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			branding Products 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 Merck found not liable in second Vioxx trial A New Jersey state court jury found Merck & Co. Inc. not liable in the second trial over Vioxx (rofecoxib), its COX-2 inhibitor that was taken off the market in September 2004 because of potential cardiovascular risks. Frederick Humeston, from Boise, Idaho, had a myocardial infarction on Sept. 18, 2001, at the age of 56. He alleged that his intermittent use of Vioxx throughout a two-month period caused the MI. According to The Wall Street Journal, the jury determined that "Vioxx was not a substantial factor in causing the heart attack." It also concluded that either Merck had adequately warned physicians of the potential risks of Vioxx or the company did not know the risks existed when Humeston was prescribed the drug. "Merck is satisfied with the jury verdict," said Kenneth Frazier, Merck's senior vice president and general counsel. "There will be other Vioxx trials, and we will vigorously defend them one by one over the coming years." Merck lost its first Vioxx trial in August. A jury found the company liable for the death of a Texas man who took the drug, awarding his widow $253.4 million. Merck plans to appeal that verdict. Unlike the man in Texas, Humeston survived and returned to work approximately two weeks later, with no physician restrictions, Merck noted. The first federal Vioxx case will open in Houston on Nov. 28, The Journal reported. Shares of Merck closed at $29.48, up $1.07, or 3.8 percent, in heavy trading on the New York Stock Exchange. branding Products FDA approves Novartis' oral iron chelator, Exjade Novartis AG's once-daily oral iron chelator, Exjade (deferasirox), was approved by the Food and Drug Administration for the treatment of chronic iron overload resulting from blood transfusions in adults and children aged 2 years or older. Exjade tablets are dispersed in a glass of juice or water, whereas the current standard of care, Novartis' Desferal (deferoxamine mesylate), often requires a subcutaneous infusion lasting eight to 12 hours per night for five to seven nights a week as long as the patient has excess iron, the company said. Novartis expects the approval to boost the acceptance of iron chelation therapy, especially among children, since the treatment no longer entails "burdensome continuous infusion therapy." "We believe Exjade is a significant breakthrough that will fill an important gap in protecting patients from the cumulative toxicity of iron overload by making iron chelation therapy much more acceptable," said David Epstein, president of Novartis Oncology. "Until now, patients may have avoided the potentially life-saving benefits of iron chelation because the standard therapy can be difficult to use." An FDA advisory panel supported Exjade's approval in September, although it expressed concern regarding potential excess liver and kidney toxicity associated with the drug, as well as the drug's safety in children aged less than 5 years, Reuters reported. branding Products Corautus Genetics' VEGF-2 granted fast track status for severe angina related to cardiovascular disease Corautus Genetics Inc.'s vascular endothelial growth factor-2 (VEGF-2) received a fast track designation from the Food and Drug Administration as a treatment for severe angina associated with cardiovascular disease. "The fast track application was submitted based upon the large unmet medical need that our VEGF-2 program addresses," said Richard Otto, chief executive officer of Corautus. "Severe angina resulting from coronary artery disease is a serious, debilitating and potentially life-threatening disease." The safety and efficacy of VEGF-2 for this indication are currently being studied in GENASIS, the largest cardiovascular study of its kind, according to Corautus. "Receiving this fast track designation is another step in our regulatory strategy that is designed to afford us the opportunity to accelerate the development of VEGF-2 to commercialization," said Otto. Corautus entered into a strategic alliance with Boston Scientific Corp. in July 2003 for the development, commercialization and distribution of VEGF-2 gene therapy products. Currently, Corautus is developing a gene transfer product that uses the VEGF-2 gene to promote therapeutic angiogenesis in ischemic muscle. branding Products Bayer, Onyx report favorable interim trial results with Nexavar in treatment of advanced renal cell cancer Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc. said interim results from a late-stage trial indicate that Nexavar (sorafenib tosylate), a drug for treating patients with kidney cancer, extends survival by an estimated 39 percent compared with placebo. In the Phase III trial, more than 900 patients with advanced kidney cancer were randomized to receive Nexavar 400 mg or placebo twice daily. Endpoints include overall survival, progression-free survival, best response, quality of life and safety. The preliminary findings, which were presented at the European Cancer Conference in Paris, did not reach statistical significance because there is not yet enough data. Early results, however, "suggest a favorable survival trend for patients who received Nexavar," the companies said. "These data build on the previously announced finding that disease progression was significantly delayed in advanced kidney cancer patients who received Nexavar," said Bernard Escudier, a co-lead investigator of the study. "As a clinician who regularly sees individuals suffering from this disease, I am encouraged by this growing body of data and what they may mean for patients and their families." The interim analysis was conducted following a decision by the companies to allow patients receiving placebo to cross over to treatment with Nexavar based on ethical considerations. Nexavar is the first oral multikinase inhibitor that targets kinases in both the tumor cell and its vasculature, according to Bayer and Onyx. The companies filed a New Drug Application in July for the drug as a treatment for advanced renal cell cancer. Onyx shares closed at $29.51, up $5.80, or 24.5 percent, in heavy trading on the Nasdaq, while Bayer shares closed at $35.02, down $0.12, or 0.3 percent, in moderate trading on the New York Stock Exchange. branding Products Amgen, Abgenix report positive trial results for panitumumab in patients with chemotherapy-refractory metastatic colorectal cancer Amgen Inc. and Abgenix Inc. said their Phase III trial of panitumumab met the primary endpoint of improving progression-free survival in patients with metastatic colorectal cancer who had not responded to standard chemotherapy. In the open-label trial, a total of 463 patients were randomized to receive infusions of panitumumab 6 mg/kg of body weight every two weeks in addition to supportive care, or supportive care alone. Per protocol, patients were not required to receive pre-medication or a loading dose prior to the administration of panitumumab. Patients who received panitumumab experienced a 46 percent decrease in tumor progression rate compared with patients who received supportive care alone. This result surpassed the pre-specified 33 percent decrease in tumor progression rate the trial was designed to demonstrate. The trial also met a secondary endpoint of objective response rate, as assessed by central radiology review, the companies said. Panitumumab, the first fully human monoclonal antibody that targets the epidermal growth factor receptor, received fast track designation from the Food and Drug Administration in July. The companies are working to submit a Biologics License Application for the drug by the end of the year as a treatment for patients who have failed prior standard chemotherapy. Abgenix shares closed at $12.90, up $3.53, or 37.7 percent, in heavy trading, while Amgen shares closed at $77.51, up $3.61, or 4.9 percent, in moderate trading, both on the Nasdaq. branding Products Prices of branded drugs continue to rise faster than inflation but at slower rate than previous years, AARP analysis shows For the period between July 2004 and June 2005, manufacturer prices for the 193 branded drugs most often used by seniors substantially outpaced the rate of inflation, a new AARP report shows, but the rate of increase was lower than that seen in 2003 and 2004. AARP's Data Digest reported on changes in manufacturers' prices between April and June 2005. The analysis compared changes in wholesale acquisition costs with the rate of inflation as measured by the Consumer Price Index-All Urban Consumers. In the 12 months ended June 2005, manufacturer prices for brand-name drugs rose 6.1 percent, when measured as a 12-month rolling average and weighted by actual 2003 sales to Americans aged 50 years or older. This price increase represented slightly more than twice the rate of general inflation (3 percent). However, the prices rose at a slower pace than that of previous years, which reflected increases of 7.1 percent and 7 percent, respectively, for the 12-month periods ended December 2004 and December 2003. If the full price increases for 187 common brand-name drugs used to treat chronic conditions had been passed on to consumers, the typical older American (one who takes three prescriptions per day) would likely have paid an average of $97.14 more during the 12 months ending with the second quarter of 2005, the report said. During the first two quarters of 2005, prices for 142 of the most commonly used prescription drug products increased at least 2.9 percent, nearly twice the rate of inflation during the same period (1.5 percent). Three of the drugs increased in price by more than 10 percent; Boehringer Ingelheim GmbH's bronchodilator, Atrovent (ipratropium bromide), had the highest price increase at 18.6 percent. None of the 75 generic drugs studied changed in manufacturer list price during the second quarter of this year, and only three increased in price during the first quarter. In response to the AARP report, the Pharmaceutical Research and Manufacturers of America cited a paper from the American Enterprise Institute, which stated that wholesale prices do not incorporate the discounts frequently offered by drug manufacturers. PhRMA also pointed to the Consumer Price Index, which shows that overall medical care inflation increased at an annualized rate of 4.2 percent between July 2004 and July 2005. During the same period, the index shows that prescription drug prices rose only 3.4 percent. branding Products branding Products The Food and Drug Administration The Food and Drug Administration and BG Medicine Inc. will collaborate on the Liver Toxicology Biomarker Study, a project that "aims to discover signs of human liver toxicity in a standard test used in the initial stages of drug development," the FDA said. The FDA and BG Medicine designed the study with input from other pharmaceutical companies, all of which will have access to the study data, as well as a perpetual license to any biomarkers discovered during the study. Dr. Janet Woodcock, the FDA's deputy commissioner for operations, said that liver toxicity is "a common reason for drug development failure." She noted that, "[b]y identifying biomarkers for liver toxicity at the start of the development process, this research should yield important benefits for the industry, the FDA and the public." branding Products branding Products Eli Lilly and Co. Eli Lilly and Co. said in a regulatory filing with the Securities and Exchange Commission that the U.S. Attorney's office is conducting an inquiry into certain rebate agreements Lilly had with an unspecified pharmacy benefit manager. Included in the inquiry is a review of the company's Medicaid best price reporting related to the sales of products covered by rebate agreements, such as antidepressant Prozac (fluoxetine hydrochloride) and antipsychotic Zyprexa (olanzapine). branding Products branding Products Par Pharmaceutical Companies Inc. Par Pharmaceutical Companies Inc. entered into an agreement with Valeant Pharmaceuticals North America to promote Valeant's cannabinoid agonist, Cesamet (nabilone), for the treatment of chemotherapy-induced emesis (nausea and vomiting), after the drug is approved by the Food and Drug Administration. Under the agreement, Par will promote the antiemetic to physicians in the United States, with Valeant to record sales and fund the drug's marketing expenses. Valeant has already received an approvable letter from the FDA and is now waiting for final approval. branding Products branding Products Chromos Molecular Systems Inc. Chromos Molecular Systems Inc. entered into an agreement to acquire Targeted Molecules Corp. (TMC), a private biotechnology company based in San Diego and focused on the research and development of two humanized monoclonal antibody product candidates for the treatment of multiple sclerosis and acute thrombosis. TMC has demonstrated these candidates to be efficacious in preclinical, proof-of-principle studies. Along with the acquisition, Chromos said it will complete a private placement to raise at least $6 million, which will be used to finance operations. branding Products


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