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Trade Name SearchBrand 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 Remicade treatment leads to long-term mucosal healing, clinical remission in ulcerative colitis, study shows A pooled analysis of the ACT I and ACT II trials demonstrated Centocor Inc.'s Remicade (infliximab) can provide long-term mucosal healing and clinical remission, as well as fewer hospitalizations and significant improvements in quality of life, in patients who have ulcerative colitis.Data from the two Phase III trials were presented in Copenhagen, Denmark, at the United European Gastroenterology Week meeting. Each study enrolled 364 patients who had active ulcerative colitis that was unresponsive to at least one conventional treatment. The subjects were randomized to receive Remicade (5 mg/kg of body or 10 mg/kg) or placebo at weeks zero, two, six and every eight weeks thereafter until week 22. Participants in ACT I were followed through week 46. At week eight, significantly higher proportions of patients in the Remicade arms achieved mucosal healing, defined as an endoscopy subscore of 0 or 1, as compared with the placebo group (Remicade 5 mg/kg, 61.2 percent and Remicade 10 mg/kg, 60.3 percent vs. placebo, 32.4 percent). Even at week 30, approximately 50 percent of the Remicade-treated patients maintained this mucosal healing compared with only 27.5 percent of those who received placebo. With respect to clinical remission at week eight, more than 29 percent of patients in the Remicade groups reached clinical remission, while those in the placebo arm achieved remission at a rate of 10.2 percent. Results were similar at week 30. Moreover, one sub-analysis showed the average number of hospitalizations was 50 percent lower in the combined Remicade-treated patients than in the placebo-treated patients and that the time to first hospitalization was longer with Remicade rather than with placebo. Another sub-analysis demonstrated Remicade therapy led to significantly greater improvements in health-related quality of life, as measured by two standard questionnaires. Finally, results from a 54-week extension of ACT I showed maintenance of mucosal healing, sustained response and sustained remission occurred in a greater proportion of the patients who received Remicade as compared with those who received placebo. Remicade is marketed by Schering-Plough Corp. outside of the United States, by Xian-Janssen Pharmaceutical Ltd. in China and by Tanabe Seiyaku Co. Ltd. in Japan and parts of Asia. Trade Name Search Greater inhibition of platelet aggregation seen with prasugrel versus Plavix A pooled analysis showed that a greater proportion of subjects responded to Eli Lilly and Co. and Sankyo Co. Ltd.'s investigaional drug, prasugrel, than to Bristol-Myers Squibb Co. and sanofi-aventis Group's Plavix (clopidogrel bisulfate) when inhibition of platelet aggregation was evaluated. Lilly and Sankyo developed prasugrel as a potential antiplatelet agent for patients who have had a myocardial infarction or have unstable angina. In three early-phase studies, 112 healthy adults were randomized to receive a 60 mg loading dose of prasugrel or a 300 mg loading dose of Plavix in a two-way crossover design. Researchers used adenosine diphosphate to induce platelet aggregation in the participants' blood samples. Nonresponders were those who achieved less than 25 percent inhibition of platelet aggregation (IPA) or a difference of less than 20 percent in maximum platelet aggregation (MPA) in response to 5 micromolar (mcM) of adenosine diphosphate. When the amount of adenosine diphosphate was raised to 20 mcM, patients who achieved less than 20 percent of IPA or a difference of less than 15 percent in MPA were also considered nonresponders. All patients responded to the loading dose of prasugrel. However, when the same patients were treated with Plavix, 22 percent were nonresponders based on IPA in response to 5 mcM of adenosine diphosphate, and 43 percent were nonresponders based on IPA in response to 20 mcM of adenosine diphosphate. These results were presented in Washington, D.C., at the Cardiovascular Research Foundation's 17th Annual Transcatheter Cardiovascular Therapeutics scientific symposium. "We are studying whether more reliable inhibition of platelet aggregation could have an important effect on patient outcomes," said Govinda Weerakkody, a principal research scientist at Lilly. The Phase III TRITON-TIMI 38 trial is under way to compare prasugrel with Plavix in as many as 13,000 patients with acute coronary syndrome who have had an MI or have unstable angina and are set to undergo percutaneous coronary intervention. The primary focus of this trial is to compare the drugs' ability to prevent MI, stroke or death in patients who undergo percutaneous coronary intervention. The study is expected to end in early 2007, with regulatory submissions following in the second half of that year. The companies had originally expected the drug would be submitted for regulatory approval in the first half of 2007, The Associated Press reported, but the trial is expected to take longer than researchers had anticipated. Trade Name Search Risperdal effective, well-tolerated treatment for behavioral, psychological symptoms of dementia, associated sleep disturbances Janssen L.P.'s atypical antipsychotic, Risperdal (risperidone), appears to be a safe and effective treatment for behavioral and psychological symptoms of dementia and associated sleep disturbances, a new study found. The open-label, 12-week, observational, prospective study included 338 patients. Of these, 321 patients completed the study. Researchers used the neuropsychiatric inventory (NPI) total and subscale scores to assess the effects of Risperdal. Patients and caregivers were asked to rate sleep-wake cycle disturbances using a newly developed sleep behavior questionnaire that included assessment of sleep duration, quality, awakenings and effects on daily activities. Tolerability was assessed using the Udvalg for Kliniske Undersogelser (UKU) subscale for extrapyramidal symptoms. Adverse events were also recorded. The mean NPI score was 28.7 at baseline. Following a 12-week treatment regimen of Risperdal (mean dose 1.49 mg/day at endpoint), the mean NPI score was reduced to 10.6. Patients and caregivers reported significant improvements from baseline following the treatment period in terms of total sleep hours at night (5.5 hr vs. 7.1 hr) and hours awake in bed at night (2.3 hr vs. 1.2 hr). At baseline, 40.1 percent reported insomnia; this rate dropped to 8.4 percent after the treatment period. A total of 10 adverse events were reported by six patients, including somnolence and sialorrhea. Scores on the UKU subscale also improved significantly (mean 4.0 at baseline vs. 1.7 at week 12), the authors noted. The study was published online ahead of print by International Psychogeriatrics. Trade Name Search Sirna reports positive updated Phase I trial data for Sirna-027 Sirna Therapeutics Inc. announced that clinical data continue to show that its short interfering RNA (siRNA) molecule, Sirna-027, which targets vascular endothelial growth factor receptor-1 (VEGFR-1), is safe and well tolerated. Dr. Edward Quinlan, of the Wilmer Eye Institute at The Johns Hopkins University, presented the updated interim data on Sirna's Phase I trial for age-related macular degeneration at the 109th Annual Meeting of the American Academy of Ophthalmology in Chicago. Quinlan concluded from the trial data that all patients showed visual acuity stabilization at eight weeks after receiving a single injected dose of Sirna-027. Also, 23 percent of those patients showed clinically significant improvement of at least three lines on the Early Treatment of Diabetic Retinopathy Study eye chart. No dose-limiting toxicities were observed. These most recent results highlight continued "biological activity in humans of a synthetic siRNA" as demonstrated by a relevant reduction in central foveal thickness measured by ocular coherence tomography (OCT) in the majority of patients, the company said. "With the trial approaching completion, I am encouraged by these positive results and believe this drug may play an important role in the future treatment of AMD," said Sirna-027 clinical investigator Dr. Peter Kaiser, of the Cole Eye Institute at the Cleveland Clinic. Recently, Sirna and Allergan Inc. formed a strategic alliance to develop Sirna-027 and to discover and develop other new RNAi-based therapeutics against certain gene targets in ophthalmic diseases. Allergan will assume all developmental responsibilities for Sirna-027 following completion of the Phase I trial, which is anticipated to be by the end of the year. The companies expect Sirna-027 to enter Phase II trials in 2006. Trade Name Search Abbott's Q3 net earnings fall, sales rise Abbott's sales for the third quarter of 2005 increased, while its net earnings fell as compared with the same quarter of 2004. Net earnings decreased 15.3 percent to $680.7 million, or $0.44 per diluted share, compared with $804.1 million, or $0.51 per diluted share, in the third quarter of 2004. The company's profits fell due to several charges that offset increased sales of prescription drugs and medical devices. Excluding charges, Abbott earned $0.58 per share, which is in line with the company's own guidance of $0.56 to $0.58 per share and the $0.58 per share estimate by analysts polled by Thomson First Call, according to The Wall Street Journal. Net sales totaled $5.38 billion, an increase of 15 percent from $4.68 billion in the previous year's same period. The company said an increase in total sales was favorably impacted by 1.1 percent by the effect of the exchange rate. The firm's pharmaceutical products group was led by strong sales of arthritis drug Humira (adalimumab), which increased 56.5 percent to $356 million globally, and pain reliever Mobic (meloxicam), which increased 146.2 percent to $310 million in the United States. Abbott currently co-promotes Mobic in the United States with Boehringer Ingelheim GmbH. Other strong contributors to strong sales were HIV drug Kaletra (lopinavir/ritonavir), which increased 16.2 percent to $260 million globally, and antibiotic Omnicef (cefdinir), which increased 72.6 percent to $87 million in the United States. Excluding special items, the company expects fourth-quarter earnings per share of $0.75 to $0.77. As a result, the company is narrowing its earnings-per-share guidance for 2005 to $2.49 to $2.51, also excluding items. Previously, Abbott expected to earn between $2.47 and $2.53 per share. Abbott shares closed at $43.95, up $1.55, or 3.7 percent, in heavy trading on the New York Stock Exchange. Trade Name Search Roche's Q3 sales beat analysts' expectations, spurred by demand for Avastin, Tamiflu F. Hoffmann-La Roche Ltd. posted a 17 percent increase (in local currencies) in sales during the third quarter of 2005 as a result of strong demand for its oncology drugs and Tamiflu (oseltamivir phosphate) influenza treatment. "Roche posted significant double-digit gains in the third quarter, maintaining the strong sales growth of the first half-year," explained Franz Humer, the company's chief executive officer. "Our pharmaceuticals division gained additional market share, with all major products contributing to this strong performance, particularly our new cancer medicines." In total, sales rose to approximately $6.82 billion from approximately $5.69 billion in the third quarter of 2004. Analysts polled by Dow Jones Newswires had predicted approximately $6.6 billion in sales. The pharmaceuticals division sales increased 21 percent from one year ago to approximately $5.24 billion this past quarter. Specifically, Genentech Inc.'s sales jumped 42 percent to approximately $1.37 billion and Roche Pharmaceuticals' sales rose 17 percent to approximately $3.24 billion. Roche holds a majority interest in Genentech. Avastin (bevacizumab), which is used in combination with chemotherapy to treat metastatic colorectal cancer, and Tamiflu, which is being stockpiled as one of the few drugs effective against the avian H5N1 flu in animal models, showed the most sales growth both worldwide and in the United States: global sales increased 107 percent to approximately $375.5 million for Avastin and 148 percent to $215.6 million for Tamiflu. Rituxan (rituximab), a non-Hodgkin's lymphoma treatment sold as MabThera in Europe, had the highest sales at $818.9 million, up from $677.5 million in the year-ago period. The drug is co-marketed by Biogen Idec Inc. in the United States. Roche also affirmed that its full-year pharmaceutical sales would see a double-digit increase, Dow Jones Newswires reported. Trade Name Search Trade Name Search The Food and Drug Administration The Food and Drug Administration appointed Dr. Gerald Dal Pan as director of the Office of Drug Safety in the Center for Drug Evaluation and Research (CDER). He will be in charge of drug safety issues related to approved drugs currently on the market. Since 2003, Dal Pan has served as the director of the Division of Surveillance, Research, and Communication Support in the Office of Drug Safety in CDER. Trade Name Search Trade Name Search Schering AG Schering AG obtained exclusive, global license to Sonus Pharmaceuticals Inc.'s investigational Tocosol paclitaxel cancer therapy that has shown anti-tumor activity in solid tumors. In exchange, Sonus will receive an up-front fee, milestone payments, royalties and an approximately 15-percent equity investment from Schering. The companies plan to submit a New Drug Application for the drug's use in metastatic breast cancer by the end of 2007. Sonus' Tocosol technology allows approximately 70 percent more paclitaxel to be delivered than Bristol-Myers Squibb Co.'s Taxol (paclitaxel), Schering said. Trade Name Search Trade Name Search The Medicines Co. The Medicines Co. is resuming Phase III clinical safety trials of clevidipine, an intravenous, short-acting hypertension agent. A review of interim safety results found no significant differences between clevidipine and comparator treatments. Specifically, the frequency of atrial fibrillation was similar between the randomized groups. In March, the company voluntary suspended patient enrollment in the trials due to reports of higher occurence of atrial fibrillation in patients randomized to clevidipine than in patients randomized to comparator drugs. The company expects to complete enrollment in the clinical safety studies in the next 12 months. Trade Name Search Trade Name Search Novavax Inc. Novavax Inc. granted exclusive North American rights for Estrasorb (estradiol), a topical emulsion form of the naturally occurring hormone 17 beta-estradiol, to Esprit Pharma Inc. Estrasorb, the first prescription topical emulsion for estrogen therapy, is approved to treat moderate to severe vasomotor symptoms, or hot flashes, that are associated with menopause. The product uses Novavax's patented and proprietary micellar nanoparticle drug-delivery platform. Trade Name Search Trade Name Search SGX Pharmaceuticals Inc. SGX Pharmaceuticals Inc.'s Troxatyl (troxacitabine) received fast track designation from the Food and Drug Administration as a potential third-line treatment of acute myeloid leukemia in adults. The product has already been granted orphan drug status. Troxatyl is currently being tested in a Phase II/III trial for this indication, as well as in a Phase I/II trial for refractory solid tumors. 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