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			Marketing Slogan 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 REJECTS EXANTA ___________________________________________________________________________ The Food and Drug Administration rejected AstraZeneca Plc's oral anticoagulant Exanta (ximelagatran) Friday, following the advice of an advisory panel that met last month. AstraZeneca was seeking approval of Exanta to be used for stroke prevention in patients with atrial fibrillation, for prevention of blood clots in patients undergoing knee-replacement surgery and for the long-term secondary prevention of blood clots following standard treatment of a clot. The firm did not reveal details of the FDA action letter, but the advisory committee expressed concerns in September about the long-term risk of liver damage associated with Exanta. Additionally, panel members had worries about the risk of heart attack in knee-surgery patients who use the drug on a short-term basis, The Wall Street Journal reported. AstraZeneca said in a press release that it continues to believe in the benefit/risk profile of Exanta and is considering how to proceed further with the FDA. Exanta is approved in Europe for the prevention of blood clots in patients undergoing hip- and knee-replacement surgeries. FDA OFFICIALS REPORTEDLY ASKED RESEARCHER TO TONE DOWN EARLIER STUDY CONCLUSION REGARDING VIOXX'S POTENTIAL CARDIAC RISKS ___________________________________________________________________________ The Food and Drug Administration asked one of its researchers to soften the conclusion of a review showing that Merck & Co. Inc.'s Vioxx (rofecoxib) was linked to risk of acute myocardial infarction (AMI) and sudden cardiac deaths, Sen. Charles Grassley (R-Iowa) said in a news release Thursday, according to The Washington Post. David Graham, associate science director of the Office of Drug Safety, and other researchers reviewed approximately 1.4 million Kaiser Permanente patients who received Vioxx or Pfizer Inc.'s Celebrex (celecoxib). Graham and other researchers concluded that 27,000 heart attacks and sudden cardiac deaths would have been avoided if patients had used Celebrex instead of Vioxx. Results of this FDA-funded study were first presented in August at the 20th International Conference on Pharmacoepidemiology and Therapeutic Risk Management in France. Earlier in the month, John Jenkins, director of the FDA's Office of New Drugs, said the study's proposed conclusion "is pretty strong language since to my knowledge FDA is not contemplating such a warning for labeling," according to The Wall Street Journal. He recommended, "I think something like, 'this and other studies suggest an increased risk of AMI with rofecoxib use and should be considered by prescribers when making individual treatment decisions.'" Graham responded, "I've gone about as far as I can without compromising my deeply-held conclusion about this safety question." The abstract's final conclusion read "this and other studies cast serious doubt on the safety of rofecoxib" at doses greater than 25 mg "and its use by physicians and patients." Grassley said Graham had told him that agency officials "ostracized" him and subjected him to "veiled threats" as he worked to have his study cleared for publication, The Post reported. Steven Galson, acting director of the agency's drug center, said Graham's study was going through the same review process used for all major drug safety issues. "There was no battle because there was no data," Galson said. "We were waiting all summer, but he missed his deadline." Just after Merck took Vioxx off the market, Galson said in teleconference that the agency had only received an abstract of Graham's work and was waiting for the full report. In a statement released Thursday, the FDA said that after discussing the abstract with agency officials, Graham had decided to revise the abstract. "He transmitted his completed report to his agency supervisors on Sept. 30. The standard agency review process for this type of report is a more rigorous scientific peer review." AHA WILL NOT ENDORSE EBT TO ASSESS HEART ATTACK RISK ___________________________________________________________________________ The American Heart Association has elected not to publish a paper that was expected to "endorse" the use of electron beam tomography (EBT) to assess heart attack risk in patients deemed at intermediate risk based on age, health habits and measurements of cholesterol and blood pressure, according to The Wall Street Journal. Last month, the Journal reported the AHA was planning to publish a statement in its journal Circulation, which would recommend the use of heart scans to determine proper therapy in intermediate-risk patients. The Journal predicted the guidelines would spark wider use of heart scans and could prompt insurers to increase reimbursement of the technology. A Journal report on Friday, however, quoted Circulation Editor-in-Chief Dr. Joseph Loscalzo as saying the AHA would not endorse heart scans or alter its position on scanning. "When individuals provide information to the media in advance of ... publication, there is risk that the individuals' perspective .. may not accurately reflect" the final message. Loscalzo added that the AHA's decision not to publish the paper was influenced by concern for the "sanctity" of medical information and the importance of not releasing information to the public before it is ready to be published. Dr. Mathew Budoff, the head of a committee that wrote the paper, had reportedly indicated the statement would revise the AHA's stance, issued in 2000, that there was not enough evidence to support wide use of heart scans. He told the Journal that new research has been presented since 2000 that supports the use of heart scans in patients who are on the borderline for needing aggressive intervention. Budoff reportedly said the AHA statement would recommend EBT over computed tomography (CT) scans because EBT is more accurate and exposes patients to less radiation. Both tests are used to measure the volume of calcium in a patient's arteries. Former AHA President Robert Bonow said data indicate the scans accurately identify coronary calcium, but they have not been shown to improve patient outcomes. The tests cost $250 to $400, according to the Journal, but are prone to overuse. The Journal added that many physicians believe cheaper diagnostic tools, such as a blood test for C-reactive protein (which costs approximately $8), are just as effective in predicting heart attack risk. COX-2 MARKET GROWS DURING WEEK OF VIOXX RECALL AS CONSUMERS REPLACE SUPPLIES; PFIZER GAINS MOST MARKET SHARE ___________________________________________________________________________ Verispan reported U.S. consumers purchased nearly 913,000 prescriptions for COX-2-specific inhibitors during the week ended Oct. 1--the week of the recall of Merck & Co. Inc.'s Vioxx (rofecoxib)--7 percent more than in the week ended Sept. 24. The number of new prescriptions exceeded 484,000, up 28 percent from the previous week. "The increase in the COX-2 market makes sense because patients are immediately discontinuing Vioxx and are replacing their supply with comparable alternatives," said Verispan Chief Executive Officer Greg Porter. Verispan projected that 162,125 new prescriptions during the week were product switches by former Vioxx users. Thirty-eight percent of patients who switched from Vioxx purchased Pfizer Inc.'s Celebrex (celecoxib), 32 percent switched to Pfizer's Bextra (valdecoxib) and 10 percent switched to Abbott Laboratories and Boehringer Ingelheim Pharmaceuticals Inc.'s Mobic (meloxicam). Eighteen percent of Vioxx users switched to a generic, non-specific, nonsteroidal anti-inflammatory drug. Overall Celebrex prescriptions increased 26 percent week-over-week to 451,511, Bextra prescriptions were up 32 percent to 294,260 and prescriptions of Mobic climbed 43 percent to 90,495. Vioxx prescriptions fell only 37 percent--from 265,626 to 167,062--since the recall was announced on Sept. 30, one day before the end of the study period. DECREASED COSTS, BETTER EFFICACY ASSOCIATED WITH ZYVOX COMPARED WITH VANCOMYCIN IN NEW SKIN INFECTION TRIAL ___________________________________________________________________________ Pfizer Inc.'s Zyvox (linezolid) may be linked with higher cure rates and lower costs compared with vancomycin for the treatment of complicated skin and soft tissue infections, according to new data. The study, which was a sub-analysis of a randomized open-label multicenter Phase IV study, included 717 patients assigned to either oral or intravenous Zyvox (n=366) or intravenous vancomycin (n=351). The patients had complicated skin and soft tissue infections caused by suspected or proven methicillin-resistant Staphylococcus aureus. In the intent-to-treat group, 92 percent of Zyvox-treated patients were cured compared with 86 percent of vancomycin-treated patients. Clinical cure was defined as complete resolution of baseline signs and symptoms. Cost savings per patient totaled $652 with Zyvox, or an average total cost of $5,143 compared to $5,794 with vancomycin. Researchers noted that the lower costs were associated with the oral option as well as an earlier discharge from the hospital. The data were presented in Boston at a meeting of the Infectious Diseases Society of America. STUDIES SHOW HOSPITAL CARE VARIES, MORE RESOURCE USE MAY NOT RESULT IN BETTER CARE ___________________________________________________________________________ There appears to be a striking variation across hospitals regarding use of resources by Medicare patients with chronic illnesses, but higher-intensity hospitals may not result in higher quality of care or better survival, two new studies show. In one, John Wennberg and colleagues analyzed variations in the amount of care used by 90,616 patients with solid tumor cancers, congestive heart failure (CHF) and chronic obstructive pulmonary disease (COPD) during their last six months of life at 77 well-known academic medical centers. Average rates of resource use by patients with cancer were lower than rates of use by patients with COPD or CHF. The mean rate for patient days in hospital and for physician visits by patients with COPD or CHF was approximately 21 to 28 percent greater than that of patients with cancer. Correlations also indicated that, except for intensive care unit (ICU) use by patients with cancer, the system of care--especially the hospital--was much more important in determining the frequency of care use than the nature of a patient's chronic illness. Moreover, hospitalized patients received very different amounts of care: patients receiving most of their care from Mount Sinai Medical Center spent nearly twice as many days in the hospital as patients who went to St. Mary's and Rochester Methodist Mayo Clinic hospitals. Technology use, as measured by the number of ICU days, was three times greater for patients at the University of California, Los Angeles Medical Center than for patients admitted to Massachusetts General Hospital. Similar results were found in a second trial, during which Elliott Fisher and colleagues evaluated initial hospitalizations for acute myocardial infarction, colorectal cancer or hip cancer at 299 hospitals between 1993 and 1995. Hospitals were divided into 1 of 5 groups based on the overall intensity of medical services they delivered to patients with chronic illnesses. After the acute episode, per patient spending on hospital and physician services was between 47 and 58 percent higher in the high-intensity hospitals than in the lower-intensity hospitals. Use of resources increased linearly and substantially across the different intensity groups; compared with the lower-intensity hospitals, all evaluation and management services were performed at higher rates and use of the hospital as the site of patient care was greater at the higher-intensity hospitals. However, based on quality-of-care measures drawn from chart reviews by the Cooperative Cardiovascular Project, higher-intensity academic medical centers were associated with either no difference or a decrement in quality as intensity increased. There was also no link between increased intensity across these major medical centers and improved survival. "The similar results achieved with markedly different levels of resource inputs imply large differences in the longitudinal efficiency of chronic disease care across these hospitals," the study authors concluded. Both studies were published on Oct. 7 as part of a Health Affairs Web exclusive issue. Marketing Slogan ALPHARMA INC. ___________________________________________________________________________ Alpharma Inc. and Pfizer Inc. each launched generic versions of Pfizer's Neurontin (gabapentin) 100 mg, 300 mg and 400 mg capsules Friday. The firms are awaiting a decision in patent litigation regarding the drug, which is approved for postherpetic neuralgia (pain associated with shingles) and partial seizures in adults and children. Pfizer's generic formulation was launched through its subsidiary Greenstone Ltd. Marketing Slogan BRISTOL-MYERS SQUIBB CO. ___________________________________________________________________________ Bristol-Myers Squibb Co. is reducing its primary care sales force by nearly 500 positions in an effort to focus its efforts on specialty areas such as diabetes, cancer and cardiovascular disease, The Star-Ledger in Newark, N.J., reported. The company also said it will add 200 sales positions for its HIV and antipsychotic drugs. Marketing Slogan VENTIV HEALTH INC. ___________________________________________________________________________ Ventiv Health Inc. signed a multi-year agreement to market and sell Ranbaxy Pharmaceuticals Inc.'s acne therapy Sotret (isotretinoin) in the United States. Ventiv said Sotret is the only brand of isotretinoin that offers a 30 mg dosage strength. Marketing Slogan CELLEGY PHARMACEUTICALS INC. ___________________________________________________________________________ Cellegy Pharmaceuticals Inc. entered into a definitive agreement to acquire Biosyn Inc., which Cellegy said has the most advanced microbicide being developed for the prevention of HIV transmission. Biosyn's Savvy (C31G 1%) vaginal gel is currently being examined in two Phase III trials in Africa. Biosyn also has $50 million in commitments for grant funding, Cellegy said. Cellegy exchanged 2.5 million shares of its stock for all of Biosyn's stock and made a $3.25 million cash payment. It will owe an additional $15 million if Savvy is approved in the United States and selected foreign markets. Marketing Slogan THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES ___________________________________________________________________________ The U.S. Department of Health and Human Services granted three-year contracts worth $100.6 million and $76.3 million to Bavarian Nordic Research Institute A/S and Acambis Inc., respectively, to develop modified vaccinia Ankara (MVA) vaccines, Reuters reported. MVA is a weakened form of smallpox vaccine being developed for use in individuals with weak immune systems. Avecia Biotechnology Ltd. was also awarded a three-year $50.7 million contract to develop a vaccine against plague. Marketing Slogan


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