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			Survey Hosting 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 SANDOZ TO UNDERGO RESTRUCTURING, RE-INTEGRATION WITH PARENT COMPANY NOVARTIS, ACCORDING TO UNRELEASED REVIEW Novartis AG is expected to announce plans this week to restructure and potentially relocate its generic drug subsidiary Sandoz, according to the Financial Times. Early this week, the McKinsey & Co. consulting firm will present its "Victory" project review about Sandoz's operations. The report focuses on ways to cut costs and improve the subsidiary's integration with Novartis, which could include Sandoz's transfer to Novartis' headquarters in Basel, Switzerland, the report said. The generics subsidiary is currently headquartered in Vienna, Austria, where it had benefited from special tax breaks. According to the Times article, Novartis' Chief Executive Daniel Vasella was unhappy with Sandoz's progress. Sandoz sales during the first nine months of this year rose by only 2 percent in U.S. dollars--but fell by 3 percent in local currency--to $2.18 billion, as reported in the financial results released by Novartis. During the third quarter, the subsidiary's operating income dropped 96 percent from the previous year to $4 million. Earnings were affected by competition, currency factors and problems in Germany that led to a $73 million impairment charge, the Times explained. Novartis said that effective Nov. 1, Andreas Rummelt, head of global technical operations in pharmaceuticals, replaced Christian Seiwald as Sandoz's chief executive. The move is expected to prompt a new emphasis on streamlining product development and manufacturing activities at Sandoz, as well as cut costs and improve integration across the business. MANY AMERICANS HAVE POSITIVE VIEWS OF COST-CONTAINMENT STRATEGIES, SURVEY SUGGESTS Many Americans appear receptive to managed care cost-containment strategies such as therapeutic substitution and requiring prior authorization for expensive procedures, according to a recent survey. Between Aug. 4 and Aug. 10, a total of 2,024 adults were interviewed by telephone. Survey responses showed 52 percent of participants spent less than $500 out of pocket on medical expenses during the 12 months prior to being surveyed, while 26 percent spent $500 to $1,999 and 16 percent spent $2,000 or more. Furthermore, 45 percent of respondents said they were "very concerned" about the amount they pay for health care, while 25 percent were "somewhat concerned" and 29 percent were either "not too concerned" or "not at all concerned." The subjects were also asked about their perceptions of four cost-containment strategies: requiring a referral to see a specialist, requiring substitution of similar but less costly drugs, requiring approval for new or costly medical procedures recommended by one's physician and paying a bonus to physicians who keep their patients' health care costs down. Results showed 54 percent of individuals polled believe requiring substitution of less expensive drugs is a "good" idea or "very good" idea, while 41 percent opposed the strategy. Requiring a referral to see a specialist was supported by 52 percent and opposed by 43 percent. The other two strategies received less backing, with only 43 percent and 30 percent of respondents supporting a prior-approval requirement and a physician bonus, respectively (52 percent and 66 percent opposed). The authors noted that people aged 18 to 34 years were most likely to support cost-containment strategies. Income had little effect on the level of support overall, but markedly affected opinions among individuals with "fair" or "poor" self-reported health status. Among those in fair or poor health, those with less than $25,000 in annual income were 50 percent more likely to support each of the four cost-containment strategies than those earning $75,000 or more. Survey participants were also asked whether they would be willing to accept a higher deductible or premium in exchange for fewer restrictions on use of health care services, showing that only 27 percent would be willing to accept such a tradeoff. Patients in fair or poor health were the subjects least likely to respond favorably to this question. Finally, when asked if they believe managed care can keep health care costs down without hurting people's health, only 30 percent of respondents said they believed it could be done. The study authors noted that people with lower incomes, those without insurance and those who are black or Hispanic appeared to have a more favorable view of managed care than those who have higher incomes, are insured and are white. "Despite an overall lack of confidence in managed care, Americans appear to be receptive to specific managed care practices," the study authors concluded. "Those designing cost- containment strategies must find a balance between imposing restrictions that moderate use and hold down costs and allowing consumers to retain some control over their own health care." This study can be found on the Web site of the journal Health Affairs. CERVARIX VACCINE EFFECTIVELY PREVENTS INCIDENT, PERSISTANT INFECTIONS WITH 2 TYPES OF HUMAN PAPILLOMAVIRUS, RESULTS SHOW Data published in the Nov. 13 issue of The Lancet indicates that the Cervarix human papillomavirus (HPV) vaccine is highly effective in preventing both incident and persistent genital HPV-16 and HPV-18 infections. GlaxoSmithKline Plc and MedImmune Inc. are developing the recombinant, bivalent HPV-16/18 L1 virus-like particle vaccine. The trial included 1,113 females aged 15 to 25 years who were seronegative for HPV-16 and HPV-18 antibodies according to enzyme-linked immunosorbent assay and were HPV-DNA-negative for 14 high-risk HPV types within 90 days of enrollment. The participants were randomized to receive 0.5 mL of Cervarix or a placebo vaccine at 0 month, one month and six months. A total of 958 women completed the 18-month phase, and patients were followed for up to 27 months. Vaccine efficacy was 91.6 percent against incident infection in the according-to-protocol analyses. Based on the same analyses, vaccine efficacy was 100 percent against persistent HPV-16 and HPV-16/18 infections detected in both cervical and combined cervical and cervicovaginal samples. In the intention-to-treat analysis, the rate of vaccine efficacy was 95.1 percent against persistent cervical infection and 92.9 percent against cytological abnormalities associated with HPV-16/18 infection. The researchers also noted that Cervarix was highly effective against the histological development of HPV-16/18-associated cervical intraepithelial neoplasia. "Our findings indicate that the vaccine could contribute substantially to reducing worldwide rates of cervical cancer," they concluded. GSK and MedImmune's Web sites report that GSK initiated Phase III trials with the vaccine in May and that a filing with the Food and Drug Administration is expected in 2008. NEW RESEARCH INDICATES SEVERAL ANTIEPILEPTIC DRUGS ARE ASSOCIATED WITH SLIGHT BUT SIGNIFICANT RISK OF FRACTURE The results of a recent population-based study suggest that several antiepileptic drugs (AED) are associated with an increased bone fracture risk. To evaluate the risk of fracture associated with AED use, researchers identified 124,655 patients who had sustained a fracture during the year 2000 along with 373,962 age- and sex-matched controls in the National Hospital Discharge Register of Denmark. Information pertaining to AED use was obtained from The National Pharmacologic Database. Epilepsy was diagnosed in 2.5 percent of fracture cases and 1.3 percent of controls. Any AED use was documented in 5.7 percent of cases and 2.9 percent of controls. Specific AEDs used included carbamazepine, Novartis AG's Trileptal (oxcarbazepine), clonazepam, ethosuximide, phenobarbital, phenytoin, GlaxoSmithKline Plc's Lamictal (lamotrigine), primidone, Cephalon Inc.'s Gabitril (tiagabine hydrochloride), topiramate, valproate and Aventis SA's Sabril (vigabatrin). Ovation Pharmaceuticals Inc. acquired exclusive U.S. marketing rights to Sabril from Aventis in April of this year; the drug has not yet been approved in the United States. In unadjusted analyses, all AEDs evaluated were associated with an increased fracture risk. After adjusting for prior fractures, prior use of corticosteroids, comorbidities, social variables and an epilepsy diagnosis, patients taking carbamazepine, Trileptal, clonazepam, phenobarbital and valproate were 1.18, 1.14, 1.27, 1.79 and 1.15 times as likely to sustain a fracture compared to respondents who did not take AEDs. However, the authors noted that "the increase in relative risk was in the same range for the significant and nonsignificant results." Additionally, the AEDs that were significantly associated with an increased risk of fracture all had larger sample sizes compared to AEDs for which the risk was not significant. As a result, they cautioned that "[a] limited significant increase cannot be excluded for the other AEDs because of the statistical power." When the investigators stratified patients into tertiles based on defined daily dosages of AEDs, they observed a significant dose-response relationship for carbamazepine, phenobarbital, Trileptal and valproate as well as a marginally significant dose-response relationship for clonazepam. Additionally, in pooled analyses, the investigators noted that the risk of any fracture was higher with liver-inducing AEDs compared to noninducing AEDs. The researchers also observed a trend toward increased fractures with increasing numbers of AEDs used. The authors pointed out that the study was limited due to the prescription database spanning only five years, to their inability to distinguish patients with active epilepsy from those in remission and to their inability to account for certain potential confounders, such as a family history of fractures or smoking status. The results of this study were published in the November issue of the journal Epilepsia. CHRONIC CARE PROGRAMS MAY LENGTHEN LIVES FOR OLDER PATIENTS, BUT MAY NOT YIELD HEALTH SAVINGS, NEW ANALYSIS SHOWS Elderly patients assigned to chronic care or disease management programs may live longer, but do not appear to have reduced expenses, The Wall Street Journal reported. University of Texas researchers presented the study in New Orleans at the American Heart Association's Scientific Sessions 2004. Included in the study were 1,069 patients (average age, 71 years) who were either assigned to a nurse to help manage their disease (n=710) or to a control group (n=359). At 18 months, patients in the disease management group lived an average of 76 days longer than those in the control group. However, there were no differences in prescription drug costs, physician visits or hospitalizations. According to the Journal, the Centers for Medicare & Medicaid Services is enrolling 300,000 chronically ill Medicare beneficiaries in 10 pilot chronic care programs across the nation to assess if such strategies can lower Medicare expenses. NEW STUDY SUGGESTS EFFERVESCENT ASPIRIN MAY BE AS EFFECTIVE AS IMITREX, IBUPROFEN IN REDUCING MIGRAINE PAIN AFTER 2 HOURS; IMITREX MORE EFFECTIVE IN PRODUCING PAIN-FREE RESPONSE The results of a recent placebo-controlled trial comparing effervescent aspirin, ibuprofen and GlaxoSmithKline Plc's Imitrex (sumatriptan) suggest that aspirin may be as effective as both comparators in reducing migraine pain after two hours. However, Imitrex appears more effective in producing a pain-free response. Researchers recruited 312 patients in Germany, Italy and Spain to participate in a three-fold, crossover, double-blind trial of Imitrex 50 mg, effervescent aspirin 1,000 mg, ibuprofen 400 mg and placebo. The primary endpoint of the study was a reduction in pain severity from moderate or severe to mild or no pain. Overall, 52.5 percent of patients randomized to aspirin, 60.2 percent of patients randomized to ibuprofen, 55.8 percent of patients randomized to Imitrex and 30.6 percent of patients randomized to placebo achieved the primary endpoint. While all active study drugs were superior to placebo with respect to the primary endpoint, the differences between the study drugs were not significant. However, 27.1 percent, 33.2 percent, 37.1 percent and 12.6 percent of patients receiving aspirin, ibuprofen, Imitrex and placebo were pain-free after 2 hours, respectively, with a significant difference between aspirin and Imitrex. Additionally, 4.1 percent of patients receiving aspirin, 5.7 percent of patients receiving ibuprofen, 6.6 percent of patients receiving Imitrex and 4.5 percent of patients receiving placebo reported drug-related adverse events. The results of this study were published in the November issue of the journal Cephalalgia. Survey Hosting THE FOOD AND DRUG ADMINISTRATION The Food and Drug Administration has planned an advisory panel meeting for Feb. 16 and 17 to discuss whether the heart problems observed with Merck & Co. Inc.'s Vioxx (rofecoxib) can be generalized to the entire class of COX-2 inhibitors. Dr. Curt Ferberg of the Wake Forest University School of Medicine had been invited to the meeting, but had his invitation rescinded after he presented a study of Pfizer Inc.'s Bextra (valdecoxib) at the American Heart Association meeting held last week, according to The Associated Press. Dr. Ferberg was told not to attend the meeting since he had already expressed his views in public. Ferberg reportedly said Bextra is as dangerous as Vioxx, and Pfizer is trying to suppress that information. Survey Hosting CARDINAL HEALTH INC. Cardinal Health Inc. acquired exclusive U.S. rights to market, sell and distribute MonoGen Inc.'s advanced new automation technology for diagnostic laboratories, the company said in a press release. The MonoGen system automates the preparation of patient specimens for cell-based diagnosis. Financial terms of the agreement were not disclosed. Survey Hosting ROCHE DIAGNOSTICS CORP. Roche Diagnostics Corp. filed a complaint in U.S. District Court, alleging that Biosite Inc. is infringing two Roche patents. One patent is for a biosensor, while the other relates to a device that separates plasma or serum from whole blood and analyzes it, The Associated Press reported. Biosite said it believes the allegations are without merit. Survey Hosting GLYCOGENESYS INC. GlycoGenesys Inc. said it received a favorable decision in final and binding arbitration proceedings against David Platt, the company's former chief executive officer, who is now CEO of Pro-Pharmaceuticals Inc. The ruling affirms GlycoGenesys' exclusive rights to intellectual property relating to GCS-100, the company's lead drug candidate. Survey Hosting


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