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			Survey Panel 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 Amylin, Lilly's Byetta plus thiazolidinediones may help patients with diabetes achieve glycemic control, research finds Patients with diabetes who use Amylin Pharmaceuticals Inc. and Eli Lilly and Co.'s Byetta (exenatide) injection in addition to thiazolidinediones (TZDs) may reduce their blood sugar levels, according to new data. In the double-blind study, 233 patients with type 2 diabetes who were not achieving adequate blood glucose control using a TZD either alone or with metformin were randomized to receive Byetta or placebo for 16 weeks in addition to their usual TZD regimen with or without metformin. Byetta was administered twice daily as a subcutaneous injection in a 5 mcg dose for one month, followed by three months of a 10 mcg dose twice daily. On average, A1C levels, a measure of glucose control, were approximately 7.9 percent at baseline. By the end of 16 weeks, Byetta-treated patients improved their A1C levels by approximately 0.9 percentage points. Sixty-two percent of the Byetta group who had a baseline A1C level of more than 7 percent reduced their A1C to 7 percent or less versus 16 percent of the placebo group who reached this level. The American Diabetes Association recommends a target level of less than 7 percent. Furthermore, patients who received Byetta lost approximately 3 lbs on average at 16 weeks as compared with patients treated with placebo. Nausea was the most common adverse event, which occurred in 40 percent of the Byetta group and 15 percent of the placebo group. Amylin and Lilly said this study will likely be presented in full at an upcoming scientific forum and will provide the basis of a supplemental New Drug Application submission to the Food and Drug Administration currently planned for 2006. Byetta is currently indicated as adjunctive therapy to improve glycemic control in patients with type 2 diabetes who are taking metformin or a sulfonylurea, either alone or in combination, but who have not achieved adequate glycemic control. Survey Panel New data show Takeda's Actos reduces MIs in high-risk patients with type 2 diabetes Takeda Pharmaceutical Co. Ltd.'s Actos (pioglitazone hydrochloride), which is co-promoted by Eli Lilly and Co., significantly reduced the rate of fatal and nonfatal myocardial infarctions and acute coronary syndrome in high-risk patients with type 2 diabetes who previously had an MI. The data, which were presented at the annual meeting of the American Heart Association in Dallas, come from secondary analyses of the PROactive study. In the randomized, double-blind, placebo-controlled study, researchers examined the effects of Actos, when added to standard care treatment, on mortality and morbidity associated with cardiovascular disease progression in more than 5,000 high-risk patients with type 2 diabetes. The study focused on two endpoints: "a primary combination endpoint of seven different macrovascular events of varying clinical importance, and a principal secondary combination endpoint of life-threatening events including death, heart attack and stroke." title="branding company" Results from the secondary analyses of the study, which assessed the effects of Actos on cardiovascular morbidity and mortality in 2,445 high-risk patients who previously had an MI, showed that Actos reduced the risk of repeat fatal and nonfatal MIs by 28 percent. The risk of ACS was reduced by 37 percent, and a 19-percent risk reduction was observed in the composite endpoint of nonfatal MIs, coronary revascularization, ACS and cardiac death. These results are in addition to previously reported results from the PROactive study that showed ACTOS significantly reduced the combined risk of MIs, strokes and death by 16 percent in high-risk patients with type 2 diabetes. These results are far above those seen with standard of care treatment, according to Takeda. "Takeda is breaking new ground with the PROactive study. Never before have this many high-risk people with type 2 diabetes and cardiovascular disease been studied," said Dr. Robert Spanheimer, medical director for diabetes and metabolism at Takeda Pharmaceuticals North America. "Through this innovative research, we now know that Actos can markedly reduce the recurrence of heart attacks." Survey Panel Biogen Idec, Genentech's Rituxan significantly improves RA symptoms, according to new data Treatment with Biogen Idec Inc. and Genentech Inc.'s Rituxan (rituximab) and methotrexate significantly improves the symptoms of rheumatoid arthritis relative to treatment with methotrexate plus placebo, according to findings presented at the American College of Rheumatology's annual scientific meeting in San Diego. The data presented were derived from the REFLEX trial, a Phase III, double-blind, placebo-controlled study, which involved 520 patients with active RA who had an inadequate response or were intolerant to treatment with at least one anti-tumor necrosis factor therapy. Participants were randomized to receive two infusions of Rituxan or matching placebo on days one and 15 of the 24-week study. All patients also received a stable dose of methotrexate. The primary endpoint was the proportion of patients in each group who achieved an ACR 20 response, defined as at least a 20-percent improvement in the number of swollen and tender joints. After six months, 51 percent of Rituxan-treated patients achieved an ACR 20 response compared with 18 percent of placebo-treated patients. Similarly, 27 percent of the Rituxan group achieved an ACR 50 response and 12 percent achieved an ACR 70 response compared with 5 percent and 1 percent, respectively, in the placebo group. Differences between the two groups were observed after eight weeks of treatment and were maintained throughout the six-month follow-up. "These data will be of great interest to both physicians and patients, since they suggest that [Rituxan] may offer patients the opportunity of at least six months relief of their symptoms with just two infusions," title="branding company" said Dr. Stanley Cohen, lead investigator of the study. In August, Biogen Idec and Genentech submitted these data to the Food and Drug Administration as part of a supplemental Biologics License Application for Rituxan in the treatment of RA; the application was granted priority review status last month. Rituxan is currently approved as a treatment for non-Hodgkin's lymphoma. While Biogen Idec and Genentech co-market the drug in the United States, F. Hoffmann-La Roche Ltd. markets rituximab in the rest of the world-except Japan-with the brand name MabThera. Survey Panel Abbott's Humira effective in patients with AS who failed to respond to NSAIDs, DMARDs Patients with active ankylosing spondylitis (AS) who were treated with Abbott's Humira (adalimumab) in the double-blind, Phase III ATLAS trial showed significantly better response rates than did patients treated with placebo, according to data presented at the annual scientific meeting of the American College of Rheumatology in San Diego. Humira has proved effective in targeting tumor necrosis factor (TNF) in patients with rheumatoid arthritis; the ATLAS trial was conducted to determine whether the drug is of benefit to patients with AS. All patients enrolled in the trial had previously failed to respond adequately to treatment with at least one nonsteroidal anti-inflammatory drug or disease-modifying antirheumatic drug. After enrollment, they were randomized to receive 40 mg of Humira (n=208) or placebo (n=107) every other week for 24 weeks. An efficacy assessment was made at week 12, at which time those who had not achieved an ASsessment in AS (ASAS) 20 response were given the option of early escape therapy. In addition to ASAS criteria, total back pain, the Bath AS Functional Index, the Patient's Global Assessment of disease activity and the Bath AS Disease Activity Index were used to assess the drug's efficacy. Patients treated with Humira demonstrated an ASAS 20 response as early as two weeks into the treatment period, a result that was statistically significant when compared with the placebo group (week 12, 58 percent vs. 22 percent; week 24, 50 percent vs. 20 percent). Moreover, the percentage of Humira-treated patients who achieved an ASAS 20 response at weeks 12 and 24 was more than twice that of the patients who received placebo. Also in comparison with the placebo group, those in the Humira group exhibited significant improvements on all of the other assessment parameters at weeks 12 and 24. In addition, the researchers found that nearly twice as many patients who received placebo chose early escape therapy at week 12 as did patients treated with Humira (50 percent vs. 26 percent, respectively). The study drug was not associated with any serious or severe adverse events, including serious infectious adverse events. Humira is currently approved for moderate to severe rheumatoid arthritis and for psoriatic arthritis. Abbott is seeking approval for Humira in AS. Survey Panel Erbitux plus radiation may significantly improve locoregional control, survival among patients with cancer of head, neck ImClone Systems Inc.'s Erbitux (cetuximab), which is distributed and marketed by Bristol-Myers Squibb Co., in combination with radiation appears to be more effective than radiation alone in achieving locoregional control and survival among patients with squamous cell carcinoma of the head and neck area, a new study demonstrates. In total, 424 patients with locoregionally advanced squamous cell cancer that had spread through the head and neck region were randomized in the Phase III study to receive weekly Erbitux combined with radiation (n=211) or radiation alone (n=213) for six to seven weeks. The Erbitux-radiation combination demonstrated a statistically significant 9.5-month improvement in the median duration of locoregional control, or the prevention of the spread of cancer beyond the head and neck area, ImClone said. The median duration of control was 24.4 months for the patients treated with both Erbitux and radiation and 14.9 months for the patients treated with radiation alone. Furthermore, the combination group experienced a 19.7-month improvement in median survival when compared with radiation alone. Median overall survival was 49 months for the combination group and 29.3 months for the group treated with radiation alone. Three-year survival rates were also greater in the Erbitux combination group versus the radiation-only group (56.1 percent vs. 45 percent). Erbitux plus radiation treatment also led to a 32-percent reduction in the risk of locoregional recurrence as compared with radiation alone. The findings were presented in Philadelphia at the American Association for Cancer Research, the National Cancer Institute and the European Organization for Research and Treatment of Cancer's International Conference on Molecular Targets and Cancer Therapeutics. Erbitux, an IgG1 monoclonal antibody, was approved in February 2004 for use in combination with Pfizer Inc.'s Camptosar (irinotecan hydrochloride) for the treatment of epidermal growth factor receptor (EGFR)-expressing, metastatic colorectal cancer in patients who are refractory to Camptosar-based chemotherapy or as a single agent in the treatment of EGFR-expressing, metastatic colorectal cancer among patients who are intolerant to Camptosar-based chemotherapy. The Food and Drug Administration recently granted Erbitux priority review as a treatment for squamous cell carcinoma of the head and neck. ImClone noted that the FDA has until March to take action on the firm's supplemental Biologics License Application. Survey Panel Centocor, Schering-Plough's golimumab meets primary endpoint in Phase II rheumatoid arthritis study Results from a Phase II study of Centocor Inc. and Schering-Plough Corp.'s golimumab, formerly known as CNTO 148, showed that the drug achieved the primary endpoint and significantly improved signs and symptoms of moderately to severely active rheumatoid arthritis. Researchers randomized adult patients who had active RA for at least three months despite methotrexate (MTX) therapy to one of five treatment groups: placebo every two weeks, 50 mg of golimumab every two weeks, 50 mg of golimumab every four weeks, 100 mg of golimumab every two weeks or 100 mg of golimumab every four weeks. All patients also received stable doses of at least 10 mg/week of MTX. The study showed that significantly more patients in all groups who received subcutaneous injections of golimumab in combination with MTX achieved an American College of Rheumatology 50 response versus patients who received placebo plus MTX. An ACR 50 response represents a "marked improvement in arthritis symptoms," Centocor said. At week 16, 62 percent of all patients treated with a combination of golimumab and MTX experienced at least a 20 percent improvement in arthritis symptoms compared with 37 percent of placebo-treated patients. Additionally, 31 percent of patients in the golimumab-treatment groups achieved an ACR 50 response and 12 percent achieved an ACR 70 response compared with 6 percent and 0 percent, respectively, of patients in the placebo group. Overall, all golimumab-treatment groups achieved higher ACR 20 response rates than the placebo group. Sixty-three percent of patients who received golimumab 50 mg every four weeks and 79 percent of patients who received golimumab 100 mg every two weeks achieved an ACR 20 response compared with 37 percent in the placebo group. Both of these golimumab groups were significantly more effective than placebo. At 16 weeks, 27 percent of patients in the golimumab plus MTX group achieved remission as assessed by the Disease Activity Score of 28 joints (DAS28) compared with six percent of patients receiving MTX alone. DAS28 measures tender and swollen joints, inflammation and overall disease activity. The study's findings will be presented this week at the American College of Rheumatology annual scientific meeting in San Diego. Survey Panel Survey Panel Merck & Co. Inc. Merck & Co. Inc. and Schering-Plough Corp. launched a large-scale clinical trial to evaluate the effectiveness of Vytorin (ezetimibe/simvastatin) compared with Merck's Zocor (simvastatin) in treating approximately 10,000 high-risk patients with coronary artery disease and acute coronary syndromes. The primary endpoint of the trial is "the composite of cardiovascular death, myocardial infarction, nonfatal stroke, rehospitalization for ACS or revascularization (occurring 30 days or more after the initial event)." The study is intended to show that Vytorin lowers LDL cholesterol below previous levels observed in prior large outcomes trials, which indicated that lower LDL cholesterol levels led to reduced cardiovascular risk. Survey Panel Survey Panel F. Hoffmann-La Roche Ltd. F. Hoffmann-La Roche Ltd. and Gilead Sciences Inc. ended their dispute regarding their 1996 development and license agreement for influenza drug Tamiflu (oseltamivir phosphate), "in the interest of working together to address public health needs," the companies said. Under the terms of the amended agreement, the companies will form joint committees to oversee manufacturing, commercial and pandemic planning for the drug. Beginning in 2007, Gilead will have the option to co-promote Tamiflu in certain areas in the United States. Tamiflu was invented by Gilead and licensed to Roche in 1996. The companies collaborated on the drug's development. In June 2005, Gilead issued a notice of termination to Roche for the companies' 1996 agreement; the companies subsequently entered into arbitration. Following this amendment to the 1996 agreement, Gilead has terminated arbitration proceedings. Survey Panel Survey Panel Novartis AG Novartis AG needs to collect more data regarding its transplant drug Certican (everolimus) before the company can secure approval to market the drug for the prevention of organ rejection following a heart transplant, according to a ruling by an advisory panel to the Food and Drug Administration. The panel advised 7-6 against approval, pushing potential approval back to the end of 2007 or 2008 at the earliest, according to Kenneth Somberg, Novartis' global head of clinical research for transplantation and immunology, Reuters reported. The FDA previously voiced concerns about the drug, citing a need for demonstrable evidence of safety and efficacy in a randomized trial. Survey Panel Survey Panel Schering-Plough Corp. Schering-Plough Corp. and Oncomethylome Sciences entered into a collaboration and license agreement permitting Schering-Plough to use Oncomethylome's assay technology that measures the methylation status of the MGMT gene in patients with glioblastoma multiforme, a type of malignant brain cancer that is treated with Schering-Plough's Temodar (temozolomide). Under the terms of the agreement, Schering-Plough will receive a worldwide, non-exclusive license to use Oncomethylome's pharmacogenomic assays and technology in this capacity, and Oncomethylome will receive an up-front license payment, milestone payments and sample processing fees. Further financial terms were not disclosed. Survey Panel Survey Panel Adherex Technologies Inc. Adherex Technologies Inc. expects to have eniluracil, a chemoenhancer, into Phase III trials by the middle of 2007. Eniluracil, which the company in-licensed from GlaxoSmithKline Plc in July, is designed to inhibit the breakdown of 5-fluorouracil (5-FU), a commonly used chemotherapy. Development of the drug was stopped after three Phase III trials conducted by GSK failed. Since then, Adherex has generated new data that show how eniluracil works. It will begin preliminary studies to define the drug's optimal dose, the optimal dose ratio of eniluracil to 5-FU and the clinical response rate to the appropriate combination of the two treatments. Adherex expects this data to be available beginning in 2006 in order for the Phase III trials to begin in 2007. Survey Panel


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