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			Brand Extension 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 New indication, boxed warning added to Mobic label The Food and Drug Administration approved an expanded indication, new label warnings and a medication guide for Boehringer Ingelheim Pharmaceuticals Inc.'s Mobic (meloxicam) tablets and oral suspension. Abbott co-promotes the drug in the United States. Mobic is now indicated to relieve the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients aged 2 years or older. The drug is already approved to treat osteoarthritis and rheumatoid arthritis. In two 12-week, double-blind, parallel-arm trials, similar proportions of patients who received Mobic or naproxen achieved an American College of Rheumatology (ACR) Pediatric 30 response, according to Mobic's prescribing information. As a measure of improvement in juvenile rheumatoid arthritis, the ACR Pediatric 30 represents a 30 percent improvement in at least three of six response criteria without a worsening of more than 30 percent in one of the remaining criterion. Additionally, Mobic's label now includes a boxed warning about cardiovascular risks (serious cardiovascular thrombotic events, myocardial infarction and stroke) and gastrointestinal risks (bleeding, ulceration and perforation of the stomach or intestines) that can occur in patients taking the drug and be potentially fatal. The cardiovascular risk information has also been expanded. Finally, the drug must now be accompanied by an FDA-approved medication guide that contains questions and answers about the safety of nonsteroidal anti-inflammatory drugs such as Mobic. Brand Extension FDA grants second orphan drug designation to Antisoma cancer treatment Antisoma Plc said the Food and Drug Administration granted orphan drug status to its drug AS1411 for the treatment of renal cancer. The drug previously received an orphan drug designation for the treatment of pancreatic cancer, the firm said. Antisoma said promising Phase I trial results of AS1411 in renal cancer were presented at this year's meeting of the American Society of Clinical Oncology; the firm added that it expects to reopen this trial "shortly." "The grant of orphan drug status for AS1411 in renal cancer is a further boost to our development program, strengthening our commercial position in an indication where the drug has shown very promising first results in clinical trials," said Glyn Edwards, Antisoma's chief executive officer. According to the firm, AS1411 is an oligonucleotide that can bind to the protein nucleolin, which is found on the surface of cancer cells. Brand Extension sBLA filed for additional non-Hodgkin's lymphoma indication for Rituxan Genentech Inc., Biogen Idec Inc. and F. Hoffman-La Roche Ltd. completed the filing of a supplemental Biologics License Application with the Food and Drug Administration for an additional indication for Rituxan (rituximab). Rituxan is currently approved for the treatment of relapsed or refractory, low-grade or follicular, CD-20-positive, B-cell, non-Hodgkin's lymphoma (NHL). The companies are seeking to expand the drug's indication to include use in previously untreated (front-line) patients with intermediate grade or aggressive, CD-20-positive, B-cell, NHL in combination with CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) or other anthracycline-based chemotherapy regimens. The sBLA filing includes data from three Phase III studies that evaluated the efficacy endpoint of overall survival. "The addition of Rituxan to CHOP represents the first significant improvement in intermediate grade or aggressive CD-20-positive, B-cell NHL treatment since the development of the CHOP regimen more than 30 years ago," said Dr. Burt Adelman, Biogen Idec's executive vice president for development. In addition, the firms included a request for a priority review designation in the sBLA. Rituxan is also being studied as a potential treatment for rheumatoid arthritis, lupus, multiple sclerosis and antineutrophil cytoplasmic antibody-associated vasculitis, the companies said. Genentech developed Rituxan and co-markets it in the United States with Biogen Idec; Roche markets the drug as MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai Pharmaceutical Co. Ltd. and Zenyaku Kogyo Co. Ltd. Brand Extension American College of Cardiology, American Heart Association support use of BiDil in new guidelines The American College of Cardiology and the American Heart Association supported the use of NitroMed Inc.'s BiDil (isosorbide dinitrate/hydralazine hydrochloride) and expanded the number of patients eligible for implantable cardioverter defibrillators in their newest guidelines for heart failure. Specifically, the new recommendations say the addition of BiDil to standard therapy for heart failure, including ACE inhibitors (ACEI) and beta blockers, is reasonable and can be effective in black patients with New York Heart Association functional class III or class IV heart failure. "Others may benefit similarly, but this has not yet been tested," the guidelines go on to say. In June, the Food and Drug Administration approved the use of BiDil for treating chronic heart failure in self-identified black patients. However, the guideline committee warned that BiDil "should not be used for the treatment of heart failure in patients who have no prior use of an ACEI and should not be substituted for ACEIs in patients who are tolerating ACEIs without difficulty." In terms of implantable cardioverter defibrillators, the guidelines recommend that patients with ischemic cardiomyopathy who are in functional class I and have a low ejection fraction be considered for these devices. The guidelines included other changes as well. The committee recommended that left ventricular assist devices be considered as permanent or "destination" therapy in certain patients and that cardiologists work to support and comfort dying patients and their families. "Cardiologists aren't used to talking about hospice. They are more used to doing interventions. So it is a big shift," said Dr. Mariell Jessup, co-author of the recommendations, in a press release from the groups. The term "congestive heart failure" was also changed to "heart failure" to reflect the disease's broad spectrum. Jessup explained the panel dropped "congestive" because patients can have few or no symptoms of congestion but still have a severely abnormal heart with symptoms caused by poor cardiac output. The guidelines will be published in the Sept. 20 issues of the journal Circulation and the Journal of the American College of Cardiology. Brand Extension Daily Nexium more effective in maintaining erosive esophagitis remission than on-demand Nexium, study shows A once-daily dose of AstraZeneca Plc's Nexium (esomeprazole magnesium) appears to maintain healed erosive esophagitis better than on-demand Nexium doses, according to results published this month in the journal Alimentary Pharmacology & Therapeutics. The trial enrolled 539 patients with erosive reflux esophagitis of grades A to D on the Los Angeles classification scale. The patients first received 40 mg of Nexium each day for four to eight weeks until their condition healed (n=494). Then, 477 of the participants were randomized to six-month maintenance therapy with 20 mg of Nexium taken either once daily or on-demand (up to one tablet per day when heartburn was troublesome). After six months, a higher proportion of patients taking the once-daily Nexium were in endoscopic remission as compared with the on-demand group (81 percent vs. 58 percent); thus, the once-daily therapy was linked to a significantly longer time in remission than the on-demand treatment. The treatment groups did not significantly differ in terms of overall symptomatic relapse, defined as moderate or severe heartburn that persisted for three consecutive days (5 percent with daily Nexium vs. 5.7 percent with on-demand Nexium). However, when individual symptom responses were assessed, heartburn and the severity of other reflux symptoms, acid regurgitation, dysphagia and epigastric pain were significantly less troublesome in the patients who took Nexium each day as compared with those in the on-demand Nexium group. "In our population, continuous maintenance therapy with 20 mg [Nexium] was more effective than on-demand, indicating that these patients need a more consistent acid suppression to stay in remission," the researchers commented. "As with other inflammatory conditions, the goal of treatment in the long term is to minimize inflammation. Perhaps this should also be the goal for treatment of erosive esophagitis. If so, the results of this study question the practice of symptom-driven maintenance treatment of erosive esophagitis," they concluded. Brand Extension J&J's Cypher superior to Boston Scientific's Taxus, studies suggest Johnson & Johnson's sirolimus-eluting stent, Cypher, was shown to be more effective than Boston Scientific Corp.'s paclitaxel-eluting stent, Taxus, in preventing the reclogging of arteries, according to two studies published in the Aug. 18 issue of The New England Journal of Medicine. In the first study, researchers conducted a randomized, controlled, single-blind trial comparing Cypher with Taxus in 1,012 patients undergoing percutaneous coronary intervention. The primary endpoint was the occurrence of major adverse cardiac events, which researchers defined as a composite of death from cardiac causes, myocardial infarction and ischemia-driven revascularization of the target lesion, by nine months. The rates of major adverse cardiac events at nine months were 6.2 percent in the Cypher group and 10.8 percent in the Taxus group. The difference was caused by a lower rate of target-lesion revascularization in the Cypher group, the investigators explained, adding that the Cypher stent was associated with a 44 percent decrease in the risk of a major cardiac event at nine months compared with the Taxus stent. In a stratified analysis of the primary endpoint, the difference between the Cypher and Taxus stents was more pronounced among the 201 patients with diabetes than among the 811 patients without diabetes. Rates of death from cardiac causes were low in both stent groups (Cypher, 0.6 percent vs. Taxus, 1.6 percent); the rates of myocardial infarction were also low (Cypher, 2.8 percent vs. Taxus, 3.5 percent). In the second study, designed to show noninferiority of the Taxus stent as compared with the Cypher stent, researchers enrolled 250 patients with diabetes and coronary artery disease. The primary endpoint was in-segment late luminal loss and the secondary endpoints were angiographic restenosis and the need for revascularization of the target lesion during a nine-month follow-up period. The difference in in-segment late luminal loss between the Taxus group and the Cypher group was 0.24 mm, demonstrating the statistical superiority of the Cypher stent, the authors noted. In-segment restenosis was found on follow-up angiography in 16.5 percent of the patients in the Taxus group and 6.9 percent of the patients in the Cypher group. Target-lesion revascularization was performed in 12 percent of the patients in the Taxus group as compared with 6.4 percent of the patients in the Cypher group. "The data overall, from randomized clinical trials and from registries, suggest that [Cypher] stents provide an angiographic and clinical edge over [Taxus] stents," said Dr. David Moliterno, a cardiologist at the University of Kentucky, in an accompanying editorial. In contrast, he said, Boston Scientifics' Taxus "holds and edge on availability, deliverability and cost." Brand Extension Brand Extension Teva Pharmaceutical Industries Ltd. Teva Pharmaceutical Industries Ltd. received tentative approval from the Food and Drug Administration for its Abbreviated New Drug Application for granisetron hydrochloride injection in 1 mg/mL single-dose vials and 4mg/4mL multi-dose vials. Teva expects to receive final approval of these products following the expiration of F. Hoffman La-Roche Ltd.'s patent in December 2007 for the branded drug, Kytril, which is indicated to prevent and treat nausea and vomiting associated with chemotherapy, radiation therapy and anesthesia used during surgery. Total annual sales for both formulations of the branded product are approximately $140 million for all indications, according to Teva. Brand Extension Brand Extension Gilead Sciences Inc. Gilead Sciences Inc. and Achillion Pharmaceuticals Inc. began dosing patients in a Phase I study of GS 9132, which is designed to treat hepatitis C. The study's goal is to evaluate the pharmacokinetics, tolerability and safety of single escalating doses of the compound--also known as ACH-806--in approximately 20 healthy volunteers. In November 2004, the firms signed an agreement granting Gilead worldwide rights to research, develop and commercialize certain Achillion compounds for the treatment of hepatitis C. Brand Extension Brand Extension Large Scale Biology Corp. Large Scale Biology Corp. (LSBC) and privately held BioCatalytics Inc. entered into a multi-year collaboration and license agreement "with the goal of applying each company's proprietary technologies to develop improved enzymes for chemical synthesis," LSBC said. Under the agreement, BioCatalytics will pay a commercial license fee to LSBC for the use of certain protein improvement technologies in BioCatalytics' "field of interest." Also, BioCatalytics will pay royalties on sales of products developed through use of LSBC's technologies. Other terms were not disclosed. Brand Extension Brand Extension X-Cell Medical Inc. X-Cell Medical Inc. initiated the ETHOS I study to compare the Ethos I drug-eluting stent system with a bare-metal stent in eliminating restenosis among patients eligible for balloon angioplasty. Ethos I stents release 17(beta)-estradiol, a drug that could provide a new and safer approach for reducing restenosis in coronary arteries, the firm said. Up to 150 patients with ischemic heart disease due to discrete de novo and/or restenotic coronary artery lesions are expected to be included in the trial. Brand Extension Brand Extension


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