Global Market Research - Brand Institute, inc.



			Global Market Research 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 J&J to acquire Animas for approximately $518 million Johnson & Johnson entered into a definitive agreement to acquire all outstanding shares of Animas Corp., a firm that specializes in insulin delivery, in a cash-for-stock transaction valued at approximately $518 million. Animas is expected to operate as a stand-alone organization reporting through LifeScan Inc., a J&J company that provides blood glucose-monitoring systems. The acquisition enables LifeScan to quickly gain entry into the insulin delivery pump market, J&J said. "Diabetes is a worldwide issue, growing at an alarming rate," said Eric Milledge, J&J company group chairman who has responsibility for the LifeScan business. "Our vision is to create a world without limits for people with diabetes. The combination of Animas' insulin delivery systems and LifeScan's glucose monitoring systems will allow us to offer more comprehensive disease management solutions for our patients," he added. Animas shareholders will receive $24.50 for each outstanding share owned. The value of the transaction is based on the expected value of Animas' 22 million fully diluted shares outstanding, net of estimated cash on hand, on the anticipated closing date. Although the boards of directors of each company have approved the acquisition, it is still subject to approval by Animas stockholders and certain regulatory groups. The transaction is expected to close in the first quarter of 2006. Animas shares closed at $24.03, up $5.83, or 32 percent, in heavy trading on the Nasdaq. J&J shares closed at $60.86, up $0.70, or 1.2 percent, in moderate trading on the New York Stock Exchange. Global Market Research Novartis discontinues development of NKS104 cholesterol therapy Novartis AG terminated development efforts associated with NKS104 (pitavastatin), a Phase II compound that was being examined for treating high cholesterol. The firm's decision was based on recent investigational trials that showed "the compound was no longer competitive enough" to warrant further financial investment. Novartis intends to find a licensing partner for NKS104. "The discontinuation of NSK104 was widely anticipated due to the emergence of liver enzyme elevations and the lack of a major clinical differentiation over AstraZeneca [Plc]'s superstatin Crestor [rosuvastatin]," Bob Pooler, an analyst at Zurich, Switzerland's Lombard Odier Darier Hentsch bank, told Dow Jones Newswires. As a result of the termination, the company expects to recognize a $266 million charge in the fourth quarter of 2005 to fully write off the remaining value of the asset. In this year's third quarter, Novartis recorded a $66 million charge associated with the acquired and capitalized marketing rights for NKS104. Vontobel Group analysts said the charges would lower the firm's net profit estimate by 3 or 4 percent for 2005, Reuters reported. European rights to NKS104 were obtained under a licensing agreement from Japan-based Kowa Co. Ltd. Global Market Research FDA gives final confirmation regarding safety, efficacy of anthrax vaccine The Food and Drug Administration issued a Final Order confirming that Emergent BioSolutions Inc.'s anthrax vaccine, BioThrax (anthrax vaccine absorbed), is safe and effective for immunization against anthrax infection, regardless of the route of exposure. The data supporting the decision consisted of more than 20 scientific studies appearing in 27 peer-reviewed journals, along with recommendations from expert panels that included the Institute of Medicine's Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, the U.S. Department of Health and Human Services' Anthrax Vaccine Expert Committee, the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices and the FDA's Panel on Review of Bacterial Vaccines and Toxoids. "After review of the comments and finding no additional scientific evidence to alter the proposed categorization, [the] FDA accepts the Panel's recommendation and adopts category I as the final category for AVA and determines AVA to be safe and effective and not misbranded," the Final Order reads. "[The] FDA agrees with the report's finding that certain studies in humans and animal models support the conclusion that AVA is effective against Bacillus anthracis strains that are dependent upon the anthrax toxin as a mechanism of virulence, regardless of the route of exposure." Specifically, the FDA could not "conclude that there is a causal relationship between serious adverse events (other than some injection site reactions and some reports of allergic reactions) or deaths and AVA." Furthermore, some military personnel even submitted statements saying the vaccine is important for soldiers who enter potentially dangerous areas, the order said. The current review was the result of a court order stemming from U.S. District Judge Emmet Sullivan's 2004 finding of fault in the FDA's process for approving the vaccine, Dow Jones Newswires reported. Sullivan ordered the Pentagon to suspend mandatory vaccination of soldiers, but allowed them to resume several months later on a voluntary basis, Dow Jones Newswires added. The U.S. Department of Defense said the vaccine will still only be given to soldiers who volunteer for it. Global Market Research Health Canada prohibits Bextra's return to market in Canada After a review of safety data, Health Canada said that Pfizer Inc.'s selective COX-2 inhibitor Bextra (valdecoxib), which was voluntarily pulled from the market in April because of safety concerns, will not be allowed to return to Canadian pharmacies for sale. Pfizer Canada Inc. submitted information to the Canadian health regulatory body, but after consulting with external experts and the public, Health Canada determined there was not sufficient evidence to establish an acceptable safety profile to recommend Bextra as a pain management and arthritis therapy. Following Merck & Co. Inc.'s withdrawal of Vioxx (rofecoxib) in September 2004 due to an increased cardiovascular risk, a team of Health Canada experts initiated a review of related therapies such as Bextra to determine if they had a similar cardiovascular risk. The agency called on external experts and the public as part of its COX-2 Expert Advisory Panel that met in June 2005. As a result of the stop-sale order, Pfizer will not be able to bring Bextra back to the market without further consultation with Health Canada, the agency noted. In May, Pfizer said it would continue to discuss options with the Food and Drug Administration for returning Bextra to the U.S. market. Global Market Research F. Hoffmann-La Roche completes four Phase III trials of investigational long-acting anemia agent, CERA F. Hoffmann-La Roche Ltd. said it has completed all four maintenance studies in its Phase III renal program for Cera (continuous erythropoietin receptor activator), the only anemia drug to be studied in long-dosing intervals of once every four weeks for its initial filing. The four maintenance studies, conducted in patients on dialysis and on stable maintenance treatment of anemia with epoetin or Amgen Inc.'s Aranesp (darbepoetin alfa), randomized patients to switch to Cera (administered once either every two or every four weeks) or continue their current treatment. The studies met their primary endpoints (change in hemoglobin concentration between baseline and evaluation period) and demonstrated that the drug was effective in maintaining hemoglobin levels with extended dosing intervals, administered either intravenously or subcutaneously. Based on the data from the Phase III program, the company said it will move forward with the Biologics License Application and expects to file the BLA with the Food and Drug Administration in 2006. A full review of the drug's benefit-risk assessment will be conducted by health authorities after filing. In addition to the four maintenance studies, the Phase III program included two correction studies in patients with chronic kidney disease either on or not on dialysis, which are nearing completion, the company added. Combined, the Phase II and III programs involved more than 2,700 patients. "Cera's unique ability to provide up to once-monthly dosing may potentially offer a convenient and efficacious treatment option for patients with anemia in all stages of chronic kidney disease," said Richard Hinson, the company's vice president of operations. Global Market Research Enbrel helps psoriasis patients with depression, fatigue, study suggests Treatment with Amgen Inc. and Wyeth's Enbrel (etanercept) appears to relieve symptoms of depression and fatigue in patients with psoriasis, according to a study published online ahead of print on Dec. 15 in The Lancet. The study, which included 618 patients with moderate to severe psoriasis, was designed to evaluate the efficacy of Enbrel in these patients, but the researchers also assessed its effect on fatigue and depression. The subjects were randomized to receive placebo or 50 mg of Enbrel twice each week. Nearly one-half of the patients (47 percent) who received Enbrel achieved a 75 percent reduction in Psoriasis Area and Severity score at 12 weeks compared with 5 percent who received placebo. Additionally, a greater proportion of patients who received Enbrel experienced at least a 50 percent improvement in depression, as measured by the Hamilton rating scale for depression and the Beck depression inventory, during this period compared with those who received placebo. Moreover, patients who received Enbrel also had "significant and clinically meaningful improvements in fatigue," as evaluated by the functional assessment of chronic illness therapy fatigue scale, the authors wrote. Although improvements in symptoms of fatigue correlated with improvements in joint pain--suggesting that the two were closely related--the improvements in depression symptoms correlated less with objective measures of skin clearance or joint pain, suggesting the treatment had a direct effect on depression severity. However, "[t]o study any such effect, it would be necessary to examine patients who did not have psoriasis but had been diagnosed with depression," the authors wrote. Global Market Research Global Market Research F. Hoffmann-La Roche Ltd. F. Hoffmann-La Roche Ltd.'s Tamiflu (oseltamivir phosphate) influenza treatment might be linked to the deaths of two older adults who received the therapy, Japanese health officials said in a Dow Jones Newswires report. No definitive conclusions could be drawn, though, as both men were taking other treatments at the time of their deaths. Tamiflu has already been investigated in relation to the deaths of 12 Japanese children and two teenage boys. Last month, the Food and Drug Administration's Pediatric Advisory Committee saw no evidence that Tamiflu caused the deaths of the 12 children. Global Market Research Global Market Research Novo Nordisk A/S Novo Nordisk A/S and Neose Technologies Inc.'s current license agreement will be expanded to provide additional research and development funding to Neose as well as more potential milestone payments. The agreement, which the companies originally signed in November 2003, allows for research and development activities in which Neose's GlycoPEGylation technology is used to develop a next-generation version of a therapeutic protein currently marketed by Novo Nordisk. Global Market Research Global Market Research Mentor Corp. Mentor Corp. has received more than 10 initial purchase offers for its urology business unit from strategic bidders and buyout groups, according to sources familiar with the situation, Reuters reported. In October, Mentor said it was evaluating strategic alternatives for its urology business so the firm could enhance shareholder value and focus on its cosmetic medical products, which include breast implants and facial rejuvenation products. Founded in order to develop bladder control and urinary management products, the firm now feels the value of the urology division is not reflected in the public equities market valuation of Mentor. Last month, Mentor proposed purchasing Medicis Pharmaceutical Corp. in a stock-for-stock transaction, but the bid was unanimously rejected by Medicis' board of directors. Global Market Research Global Market Research OraSure Technologies Inc. OraSure Technologies Inc.'s OraQuick oral HIV test's use has been discontinued by the L.A. Gay & Lesbian Center, due to growing concerns surrounding the test's reliability. The center recorded 13 false-positives with the test in November, and clinics in San Francisco and New York have also reported large numbers of false-positives, the Center said. OraSure claimed the issues are "isolated," Reuters reported. Douglas Michels, the company's chief executive officer, stated that finding out why these clinics are reporting such high rates of false-positives is his "top priority," Reuters added. OraSure shares closed at $8.46, down $2.91, or 25.6 percent, in heavy trading on the Nasdaq. Global Market Research Global Market Research Invitrogen Corp. Invitrogen Corp. and genOway signed a co-marketing agreement regarding RNA interference-related services. Under the agreement, the companies will create a services platform providing RNAi vector design through the creation of RNAi transgenic rodent models by combining Invitrogen's expertise in RNAi research technologies with genOway's portfolio of transgenesis technologies and experience with RNAi in vivo. Financial terms of the agreement were not disclosed, beyond that the companies will share revenues. Global Market Research


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