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Trade NamingBrand 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 Lunesta trial shows significant improvement in sleep measures A Phase IIIb/IV study evaluating the safety and efficacy of Sepracor Inc.'s Lunesta (eszopiclone) for the treatment of insomnia in perimenopausal and menopausal women showed a statistically significant improvement from baseline compared with placebo.The six-week, double-blind trial included 410 patients who were randomized to receive Lunesta 3 mg or placebo nightly. Results showed there was a statistically significant improvement in patient-reported measures of sleep latency, wake time after sleep onset and total sleep time for each week of the four-week, double-blind treatment period. Patients who received Lunesta also experienced significant improvements in further sleep measures and daytime function measures, including sleep quality, sleep depth, daytime alertness, ability to function, ability to think and concentrate clearly and sense of well-being versus those patients who received placebo. Compared with baseline and averaged across the treatment period, women who were treated with Lunesta had fewer total nocturnal awakenings and fewer awakenings due to hot flashes as compared with patients in the placebo group, the company said. A physician global assessment was also statistically significantly improved at the end of the treatment period for women treated with Lunesta compared with those treated with placebo. The data were presented at the North American Menopause Society's annual meeting in San Diego. Trade Naming Berlex' Betaseron delays development of MS in early stage, data reveal In patients with the first clinical signs of multiple sclerosis, Berlex Inc.'s Betaseron (interferon beta-1b) 250 mcg treatment delayed the onset of clinically definite MS (CDMS) by one year (363 days) compared with placebo, according to findings from a new study. The Phase III, double-blind, randomized BENEFIT study followed 487 patients who had a single clinical episode suggestive of MS for up to 24 months. Researchers evaluated two primary endpoints: time to CDMS, based on a relapse or an Expanded Disability Standard Scale progression of 1.5 points, and time to MS, according to the criteria determined by McDonald et al. (2001). One-fourth of the patients in the placebo group developed CDMS by day 255 of the study. For a comparable number of patients to develop CDMS in the treatment group, it took 618 days. At the end of the two-year evaluation, 45 percent of the placebo group had developed CDMS compared with 28 percent of the patients in the Betaseron group, for a relative risk reduction of 50 percent in patients who received Betaseron. "Treatment with [Betaseron] appears to delay patient progression to CDMS when they have been identified as being at risk of developing the disease," said Ludwig Kappos, lead investigator of the study. Schering AG, Berlex' parent company, plans to file for a wider label for Betaseron in the United States and Betaferon in Europe, Reuters reported. Interferon beta-1b 250 mcg is marketed as Betaseron in the United States and as Betaferon in Europe. The data were presented at the joint 21st Congress of the European Committee for the Treatment and Research in Multiple Sclerosis/10th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis in Thessalonki, Greece. Trade Naming Cardiome, Astellas' investigational AF treatment meets primary endpoint in Phase III study Cardiome Pharma Corp. and Astellas Pharma US Inc.'s Phase III study of intravenous RSD1235 met its primary endpoint of returning normal heart rhythm to patients with recent-onset atrial fibrillation (AF). The ACT 3 study included 276 patients with atrial arrhythmia. Of these 276 patients, 170 had recent-onset AF (defined as more than three hours but less than seven days), 69 had longer-term AF (defined as more than seven days but less than 45 days) and 23 had atrial flutter. The primary endpoint was the conversion of recent-onset AF to normal heart rhythm for at least one minute within 90 minutes of when RSD1235 dosing began. Of the 170 patients with recent-onset AF, 52 percent of those who received RSD1235 converted to normal heart rhythm (median time to conversion, 8 minutes) as compared with 4 percent of those who received placebo. The companies noted that these results are the same as those seen in the pivotal Phase III ACT 1 trial. In the patients with an AF duration of between three hours and 45 days, 41 percent of those who received the study drug had their AF terminated, while only 4 percent of those who received placebo experienced termination of AF. In the longer-term AF population, 9 percent of those who took RSD1235 experienced AF termination compared with 3 percent of those who took placebo. In the patients with atrial flutter, 7 percent of those who took RSD1235 returned to normal heart rhythm as compared with 0 percent of placebo-treated patients. "We are once again pleased to see clear and decisive results from our RSD1235 IV clinical program, in particular the consistency of these results with our previous studies," Bob Rieder, chief executive officer of Cardiome, said in a press release. "With the ACT 1 and ACT 3 studies now completed, we look forward to working with our partner Astellas toward submitting an New Drug Application for RSD1235 IV." Cardiome and Astellas are co-developing RSD1235, with Astellas responsible for 75 percent of costs. Cardiome has the rights to the intravenous formulations everywhere except Canada, the United States and Mexico, and also retains worldwide rights to an oral formulation intended to prevent AF. Trade Naming BioSante releases positive data on menopause treatment, intends to file NDA in Q4 BioSante Pharmaceuticals Inc. released additional safety and efficacy results from a Phase III trial of Bio-E-Gel (bioidentical estradiol), an estrogen replacement therapy, and said it plans to file a New Drug Application for the transdermal gel in the fourth quarter. The randomized, double-blind study was conducted during a period of 12 weeks and included 484 symptomatic menopausal women. The trial evaluated three dosage levels of Bio-E-Gel to establish the lowest effective dose and optimal safety profile for the drug. The results showed that the three dosages of Bio-E-Gel significantly decreased the number of hot flashes in women with menopause. The most effective dose was found to significantly decrease the number of hot flashes from 12.9 per day at baseline to 1.6 per day after treatment, a reduction of 88 percent. This decrease was also significant as compared with placebo. There was a mean decrease of 11.3 hot flashes per day with Bio-E-Gel and a decrease of 6.1 hot flashes per day with placebo. "The Bio-E-Gel results compare very favorably to results reported in other estrogen therapy studies," said Dr. Leah Lehman, vice president of product development at BioSante. "In addition, Bio-E-Gel may be used at a lower dose than other estrogen products on the market, an important potential safety advantage." Bio-E-Gel uses Antares Pharma Inc.'s Advanced Transdermal Delivery gel system to deliver hormones across the skin. BioSante licensed this technology from Antares for North America and other territories. These data were presented at the North American Menopause Society's annual meeting in San Diego. Trade Naming Altana acquires prescription dermatology business from GSK Altana Inc. acquired GlaxoSmithKline Plc's U.S. prescription dermatology business for an undisclosed amount. PharmaDerm, a division of Altana Inc., will manufacture and market five former GSK products including Aclovate (alclometasone dipropionate), a synthetic corticosteroid, Cutivate (fluticasone propionate) and Temovate (clobetasol propionate), both anti-inflammatory drugs, the antibiotic Emgel (erythromycin) and Oxistat (oxiconazole nitrate), an antifungal drug. PharmaDerm's current product portfolio includes ApexiCon E Cream (diflorasone diacetate, 0.05%) for steroid responsive dermatoses like eczema, psoriasis and contact dermatitis, and ClindaMax lotion (clindamycin phosphate, 1%) for the treatment of acne. "The addition of new product lines allows us to significantly enhance our existing sales and marketing capability and to broaden our offering to the dermatology marketplace," said Malcolm McCoy, vice president of sales and marketing at PharmaDerm. GSK received approval from the Food and Drug Administration for Cutivate Lotion in March 2005. An official launch date has yet to be set, but PharmaDerm is planning to launch it this fall. Trade Naming Omnicare to close 17 facilities, lay off 730 employees Omnicare Inc. will close 17 facilities, 15 of which are pharmacy operations, and will cut 730 jobs as a result of its recent acquisition of NeighborCare Inc. "Given the geographic overlap of the NeighborCare and Omnicare pharmacies, substantial opportunities for consolidation exist," said Joel Gemunder, Omnicare's chief executive officer. "While the majority of consolidations will result in NeighborCare pharmacies being folded into Omnicare pharmacies, our review of the location, capacity and operating performance of all pharmacies has also identified certain Omnicare pharmacies for consolidation into NeighborCare locations." Omnicare will offer severance packages to the approximately 3.7 percent of its total workforce that will be laid off. The company expects to record a restructuring charge of approximately $20 million before taxes to cover severance costs, lease terminations and writing off leasehold improvements. Approximately $18 million of this charge will be taken in the third and fourth quarters of 2005, with the remaining $2 million being taken in the first two quarters of 2006. The restructuring is expected to save approximately $40 million before taxes on an annualized basis, with the majority of the savings occurring in 2006. Omnicare expects to finish the closures and layoffs in 12 months. Trade Naming Trade Naming GlaxoSmithKline Plc GlaxoSmithKline Plc is being noted as one of the companies likely to acquire the nonprescription drugs arm of retailer Boots Group Plc in a sale that could be worth between $2.47 billion and $2.56 billion, Reuters reported, attributing the speculation to "an industry source." Other suitors include Bayer AG, Reckitt Benckiser Plc, a maker of household cleaning products, Pfizer Inc., Johnson & Johnson and Novartis AG. All bidders were required to turn in their second and final bid by Sept. 29. Trade Naming Trade Naming Biogen Idec Inc. Biogen Idec Inc. announced the initiation of the Global Adherence Project, a multinational study designed to evaluate patient adherence to long-term treatments for multiple sclerosis in a real-world setting. The cross-sectional, observational study is estimated to enroll more than 1,800 patients with relapsing-remitting MS in 24 countries who are currently taking one of the following therapies: Biogen Idec's Avonex (interferon beta-1a), Berlex Inc.'s Betaseron (interferon beta-1b), Teva Pharmaceutical Industries Ltd.'s Copaxone (glatiramer acetate) or Serono Inc. and Pfizer Inc.'s Rebif (interferon beta-1a). Study participants will be evaluated using a validated MS quality-of-life scale. In addition, a self-reported questionnaire will obtain data on disease status, treatment and factors that may have affected adherence to treatment during the course of a patient's therapy, Biogen Idec explained. Trade Naming Trade Naming Guidant Corp. Guidant Corp.'s Vitality HE implantable cardioverter defibrillator was approved by the Food and Drug Administration. The high-energy system has "exceptional longevity with the capacity to deliver more energy to defibrillate the patient," Guidant said, adding that the ICD should be available in early October. Trade Naming Trade Naming Avalon Pharmaceuticals Inc. Avalon Pharmaceuticals Inc.'s Investigational New Drug Application has been activated by the Food and Drug Administration, permitting the firm to begin a Phase I trial testing the oral small molecule inhibitor AVN944 in patients with advanced hematological malignancies. "We look forward to initiating clinical trials in the next months at several leading cancer treatment centers in the United States," said Kenneth Carter, chief executive officer of Avalon. AVN944, which was in-licensed from Vertex Pharmaceuticals Inc., inhibits the inosine monophosphate dehydrogenase enzyme, which is essential for the de novo synthesis of the nucleotide guanosine triphosphate, Avalon said, noting that the drug has been shown to be well tolerated and orally bioavailable in normal human volunteers. Trade Naming Trade Naming Alteon Inc. Alteon Inc.'s Phase IIa trial of alagebrium in diabetic patients with erectile dysfunction will remain on clinical hold. After reviewing preclinical toxicity data submitted by Alteon, the Food and Drug Administration's Center for Drug Evaluation and Research's Division of Reproductive and Urologic Drug Products placed a clinical hold on further enrollment in the company's Phase IIa study in June. The Division then requested further preclinical toxicity data, which the Company submitted in August. Now that these data have been reviewed, the Division has decided to maintain the clinical hold until further preclinical testing has been completed. Trade Naming Trade Naming
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