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			Find Company Name 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 Dov halts anxiety drug trial; shares fall Elevated liver enzyme levels in one study patient prompted Dov Pharmaceutical Inc. to suspend dosing in the Phase III trial of its investigational anxiety treatment, ocinaplon. Dov shares fell 16.6 percent on the news. Approximately 200 of the intended 373 healthy patients and patients with generalized anxiety disorder were randomized to either 60 mg/day of ocinaplon or placebo in the four-week, double-blind trial. Although several trial participants were found to have enzyme elevations in liver function tests, only one patient had elevations "of sufficient concern that Dov, in consultation with the independent data monitoring committee, decided to suspend the trial." The company, which has notified the Food and Drug Administration of its actions, will now unblind the study and evaluate safety findings from all participants. Dov will monitor the currently enrolled trial participants and, after a full review and analysis, will decide whether to continue the study "or select a back-up compound," a process that will likely take several months, the company noted. Before resuming or making changes to the trial, Dov will consult with the FDA. "While committed to moving forward with the development of ocinaplon, Dov is, first and foremost, dedicated to ensuring the safety of all participants in our clinical trials," said Dr. Warren Stern, senior vice president of drug development at Dov. "In addition to ocinaplon, Dov's active and ongoing GABA modulator program for the treatment of anxiety includes several late-stage preclinical candidates that could substitute for ocinaplon if required." Dov shares closed at $14.99, down $2.98, in heavy trading on the Nasdaq. Find Company Name Trial results show Wyeth's Protonix better manages heartburn in patients with GERD than placebo Wyeth's Protonix (pantoprazole sodium) was shown to be superior to placebo for the long-term management of heartburn in patients who have uncomplicated gastroesophageal reflux disease, according to a study published online Aug. 19, ahead of print, in the journal Digestion. The trial enrolled 634 patients who had heartburn and GERD of grade 0/1 by endoscopy. During the acute study phase, patients received 20 mg of Protonix once daily for four weeks. Of these, 87.1 percent of patients in the intent-to-treat analysis and 90 percent of patients in the per-protocol analysis showed no heartburn and continued into the long-term phase of the study. At this point, they were randomized to take either 20 mg or 40 mg of Protonix or placebo on demand (along with antacids as rescue medication) for six months. On average, the patients perceived a daily symptom load of 3.93 with placebo, 2.91 with 20 mg of Protonix and 2.71 with 40 mg of Protonix in the intent-to-treat evaluation, demonstrating a significantly lower symptom load with Protonix. The average number of antacid tablets taken was also significantly lower with Protonix (0.45 with 20 mg, 0.33 with 40 mg and 0.68 with placebo). The differences between the Protonix groups were not significant. Additionally, Protonix led to a significantly lower rate of discontinuation due to insufficient heartburn control compared with placebo (intent to treat: 2.8 with 20 mg, 0.9 with 40 mg and 10.9 with placebo). The researchers said these findings "favor on-demand therapy with 20 mg of [Protonix] for the long-term management of heartburn" in this patient group. Find Company Name Topamax may be cost effective in preventing migraines, study finds The use of Ortho-McNeil Neurologics Inc.'s Topamax (topiramate) appears to be a cost-effective way to effectively prevent migraines, according to results of a model published in the September issue of the journal Headache. The economic impact of migraines on patients, employers, health systems and society continues to be substantial despite advances in treatment options, the study authors noted. Although most treatment strategies are geared toward acute episodes, preventive therapy is appropriate for patients with frequent migraine attacks or for those who experience attacks that disrupt their daily routine, the investigators added. Researchers collected data from published literature and pooled results of two randomized, double-blind, placebo-controlled trials of Topamax in migraine prevention. Model inputs included baseline migraine frequency, treatment discontinuation, treatment response, cost of preventive therapy, cost of acute treatment per attack, hours of disability per attack, hourly wage and quality-of-life weights. Model outcomes included the number of migraines averted, disability hours, total cost of acute and preventive treatment and lost wages. Results were presented as cost per migraine averted and cost per quality-adjusted life years (QALY). An estimated 1.85 migraines per patient and nearly five hours of disability per month would be prevented by the use of Topamax as compared with no preventive treatment, model results indicated. The ensuing savings in cost of acute care ($27) and work loss ($51) offset 68 percent of the expected monthly cost of Topamax ($113), the authors said. "These savings translate into direct (e.g., acute treatment costs) and indirect (e.g., lost wages) savings that yield a base-case incremental cost per migraine averted of $19 and a cost per QALY of about $11,000," they added. When indirect costs were excluded from the analysis, the cost per QALY was approximately $26,000. "The cost-effectiveness of [Topamax] depends on utility gains associated with a reduced frequency of migraine headaches, which is the subject of ongoing research," the authors concluded. "However, results from our model suggest that the use of [Topamax] in prevention of migraine may offer reasonable value for money relative to many well-accepted medical interventions." Topamax is indicated as a treatment for epilepsy and for the prevention of migraine. Find Company Name Study suggests Cozaar, not Norvasc, has antiproteinuric effect in type 2 diabetes patients with overt nephropathy In a study of patients with type 2 diabetes and overt nephropathy, both Merck & Co. Inc.'s Cozaar (losartan potassium) and Pfizer Inc.'s Norvasc (amlodipine besylate) achieved similar reductions in blood pressure; however, only Cozaar exhibited an antiproteinuric effect. Investigators conducted an open-label, parallel-prospective, randomized study of hypertensive patients with type 2 diabetes and nephropathy. Eligibility criteria included an office systolic blood pressure of 140 mm Hg to 200 mm Hg and diastolic blood pressure of 90 mm Hg to 110 mm Hg on at least three separate occasions after a two-week observation period without hypertension medication. Overt diabetic nephropathy was diagnosed by urinary albumin excretion of more than 300 mg/day and less than 3,000 mg/d during at least two of three consecutive visits. After the observation period, participants were randomized to receive Cozaar 25 mg/d (n=44) or Norvasc 2.5 mg/d (n=43), titrated to 100 mg or 10 mg at two- to four-week intervals during 12 weeks. The titration phase was followed by a maintenance phase lasting up to 12 weeks. Participants' 24-hour blood pressure and urinary albumin excretion were measured before and during treatment; simultaneously, the authors performed power spectral analysis of heart rate to evaluate low frequency and high frequency components and their ratios as an index of sympathovagal balance. With Cozaar, mean blood pressure decreased from 162/91 mm Hg to 150/82 mm Hg during daytime and from 146/82 mm Hg to 137/74 mm Hg during nighttime. Significant reductions were also seen with Norvasc, from 159/90 mm Hg to 147/82 mm Hg during daytime and from 143/81 mm Hg to 131/72 mm Hg during nighttime. A significant reduction in 24-hour urinary albumin excretion was observed with Cozaar, from 810 mg/d to 570 mg/d. In contrast, no significant reduction was seen with Norvasc (790 mg/d vs. 790 mg/d). "These findings suggest that 24-hour blood pressure regulation alone is not enough to improve overt nephropathy, and additional beneficial effects of [Cozaar] on intraglomerular mechanism are crucial for an antiproteinuric effect," the researchers concluded. The study appeared in the August issue of Diabetes Care. Find Company Name Fewer women with osteoporosis who receive Forteo report moderate, severe back pain than do those treated with Fosamax, data indicate Women with osteoporosis who receive Eli Lilly & Co.'s Forteo (teriparatide recombinant human) seem less likely to report moderate or severe back pain than do women treated with Merck & Co. Inc.'s Fosamax (alendronate sodium), according to study results published in the August issue of The Journal of Rheumatology. Researchers randomized 146 postmenopausal women with osteoporosis to either daily self-injected Forteo 40 mcg plus an oral placebo or daily oral Fosamax 10 mg plus self-injected placebo. Patients were treated for a median of 14 months. In addition, 72 percent of patients enrolled in a nontreatment follow-up study. Investigators recorded adverse events and incidences of new or worsening back pain at each visit. Compared with Fosamax-treated patients, fewer women who received Forteo reported moderate or severe back pain during the trial, during the interval that included the trial plus an additional 18 months of observation and during the interval that included the trial plus an additional 30 months of observation. Also, the cumulative incidence of reported moderate to severe back pain was significantly lower in Forteo-treated patients during the trial, the trial plus 18 months of additional observation and the trial plus 30 months of additional observation. The authors noted that the number of patients who reported severe back pain was small during all observation periods and did not demonstrate significant differences. Find Company Name NSAIDs, aspirin appear to be responsible for fatal GI events even at low doses, study suggests As many as one-third of all hospitalizations and deaths due to gastrointestinal bleeding may be caused by aspirin or nonsteroidal anti-inflammatory drugs, such as ibuprofen, even at low doses, researchers reported. The study, which examined data from a total of 8,010 serious gastrointestinal events, was designed to assess the impact of aspirin and NSAID use on patient mortality. While previous reports may have overestimated the number of deaths attributable to aspirin and NSAID use, they did not address the role of low-dose pain medications, according to the study. In the current analysis, the mortality rate due to aspirin and NSAID use was more than 21 cases per 1 million people, or approximately 15 deaths per 100,000 aspirin or NSAID users, with approximately one-third of these due to low doses of the drugs. The authors also noted that nearly 90 percent of deaths occurred in patients aged 60 years or older. These results suggest "the importance of taking ever-greater steps to research new and better alternatives to treat pain and inflammation in the elderly, to heighten physician and public awareness of the associated problems of NSAID therapy and to educate them on the use of appropriate prevention strategies," the authors concluded. The data come from a Spanish study published in the August issue of the American Journal of Gastroenterology. Find Company Name Find Company Name Merck & Co. Inc. Merck & Co. Inc. may consider settling a small number of lawsuits related to Vioxx (rofecoxib) in cases where patients took the drug for more than 18 months and had no other risk factors for myocardial infarctions or strokes, according to The Wall Street Journal. "[W]e're going to have to carefully look at those cases," a Merck spokeswoman said, The Journal reported. Earlier this month, after a jury found the company liable for the 2001 death of a Texas man who once took Vioxx and awarded his widow $253.4 million, Merck said it planned to "vigorously defend [pending Vioxx-related lawsuits] one by one over the coming years." Find Company Name Find Company Name Barr Pharmaceuticals Inc. Barr Pharmaceuticals Inc. received a letter from the Food and Drug Administration saying the agency has deferred its decision on Barr's supplemental New Drug Application for over-the-counter status for Plan B emergency contraceptive. Although the FDA stated "the available scientific data are sufficient to support the safe use of Plan B as an OTC product . . . for women who are 17 years of age and older," the agency delayed taking action on the sNDA. The FDA plans to seek public comment on the issues that surround granting a product OTC status in one age group and prescription status in another age group, but gave no indication of when it would start or finish the rulemaking proceeding for this "dual-label" concept. Find Company Name Find Company Name The National Institutes of Health The National Institutes of Health released its final ethics rules that will allow NIH employees to continue outside activities with scientific or professional organizations, data or safety monitoring boards, etc., unlike the rules proposed in February. Such activities are "subject to prior approval and review by ethics officials," NIH said. The rules also state that senior employees, their children and their spouses may not hold more than $15,000 in stock per company of "substantially affected organizations." NIH staff will also be banned from consulting with these organizations. Find Company Name Find Company Name Peregrine Pharmaceuticals Inc. Peregrine Pharmaceuticals Inc. granted Medarex Inc. a license for certain intellectual property rights to its vascular targeting agent technology platform. The license permits Medarex to develop and commercialize their prostate-specific membrane antigen monoclonal antibody conjugates to therapeutic agents and use the resulting conjugate to treat "a wide range of solid tumors." Under the agreement, Peregrine will receive an up-front payment and annual maintenance fees; the firm could also receive future payments based on the achievement of clinical milestones and royalties on net sales if a product developed through the agreement is approved by the Food and Drug Administration. Full financial details were not disclosed. Find Company Name Find Company Name


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