Corporate Identity - Brand Institute, inc.



			Corporate Identity 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 Takeda's Rozerem insomnia treatment approved by FDA Takeda Pharmaceuticals North America Inc.'s New Drug Application for Rozerem (ramelteon) 8 mg tablets was approved Friday for the treatment of insomnia characterized by difficulty with sleep onset. The approval by the Food and Drug Administration allows physicians to prescribe the drug for long-term use in adults; the drug should be available to patients by late September. According to Takeda, Rozerem is the only prescription sleep drug that has not demonstrated evidence of abuse and dependence and, therefore, was not classified as a controlled substance by the U.S. Drug Enforcement Administration. All other prescription drugs that treat insomnia carry Schedule IV controlled substance classifications, Takeda said. Rozerem is the first prescription insomnia drug with a new therapeutic mechanism of action in 35 years, the company said. It works by selectively targeting two receptors in the brain's suprachiasmatic nucleus, which regulates a person's 24-hour biological cycle, including the sleep-wake cycle. The NDA, which was submitted last September, was based on data from studies involving more than 4,200 patients, aged 18 to 93 years. One study involved 472 patients who received single daily doses of the drug for up to one year. Recent trials have shown the drug to be safe for older adults, along with those who have mild to moderate chronic obstructive pulmonary disease and mild to moderate sleep apnea, Takeda said. Corporate Identity Express Scripts to acquire Priority Healthcare for $1.3 billion Express Scripts Inc., a pharmacy benefits company, signed a definitive agreement to acquire Priority Healthcare Corp. in a cash transaction worth $1.3 billion. As per the agreement, each share of Priority will be purchased for $28 in cash. Including the write-off of deferred financing fees and merger-related costs, Express Scripts estimates the acquisition will be dilutive to the company's 2005 earnings per share by $0.01 and accretive to its 2006 results by $0.02 or $0.03. According to Express Scripts, the acquisition is intended to further establish the company's subsidiary, CuraScript Pharmacy Inc., as a leader in the specialty pharmaceuticals market. Express Scripts said the combined company will generate more than $3 billion in annual revenue, strengthening its presence in the areas of oncology, multiple sclerosis, rheumatoid arthritis, hepatitis, fertility, hemophilia, asthma, pulmonary hypertension and psoriasis. "We are creating one of the largest and most comprehensive specialty platforms in the industry," said Dom Meffe, chief executive officer of CuraScript. "Our client-centric, patient care model will include an enhanced capacity for providing cost-effective, single-source solutions for the broad range of specialty therapies. Traditional direct-to-patient pharmacy programs, combined with the efficiencies gained from organizing elements of the supply chain will offer clients and patients alike . . . an ideal one-stop delivery solution." Express Scripts expects to finance the acquisition with cash on hand and bank debt. The transaction is expected to close in the fourth quarter of this year. Express Scripts shares closed at $48.39, up $0.41, or 0.9 percent, in moderate trading, while Priority's shares closed at $27.57, up $1.72, or 6.7 percent, in heavy trading. Both are traded on the Nasdaq. Corporate Identity FDA expands Adderall XR indication to include adolescents The Food and Drug Administration approved Shire Pharmaceutical Group Plc's Adderall XR (mixed amphetamine salts) as a once-daily treatment for adolescents aged 13 to 17 years with attention-deficit/hyperactivity disorder. Adderall XR was already indicated for the treatment of children aged 6 to 12 years and adults aged 18 years or older. The new approval is based on data Shire provided in a supplement to its New Drug Application. A randomized, double-blind trial revealed that, at doses between 10 mg and 40 mg daily, Adderall XR was significantly more effective than placebo in the treatment of ADHD symptoms in adolescents. According to Shire, 63 percent of investigators in the study considered their subjects' ADHD symptoms to be much improved or very much improved with Adderall XR versus 27 percent for placebo. Overall, Adderall XR was safe and well tolerated. Loss of appetite, insomnia, abdominal pain and weight loss were the most commonly reported adverse events. Corporate Identity Amoxicillin Pulsys fails to meet endpoints in Phase III trial Advancis Pharmaceutical Corp.'s investigational pediatric strep throat treatment, Amoxicillin Pulsys, failed to meet the endpoints of a Phase III trial. The study compared once-daily doses of Amoxicillin Pulsys 775 mg and 475 mg sprinkles, administered for a period of seven days, with a 10 mg/kg of body weight oral suspension of penicillin VK administered four times daily for 10 days. Advancis said that Amoxicillin Pulsys failed to demonstrate statistical noninferiority to the comparator therapy in bacterial eradication at the post-therapy test-of-cure visit. Specifically, 65.3 percent of patients treated with Amoxicillin Pulsys and 68 percent of patients treated with penicillin exhibited bacterial eradication at this visit. Amoxicillin Pulsys also failed to meet the trial's secondary endpoints, including bacterial eradication at the late post-therapy visit and clinical cure at the test-of-cure visit. The company said it will review study data and evaluate what steps, if any, can be taken to improve future outcomes. Advancis announced in June that the Amoxicillin Pulsys product for adults also failed to demonstrate statistical noninferiority to a comparator therapy. Advancis shares closed at $1.45, down $0.30, or 17.1 percent, in heavy trading on the Nasdaq. Corporate Identity GSK, Adolor receive FDA approvable letter for postoperative ileus drug Entereg GlaxoSmithKline Plc and Adolor Corp. received an approvable letter from the Food and Drug Administration for Entereg (alvimopan), a drug intended to help manage postoperative ileus by enabling patients to recover gastrointestinal function more quickly following bowel resection surgery. Prior to FDA approval of the drug, Adolor and GSK must show that patients who have had bowel resection surgery and have been treated with Entereg experience a clinically meaningful median reduction in time to GI function recovery. The companies must also demonstrate statistically significant results in at least one additional study. "We intend to request a meeting with the FDA as quickly as possible to discuss the approvable letter and determine the appropriate next steps for the New Drug Application," said Bruce Peacock, Adolor's chief executive officer. Currently, Adolor is conducting a study designed to enroll as many as 660 patients who have had bowel resection surgery; patients are being randomized to receive placebo or 12 mg of Entereg twice daily. Adolor said data from this trial may be used to meet the requirements of the FDA's approvable letter. Adolor shares closed at $10.48, up $0.22, or 2.1 percent, in heavy trading on the Nasdaq. GSK shares closed at $46.50, down $0.50, or 1.1 percent, in moderate trading on the New York Stock Exchange. Corporate Identity GSK's Lamictal effective in treating certain patients with epilepsy, population-based study suggests The results of a population-based study suggest that GlaxoSmithKline Plc's Lamictal (lamotrigine) is an effective treatment option for patients with insufficient seizure control and for those who experience adverse reactions to other antiepileptic drugs (AEDs). The researchers reviewed the medical charts of 165 patients from 37 different medical centers in the Netherlands. The two-year study period for each patient included the year before beginning treatment with Lamictal and concluded one year after the initiation of treatment with Lamictal. Effectiveness of the drug was evaluated during the first year of use and was measured by reduction in seizure frequency and retention time. Patients who received Lamictal as their initial AED were excluded from the study. Based on predetermined criteria, researchers found Lamictal effective in 78 of the 165 patients (47 percent). Lamictal was significantly less effective (40.2 percent) in the 112 patients who initiated treatment because of insufficient seizure control than it was among the 53 patients who initiated treatment with Lamictal because of adverse reactions to other AEDs (62.2 percent). In the group treated with Lamictal because of insufficient seizure control, 16 patients became seizure free. In the same group, 40 patients continued Lamictal treatment without experiencing at least a 50 percent reduction in seizures. The researchers found that factors affecting Lamictal's effectiveness included the duration of epilepsy, baseline seizure frequency, use of valproate, drug load and the number of AEDs used concurrently. "It can be concluded from the present study that [Lamictal] is an effective treatment option and a useful alternative for patients with varying needs, including those with inadequate seizure control and intolerable side effects," the authors wrote. The study appeared online, ahead of print in the July issue of Epilepsy Research. Corporate Identity Roche operating profit led by strong pharmaceutical sales in first half of 2005 During the first six months of 2005, F. Hoffman-La Roche Ltd.'s operating profit increased 30 percent on strong sales by the company's pharmaceutical division. Net income for the first half of 2005 was approximately $2.53 billion, up from approximately $2.49 billion in the first half of last year. Roche reported an operating profit of approximately $3.3 billion for the first half of the year, which compares with an operating profit of approximately $2.66 billion in the first half of 2004. Sales for the first six months increased to approximately $12.96 billion; sales for the same period last year were approximately $11.6 billion. The company said its pharmaceuticals division saw "very strong growth" during this period, led by oncology products such as Tarceva (erlotinib hydrochloride) and Avastin (bevacizumab), and influenza drug Tamiflu (oseltamivir phosphate). OSI Pharmaceuticals Inc. and Genentech Inc. co-market Tarceva in the United States; Roche sells the drug in other countries. Avastin was developed by Genentech, which markets the drug in the United States. Roche increased its guidance for the year, noting that the operating profit margin of its pharmaceuticals division is expected "to be better again than previously announced." Corporate Identity Corporate Identity Schering-Plough Corp. Schering-Plough Corp. and Millennium Pharmaceuticals Inc. are restructuring their collaboration for Integrilin (eptifibatide), a cardiovascular drug the companies co-promote in the United States. They also share profits related to the drug. Under the revised agreement, which is expected to take effect Sept. 1, Schering-Plough will pay Millennium $35.5 million up front for exclusive U.S. rights to Integrilin, in addition to royalties and approximately $45 million to $50 million for existing inventories of the drug. Corporate Identity Corporate Identity Schering AG Schering AG's net sales during the first six months of 2005 rose 6 percent to approximately $3.08 billion. Operating profit for the six-month period was approximately $563.7 million, up 12 percent from the first half of 2004, and the company's earnings per share increased 24 percent to approximately $2.03. In addition, sales of Schering's birth control drug Yasmin (drospirenone/ethinyl estradiol) increased 34 percent during the first half of 2005 to approximately $309.7 million. For the full year, the company expects its operating margin to be between 16.5 percent to 17 percent. Schering shares closed at $63.99, up $1.09, or 1.7 percent, in moderate trading on the New York Stock Exchange. Corporate Identity Corporate Identity Alpharma Inc. Alpharma Inc. will revise the labeling for pain drug Kadian (morphine sulfate) following a request from the Food and Drug Administration. Based on in vitro pharmacokinetic studies, the FDA said the extended-release characteristics of Kadian may be compromised when the drug is combined with alcohol. Pending further data, the FDA asked Alpharma to update the label to "provide adequate information for the safe and effective use of the drug." Alpharma said it is working with the agency to implement the changes and plans to conduct studies that will evaluate the clinical implications of the in vitro study data. Corporate Identity Corporate Identity OSI Pharmaceuticals Inc. OSI Pharmaceuticals Inc. initiated a Phase I study of PSN357, a glycogen phosphorylase inhibitor designed to lower blood glucose levels quickly by preventing glycogen breakdown in the liver. The open-label study, which will assess the drug's safety and tolerability, is expected to enroll up to 112 healthy subjects and will last from three to six months. PSN357 is the first product of OSI's diabetes research program. Corporate Identity Corporate Identity Guidant Corp. Guidant Corp. revised its June 17 recommendations for Ventak Prizm AVT, Vitality AVT and Contak Renewal AVT implantable cardioverter defibrillator devices after learning that one of the recommendations may significantly increase the likelihood of malfunction. Guidant initially recommended a programming change to prevent the devices from latching, or locking up. A subsequent incident, however, led the company to determine that the programming change may actually increase the probability of latching. As a result, Guidant updated its programming recommendation and is developing a noninvasive software solution for the Vitality AVT and Renewal AVT devices. Pending regulatory approval, the new software solution may be available by the end of the year. Corporate Identity Corporate Identity


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