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			Proprietary Naming 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 FDA APPROVES LABELING SHOWING XENICAL DELAYS ONSET OF TYPE 2 DIABETES The Food and Drug Administration approved new labeling for Hoffmann-La Roche Inc.'s weight-loss drug Xenical (orlistat), which indicates the compound delays the onset of type 2 diabetes in obese patients with impaired glucose tolerance. "The label change makes Xenical the first weight loss medication to show a reduction in the risk of developing type 2 diabetes, important news for obese adults in the U.S. with impaired glucose tolerance," said Dr. Marc Jacobson, of the North Shore-Long Island Jewish Health System, in a Roche press release. Approval of the new labeling was based on a four-year study involving 3,304 obese patients with normal (n=2,643) or impaired glucose tolerance (n=661). Results at four years showed Xenical reduced the relative risk of developing type 2 diabetes by 42 percent in patients with impaired glucose tolerance as compared with placebo. Xenical did not reduce the risk among patients who had normal glucose tolerance at baseline. Furthermore, at four years, 21 percent of Xenical-treated patients had lost 10 percent of their body weight or more and 45 percent had lost more than 5 percent, compared with 10 percent and 28 percent, respectively, among placebo-treated patients. Roche said this study marks the first time a weight-loss drug has been shown to prevent or delay the onset of type 2 diabetes. This effect is believed to be due to the weight loss itself rather than any independent effect of Xenical on glucose or insulin metabolism, the company noted. Xenical was approved by the FDA in 1999 for use in conjunction with a reduced-calorie diet for obesity management, including weight loss and weight management, as well as to reduce the risk of weight regain following weight loss. MERCK RECEIVES APPROVABLE LETTER FOR ARCOXIA; EMPHASIZES ITS APPROPRIATE RESPONSE TO VIOXX SAFETY CONCERNS On the same day that Merck & Co. Inc. announced its receipt of an approvable letter from the Food and Drug Administration for use of Arcoxia (etoricoxib) in several inflammatory conditions, the company said it "acted responsibly and appropriately as it developed and marketed Vioxx [rofecoxib]," its other COX-2 inhibitor recently taken off the market. In one press release issued Friday, Merck said the FDA has requested additional safety and efficacy data for Arcoxia before the drug can be approved. The company plans to collaborate with the regulatory agency to address these requirements, according to President and Chief Executive Officer Raymond Gilmartin. Merck is seeking indications for Arcoxia in osteoarthritis, rheumatoid arthritis, chronic low back pain, acute pain, dysmenorrhea (menstrual pain), acute gouty arthritis and ankylosing spondylitis. But after Merck recently pulled Vioxx from the market, analysts and physicians cited by The Associated Press believe Arcoxia will only be approved once a study is completed, which is scheduled for early 2006, and demonstrates no increased risk of heart attacks and strokes among users of the drug. Merk released results in San Antonio, Texas, at the annual meeting of the American College of Rheumatology showing no statistical difference in adverse cardiovascular events among patients who received Arcoxia or diclofenac sodium. The AP reported patients were in the trial for an average of nine months, but Vioxx-treated patients did not show safety issues until 18 months of use. In a second press release relating to pending Vioxx litigation, Merck defended its actions in investigating and addressing Vioxx's safety issues once questions arose. Merck made these statements in response to the public disclosure of several documents under court protection, as "the documents, the surrounding events and the business practices of Merck may well be misinterpreted in any reporting." BMS REPORTS DECLINE IN EARNINGS FOR THIRD QUARTER Bristol-Myers Squibb Co. posted an increase in net sales during the third quarter of 2004, but net earnings fell due to exclusivity losses of key drugs and increased spending on research and development. The company also lowered earnings per diluted share guidance for the full year of 2004. The company earned a net $758 million, or $0.38 per share, during the quarter, down from $906 million, or $0.47 per share, one year ago. On a non-Generally Accepted Accounting Principles basis, excluding specified items, earnings per share reached $0.44. This beat the $0.39 per share forecast by analysts polled by Thompson First Call, CBS MarketWatch reported. Net sales rose from $5.37 billion last year to $5.43 billion, impacted by foreign exchange rate fluctuations, selling price changes and volume decreases mostly resulting from exclusivity losses. As compared to the third quarter of 2003, worldwide pharmaceutical sales remained constant at $3.8 billion, led by Plavix (clopidogrel bisulfate). Sales of Plavix, the platelet aggregation inhibitor that BMS launched with sanofi-aventis Group, rose 30 percent to $902 million. However, U.S. pharmaceutical sales dropped 2 percent to $2.1 billion as cardiovascular drug, Privation (pravastatin sodium), and cancer drug injection, Paraplatin (carboplatin aqueous solution) experienced increased competition and the Glucophage (metformin hydrochloride) franchise, used for glycemic control, lost exclusivity. BMS cautioned in the press release that it expects "substantial incremental sales losses in each of 2005, 2006 and 2007" as certain products continue to lose exclusivity protection throughout the next few years. Research and development spending also increased 9 percent to $615 million this past quarter. "[O]ur earnings will continue to be pressured through our portfolio transition to the end of 2006 as a result of exclusivity losses of higher margin products, as well as higher investments in R&D and key product support," said Peter Dolan, chief executive officer. The company affirmed its previously issued full-year 2004 guidance of between $1.60 to $1.64 earnings per share on an adjusted non-GAAP basis. However, based on certain restructuring and other charges recorded in the third quarter, BMS lowered earnings guidance to a range of $1.39 to $1.44 per share from a previous estimate of $1.43 to $1.48 per share. Shares of BMS closed at $23.43, down 2.4 percent, or $0.58, in heavy trading on the New York Stock Exchange. TEMODAR SNDA GRANTED PRIORITY REVIEW STATUS Schering-Plough Corp.'s Temodar (temozolomide) received a priority review designation from the Food and Drug Administration for the treatment of glioma, a form of brain tumor. The firm submitted a supplemental New Drug Application for Temodar in September, requesting approval to market the product for use in patients with newly diagnosed high-grade gliomas concomitantly with radiotherapy and then as adjuvant treatment after the patient has completed radiotherapy. The application also seeks approval to treat patients with recurrent and refractory high-grade gliomas. The sNDA is supported by a recently completed Phase III study in patients with newly diagnosed glioblastoma multiforme, a form of malignant glioma. Temodar was previously issued an orphan drug designation by the FDA for the treatment of newly diagnosed high-grade gliomas. The product, which is currently indicated for the treatment of adult patients with refractory anaplastic astrocytoma (a form of brain tumor), generated $121 million in sales during the third quarter of this year. USING OTC DRUGS FOR UPPER RESPIRATORY INFECTION MAY SAVE $9 PER EPISODE COMPARED WITH NON-TREATMENT, NEW ANALYSIS REVEALS A new study shows that use of over-the-counter drugs for the common cold may offer substantial cost savings to the health care system and overall economy. Consumer Healthcare Products Association commissioned the study, in which researchers from Northwestern University compared use of OTC treatments with non-treatment for symptoms of upper respiratory infections in a decision analytic model. OTC use cost $184 per upper respiratory episode compared with $193 per episode for non-treatment. The authors noted that the majority of savings can be attributed to improved productivity and a reduction in physician visits after the treatment of cold symptoms. According to estimates showing an average of three upper respiratory infections per year among Americans between 18 and 65 years, use of OTC drugs could save $4.75 billion annually. The study was presented in Beijing at the World Self-Medication Industry meeting. SLOWING RENEWAL RATE INCREASES EXPECTED FOR HMOS, PPOS IN 2005, NEW REPORT REVEALS The renewal rate increases for HMOs and PPOs are 11 percent and 13 percent, respectively, which represent slowing compared with previous years, results from a new survey by consulting firm Milliman indicate. The 2004 Group Health Insurance Survey included HMOs and fully insured PPOs that serve the commercial large group employer market and does not account for differences in benefit design scope, cost-sharing levels and member demographics. The survey asked participants to respond to a given set of benefits and demographics for a 250-employee group. In 2003, HMOs anticipated a renewal rate increase of 15 percent in 2005. The results from the 2004 survey, however, show HMOs anticipate a rate increase of 11 percent. For PPOs, the anticipated rate increase is 13 percent. According to the results, HMO administrative expenses dropped to 12 percent of the premium, the lowest level reported in the 13-year history of Milliman's survey. Eighty-nine percent of survey respondents said a consumer-driven health plan would be offered to employees in 2005 compared with 29 percent who said so in 2003. Survey participants also expect that 7.8 percent of the total annual commercial group premium revenue in 2005 will be attributable to such consumer-driven health products--up from 3.3 percent last year. "Continued double-digit increases and the recent Medicare Modernization Act are the likely drivers behind the movement to [consumer-driven health] approaches by insurers and employers alike," study author Steve Cigich said in a Milliman press release. Furthermore, all respondents currently offering a Medicare Advantage product said they plan to continue this program next year and 41 percent said they expect to expand it. Proprietary Naming TAKEDA PHARMACEUTICALS NORTH AMERICA INC. Takeda Pharmaceuticals North America Inc. submitted a New Drug Application to the Food and Drug Administration for Actoplus Met (pioglitazone hydrochloride/metformin), which combines Takeda and Eli Lilly and Co.'s Actos (pioglitazone hydrochloride) with metformin for the treatment of type 2 diabetes. U.S. sales of Actos totaled $1.36 billion in fiscal 2003. Proprietary Naming EISAI CO. LTD. Eisai Co. Ltd. and Bristol-Myers Squibb Co. terminated their licensing agreement for ravuconazole, a broad-spectrum antifungal triazole currently in Phase II development. Eisai reacquired worldwide rights to the drug and will now independently develop ravuconazole, mainly in the United States. Eisai said the compound shows "a promising advance" in antifungals for the treatment of immunocompromised patients, such as organ transplant recipients and individuals with HIV infection or cancer, who are at risk for developing serious fungal infections. Proprietary Naming WYETH Wyeth entered into a collaboration with Plexxikon Inc. to develop Plexxikon's PLX204 as well as other small-molecule drugs for the treatment of type 2 diabetes and other metabolic disorders. Plexxikon has completed a clinical study of PLX204 in preparation for an Investigational New Drug Application filing. Plexxikon will receive more than $22 million from Wyeth in research funding and an upfront license fee. Future milestone payments could total nearly $350 million. Proprietary Naming INSPIRE PHARMACEUTICALS INC. Inspire Pharmaceuticals Inc. President Gregory Mossinghoff told the company he plans to resign from his position in order to pursue other opportunities. Mossinghoff will remain with the company through June to ensure a smooth transition of his responsibilities to existing members of Inspire's management team, according to a press release. Inspire said it currently has no plans to fill the position of president. Proprietary Naming


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