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			Business Slogan 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 FDA approves Novo Nordisk's Levemir for use in children with diabetes Novo Nordisk Inc. said its diabetes therapy Levemir (insulin detemir) was approved by the Food and Drug Administration for pediatric use. Levemir, a novel form of insulin that provides up to 24-hour duration of action, was also approved in June for use in adults. The drug will be launched for adults and children within the next eight months, according to the company. "Our pediatric data further enhances the already strong product profile of Levemir, making it an important new treatment option for patients in both the pediatric and adult age ranges with this devastating disease," said Dr. Peter Aurup, Novo Nordisk's vice president of clinical development, medical and regulatory affairs. The approval for children is based on data from a trial of Levemir in 347 children and adolescents with type 1 diabetes. During a 26-week treatment period, the patients received Levemir as the basal insulin and the company's NovoLog (insulin aspart), a rapid-acting insulin, as the bolus treatment. Levemir was found to be safe and effective in this study. Business Slogan Herceptin cuts risk of recurrence in half for women with early-stage breast cancer, study shows Treatment with Genentech Inc.'s Herceptin (trastuzumab), a targeted therapy for HER2-positive breast cancer, reduces the risk of recurrence in patients with early-stage breast cancer by as much as 50 percent, according to results from three studies published in the Oct. 20 issue of The New England Journal of Medicine. The HERA trial was designed to assess the drug's efficacy and safety profile in 5,081 women with surgically removed HER2-positive breast cancer who had completed at least four cycles of neoadjuvant or adjuvant chemotherapy prior to randomization. The patients were randomized to observation or one or two years of treatment with Herceptin. At one year of follow-up, 220 events (death, recurrence or new disease) occurred in the observation group compared with 127 events in the Herceptin group. Overall survival was similar between the two groups. The combined data from two other trials comparing adjuvant chemotherapy with or without concurrent Herceptin treatment in women with surgically removed HER2-positive breast cancer revealed similarly positive outcomes. An interim analysis in March disclosed 394 events of recurrent cancer, second primary cancer or death before recurrence; 133 of these events occurred in the Herceptin group compared with 261 events in the control group. At three years, the absolute difference in disease-free survival between the Herceptin and control groups was 12 percent, the authors noted, adding that treatment with Herceptin was associated with a 33 percent reduction in the risk of death. Additionally, all subgroups, including women with estrogen receptor-positive and -negative tumors, benefited from treatment with Herceptin. In an accompanying editorial, Dr. Gabriel Hortobagyi wrote, "On the basis of these results, our care of patients with HER2-positive breast cancer must change today." Hortobagyi noted that by four years, the projected absolute benefit of the two combined trials is 18 percent, "exceeding all previously reported therapeutic benefits in breast cancer." He also said that Herceptin has nullified the initial recurrence peak typically found in the first two to three years, an observation that "suggests a dramatic and perhaps permanent perturbation of the natural history of the disease, maybe even a cure." Herceptin, which is already approved for treating metastatic breast cancer in specific patient groups, is marketed in the United States by Genentech, internationally by F. Hoffmann-La Roche Ltd. and in Japan by Chugai Pharmaceutical Co. Ltd. Business Slogan Pfizer's Q3 profit hurt by generic competition; shares fall Pfizer Inc.'s net income fell 52 percent in the third quarter as the drug maker felt the effects of generic drug competition for certain key products. The company earned $1.59 billion, or $0.22 per diluted share, in the most recent quarter compared with $3.34 billion, or $0.44 per diluted share, earned in the third quarter last year. The firm's revenue dropped 5 percent to $12.19 billion in the third quarter, down from $12.83 billion in the third quarter of 2004. On average, Thomson First Call analysts had expected Pfizer to earn $0.48 per share on $12.52 billion in revenue, The Wall Street Journal reported. Pfizer attributed its lower earnings and revenue to the loss of U.S. exclusivity on postherpetic neuralgia and epilepsy treatment Neurontin (gabapentin), antifungal drug Diflucan (fluconazole) and blood pressure drug Accupril (quinapril hydrochloride). The firm also cited negative effects from its COX-2 inhibitors, Celebrex (celecoxib) and Bextra (valdecoxib). For the full year, Pfizer now expects to earn between $1.02 and $1.04 per diluted share. On an adjusted basis, it expects earnings of $1.92 to $1.94 per share, down from the company's previous guidance of approximately $1.98 per share. The company pulled its previously issued forecast for 2006 and 2007 "in light of current and anticipated business conditions," and expects to reissue guidance early in 2006. Pfizer shares closed at $21.90, down $2.07, or 8.6 percent, in heavy trading on the New York Stock Exchange. Business Slogan Pargluva associated with increased risk of major adverse cardiovascular events, researchers suggest Treatment with Bristol-Myers Squibb Co. and Merck & Co. Inc.'s Pargluva (muraglitazar) was associated with an excess incidence of death, major adverse cardiovascular events and congestive heart failure and should not be approved to treat type 2 diabetes until further testing has been carried out, according to a study published in JAMA. The study, which was published online Oct. 20, consisted of a review of documents relating to Phase II and III clinical trial results that were released under public disclosure laws for the Food and Drug Administration advisory committee meeting. In the prospective, double-blind trials, a total of 3,725 patients were randomized to receive differing doses of Pargluva, Takeda Pharmaceutical Co. Ltd.'s Actos (pioglitazone hydrochloride) or placebo, either as monotherapy or as a combination treatment with metformin or glyburide. Actos is co-promoted by Eli Lilly and Co. Death, myocardial infarction or stroke occurred in 1.47 percent of patients who received Pargluva compared with 0.67 percent of patients who received placebo or Actos, resulting in more than a two-fold increase in risk. This increase in risk was also exhibited in more comprehensive outcome measures that included the rates of transient ischemic attack and congestive heart failure along with death, MI and stroke; 2.11 percent of patients who received Pargluva experienced one of these adverse events compared with 0.81 percent of patients who received placebo or Actos. "[Pargluva] appears to increase the risk for morbidity and mortality in diabetic patients during relatively short-term treatment," the authors of the study wrote. "The estimated magnitude of this risk is substantial, with relative risks indicating a doubling for irrevocable, major endpoints and composite outcomes. The consistency of these relative risks suggests that this result is not due to chance. "Accordingly, [Pargluva] should not be used or approved to treat patients with diabetes until an appropriate dedicated trial to assess cardiovascular outcomes is performed," they concluded. However, using this same data, an FDA advisory committee voted 8-1 in favor of approving Pargluva in September. Then, the FDA issued an approvable letter for Pargluva earlier this week. The regulatory agency requested additional safety information to address more fully the drug's cardiovascular safety profile. Dr. James Brophy, the author of an accompanying editorial, wrote that "specific methodological decisions in the sponsor's FDA application . . . may foster an illusion of safety." He remarked that while the flaws were "perhaps unintentional," they were "nevertheless disingenuous." Representatives of JAMA said the journal published the recent study and editorial online, ahead of print, "because of their timeliness and potential importance for public health." In his editorial, Brophy remarked, "The question now is, which safety message will the FDA buy?" Business Slogan Amgen's 2005 Q3 net income increases on strong drug sales Amgen Inc.'s third-quarter net income surged as the firm's key products continued to make strong gains in sales. Amgen earned $967 million, or $0.77 per diluted share, in the third quarter. Last year, the biotech company earned $236 million, or $0.18 per diluted share, after taking large, acquisition-related charges. Excluding charges, Amgen earned $0.85 per share this quarter; Reuters Estimates said this beat analysts' average expectations by $0.03. Third-quarter revenue increased 16 percent, from $2.71 billion in 2004 to $3.15 billion in 2005. Overall, total product sales rose from $2.56 billion in 2004's third quarter to $3.05 billion in the third quarter of 2005. In particular, worldwide sales of anemia treatment Aranesp (darbepoetin alfa) grew from $608 million in 2004's third quarter to $840 million in the most recent quarter. According to Reuters, Wall Street had forecast Aranesp sales of approximately $860 million, leading some analysts to question whether higher-than-expected sales during the second quarter were a fluke. Reuters also noted that rheumatoid arthritis and psoriasis treatment Enbrel (etanercept), which the company co-promotes with Wyeth in North America, beat analysts' expectations. The drug had worldwide sales of $668 million, up from $496 million during the third quarter of last year; analysts were expecting sales of $665 million. Amgen reiterated its 2005 guidance of revenue growth in the mid- to high teens and adjusted earnings per share of $3.10 to $3.20. Amgen shares closed at $74.10, down $3.99, or 5.1 percent, in heavy trading on the Nasdaq. Business Slogan Lilly reports increased 2005 Q3 net income Eli Lilly and Co.'s net income increased 5 percent in the third quarter as sales of the company's newer products continued to grow. Lilly earned $794.4 million, or $0.73 per diluted share, this quarter compared with $755.2 million, or $0.69 per diluted share, in the third quarter of 2004. Analysts had expected Lilly to earn $0.71 per share, according to Reuters Estimates. Worldwide sales for the third quarter increased 10 percent, from $3.28 billion in 2004 to $3.60 billion in 2005. Worldwide sales of osteoporosis drug Forteo (teriparatide) jumped 77 percent in the third quarter, while sales of attention-deficit/hyperactivity disorder treatment Strattera (atomoxetine hydrochloride) fell 14 percent compared with last year's third quarter. Lilly recently added a black box warning to Strattera's label to reflect a possible increased risk of suicide associated with the drug. For the full year, Lilly expects to earn from $1.90 to $1.96 per share, with full-year sales growth of 6 percent to 8 percent. In the upcoming quarter, Lilly expects to earn $0.73 to $0.79 per share. Lilly shares closed at $51.25, down $0.35, or 0.7 percent, in heavy trading on the New York Stock Exchange. Business Slogan Business Slogan Genentech Inc. Genentech Inc. entered into a collaboration with non-profit organization Accelerate Brain Cancer Cure (ABC2) to investigate Avastin (bevacizumab) as a treatment for patients with glioblastoma multiforme (GBM), a highly aggressive form of brain cancer. The initial stage of the collaboration will focus on a novel imaging study of patients with recurrent GBM, in which researchers plan to study several potential mechanisms of activity and determine if early responses seen on magnetic resonance imaging scans indicate clinical benefit. ABC2 and Genentech will share development expenses during this stage; if results are encouraging, ABC2 will then provide access to other resources, including the organization's network of research centers, for a randomized clinical trial sponsored by Genentech involving patients with relapsed GBM. Business Slogan Business Slogan Schering AG Schering AG is planning another Phase III clinical trial to examine sargramostim as a potential treatment for Crohn's disease. The trial is being initiated following a delay in patient recruitment for one of two other Phase III studies of the drug. The delay has caused the company to push back the anticipated filing date of the drug for this indication, from the fourth quarter of this year to the end of 2007 or beginning of 2008. Schering already markets sargramostim under the brand name Leukine as a support treatment in hematological disorders, according to a Dow Jones Newswires report. Business Slogan Business Slogan Xanthus Life Sciences Inc. Xanthus Life Sciences Inc. is starting a Phase II study to test Xanafide (amonafide malate) in combination with cytosine arabinoside (ara-C) as a treatment for secondary acute myeloid leukemia (AML). "We are extremely encouraged by the 46 percent response rate achieved in the Phase I trial of [Xanafide] and ara-C in patients with AML, together with the acceptable safety profile, given that the vast majority of enrollees in this Phase II trial are likely to be elderly, with high-risk AML," said Dr. Robert Capizzi, Xanthus' chief medical officer. The study is expected to enroll as many as 60 patients with secondary AML; the primary endpoint is the rate of complete remission. Capizzi noted that no treatment is currently approved specifically to treat secondary AML. Business Slogan Business Slogan Novo Nordisk A/S Novo Nordisk A/S and ZymoGenetics Inc. initiated a Phase I study of rFXIII (recombinant coagulation factor XIII) in patients who are undergoing cardiac surgery. The study is designed primarily to assess the product's safety at different doses. Novo Nordisk obtained a worldwide, exclusive license to rFXIII in late 2004. ZymoGenetics received an undisclosed milestone payment as a result of the trial initiation. Business Slogan


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