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			branding Strategy 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 grants Tysabri priority review for MS Biogen Idec Inc. and Elan Corp. Plc's supplemental Biologics License Application for Tysabri (natalizumab) for the treatment of multiple sclerosis was granted priority review by the Food and Drug Administration. The filing includes a risk management plan, revised label and an integrated safety assessment of patients treated with Tysabri in clinical trials. The sBLA also includes final two-year data from the Phase III AFFIRM monotherapy trial and the SENTINEL add-on trial, which tested the drug in combination with Biogen Idec's Avonex (interferon beta-1a) in treating MS. "We believe that the acceptance of the sBLA for priority review is another step in our ongoing commitment to provide Tysabri as a treatment option for MS patients in need," said Dr. Lars Ekman, executive vice president of research and development at Elan. "We will continue to work closely with the FDA as they review the filing so that Tysabri can be made available with an appropriate benefit-risk profile." In February, Biogen Idec and Elan voluntarily withdrew Tysabri from the U.S. market based on reports of progressive multifocal leukoencephalopathy. branding Strategy VNU, IMS call off $6.9 billion merger VNU NV and IMS Health Inc. agreed to terminate their planned $6.9 billion merger due to shareholder opposition. Shareholders who represent nearly 50 percent of VNU's outstanding shares vowed not to support the merger "under any circumstances," VNU said, noting that the transaction would have required approval from a majority of shareholders. The shareholders have been voicing their disapproval over the proposed acquisition since the companies first entered into the agreement in July, The Wall Street Journal reported. In accordance with the termination agreement, VNU will reimburse IMS $15 million for its out-of-pocket costs related to the transaction. If IMS is acquired in the next year, it will return the $15-million payment to VNU. Also, should VNU be acquired in the next year, the company will pay an additional $45 million to IMS. "While we regret that the merger with VNU will not happen, our business is strong," said David Carlucci, IMS chief executive officer. "We are executing on our strategy and will look for ways to provide clients with even more comprehensive information and analysis." The companies have agreed to work together to "pursue the many joint revenue opportunities" that resulted from the planning of the merger, Carlucci added. IMS said it is keeping its full-year guidance of between 10 percent and 12 percent constant-dollar revenue growth and full-year adjusted earnings per share of between $1.32 and $1.35. After calling off the merger, VNU CEO Rob van den Bergh said he has decided to step down. Van den Bergh will stay on until the company's supervisory board finds his successor. branding Strategy Remicade plus methotrexate not superior to Remicade alone in patients with AS, according to new data Combination therapy with Centocor Inc.'s Remicade (infliximab) plus methotrexate does not appear to be superior to Remicade monotherapy in the treatment of ankylosing spondylitis, new data suggest. As part of a one-year, open-label, prospective study, researchers evaluated the efficacy of the two treatment regimens in 123 patients with active AS. Characteristics at baseline were similar between patients treated with Remicade monotherapy (n=62) and those treated with Remicade plus methotrexate (n=61). All patients were treated with a loading regimen of three infusions of Remicade, administered at a dosage of 5 mg/kg of body weight at weeks zero, two and six. Subsequently, they received Remicade therapy on demand until week 54 but were required to wait at least four weeks between infusions. Patients in the combination therapy group also received methotrexate 12.5 mg/week, starting four weeks prior to the first infusion of Remicade. Clinical response parameters, including the Bath AS Disease Activity Index (BASDAI) and a global assessment of pain, were evaluated on a weekly basis by phone. Patients also reported weekly self-assessments of relapse (defined as a negative response to "disease is well controlled" title="branding company" or a positive response to "disease is worsening" title="branding company"), which were then validated by an increase in BASDAI score of at least one point or an increase in the global pain assessment of at least two points. A similar proportion of patients in the monotherapy and combination therapy groups completed the study (73 percent vs. 66 percent, respectively). An intent-to-treat analysis revealed that a similar proportion of both groups also achieved an ASsessment in AS (ASAS) 20 response (40 percent vs. 51 percent, respectively). Further, the percentages of patients meeting ASAS International Working Group criteria for partial remission were similar in both groups (5 percent vs. 10 percent). That the average number of Remicade infusions administered after the loading regimen was virtually the same in both groups (3.7 for Remicade alone vs. 3.3 for Remicade plus methotrexate) was further evidence that the addition of methotrexate provided no significant benefit to Remicade therapy, the authors concluded. Remicade is marketed by Centocor in the United States, while Schering-Plough Corp. markets it outside of the United States, except in parts of Asia where it is marketed by Tanabe Seiyaku Co. Ltd. or Xian-Janssen Pharmaceutical Ltd. The study was presented at the American College of Rheumatology annual scientific meeting in San Diego. branding Strategy Pfizer's new smoking-cessation aid outperforms GSK's Zyban, studies show Pfizer Inc. said its investigational drug for smoking cessation, varenicline tartrate, was shown to be more effective than GlaxoSmithKline Plc's Zyban (bupropion), which is currently the only marketed oral prescription anti-smoking medication, according to data from several studies presented at the annual meeting of the American Heart Association. The first two studies, both double-blind and placebo-controlled, included approximately 2,000 smokers who received varenicline 1 mg twice daily, Zyban 150 mg twice daily or placebo for 12 weeks. Patients were followed for 40 weeks following treatment. In each study, 44 percent of patients who received varenicline quit smoking by the end of the 12-week treatment period compared with 30 percent of patients who received Zyban and 18 percent of patients who received placebo. Patients were found to be approximately twice as likely to stop smoking with varenicline as with Zyban, and approximately four times as likely as with placebo. Furthermore, patients who received varenicline were significantly more likely to remain smoke-free after one year compared with patients who received Zyban or placebo. In a third study, patients who successfully quit smoking after 12 weeks of treatment with varenicline were randomized to receive either varenicline or placebo for an additional 12 weeks. Patients were followed for 28 weeks following this treatment. A total of 71 percent of patients who received additional varenicline remained smoke-free after six months as compared with only 50 percent of placebo-treated patients. Varenicline was well tolerated in all trials with discontinuation rates similar to placebo. Varenicline, a selective nicotinic acetylcholine receptor partial agonist, is the first of a new class of smoking-cessation therapies. If approved, Pfizer plans to market the drug under the brand name Champix. "Varenicline was specifically designed to work at the same receptor site as nicotine to relieve craving and withdrawal symptoms while at the same time blocking the reinforcing effects of nicotine," said Salomon Azoulay, Pfizer's lead researcher in charge of varenicline development. branding Strategy Abbott's investigational acute decompensated heart failure drug misses primary endpoint in mortality trial Abbott's levosimendan did not meet the primary endpoint of a statistically significant reduction in 180-day all-cause mortality in the SURVIVE trial of patients with acute decompensated heart failure (ADHF). The trial included 1,327 patients with ADHF who were randomized to receive either levosimendan bolus (12 mcg/kg of body weight) followed by a stepped dose regimen of levosimendan (between 0.1 mcg/kg/min and 0.2 mcg/kg/min) or dobutamine hydrochloride (at least 5 mcg/kg/min). Five days after infusion, mortality in the levosimendan group was reduced by 27 percent as compared with the dobutamine group. This difference in reduction fell to 14 percent at two weeks, 13 percent at one month and 6.4 percent at six months. The differences were not statistically significant, Abbott said. "Although the study did not discern a difference in long-term outcome between levosimendan and dobutamine, earlier timepoints, closer to actual drug administration, appear to favor levosimendan," said Dr. Alexandre Mebazaa, principal study investigator. Outside of the United States, levosimendan is marketed as Simdax and is approved as add-on therapy for the short-term treatment of acutely decompensated severe heart failure when standard therapy is not sufficient and there is a need for inotropic support. This study was presented in Dallas at the annual meeting of the American Heart Association. Earlier this week, another levosimendan study was presented at the conference. The 600-patient trial found that patients who received the drug had significant reductions in clinical signs and symptoms of ADHF during five days compared with those who took placebo. branding Strategy Medtronic reports record revenue on rising ICD market share Medtronic Inc. reported record revenue of $2.77 billion for the second quarter ended Oct. 28, up 15 percent from the $2.4 billion during the same period last year. Net earnings were $816.5 million, or $0.67 per diluted share, up 52 percent from the previous year's second quarter earnings of $535.7 million, or $0.44 per diluted share. Excluding special items, earnings were $657.1 million, or $0.54 per diluted share. Cardiac rhythm management quarterly revenue rose to $1.29 billion, up 17 percent from the same period last year, and spinal revenue rose to $516 million, up 20 percent from the same period last year. Medtronic's implantable cardioverter defibrillator revenue rose to $733 million during the second quarter, an increase of 34 percent from the same period last year. The company benefited from rival Guidant Corp.'s product recalls and other problems, as Medtronic's market share for ICDs soared to approximately 55 percent, Reuters reported, adding that this is the highest ever. "Balanced growth across the corporation was again led by implantable defibrillators and spinal products," said Art Collins, Medtronic's chief executive officer. "Very solid growth momentum has continued throughout the year and reflects the impact of the investments, which have been made and that are continuing. As a result, the corporation is well positioned to maintain strong financial performance going forward." Medtronic shares closed at $56.60, down $0.39, or 0.7 percent, in moderate trading on the New York Stock Exchange. branding Strategy branding Strategy The Pediatric Advisory Committee The Pediatric Advisory Committee of the Food and Drug Administration will meet Friday to discuss adverse event reports for eight drugs, including F. Hoffmann-La Roche Ltd.'s influenza drug Tamiflu (oseltamivir phosphate). Roche's unit Chugai Pharmaceutical Co. Ltd. recently told the Japanese government that two teenage boys showed abnormal behavior that led to their deaths after they took Tamiflu. branding Strategy branding Strategy Biovail Corp. Biovail Corp.'s shares fell 10.5 percent on news that Anchen Pharmaceuticals Inc.'s generic versions of Wellbutrin XL (bupropion hydrochloride extended-release) 150 mg and 300 mg were granted tentative approval by the Food and Drug Administration. Once-daily Wellbutrin XL is an antidepressant developed by Biovail and marketed by GlaxoSmithKline Plc. According to Bank of America Securities analyst David Maris, Anchen's tentative approval came sooner than was expected, The Wall Street Journal reported, adding that a patent trial between Biovail and Anchen is expected to begin in September 2006. Biovail shares closed at $22.30, down $2.61, in heavy trading on the New York Stock Exchange. branding Strategy branding Strategy Seattle Genetics Inc. Seattle Genetics Inc. initiated a single-agent, open-label, dose escalation Phase I clinical trial of its humanized CD33 monoclonal antibody, SGN-33, in patients with acute myeloid leukemia or myelodysplastic syndromes. The study, which is expected to enroll up to 60 patients, is designed to determine the safety, pharmacokinetic profile and antitumor effect of escalating doses of the drug. A previous study of the drug in patients with relapsed and refractory AML suggested that the drug's safety profile and activity in patients with low tumor burden could make it a promising treatment for hematological malignancies. branding Strategy branding Strategy Actelion Ltd. Actelion Ltd. and UCB Group replaced their existing license agreement regarding Zavesca (miglustat), an orally active therapeutic approved in Europe and North America for the treatment of mild to moderate Gaucher type 1 disease in adults when enzyme replacement therapy is not an option. Under the new agreement, Actelion will assume control of UCB's related license and patents, including any prior obligations on manufacturing and supply chain, as well as the management of patent-related activities. Actelion will make an undisclosed up-front payment to UCB in return for a single-digit royalty rate on future sales of the drug under the current indication, along with any potential sales for indications in other glycolipid storage disorders. The new agreement is effective immediately. branding Strategy


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