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Conjoint AnalysisBrand 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 BMS sells North American OTC business to NovartisNovartis AG will pay $660 million in cash to acquire Bristol-Myers Squibb Co.'s U.S. and Canadian consumer medicines business and related assets. Under the agreement, Novartis will obtain the trademarks, patents and intellectual property rights of this business segment, including the rights to Excedrin analgesic, Keri skin care and Comtrex cold and flu products. Additionally, the transaction includes production and marketing rights to BMS' North American over-the-counter portfolio; related sales of these OTC brands in Latin America, Europe, the Middle East and Africa; limited rights to Moisturel and Lac-Hydrin creams in Canada; and rights to a number of dormant trademarks. In 2004, combined sales of these products totaled $258 million, including $160 million in Excedrin sales. Novartis said the purchase will allow it to participate in the United States' largest OTC category, the adult analgesic tablet market, which boasted sales of $2 billion last year. "The acquisition of these brands, particularly Excedrin, will provide us with greater critical mass in the OTC market in the United States, as well as with key trade customers who also purchase our prescription medicines and other consumer health products," said Paul Choffat, chief executive officer of Novartis' consumer health division. "In addition, this acquisition will allow us to become a more attractive partner for switching prescription medicines to OTC use." In January, BMS announced its plan to divest the company's U.S. and Canadian consumer drug business so it could focus on specific therapeutic areas for prescription drugs. BMS noted that the remainder of its local and regional consumer drug businesses in international markets are not part of the divestiture, nor are any of its manufacturing facilities. Conjoint Analysis FDA orders Purdue Pharma to halt sales of narcotic painkiller Palladone The Food and Drug Administration ordered Purdue Pharma LP to halt sales of narcotic painkiller Palladone (hydromorphone hydrochloride), citing potentially fatal reactions when the drug is taken in combination with alcohol. A study by Purdue showed that when the once-a-day pain management drug was taken with 8 ounces of a 40 percent-alcohol solution, its extended-release mechanism could be altered, leading to a rapid release of the drug's potent narcotic agent into the bloodstream and resulting in as much as 5.5 times the normal blood concentration. This rapid release, known as dose-dumping, could lead to serious, or even fatal, adverse events in some patients, even at the lowest marketed dose (12 mg). "All powerful pain management drugs have serious risks if used incorrectly, but the current formulation of Palladone presents an unacceptably high level of patient risk," said Dr. Steven Galson, the FDA's acting director of the Center for Drug Evaluation and Research. "Although we have not received reports of serious problems, this product has so far been used in a relatively small number of patients. We are concerned that as more patients take this drug, safety problems will arise since even having one alcoholic drink could have fatal implications." According to Purdue, the FDA has agreed to entertain a proposal to permit use of the drug in certain institutional settings, such as hospitals and in-patient hospices, and the company is considering the feasibility of such an arrangement. The company is also working to reformulate the drug to reduce the risk of an alcohol interaction. The Associated Press noted that the FDA's reaction was unusually swift, attributing it to increased pressure for federal regulators to more aggressively ensure the safety of drugs. Palladone was approved in September 2004 for the treatment of persistent, moderate to severe pain in patients requiring continuous, 24-hour analgesia with a high-potency opioid for an extended length of time. Concerns about the abuse potential of Palladone led the company to limit sales of the drug initially to physicians experienced in prescribing opioid painkillers, The AP reported. Conjoint Analysis Novartis releases positive Q2 financial results Novartis AG said it remains confident of achieving its financial goals for 2005, as it posted a rise in net income and sales during the quarter ended June 30. Overall, net sales of the company's prescription, generic and consumer health businesses rose 12 percent to $7.8 billion. Net sales of pharmaceuticals alone rose 12 percent to $5.1 billion, led by Diovan (valsartan) and Gleevec (imatinib mesylate). Global sales of Diovan, an angiotensin-receptor blocker, reached $912 million, while sales of leukemia drug Gleevec totaled $537 million. Net income increased from $1.5 billion pro forma in the second quarter of last year to $1.6 billion this past quarter, representing a 9 percent growth. However, operating income for Sandoz, Novartis' generic division, decreased 40 percent to $79 million, due mostly to one-time expenses of $30 million for restructuring and other charges. Novartis added that its acquisition of Hexal AG and Eon Labs Inc. will have a negative impact on group net income of between $250 million and $350 million, but it expects the companies will generate more than $1 billion in sales during the second half of this year. "Further gains in market share are expected to keep Novartis positioned as one of the fastest-growing pharmaceutical companies, delivering high single-digit net sales growth for the group and pharmaceuticals in local currencies," the firm said. "Barring any unforeseen events, group operating and net income should reach new record levels on a comparable basis (and excluding the impact of the Hexal and Eon Labs acquisitions)." In a conference call with analysts Thursday, Thomas Ebeling, who heads Novartis' pharmaceuticals division, expressed caution regarding FTY720, a drug being investigated for use in transplantion, Dow Jones Newswires reported. "One study has been completed, the other one is ongoing, and we can't make a decision before having results from the second trial," he said. "But we have to be realistic, and the likelihood that we will be able to file in this indication is low at the moment." He added that late-stage study results involving experimental diabetes drug LAF237 may not be available until early next year, even though the data were expected to be released during the fourth quarter of this year. Shares of Novartis closed at $48.28, up $1.08, or 2.3 percent, in moderate trading on the New York Stock Exchange. Conjoint Analysis Net earnings at UnitedHealth jump 36 percent during second quarter UnitedHealth Group Inc.'s consolidated net earnings jumped 36 percent from $596 million one year ago to $809 million in the second quarter of 2005 as a result of continued customer growth across all of the company's businesses. On a per-share basis, earnings rose 30 percent to $0.61, up from $0.47 in last year's second quarter. Overall consolidated revenue increased 28 percent year-over-year to $11.11 billion, up from $8.7 billion. Specifically, the firm's health care services segment, which includes UnitedHealthcare, Ovations and AmeriChoice, reported a growth in revenue to $9.81 billion, while operating earnings increased to $944 million. Among the three divisions, UnitedHealthcare led with $6.69 billion in revenue, representing 34 percent growth year-over-year; the division added 100,000 customers. Based on financial results from the first half of 2005, UnitedHealth increased its guidance for full-year 2005, projecting earnings per share growth of approximately 25 percent. "We are positioned to generate earnings of approximately $0.63 per share in the third quarter, a sizable advance, particularly given the increase in Medicare Part D launch costs that we will absorb in earnings in the second half of 2005," said Dr. William McGuire, UnitedHealth's chief executive officer. Last month, UnitedHealth and AARP announced their plan to offer an AARP-branded Medicare Part D prescription drug plan to Medicare beneficiaries. Ovations filed for approval with the Centers for Medicare & Medicaid Services. "We expect to continue to drive substantive gains in 2006, with earnings per share up at least 15 percent, excluding any contributions from the recently announced merger with PacificCare, which will further strengthen our ability to meet customer needs in key geographies and end-market segments," McGuire concluded. UnitedHealth shares closed at $50.25, down $1.15, or 2.2 percent, in heavy trading on the New York Stock Exchange. Conjoint Analysis Two Phase III studies indicate Tarceva improves survival in subsets of patients with non-small cell lung cancer Results from two Phase III studies indicate that OSI Pharmaceuticals Inc. and Genentech Inc.'s Tarceva (erlotinib) improves survival in most subsets of patients with non-small cell lung cancer (NSCLC). Both studies were published in The New England Journal of Medicine. In the first study, a randomized, double-blind, placebo-controlled trial that included 731 patients, Tarceva met the primary endpoint of prolonging survival in patients with advanced NSCLC for whom one or more chemotherapy regimens had failed. Tarceva also met all secondary endpoints, including time to symptom deterioration, progression-free survival and response rate. "This Phase III study represents an important medical advance in the field of lung cancer research, and publication in an eminent, peer-reviewed journal is testament to the significance of the data," said Dr. Frances Shepherd, the study's lead researcher. "In addition to being the first noncytotoxic treatment to improve survival in advanced lung cancer, the study showed that Tarceva extended survival across most subsets of patient populations in the trial." The second study, which analyzed tumor-biopsy samples from the first trial, assessed the role of epidermal growth factor receptor (EGFR) expression, amplification and mutation may have played in the first trial in terms of patient response and survival. The results showed that response to Tarceva was greater in patients with abnormally high copy numbers of the EGFR gene and in patients whose tumors expressed the EGFR protein, although these groups experienced no significant survival benefit compared with other subsets of patients. In addition, patients whose tumors had mutations in the EGFR gene did not survive longer than patients without the mutations. Based on the data, the authors concluded that a mutation analysis is not necessary to select patients for whom treatment with the drug is appropriate. In an accompanying editorial, Dr. James Doroshow suggested that results from these trials indicate a "renewed appreciation" for Tarceva after initial clinical data failed to show a benefit of the drug in combination with cytotoxic agents. Additionally, the response of patients without EGFR mutations in these studies suggests the existence of other signaling pathways that should be explored to "predict the therapeutic activity of this class of drugs in [NSCLC]." Conjoint Analysis Zyflo fails to provide statistically significant difference in number of inflammatory lesions, according to Phase II results In a Phase II trial of patients with acne, Critical Therapeutics Inc.'s Zyflo Filmtab (zileuton) tablets failed to reach statistical significance in the primary endpoint of number of inflammatory lesions when compared with placebo. The double-blind, 12-week trial included 101 patients with moderate to severe inflammatory facial acne who were randomized to receive 600 mg of Zyflo or placebo four times each day. From baseline to week 12, the number of inflammatory lesions fell by an average of 11.5 in the active treatment arm compared with an average decrease of 9.1 in the placebo group; the difference was not statistically significant. This corresponded to average reductions in the total number of lesions of 33.5 percent and 26.9 percent in the Zyflo and placebo groups, respectively. The company noted, however, that patients treated with Zyflo showed a trend toward significance in certain endpoints. Indeed, a positive trend toward significance was evident in the subset of patients who had more severe acne, defined as 30 or more inflammatory lesions at baseline. In this patient group, Zyflo led to an average reduction in inflammatory lesions of 16.2 versus an average reduction of 11.7 observed in the placebo group. Dr. Paul Rubin, chief executive officer at Critical Therapeutics, said this small trial supports the theory that 5-lipoxygenase inhibition may be a useful therapy for moderate to severe inflammatory acne. The 5-lipoxygenase enzyme is believed to play a key role in tissue inflammation. The firm will continue to analyze the study data and work with the researchers to determine appropriate next steps. Further details will be provided at Critical Therapeutics' second-quarter financial conference call in August. Linda Lennox, a company spokeswoman, told Reuters, "We're leaning toward a larger Phase II trial or a combination (Phase II/III) trial," although she said the company has not made a final decision. Last year, Critical Therapeutics acquired worldwide rights to Zyflo from Abbott. The drug was approved in 1996 to treat asthma but has been commercially unavailable since early 2004 due to supply depletion and manufacturing difficulties. If a supplemental New Drug Application regarding the drug's production at contract manufacturing sites is approved by the Food and Drug Administration, the firm expects to begin marketing Zyflo in the United States for asthma by the end of the year. Filmtab is a registered trademark of Abbott. Shares of Critical Therapeutics closed at $6.90, down $0.20, or 2.8 percent, in heavy trading on the Nasdaq. Conjoint Analysis Conjoint Analysis Takeda Pharmaceutical Co. Ltd. Takeda Pharmaceutical Co. Ltd. entered into an agreement with PPD Inc. to acquire the development and marketing rights to all dipeptidyl peptidase IV (DPP4) inhibitors previously granted to PPD under an agreement between PPD and Syrrx Inc. Takeda has since acquired Syrrx, which is now known as Takeda San Diego Inc. Under the new agreement, Takeda acquired all remaining rights to develop and commercialize the DPP4 inhibitors in exchange for an up-front payment of $15 million, plus development and sales milestones and royalties on sales of any DPP4 inhibitor products approved for marketing. Additionally, the agreement provides that PPD will exclusively provide Takeda with Phase II and III clinical development services for the DPP inhibitors in the United States and Europe. Further financial details were not disclosed. Conjoint Analysis Conjoint Analysis Forest Laboratories Inc. Forest Laboratories Inc. will continue to develop neramexane, an N-methyl-D-aspartate (NMDA) receptor antagonist intended to treat patients with moderate to severe Alzheimer's disease. The decision to move forward is based on positive data from a randomized, double-blind, proof-of-concept trial in which patients who received neramexane showed significant improvement in daily functioning and cognition at 12 weeks as compared with those who received placebo. The trial, which included 198 patients, also demonstrated that the safety and tolerability of neramexane were comparable to those of placebo. Conjoint Analysis Conjoint Analysis Genzyme Corp. Genzyme Corp. reported an increase in revenue of 22 percent for the second quarter of this year as compared with last year's second quarter, from $549.6 million to $668.1 million. Net income for the most recent quarter was $123.6 million, or $0.46 per diluted share, compared with a net income of $78.2 million, or $0.33 per diluted share, in the same quarter last year. The company increased its 2005 revenue guidance from a range of $2.5 billion to $2.7 billion to a range of $2.6 billion to $2.8 billion; it also revised its 2005 earnings per share guidance from a range of between $1.72 and $1.78 to $1.75 and $1.80. For the third quarter, Genzyme expects earnings of $0.45 to $0.47 per diluted share. Genzyme shares closed at $65.30, up $3.97, or 6.5 percent, in heavy trading on the Nasdaq. Conjoint Analysis Conjoint Analysis Barr Laboratories Inc. Barr Laboratories Inc. received final approval from the Food and Drug Administration to market a 60 mg capsule of fexofenadine hydrochloride, a generic version of sanofi-aventis Group's seasonal allergy drug, Allegra. Because Barr was the first applicant to file an Abbreviated New Drug Application for the generic formulation, the company is entitled to 180 days of marketing exclusivity. Conjoint Analysis Conjoint Analysis
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