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Brand ManagementBrand 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 offers divestments for EU approval of Guidant acquisition, sources sayJohnson & Johnson offered several health care product divestitures as part of a proposal that could guarantee European antitrust clearance of its $23.9 billion acquisition of Guidant Corp., according to sources familiar with the transaction, Dow Jones Newswires reported. The offers were made after the European Commission told J&J last month that the acquisition would create antitrust issues, the sources added. J&J plans to keep Guidant's cardiac stent business and sell the rest of Guidant's stent business. J&J also offered to divest Guidant's minimally invasive cardiac surgery products; combining these with similar products made by J&J's Ethicon division would make J&J too dominant in this sector, one of the sources said. Also, J&J offered to divest its Cordis Corp. division's guidewires, which are used in a variety of heart-related procedures including stent deployment. Guidant also makes guidewires. If it clears all regulatory hurdles, this merger would create the world's largest supplier of medical devices to heart specialists, Dow Jones said. The Commission has until Sept. 5 to clear or block the transaction. The U.S. Federal Trade Commission is also reviewing the merger and is expected to approve it, the wire service added. European regulators can block takeovers and mergers between U.S. firms when the combination will impact European consumers, Dow Jones noted. Last month, Guidant voluntarily advised physicians and patients of a potential degradation of the hermetic sealing component that could affect approximately 28,000 of its pacemakers. In June, Guidant recalled some of its implantable cardiac defibrillators (ICD) and advised physicians to stop implanting a number of its other defibrillators. Analysts have speculated whether these actions will affect J&J's plans to acquire Guidant. Brand Management FDA approves Alcon's cataract surgery pain drug The Food and Drug Administration approved Alcon Inc.'s New Drug Application for Nevanac (nepafenac ophthalmic suspension) 0.1% to treat pain and inflammation associated with cataract surgery. Nevanac suspension is the first ophthalmic nonsteroidal anti-inflammatory prodrug to be approved by the FDA, Alcon said, adding that it expects the drug to be on the market in the next few weeks. The approval, which followed a priority review by the agency, was based on results of two placebo-controlled studies involving more than 680 patients. Nevanac suspension was dosed three times daily starting the day prior to surgery through 14 days after the operation. Results showed that Nevanac-treated patients had significantly less ocular pain and inflammation in the early postoperative period through the end of treatment, Alcon said. Specifically, more than 80 percent of patients treated with Nevanac suspension and less than 50 percent of placebo-treated patients were pain free the day after surgery. Approximately 95 percent of Nevanac-treated patients and 45 percent of those who received placebo were pain free after two weeks of treatment. In addition, 91 percent of patients treated with Nevanac suspension and approximately 47 percent of placebo-treated patients had no clinically significant inflammation at day 14. Nevanac suspension was safe and well tolerated; no unexpected adverse events were reported, Alcon said. "The prodrug structure of Nevanac suspension offers significant advantages to ophthalmic surgeons, " said Dr. Richard Lindstrom, adjunct professor emeritus at the University of Minnesota's Department of Ophthalmology. "Nevanac suspension provides unique, target-specific activity that promotes penetration into the ocular tissues of most concern to ophthalmologists. This maximizes efficacy at the target sites of pain and inflammation following cataract surgery." Brand Management Cell Therapeutics to submit marketing applications for Xyotax in United States, Europe Cell Therapeutics Inc. decided on a plan to submit marketing applications in both the United States and Europe for Xyotax (paclitaxel poliglumex), and the U.S. application would be the first submission exclusively targeting survival in women with lung cancer. The firm will submit a New Drug Application to the Food and Drug Administration seeking approval for Xyotax as first-line monotherapy in women who have advanced non-small cell lung cancer and poor performance status. This request for a specific indication comes after Xyotax statistically significantly increased one-year survival by 60 percent in female study patients who had poor performance status. "Based on our discussions with [the] FDA, accelerated review and non-inferiority are not possible routes to pursue in the United States. We believe that a standard review based on the gender-specific survival advantage observed in women in the Stellar 3 and 4 trials is the most appropriate registration strategy in the United States," said Dr. Jack Singer, chief medical officer of Cell Therapeutics. "[W]e are committed to conducting a study to try to confirm the survival advantage seen in women who received Xyotax in the Stellar 3 and 4 studies and plan to initiate such a clinical study in the fourth quarter of 2005. This would be the first submission exclusively targeting survival in women with lung cancer." In Europe, Cell Therapeutics will seek approval for the drug to be used as monotherapy in all first-line, poor-performance-status patients who have non-small cell lung cancer. However, before the Marketing Authorization Application can be submitted to European regulators, the firm is awaiting additional input on the statistical interpretation of non-inferiority that will be needed from the European Medicines Agency's scientific committee. Previously reported data from the Stellar 3 trial indicated that Xyotax plus carboplatin was no more effective than was paclitaxel plus carboplatin at treating non-small cell lung cancer, but it did reduce certain side effects and overall neurological toxicities. Also, this past May, Cell Therapeutics said results from the Stellar 2 and Stellar 4 trials showed Xyotax (paclitaxel poliglumex) failed to demonstrate greater survival among patients with non-small cell lung cancer when compared with sanofi-aventis Group's Taxotere (docetaxel), Eli Lilly and Co.'s Gemzar (gemcitabine hydrochloride) or vinorelbine tartrate. However, Xyotax led to fewer serious side effects than did the comparator drugs, the company said. Brand Management Viagra not linked to higher short-term risk of MI, study shows Pfizer Inc.'s Viagra (sildenafil citrate) is not associated with a short-term risk for myocardial infarction, new data indicate. Prospective data from 80 completed clinical trials with Viagra were evaluated through a self-matched, case-crossover approach. The risk for MI was then ascertained within six and 24 hours after the 9,386 men ingested the drug. A total of 69 men experienced MIs during the more than 11,000 person-years of drug exposure. On average, the time from the last dose of Viagra and the onset of the MI was 14 days. Overall, 22 patients who had an MI had taken Viagra within the 24 hours beforehand, including five patients who took their last Viagra dose within six hours. Thus, patients were 80 percent as likely to have an MI within 24 hours of taking Viagra and 79 percent as likely within six hours of taking Viagra. "Any potential direct effect of [Viagra] above and beyond the effect of sexual intercourse would be apparent in the six-hour time frame," the researchers concluded. This study was published in the Aug. 1 issue of the American Journal of Cardiology. Brand Management No beneficial effect on cerebral blood flow seen with Pravachol, study of elderly patients suggests Treatment with Bristol-Myers Squibb Co.'s Pravachol (pravastatin sodium) does not appear to have a beneficial effect on cerebral blood flow (CBF) in elderly individuals at risk for cerebral vascular disease, according to a study published in the August issue of Stroke. "Aging is associated with a decline in [CBF]," the researchers wrote. "Animal studies have shown that cholesterol-lowering therapy with statins might preserve CBF." To investigate this potential, the authors conducted an analysis of CBF and brain volume among individuals participating in PROSPER, a randomized, placebo-controlled trial of Pravachol 40 mg in men and women aged 70 to 82 years with vascular disease or at risk for vascular disease. Of a total 5,804 study participants, 554 underwent brain MRI scans during the placebo lead-in period and again after a mean 33-month follow-up. The current analysis focused on the 391 individuals (226 men, 165 women; mean age, 75 years) for whom total CBF was measured on these two occasions. Results showed significant declines in CBF, both among the 198 patients assigned to placebo (from 521 mL/min to 504 mL/min) and among the 193 patients assigned to Pravachol (520 mL/min to 506 mL/min). The reduction in CBF did not differ significantly between the placebo and Pravachol groups. Furthermore, both the placebo and Pravachol groups showed significant reductions in brain volume over time, with no significant between-group difference. The authors noted that when CBF was expressed per unit of parenchymal volume, the decline over time was no longer significant. "We have shown previously that our method is sensitive to detect CBF changes, based on widespread small-vessel disease," the investigators noted. "Therefore, we also expected to demonstrate total CBF changes due to atherosclerosis of the large vessels. However, our results provide evidence that statins do not preserve brain perfusion and are consistent with earlier reports of PROSPER that treatment with 40 mg [Pravachol] daily does not reduce the risk of cerebral vascular disease in an elderly population." Brand Management Survey reveals need for more information about depression, enhanced patient/physician communication Results of a new national survey revealed a disparity between what people with depression say their knowledge about their illness is and how they actually manage it. Between April 8 and April 22, Harris Interactive conducted an online survey, sponsored by the National Alliance for the Mentally Ill (NAMI) and funded by Wyeth Pharmaceuticals, of 1,086 patients who take antidepressants for depression. Of those surveyed, 91 percent said it is important to take their antidepressant drug exactly as prescribed, but approximately 40 percent said they stopped taking their antidepressant at some point without being advised to do so by their health care professional because they felt they were no longer experiencing symptoms of depression. The survey revealed that 53 percent of respondents said they are well informed about depression and the prescription drugs that are available, and only 22 percent have ever been told that it is possible to reach a state of having little or no depression symptoms. In addition, less than 25 percent of those surveyed said they were aware of the difference between a partial and full response to a drug. Approximately 70 percent of respondents said that they initiated the conversation with their health care provider about the depression symptoms they were experiencing. Also, a majority of respondents reported that they have experienced at least six episodes of depression, but only 34 percent of those surveyed have ever discussed their risk of relapse with their physician. "These findings are of great concern because people who prematurely discontinue antidepressant therapy are much more likely to experience another episode, " said Dr. Ken Duckworth, medical director of NAMI. "If patients are unsatisfied with their treatment or believe they no longer need medication because their symptoms are improving, they may stop treatment too early and slip back into the cycle of depression. "What this means to physicians is that we must select appropriate therapies and provide the education and support necessary to help patients understand their illness and achieve success," Duckworth concluded. Brand Management Brand Management Shire Pharmaceuticals Group Plc Shire Pharmaceuticals Group Plc said Health Canada will reinstate the marketing authorization of the firm's attention-deficit/hyperactivity disorder treatment Adderall XR (mixed amphetamine salts) in the Canadian market as of Aug. 26. The reinstatement was announced after Health Canada's acceptance of recommendations from the New Drug Committee (NDC), which Health Canada appointed at Shire's request to review the Feb. 9 suspension; the suspension was based on 20 reports of sudden death among patients taking Adderall XR or Adderall. The NDC recommended the company adopt the revisions to the Canadian Product Monograph and patient leaflet. Shire was also advised to distribute a letter to health care providers and to support independent continuing medical education on sudden cardiac death in pediatric patients for physicians in Canadian. Brand Management Brand Management Scios Inc. Scios Inc. launched a comprehensive recommended use initiative for Natrecor (nesiritide), a treatment for acutely decompensated heart failure (ADHF), and said that all company activities related to the drug will be focused on use in patients with ADHF presenting to the hospital with shortness of breath at rest or with minimal activity. As part of the initiative, Scios will train its sales force and promotional speakers about Natrecor's recommended use, create new promotional materials, include recommended use language in promotional speakers' programs and advertise in "top-tier medical journals." Scios is a unit of Johnson & Johnson. Brand Management Brand Management Avanir Pharmaceuticals Avanir Pharmaceuticals announced that Eric Brandt will become its chief executive officer and president, effective Sept. 6, 2005. Brandt was previously chief financial officer and executive vice president of finance and technical operations of Allergan Inc. Separately, Allergan promoted its vice president of corporate development, Jeffrey Edwards, to fill the position of CFO and executive vice president of finance and business development. Brand Management Brand Management NeoPharm Inc. NeoPharm Inc.'s amendment to its special protocol assessment--which will allow an interim efficacy analysis of PRECISE trial data--has been approved by the Food and Drug Administration. If the results are positive, NeoPharm could submit a Biologics License Application at an earlier timepoint, the company said. The Phase III study will compare overall survival, quality of life and drug safety in 300 patients who will receive Guilford Pharmaceuticals Inc.'s Gliadel Wafer (polifeprosan 20 with carmustine implant) or NeoPharm's cintredekin besudotox to treat first recurrent glioblastoma multiforme after surgical tumor resection. Brand Management Brand Management
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