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Quantitative ResearchBrand 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 Maintenance therapy with Tysabri may sustain response, remission of Crohn's disease among those who respond to induction therapy, trial data show Biogen Idec Inc. and Elan Corp. Plc's Tysabri (natalizumab) as induction therapy provides nonsignificant improvements in the rates of response and remission in patients with Crohn's disease as compared with placebo, but those who do respond show significantly higher rates of sustained response and remission if the drug is continued long term, researchers found.The first trial, ENACT-1, included 905 patients who had moderately to severely active Crohn's disease for at least six months. Participants were randomized to receive either 300 mg of Tysabri or placebo intravenously at weeks zero, four and eight. At week 10, a greater proportion of the Tysabri group than the placebo group exhibited a response to treatment (56 percent vs. 49 percent), defined as at least a 70-point reduction in the Crohn's Disease Activity Index score from week zero. At the same time, 37 percent of the Tysabri arm achieved remission (CDAI score of less than 150 points) compared with 30 percent of the placebo arm. While the rates of both response and remission were higher with Tysabri treatment at all time points, the differences were not statistically significant. Subsequently, 339 patients who responded to Tysabri during the first trial entered ENACT-2, during which they were randomized to 300 mg of Tysabri or placebo every four weeks through week 56. At week 36, more patients who continued to receive Tysabri sustained a clinical response as compared with those who received placebo (61 percent vs. 28 percent). Similarly, nearly twice as many Tysabri-treated patients achieved sustained remission (44 percent vs. 26 percent). Researchers noted that these differences were statistically significant as early as week 20 and remained significant through week 60. The study investigators noted that the unexpectedly high proportion of patients who responded to placebo in the first trial maintained that clinical benefit in the second study, regardless of which study drug they received. In an accompanying editorial, Dr. Daniel Podolsky noted that the high frequency and durability of the placebo response in the ENACT-2 could mean the results were "partially confounded by the enrollment of some patients with little or no active disease," a possibility that was consistent with the findings of a post-hoc analysis. Biogen and Elan recently submitted a supplemental Biologics License Application to the Food and Drug Administration for the use of Tysabri as a multiple sclerosis therapy. Tysabri was voluntarily withdrawn from the market in February after patients who took the drug, which was approved to treat MS, developed PML. A total of three cases were confirmed, two of which were fatal. The study and the editorial appeared in the Nov. 3 issue of The New England Journal of Medicine. Quantitative Research Sanofi's Plavix in combination with aspirin reduces MI-related deaths, study shows In patients with acute myocardial infarction, the addition of sanofi-aventis Group's Plavix (clopidogrel bisulfate), an anti-platelet drug, to aspirin appears to significantly reduce mortality and the incidence of major vascular events in hospitals, according to a study published in the Nov. 5 issue of The Lancet. Researchers randomized 45,852 patients to receive aspirin 162 mg/day plus either Plavix 75 mg/d or placebo. All patients were admitted to one of 1,250 hospitals within 24 hours of a suspected acute MI onset. Patients received treatment for up to four weeks or until discharge. The two primary outcomes were death from any cause and the composite outcome of death, reinfarction or stroke during the scheduled treatment period. Compared with placebo, treatment with Plavix resulted in a significant 9-percent reduction in the incidence of the composite endpoint, which translates into nine fewer events per 1,000 patients treated after approximately two weeks of treatment. In addition, there was a 7-percent reduction in death from any cause among Plavix-treated patients relative to placebo-treated patients. The authors noted that these effects appeared to be consistent across a wide range of patients and were independent of other treatments administered. Overall, study findings indicated the treatment is safe, with no apparent increase in bleeding. "[Plavix] (probably starting with a loading dose) should be considered for almost all patients presenting in hospital with suspected acute MI, irrespective of their age, sex and the use of other treatments (provided that there are no strong contraindications)," the researchers suggested. They added, "If . . . early [Plavix] therapy was given in hospital to just 1 million of the 10 million patients who have a heart attack every year then it would, on present evidence, prevent about 5,000 deaths and 5,000 nonfatal reinfarctions and strokes (probably with no great increase in major bleeding). Moreover, continued treatment with [Plavix] after hospital discharge could lead to further net gains, although the benefits and hazards of more long-term therapy are still under investigation." Quantitative Research Pfizer's Sutent may slow time to progression of gastrointestinal stromal tumor, study shows Pfizer Inc.'s Sutent (sunitinib malate), an oral multitargeted tyrosine kinase inhibitor, may delay the time to progression (TTP) of gastrointestinal stromal tumors (GIST) in patients resistant to or intolerant to Novartis AG's Gleevec (imatinib mesylate) therapy, according to new data. As part of a Phase III trial, researchers randomized 312 patients with documented progression of GIST to receive Sutent (n=207) or placebo (n=105). Patients in the Sutent group received Sutent 50 mg/day for four weeks, followed by a two-week break period, in repeating six-week cycles. The study's primary endpoint was TTP. Results showed that the median TTP increased more than four-fold with Sutent as compared with placebo at the first interim analysis for efficacy. Specifically, the estimated median TTP was 6.3 months with Sutent versus 1.5 months with placebo. Improvement was observed in patients with either primary or secondary resistance to Gleevec, researchers noted. Also, Sutent therapy was associated with significantly greater estimated overall survival, although the median overall survival has not yet been reached in either treatment group. Sutent is one of a new class of cancer drugs that target multiple tumor activities. Sutent appears to shrink tumors by starving them of blood and blocking signals that tell them to grow and spread, thus causing cancer cells to die, The Associated Press reported. This study was presented in Paris at the European Cancer Conference. Quantitative Research GSK's investigational HPV vaccine appears to produce sustained immune response, study shows GlaxoSmithKline Plc's investigational human papillomavirus 16/18 L1 vaccine formulated with an adjuvant, AS04 (aluminum plus 3-deacylated monophosphoryl lipid A), may induce a stronger immune response as compared with the same vaccine formulated with aluminum salt alone, according to new data. Researchers used three methods to evaluate the vaccine's ability to induce an immune response with AS04 relative to the vaccine formulated with aluminum salt alone. Assessments included an in vitro evaluation of AS04's ability to activate the immune system as well as evaluations of the adjuvant's ability to induce HPV 16 and HPV 18 antibodies and inhibit major neutralizing epitopes in humans and animals. Results of all three assessments indicated the vaccine formulated with AS04 was associated with a stronger immune response than the vaccine formulated with aluminum salt. In addition, this response was sustained in women for at least 3.5 years post-vaccination. The study was presented at the American Association for Cancer Research's International Conference on Frontiers in Cancer Prevention Research in Baltimore, Md., and was communicated at the European Cancer Conference in Paris. Quantitative Research Critical Therapeutics' Zyflo improves lung function, reduces need for rescue drugs in patients with asthma, study finds Critical Therapeutics Inc.'s Zyflo (zileuton) tablets reduce the need for rescue medications and oral corticosteroids and significantly improve lung function in patients with severe asthma, a six-month study found. Patients with asthma were stratified into subgroups according to asthma severity (moderate, n=133; severe, n=98) and were randomized to either 600 mg of Zyflo four times each day or placebo. Researchers obtained pulmonary function measurements at 30, 60 and 120 minutes post-dose. As early as 30 minutes after receiving Zyflo, patients with both moderate and severe asthma experienced "rapid and sustained improvement in pulmonary function" as compared with those taking placebo, Critical Therapeutics said in a press release. Another analysis found that Zyflo reduced daily and nighttime symptoms among the 98 patients with severe asthma. Also, only 5.9 percent of patients with severe asthma who received Zyflo required oral corticosteroids as compared with 25.5 percent of those who received placebo. "As we begin to introduce Zyflo to thousands of respiratory specialists across the country, the data presented reinforces the concept that Zyflo may provide effective treatment for severe asthma patients whose symptoms are not effectively managed by beta agonists and oral corticosteroids," said Dr. Paul Rubin, chief executive officer of Critical Therapeutics. Zyflo was approved to treat asthma in the United States in 1996, but had not been marketed since 2003 when Critical Therapeutics acquired the worldwide rights to the drug and other formulations of zileuton from Abbott, according to Reuters. Critical Therapeutics' supplemental New Drug Application to manufacture and market Zyflo was recently approved by the Food and Drug Administration with no material changes made to the prescribing information insert for the drug, which is indicated for the prevention and chronic treatment of asthma in patients aged 12 years or older. These data were presented in two posters at the American College of Chest Physicians CHEST 2005 meeting in Montreal. Quantitative Research Ortho-McNeil enters into tramadol agreements with Biovail, Purdue Pharma Ortho-McNeil Inc. and Biovail Corp. entered into a 10-year agreement for extended-release (ER) and orally disintegrating (ODT) formulations of Biovail's pain drug, tramadol hydrochloride, which has the proposed brand name of Ultram. Under the terms of the agreement, Biovail will manufacture, supply and sell Ultram ER and Ultram ODT to Ortho-McNeil at contractually determined prices based on Ortho-McNeil's net selling price. Ortho-McNeil will distribute both versions of the product. When the transaction closes, Ortho-McNeil will make a $60 million prepayment to Biovail that will be credited against purchases of Ultram ER. The agreement, which may be extended by additional two-year periods, includes the United States and Puerto Rico, and Ortho-McNeil retained the option for Ultram ER in other locations, excluding Europe and Canada. Both formulations of Ultram have been approved by the Food and Drug Administration and are expected to be launched in the beginning of next year. Ortho-McNeil also entered into an agreement with Purdue Pharma LP. In exchange for licensing certain intellectual property rights from Purdue, Ortho-McNeil waived its three-year period of exclusivity forLabopharm Inc.'s formulation of tramadol, which will allow Purdue to distribute Labopharm's version. "This is about reducing risk while at the same time removing uncertainty with respect to the commercialization of our once-daily tramadol product in the United States," said James Howard-Tripp, chief executive officer of Labopharm. "We remain on track to file a New Drug Application by the end of the year and anticipate being in a position to launch our once-daily tramadol product in the United States as early as the fourth quarter of 2006 subject to a successful review by the FDA." Shares of Biovail closed at $25.50, up $1.17, or 4.8 percent, in heavy trading on the New York Stock Exchange. Quantitative Research Quantitative Research The Food and Drug Administration The Food and Drug Administration tentatively approved the first generic version of GlaxoSmithKline Plc's antiviral Epivir (lamivudine) oral solution 10 mg/mL as part of the President's Emergency Plan for AIDS Relief. The generic drug, which will not be available in the United States due to patents, is manufactured by India-based Aurobindo Pharma Ltd. Epivir oral solution is indicated for use in pediatric patients aged 3 months to 16 years with HIV. Quantitative Research Quantitative Research Pfizer Inc. Pfizer Inc. and Clarient Inc. entered into a master service agreement in which Clarient's BioPharma services unit will provide biopharmaceutical research services, such as immunohistochemistry (IHC) and analysis of rare cells in the systemic circulation. Clarient uses three technology platforms: flow cytometry, molecular diagnostics and IHC for the development of additional diagnostics for new therapies. Financial terms were not disclosed. Quantitative Research Quantitative Research Ligand Pharmaceuticals Inc. Ligand Pharmaceuticals Inc. and the Food and Drug Administration sent a letter to health care professionals to notify them of revisions to the prescribing information for Avinza (morphine sulfate) extended-release capsules. The pain drug now carries a strengthened warning that patients should not consume alcohol while taking the drug and that patients must not take drugs that contain alcohol while being treated with Avinza. In vitro studies done by the FDA showed that alcohol may cause a more rapid release of morphine, "which could result in the absorption of a potentially fatal dose of morphine," the letter stated. Quantitative Research Quantitative Research Mylan Laboratories Inc. Mylan Laboratories Inc. entered into an agreement with Vernalis Plc for exclusive U.S. and Canadian rights for Vernalis' Apokyn (apomorphine hydrochloride), an acute, intermittent treatment for hypomobility episodes associated with advanced Parkinson's disease, for $23 million. Under the terms of the agreement, Vernalis will complete certain Phase IV studies and Mylan will provide specified transitional services. Apokyn was approved in April 2004 as an orphan drug, granting it market exclusivity until 2011. Vernalis said Apokyn's 2006 U.S. sales are estimated to be between $6 million and $7.5 million, Reuters reported. Quantitative Research
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