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			branding Advertising 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 Guidant accepts J&J's higher offer; Boston Scientific will still pursue its bid Guidant Corp. accepted Johnson & Johnson's increased takeover offer of $23.2 billion. The firms entered into a new agreement whereby J&J will pay $37.25 in cash and 0.493 in shares of J&J common stock for each share of outstanding Guidant stock. Based on the Jan. 11 closing prices, the transaction has a value of $68.06 per share. Boston Scientific Corp., which recently offered to acquire Guidant for $25 billion in cash and stock, said it intends to "vigorously pursue" its offer. "It is clear that our $72 per share offer is superior to the $68.06 per share now being offered by Johnson & Johnson," Boston Scientific said. "Our discussions with Guidant are ongoing." Boston Scientific made its bid for Guidant earlier this month, after J&J proposed to buy Guidant for approximately $19 billion in November. J&J's original offer was for approximately $23.9 billion, but the firm decreased its bid after Guidant recalled several products and faced related regulatory investigations. The boards of directors for both J&J and Guidant voted unanimously to approve J&J's latest offer, but the merger is still subject to a vote by Guidant shareholders slated for Jan. 31. "This agreement with Johnson & Johnson provides significant financial value and certainty for shareholders," said James Cornelius, chief executive officer of Guidant. "Together with Johnson & Johnson, we will have the resources to continue to build upon the existing Guidant businesses in our pursuit of meaningful innovations to address cardiovascular disease." J&J said it has satisfied all closing conditions and has received regulatory clearance for the potential merger. branding Advertising Favrille's follicular B-cell NHL treatment granted fast track status Favrille Inc. received a fast track designation from the Food and Drug Administration for FavId (idiotype/keyhole limpet hemocyanin), its investigational treatment for B-cell follicular non-Hodgkin's lymphoma. News of the designation sent the company's shares up 33.4 percent. A Phase III trial is under way to test FavId in patients with follicular B-cell NHL who have been treated with Biogen Idec Inc. and Genentech Inc.'s Rituxan (rituximab). "We look forward to reporting additional progress in the development of FavId this year, culminating with our first look at clinical activity in our Phase III registration trial in the fourth quarter using the secondary endpoint of response improvement," said John Longenecker, chief executive officer of Favrille. The firm is almost done enrolling patients in the randomized, double-blind, placebo-controlled trial, which it began in July 2004 with a goal of enrolling 342 eligible patients. Favrille expects to have the final analysis of the trial's primary endpoint, time to disease progression (TTP), during the second half of next year. Long-term follow-up data from a Phase II trial in follicular B-cell NHL suggest that treatment with FavId after Rituxan therapy appears to improve response rates when compared with Rituxan therapy alone, Favrille said, noting that the combination of the two drugs also appears to extend TTP when compared with historical data. Rituxan, which is approved to treat follicular B-cell NHL, is marketed as MabThera by F. Hoffmann-La Roche Ltd. in countries outside of the United States, excluding Japan. Shares of Favrille closed at $5.39, up $1.35, in heavy trading on the Nasdaq. branding Advertising GSK reports shortage of Coreg, Avandamet GlaxoSmithKline Plc is experiencing a U.S. shortage of heart drug Coreg (carvedilol) and diabetes drug Avandamet (rosiglitazone maleate/metformin hydrochloride) as a result of processing issues at its Puerto Rico plant, Reuters reported. Last March, the same plant had manufacturing issues with antidepressant Paxil CR (paroxetine hydrochloride) and Avandamet. The problems led to the firm signing a consent decree with the Food and Drug Administration. According to a GSK spokeswoman cited in the Reuters report, the latest problems result from new documentation mechanisms implemented in accordance with the consent decree. "We are working though this and expect it to be a short-term issue," GSK's Nancy Pekarek said, adding that the problems will not affect the quality of the drugs and will not have a material impact on the company. GSK is informing physicians of the shortages and is advising them not to prescribe Coreg to new patients "until further notice," Reuters said. The news service noted that the shortage of Coreg is worse than that of Avandamet. Coreg is indicated to treat post-myocardial infarction, hypertension and heart failure. Avandamet is indicated to treat type 2 diabetes. branding Advertising FDA warns consumers, health care providers regarding risk of foreign drugs The Food and Drug Administration issued a Public Health Advisory to warn health care professionals and consumers that filling prescriptions outside of the United States may lead to patients inadvertently taking the wrong drugs because of confusion regarding drug brand names. "An FDA investigation has found that many foreign medications, though marketed under the same or similar-sounding brand names as those in the United States, contain different active ingredients than in the United States," the agency cautioned. As an example, the FDA noted that Boehringer Ingelheim Pharmaceuticals Inc.'s Flomax (tamsulosin hydrochloride) is indicated to treat an enlarged prostate in the United States, while in Italy, Chiesi Farmaceutici SpA's Flomax (morniflumate) is an anti-inflammatory drug. Even when drugs with identical brand names are indicated for treating the same condition, the active ingredients may not be the same, posing risks for unexpected side effects, allergies and drug interactions, the FDA advised. The agency said it identified 105 U.S. brand-name drugs with foreign counterparts that look or sound similar, which could cause the wrong drug to be dispensed. Dr. Murray Lumpkin, deputy FDA commissioner for international and special programs, said that when filling a U.S. prescription abroad, either while traveling or when shopping at foreign Internet pharmacies, consumers need to be aware of these potential health hazards. branding Advertising FDA issues guidance on making early clinical trials more effective The Food and Drug Administration issued new guidance on making the earliest phases of clinical trials more effective. "The recommendations announced today will help more researchers conduct earlier, more-informed studies of promising treatments so patients have more rapid access to safer and more effective drugs," said Health and Human Services Secretary Mike Leavitt. Leavitt noted that nine out of 10 investigational drugs currently fail during clinical testing because accurate predictions cannot be made as to how people will react to the drugs based on laboratory and animal studies. In an effort to "improve the process for bringing safe and effective drugs" to the market, the FDA laid out specific guidance for researchers who plan to conduct very early clinical studies in humans. The FDA stressed that the current regulations allow for flexibility in how much data need to be submitted in an Investigational New Drug application. "The agency believes that sponsors have not taken full advantage of that flexibility and often provide more supporting information in INDs than is required by regulations," the FDA said, adding that this is especially prevalent when sponsors are submitting INDs for exploratory trials. The FDA defined exploratory IND trials as those that are conducted early in Phase I, involve limited human exposure and are not intended to be therapeutic or diagnostic. "The common theme throughout this guidance is that, depending on the study, the preclinical testing program for exploratory IND studies can be less extensive than for traditional IND studies," the agency said. The FDA explained that this is due to the subpharmacologic doses of the investigational drugs being administered; the potential risks involved with these very small doses are lower than the risks in traditional Phase I trials. The agency also released guidance on how researchers can comply with current Good Manufacturing Practices during Phase I trials. Both sets of guidance can be found in their entirety on the FDA's Web site. branding Advertising Most physicians accept new patients with Medicare coverage despite payment cuts, according to new research The percentage of physicians accepting new Medicare patients appears to have stabilized between 2004 and 2005, despite fluctuations in payment and access during the last decade, new findings show. The Center for Studying Health System Change used its Community Tracking Study Physician Survey from the years 1996-1997 and 2000-2001 of approximately 12,000 physicians and the 2004-2005 survey of more than 6,600 physicians. According to the 2004-2005 data, 72.9 percent of physicians reported being open to all new Medicare patients, which was slightly higher than the 71.1 reported in 2000-2001. The Center remarked that this willingness to treat Medicare patients was high in light of a 5.4 percent cut in payment rates in 2002. During the 1996-1997 time period, 74.6 percent of physicians accepted all new Medicare beneficiaries as patients. When primary care physicians were evaluated separately, the increase in the percentage of physicians who accepted all new Medicare patients was significant, from 61.7 percent in 2000-2001 to 65.3 percent in 2004-2005. Only 3.4 percent of physicians who responded to the 2004-2005 survey said their practices were completely closed to new Medicare patients. Most (69.2 percent) cited inadequate reimbursement as the reason, while others referred to billing requirements and paperwork associated with Medicare patients (61 percent) and clinical burdens linked with these patients (44.8 percent). The HSC noted that physician acceptance of new Medicare patients during the time periods studied mirrored physician acceptance of new privately insured patients--both decreased between 1996-1997 and 2000-2001 and then increased in 2004-2005. The HSC said a partial explanation for this may be that physicians now have fewer restraints placed on them regarding the number of new patients they can accept into their practices. "While concerns about Medicare beneficiary access have focused on physician payment, policy makers should recognize that Medicare fees are only one factor in physician decisions to accept new patients--in other words, Medicare fees don't exist in a vacuum," said Paul Ginsburg, HSC's president. branding Advertising branding Advertising AstraZeneca Plc AstraZeneca Plc and The University of Texas M. D. Anderson Cancer Center entered into research agreements with an initial focus on treatments for aerodigestive diseases such as cancers of the head and neck, lung and colon. The three-year master agreements, the terms of which were not disclosed, are renewable and set up the framework for collaborating on multiple initiatives. "The umbrella agreements address preclinical and clinical research in a way that will allow the two organizations to more efficiently and effectively work to answer future research questions," the organizations said. branding Advertising branding Advertising Shire Laboratories Inc. Shire Laboratories Inc. sold its product formulation and development business to the newly formed Supernus Pharmaceuticals Inc. Supernus, founded by Shire Laboratories' former Chief Executive Officer Jack Khatter, will implement proprietary technologies to develop specialty products. These technologies include ProScreen and OptiScreen, which are used for lead selection and formulation optimization; Solutrol, Microtrol and EnSoTrol, which are oral controlled-release technologies; and Avert, a technology for reducing abuse potential. branding Advertising branding Advertising Forest Laboratories Holdings Ltd. Forest Laboratories Holdings Ltd. and Mylan Laboratories Inc. entered into a commercialization, development and distribution agreement for Mylan's investigational beta blocker, nebivolol. The agreement, which covers the United States and Canada, states that Forest will pay Mylan $75 million up front, in addition to potential milestone payments and royalties. Forest will assume all development, sales and marketing expenses related to the drug, and Mylan has the option of co-promoting nebivolol in the future. Last May, Mylan received an approvable letter regarding nebivolol's indication for hypertension; before the end of this year, the company expects to submit a New Drug Application for nebivolol as a treatment for congestive heart failure. Janssen Pharmaceutica NV licensed U.S. and Canadian rights to the drug to Mylan in 2001. branding Advertising branding Advertising Vertex Pharmaceuticals Inc. Vertex Pharmaceuticals Inc. extended its research collaboration with Cystic Fibrosis Foundation Therapeutics Inc. (CFFT). Under the extension, CFFT will give Vertex an extra $22 million to continue developing Vertex's "corrector" compounds, which restore functioning of the cystic fibrosis transmembrane conductance regulator protein. Vertex, which will pay royalties on net sales to CFFT, retains development and commercialization rights to any compounds discovered through the agreement. Vertex began its research program in CF in May of 2000 through the collaborative effort with CFFT, and the firms expanded their agreement in May of 2004. branding Advertising


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