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			Name Consultant 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 Pfizer claims review shows no increased risk of blindness with Viagra; works with FDA to update label Pfizer Inc. said its review of post-marketing ocular events found no evidence of an increased risk of blindness among patients taking Viagra (sildenafil citrate), a treatment for erectile dysfunction. The Food and Drug Administration also found no evidence of a causal relationship between the drug and blindness, the company said. "After more than 10 years of rigorous clinical study and worldwide safety monitoring of a medicine used by more than 27 million men, there is no evidence to suggest a link between Viagra and blindness or other serious ocular events," said Dr. Joseph Feczko, Pfizer's chief medical officer. "In addition, several studies specifically looking into the effect of Viagra in the eye by Pfizer as well as independent ophthalmologic experts found Viagra to have no serious adverse effects on the eye." Despite these findings, Pfizer said it is engaged in discussions with the FDA to update Viagra's label, informing physicians and patients that rare cases of non-arteritic anterior ischemic optic neuropathy (NAION) have been reported in some patients who have used the drug. Pfizer believes the FDA has asked makers of all oral ED treatments to include similar information in their product labels. Late last month, CBS News reported that the FDA was examining reports that certain ED drugs had been linked to blindness. The drugs in question at that time were Viagra and Lilly ICOS LLC's Cialis (tadalafil). According to a more recent report by The Wall Street Journal, the FDA said it had received 38 reports of NAION among Viagra users, four reports of the blindness among Cialis users and one case involving a patient who was taking Levitra (vardenafil hydrochloride), which is manufactured, marketed and distributed by Bayer AG, Schering-Plough Corp. and GlaxoSmithKline Plc. The Journal reported that Lilly ICOS updated Cialis' label last month disclosing information about reports of "serious visual impairment." A spokesman for Bayer told The Journal no decision has been made regarding Levitra's label, although the company is evaluating the data. "We have already conducted exhaustive studies involving 60,000 patients, and there has never been one case of sudden blindness," the spokesman said. Name Consultant Teva, Active Biotech submit IND for oral MS treatment Teva Pharmaceutical Industries Ltd. and Active Biotech AB submitted an Investigational New Drug application to the Food and Drug Administration for laquinimod, an oral drug designed to treat relapsing forms of multiple sclerosis. "This IND filing is an important step toward the initiation of pivotal studies with laquinimod which, along with Teva's development of an oral form of Copaxone [glatiramer acetate], enhances the likelihood that Teva will be the first to market an oral treatment [for MS]," said Israel Makov, Teva's chief executive officer. According to the firms, laquinimod could be the first orally administered, disease-modifying treatment for MS, both as a single agent and in combination with Copaxone. Laquinimod is currently being studied in a European Phase IIb clinical trial. With the IND filing, the companies plan to initiate a U.S. clinical trial to assess laquinimod's drug-drug interaction. Phase II results released in March indicated that laquinimod reduces the development of active magnetic resonance imaging lesions in relapsing MS. Laquinimod, a novel immunomodulatory substance, was discovered by Active Biotech. Teva acquired the exclusive rights last year to develop, register, manufacture and market laquinimod worldwide with the exception of the Nordic and Baltic countries, for which Active Biotech retained all commercial rights. Name Consultant Cubist's Cubicin meets primary endpoints in S. aureus endocarditis/bacteremia study; shares rise Cubist Pharmaceuticals Inc.'s injectable antibiotic, Cubicin (daptomycin), at 6 mg/kg of body weight once daily, met the primary endpoints of its Phase III Staphylococcus aureus endocarditis and bacteremia trial. The primary endpoints were non-inferiority in the intent-to-treat (ITT) and per protocol (PP) populations. News of the results caused Cubist shares to soar 21.9 percent. The company plans to file a supplemental New Drug Application with the Food and Drug Administration before year-end to add S. aureus endocarditis and bacteremia to Cubicin's indication statement. The trial, which Cubist said was the first-ever successfully completed registration study of endocarditis and bacteremia to focus specifically on S. aureus, included 235 patients in the ITT population and 139 patients in the PP population. In the ITT population, 37 percent of the Cubicin-treated patients were infected with methicillin-resistant S. aureus (MRSA), while 38 percent of patients in the comparator arm were infected with MRSA. The success rates of Cubicin were higher overall than those observed in the comparator arms, the company said. The greatest difference in success rates occurred in patients infected with MRSA, but the differences were not statistically significant, according to Cubist. "This is very big news for Cubist. The trial results have surpassed our expectations," said Mike Bonney, chief executive officer of Cubist. "We look forward to having these data presented to the broader scientific community, and we are eager to share the data with the FDA. A new therapy in this difficult-to-treat condition would provide a much needed alternative for these seriously ill patients." According to Cubist, Cubicin is the only once-daily bactericidal antibiotic approved by the FDA for the treatment of complicated skin and skin structure infections caused by susceptible strains of several gram-positive microorganisms. Cubist shares closed at $13.32, up $2.39, in heavy trading on the Nasdaq. Name Consultant Diuretics reduce cardiovascular risk in patients with diabetes, study finds In patients with diabetes, less costly diuretics work as well as ACE inhibitors and calcium channel blockers in protecting against myocardial infarction, improving survival and offering more protection against congestive heart failure, according to the latest results from the ALLHAT blood pressure study published in the June 27 issue of Archives of Internal Medicine. ALLHAT, which was sponsored by the National Heart, Lung and Blood Institute (NHLBI), was a randomized, double-blind trial of 42,418 patients with high blood pressure. Of this total, 31,512 participants were randomized to a diuretic (chlorthalidone), a calcium channel blocker (Pfizer Inc.'s Norvasc [amlodipine besylate]) or an ACE inhibitor (lisinopril). In 2002, results from the study demonstrated that diuretics were the best initial treatment for high blood pressure for protecting against adverse cardiovascular events. The current results focus on these high blood pressure treatments in patients with diabetes. The condition was reported in 13,101 of the treated patients, while 1,399 had elevated fasting glucose (a sign of pre-diabetes) and 17,012 had normal glucose levels. When compared with the ACE inhibitor and the calcium channel blocker, the diuretic was found to be more protective against congestive heart failure in patients with or without diabetics; better at lowering systolic blood pressure in both groups; at least equally protective against fatal coronary heart disease or nonfatal myocardial infarction in all patients; and equally protective against death from all causes, end-stage kidney disease or cancer in all patients. In black participants with or without diabetes, diuretics were also more protective against stroke when compared with the ACE inhibitor. "Controlling high blood pressure is an urgent concern, especially for people with diabetes. Our findings demonstrate the advantages of diuretics in diabetics as well as in those with impaired and normal fasting glucose levels," said Dr. Elizabeth Nabel, NHLBI director. "As a physician, I have seen the consequences of poorly controlled hypertension and diabetes. These results show many people and their families can be spared that devastation." According to the National Institutes of Health, about 73 percent of adults with diabetes have high blood pressure or are treated for hypertension. Name Consultant Researchers evaluate Lamictal, gabapentin as first-line therapies in older adults with epilepsy GlaxoSmithKline Plc's Lamictal (lamotrigine) and gabapentin appear to be viable first-line therapies for older adults with epilepsy, according to findings from a recent study in which the efficacy and tolerability of Lamictal, gabapentin and carbamazepine were compared in 593 patients aged 60 years or older with new-onset epilepsy. Patients were randomized to one of three treatment regimens: gabapentin (n=195; target dose, 1,500 mg/day), Lamictal (n=200; target dose, 150 mg/d) or carbamazepine (n=198; target dose, 600 mg/d). The primary outcome measure was retention in the trial after 12 months, a measure of both the drug's efficacy and its tolerability. A total of 276 patients completed one year of the trial. Early termination rates were significantly higher among carbamazepine-treated patients (64.5 percent) as compared with Lamictal- and gabapentin-treated patients (44.2 percent and 51 percent, respectively). The authors noted that retention rates were primarily influenced by the incidence of adverse events rather than inadequate seizure control. More patients randomized to carbamazepine withdrew due to adverse events (31 percent) as compared with Lamictal (12.1 percent) or gabapentin (21.6 percent). By contrast, relatively few patients withdrew due to inadequate seizure control, with no significant between-group differences. Similarly, seizure-free rates did not differ significantly between the groups at three months, six months or one year. Gabapentin is marketed by Pfizer Inc. under the brand name Neurontin and has been available in generic formulations since last December. The study was published in the June 14 issue of the journal Neurology. Name Consultant Extended-release methylphenidate formulations associated with greater continuity of treatment than immediate-release formulations among pediatric patients with ADHD, study findings suggest A study published in the June issue of Archives of Pediatrics & Adolescent Medicine suggests that extended-release methylphenidate (ER-MPH) formulations are associated with greater continuity of treatment than immediate-release methylphenidate (IR-MPH) formulations among children and adolescents with attention-deficit/hyperactivity disorder. Researchers analyzed California Medicaid claims filed from 2000 to 2003 that involved children and adolescents, aged 6 to 17 years, who initiated treatment with ER-MPH (n=3,444) or IR-MPH (n=8,093) for ADHD. Study cohorts were limited to children and adolescents who had not filled a prescription for MPHs, amphetamines, pemoline or Eli Lilly and Co.'s Strattera (atomoxetine hydrochloride) during the six months prior to the index prescription and who remained eligible for Medicaid benefits for the subsequent 12 months. Patients initiating ER-MPH treatment had a significantly longer mean estimated duration of treatment (140.3 days) than those initiating IR-MPH treatment (103.4 days). Even after controlling for group differences, ER-MPH initiation was associated with an average 37 percent longer duration of treatment as compared with IR-MPH treatment. In addition, researchers found drug-specific differences among patients who were treated with ER-MPH. Treatment initiation with McNeil Consumer & Specialty Pharmaceuticals' Concerta was associated with significantly longer mean duration (147.2 days) than was treatment initiation with Celltech Pharmaceuticals Inc.'s Metadate CD (113 days) or Novartis AG's Ritalin LA (101.1 days). "Initial selection of an ER formulation may help to prolong continuity of MPH therapy among youth Medicaid beneficiaries with [ADHD]," the study authors concluded. Prior to the Pediatric Advisory Committee's discussion of adverse event reporting for Concerta and other MPH products, which is slated for June 30, the Food and Drug Administration revealed intended labeling changes to these products that would disclose such psychiatric events as "visual hallucinations, suicidal ideation, psychotic behavior, as well as aggression or violent behavior." "In addition, we believe it is critical to examine the other stimulant drug products approved for ADHD, specifically the amphetamine products, and [Strattera] (not a stimulant), to determine if they too are associated with these adverse events," the FDA said in a prepared statement. The agency noted that it is looking into "additional means to better characterize the cardiovascular risks for all drug products approved for ADHD." Name Consultant Name Consultant Trimeris Inc. Trimeris Inc. and F. Hoffmann-La Roche Inc. entered into a license agreement with the University of California to market up to two patent-protected products, according to a Trimeris Securities and Exchange Commission filing cited by Dow Jones Newswires. As part of the agreement mentioned in the filing, the companies will make a one-time payment to the university for rights to market products covered by a patent on virus membrane fusion inhibition technology. The filing did not include the license fee, Dow Jones said. The companies may add other products to the license for additional fees and can end the agreement for any reason. The university has the right to end the agreement if Trimeris or Roche default on their payments. Name Consultant Name Consultant Walgreen Co. Walgreen Co.'s net earnings for the fiscal third quarter ended May 31 rose 20.1 percent to $411 million, or $0.40 per diluted share, up from $342.3 million, or $0.33 per diluted share, in the previous-year period. Net sales climbed 13.1 percent to $10.8 billion, up from $9.6 billion in the third quarter of fiscal year 2004. Prescription sales rose 14 percent and accounted for 65 percent of the firm's total quarterly sales. According to IMS Health Inc., Walgreen's pharmacy market share grew in every state in which it operates during the first quarter of calendar year 2005. Name Consultant Name Consultant Callisto Pharmaceuticals Inc. Callisto Pharmaceuticals Inc. said the Food and Drug Administration granted a second orphan drug designation to Annamycin, a second-generation anthracycline, for the treatment of acute myeloid leukemia (AML). Later this year, Callisto plans to initiate a clinical trial of Annamycin in combination with chemotherapy agent Ara-C in adult patients with relapsed AML. Last week, the FDA granted orphan drug designation to Annamycin for the treatment of acute lymphoblastic leukemia in patients with relapsed acute leukemia. A clinical trial is also planned for this indication "in the near future," according to Callisto. Name Consultant Name Consultant Boston Scientific Corp. Boston Scientific Corp. initiated a worldwide recall of all Hemashield Vantage Vascular Grafts, which are used in peripheral procedures. The reason for the recall, which pertains to Hemashield Vantage Vascular Grafts manufactured in the last two years, is potential fraying or tearing of the device during suturing. Such failures could lead to postoperative complications, according to the company, which said it knew of three reported failures and noted that all three patients were successfully treated by either resuturing or replacing the graft. The company estimates that 500 grafts have been shipped but have not been implanted. Name Consultant Name Consultant


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