statin use. The average age of participants was 75 years, and statin use was assessed for a median of five years. Although the researchers suggested that statin use might need to occur earlier and for a longer period of time to lower the risk of dementia, they noted that "analyses that stratified duration of statin use did not suggest a duration-dependent association." To explain why their findings differed from previous studies that showed a link between statin use and decreased risk of dementia, the authors said that previous studies did not consider former use or incorporate a lag period in the analysis. In addition, they suggested that the use of statins might be a sign of good health, which might be associated with a lower risk of dementia. "Although statin use is an important treatment for cardiovascular disease, additional investigation is needed to determine whether and for whom statin use may affect dementia risk," the authors concluded. Company Taglines Americans spend more on health care than other industrialized nations, but with few increased benefits, study finds The United States spends more on health care per capita than other industrialized nations, according to an analysis of data from the Organization for Economic Cooperation and Development (OECD). In 2002, Americans spent a median $5,267 per capita on health care, or 14.6 percent of the U.S. gross domestic product. This was $1,821 (53 percent) above that of Switzerland, the next-highest-spending country and $3,074 (140 percent) above the OECD median. Surprisingly, this significantly higher spending did not result in increased access to health care resources, as measured by hospital beds, physicians, nurses and magnetic resonance imaging and computed tomography scanners per capita. The United States has 2.9 hospital beds per 1,000 residents compared with a median 3.7 in the other nations examined; 2.4 physicians and 7.9 nurses per 1,000 residents compared with a median 3.1 and 8.9, respectively; and 12.8 CT scanners per million residents compared with a median 13.3 in the other nations examined. The United States had more MRI machines than many of the other nations, though they were utilized for only 10 hours per day compared with 18 hours in other nations. The authors noted that, while the United States "tends to be an early adopter of medical technologies, it does not acquire medical technology at high levels once the technology has diffused widely." While medical malpractice claims are often cited as a reason for higher medical costs in the United States, approximately two-thirds of U.S claims resulted in no payment, with "[t]he same distribution of claim results [occurring] in Canada." Furthermore, U.S. payments were lower, on average than those in Canada and the United Kingdom. However, these costs did not include the legal costs of defending malpractice claims. On the bright side for the United States, data showed that lengths of hospital stay are generally shorter and more intensive in the United States, giving a possible explanation as to why the United States has fewer resources but pays a higher price for their use. Additionally, the United States tends to avoid the waiting lists for care often found in other countries, though the authors noted that "procedures that necessitate waiting lists in other countries would account for only 3 percent of health spending" in the United States. The authors concluded by noting that "the prices of care, not the amount of care delivered, are the primary difference between the United States and other countries," adding "[t]hese higher prices are increasingly making health care unaffordable for many Americans." The analysis was published in the July/August issue of the journal Health Affairs. Company Taglines Company Taglines Aurobindo Pharma Ltd. Aurobindo Pharma Ltd. received tentative approval from The Food and Drug Administration for its version of the fixed-dose combination of 150 mg of lamivudine and 300 mg of zidovudine. The agency said Aurobindo's product is the first generic version of GlaxoSmithKline Plc's Combivir, which is manufactured under an agreement with Shire Pharmaceuticals Group Plc. The FDA's tentative approval gives the generics company the right to market the drug combination outside of the United States under the President's Emergency Plan for AIDS Relief. The lamivudine and zidovudine combination, both nucleoside reverse transcriptase inhibitors, helps keep the AIDS virus from reproducing and is used in combination with other antiretroviral agents to treat HIV-1 infection, the agency said. Earlier this month, the FDA granted tentative approval for Aurobindo's generic version of Bristol-Myers Squibb Co.'s Zerit (stavudine), another nucleoside reverse transcriptase inhibitor. Company Taglines Company Taglines Iconix Pharmaceuticals Inc. Iconix Pharmaceuticals Inc. signed an agreement to supply Neurocrine Biosciences Inc. with chemogenomic analyses on candidate compounds in Neurocrine's drug discovery programs. Under the agreement, researchers will apply Iconix's DrugMatrix technology to provide a gene expression-based chemogenomic work-up on at least 12 Neurocrine compounds with the goals of identifying pharmacological and toxicological biomarkers and detailing biochemical processes to validate new biomarkers. Financial terms of the agreement were not disclosed. Company Taglines Company Taglines Pharmacopeia Drug Discovery Inc. Pharmacopeia Drug Discovery Inc. said it entered into an agreement with Allergan Inc. to evaluate proprietary active lead compounds, discovered at Pharmacopeia, in models of ocular disease. The compounds target angiogenesis and could provide a new means of treating wet age-related macular degeneration, the leading cause of vision loss in adults older than 55 years. Under terms of the agreement, Allergan made an up-front cash payment to Pharmacopeia and may pay further preclinical and clinical payments, as well as milestone payments and royalties on any ophthalmologic drugs developed by Allergan. Pharmacopeia retains the rights to other therapeutic areas. Company Taglines Company Taglines Amarillo Biosciences Inc. Amarillo Biosciences Inc. (ABI) said it resolved clinical and safety issues with the Food and Drug Administration and is ready to begin a study of its oral low-dose interferon-alpha as a treatment for Behcet's disease. The study of 90 patients, which is scheduled to start in October 2005 and to take approximately a year to complete, will be conducted in Turkey with Nobel Ilac Sanayii ve Ticaret A.S. ABI said the incidence of Behcet's disease, an autoimmune disorder, is 600 times more common in Turkey than in the United States. The FDA has granted ABI orphan drug status for the use of this drug in this indication. ABI will seek FDA approval and will own the FDA approval, and Nobel will seek approval in selected countries outside of the United States, including Turkey. Company Taglines Company Taglines


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