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			Naming Consultants 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 Wyeth's Premarin does not increase breast cancer incidence, study shows Treatment with Wyeth's Premarin (conjugated equine estrogen) hormone replacement therapy for 7.1 years did not increase breast cancer incidence in postmenopausal women who had undergone hysterectomy, according to new findings from the Women's Health Initiative Estrogen-Alone trial. A separate WHI randomized estrogen plus progestin trial, which examined treatment with conjugated equine estrogen and progesterone, had found that the combination of estrogen and progesterone produced more health risks than benefits, including a higher incidence of breast cancer. The WHI Estrogen-Alone trial, a parallel trial, was halted early because of an increased stroke incidence and no reduction in the risk of coronary heart disease. Because preliminary analysis from this trial showed a possible reduction in breast cancers, further analysis was conducted to discover the breast cancer incidence and mammogram findings. In this trial, a total of 10,739 postmenopausal women aged 50 to 79 years with prior hysterectomy were randomized to receive Premarin 0.625 mg/day or placebo. Each patient had a mammography screening and clinical breast examination at baseline and annually. At the mean follow-up of 7.1 years, women in the Premarin group had a nonsignificant reduction for invasive breast cancer and for total breast cancer. However, an analysis that included only women who were adherent to the hormone therapy found a larger and significant reduction in the incidence of invasive breast cancer in the Premarin group as compared with the placebo group. At one year, more women in the hormone therapy group had mammograms with abnormalities that required follow-up as compared with the placebo group (9.2 percent vs. 5.5 percent). This pattern continued throughout the study, the authors said. "The findings from this current study may be reassuring because even with the reported increased number of abnormal mammograms and biopsies, there was no reported increase in breast cancer incidence, and there was a significant decrease in the most common type of breast cancer," said Dr. Hugh Taylor, director of The Yale Menopause program, in a Wyeth press release. "Initiation of [Premarin] should be based on consideration of the individual woman's potential risks and benefits," the authors concluded. The study appeared in the April 12 issue of JAMA. Naming Consultants Lilly's Evista shows mixed results in RUTH study Eli Lilly and Co.'s Evista (raloxifene hydrochloride), an osteoporosis treatment, did not prevent coronary events but did decrease the risk of invasive breast cancer in postmenopausal women in a recent study. The RUTH trial included more than 10,000 postmenopausal women who had known heart disease or who were at high risk for myocardial infarction. The placebo-controlled study was designed to determine if a 60 mg daily dose of Evista would reduce the risk of coronary events and the risk of invasive breast cancer. According to Lilly, the preliminary analyses showed that Evista treatment did not increase or decrease the combined endpoint of nonfatal MI, fatal MI and hospitalized acute coronary syndrome as compared with placebo. However, it did decrease the risk of invasive breast cancer compared with placebo. Other findings showed that there was no difference in overall mortality or cardiovascular mortality among women who received Evista as compared with women who received placebo. In addition, there was no difference in the overall number of strokes, although there was an increase in stroke mortality in the Evista group. There was also an increase in venous thromboembolic events in the Evista group, but Lilly said this was consistent with previous results and is reflected in the drug's label. Lilly's chief medical officer, Dr. Alan Breier, urged physicians to be aware of the cardiovascular findings of the study. "Because Evista did not prevent coronary events, we want to reinforce that Evista should not be prescribed for cardioprotection. Physicians should be aware that the modest reduction of ... 'bad' cholesterol, previously seen in Evista's clinical trials and currently reflected in the label, did not translate into cardioprotection in the RUTH study," he said. Breier added that the company plans to submit the breast cancer results to the Food and Drug Administration. Lilly said it will work with the agency to finalize data analyses and update the product label as needed. Evista is approved for the prevention and treatment of osteoporosis in postmenopausal women. Naming Consultants Accentia's SinuNase receives fast track status; Accentia enters into promotional agreement with Exaeris to market MD Turbo The Food and Drug Administration granted fast track status to Accentia Biopharmaceuticals Inc.'s SinuNase (amphotericin B), an investigational treatment for chronic sinusitis (CS). SinuNase is a low-dose intranasal suspension designed to treat symptoms of CS in the mucus layers of the nasal cavity, without penetrating the sinus mucosa or the rest of the body. Accentia plans to commence a four-month, randomized, double-blind, placebo-controlled Phase III clinical trial of SinuNase, which will include refractory patients who have undergone sinus surgery for CS but still experience recurrent CS. The trial will evaluate the efficacy and safety of the drug as a treatment for CS. Separately, Accentia finalized a co-promotion agreement with Inyx Inc.'s specialty pharmaceutical division, Exaeris Inc. The companies will co-market MD Turbo, a breath-activated, dose-counting companion to meter dose inhalers. MD Turbo is designed to help ensure the labeled dose is delivered at the appropriate time and assist in tracking the number of doses remaining before a refill is required. The companies anticipate that MD Turbo will be available by prescription later this quarter. Naming Consultants Advair raises costs, ED visits, study shows Treatment with GlaxoSmithKline Plc's Advair Diskus (fluticasone propionate/salmeterol xinafoate) appears to increase asthma-related costs and emergency department visits, new findings reveal. Using claims data from an employer-sponsored health plan, researchers evaluated the impact of Advair on the market. They used data from Jan. 1, 1998, to Dec. 30, 2000, and the full year 2003 (to include data after the introduction of Advair to the market). The study population included 1.4 million patients who had prescriptions filled for Advair (a fixed-dose inhaled corticosteroid and long-acting beta-agonist [LABA] combination), other inhaled corticosteroids or other LABAs. Between 1998 and 2000, results showed that for all inhaled corticosteroids, 400 prescriptions were dispensed for every 100 office visits. In 2003, this number increased to 407 prescriptions per 100 office visits, 118 of which were for Advair. The number of prescriptions for LABAs increased to 147 prescriptions per 100 office visits in 2003 from 67 prescriptions per 100 office visits in 1998. Although there was a savings of $4,789 per 100 office visits for other inhaled corticosteroids or LABAs in 2003, an additional $19,237 per 100 office visits was spent on Advair in this period. Furthermore, the researchers found that average costs for asthma prescriptions increased to $68 in 2003 from an average of $46 in the earlier period. There was a nonsignificant decrease in asthma-related hospital admissions after Advair was introduced to the market. However, asthma-related ED visits increased significantly, resulting in an additional 0.9 ED visits per 100 Advair prescriptions. "There is no consistent relationship between the trend of asthma exacerbations in the population and the introduction of the fixed-dose combination of [Advair] despite a substantial increase in expenditure," the researchers concluded. These data were presented at the annual meeting of the Academy of Managed Care Pharmacy in Seattle, Wash. Naming Consultants Labopharm's tramadol significantly reduces pain intensity, study shows A recently completed trial of Labopharm Inc.'s once-daily formulation of tramadol, a pain treatment, reached statistical significance for its primary endpoint, a comparison of pain intensity at baseline with pain intensity at the end of the study. The double-blind Phase III trial (MDT3-005), which was conducted under a special protocol assessment with the Food and Drug Administration, included approximately 1,000 patients who had received a diagnosis of moderate to severe pain associated with osteoarthritis of the knee. The patients were randomized to receive placebo or once-daily tramadol, titrated to an optimal dose of either 200 mg or 300 mg, which was continued for 12 weeks. The primary endpoint was measured by the 11-point Pain Intensity Numerical Rating Score. According to Labopharm, "Statistical significance was achieved for the primary endpoint and was maintained under additional methods of analysis." The company added that the drop-out rate was similar to its European Phase III trial (MDT3-001) and that the number of adverse events was lower than in MDT3-001. Two other U.S. Phase III trials, MDT3-002 and MDT3-003, had similar adverse events. Labopharm said the new results would be added to the company's New Drug Application for once-daily tramadol in a timely fashion so as to preserve the Prescription Drug User Fee Act action date of Sept. 26. Naming Consultants Research shows drug coverage, costs in Medicare's private stand-alone drug plans vary significantly between plans Medicare Part D stand-alone drug plans vary significantly in terms of accessibility and costs of drugs covered by the plans, according to a study by The Henry J. Kaiser Family Foundation. Researchers examined formularies, drug costs and utilization management tools in drug plans from 14 organizations, which, combined, offer a total of 35 prescription drug plans. These drug plans account for 1,222 of the 1,429 packages offered to Medicare beneficiaries. Researchers examined a sample of 152 brand-name and generic drugs, including ones that are commonly used by beneficiaries and those that are less common and high-cost. Results showed that, on average, 81 percent of drugs in the sample are covered by the plans. The coverage ranges from 64 percent of drugs in the plan with the most restrictive formulary to 97 percent in the plan with the least restrictive formulary. None of the drug plans that were studied cover all 152 of the sample drugs. All of the top 10 most commonly prescribed generic drugs are covered by 32 of the 35 plans, while only 18 of the 35 plans cover all of the top 10 brand-name drugs. Of the top 10 drugs, the most commonly omitted in favor of the generic equivalent are AstraZeneca Plc's heartburn drug, Nexium (esomeprazole magnesium), Novartis AG's hypertension drug Diovan (valsartan) and Bristol-Myers Squibb Co. and Sanofi-Aventis Group's antiplatelet, Plavix (clopidogrel bisulfate). Additionally, formulary comprehensiveness varies considerably between different drug groups; approximately 90 percent of antidepressants, beta blockers and tumor necrosis factor inhibitors are covered by the formularies versus approximately 60 percent of proton pump inhibitors and hormonal agents. Results also showed that the cost-sharing payment for drugs covered by a plan's formulary varies considerably between the Medicare drug plans, with the three-tier system of copayments being the most common cost-sharing arrangement. Among the 21 plans that use a three-tier system, the median cost sharing is $5 for first-tier, generic drugs, $25 for second-tier, preferred branded drugs and $53 for third-tier, nonpreferred branded drugs. Plans also vary significantly in the frequency that they restrict enrollees' access to specific drugs through quantity limits, prior authorization requirements and step therapy provisions, which require enrollees to try a less costly drug before they receive a more expensive alternative. Of the plans studied, 13 plans use these tools for at least one in four covered drugs. "What's not yet clear is how well people with Medicare can sort through all these differences to make informd decisions," said Drew Altman, president of the Kaiser Family Foundation. Naming Consultants Naming Consultants AstraZeneca Plc AstraZeneca Plc entered into a third agreement with Cell Signaling Technology Inc. (CST) to continue using CST's PhosphoScan technology to identify phosphorylation profiles and prospective biomarkers of kinase targeted lead compounds. According to CST, the PhosphoScan protemomics technology enables the discovery of target phoso-proflies, which "may enable biomarker assays for target validation and therapeutics kinase inhibitor clinical development." Naming Consultants Naming Consultants Amgen Inc. Amgen Inc. filed a complaint with the U.S. International Trade Commission (ITC) to request an investigation of Roche's importation of pegylated recombinant human erythropoietin (peg-EPO). According to Reuters, Roche said the action would not impact it from soon filing for approval of its experimental anemia drug Cera, which is a continuous erythropoietin receptor activator. Amgen believes the importation is unlawful because it violates patents that cover the manufacturing method for Amgen's peg-EPO. Amgen requested that the ITC issue a permanent exclusion order that would prohibit the importation. Amgen anticipates that the ITC will make a decision within 30 days as to whether it will institute a formal investigation. Naming Consultants Naming Consultants Discovery Partners International Inc. Discovery Partners International Inc. and Infinity Pharmaceuticals Inc. agreed to merge to create a new company focused on cancer drug discovery and development. The new entity, which will go by the name Infinity Pharmaceuticals Inc., will have a lead product candidate in multiple Phase I trials, a second product scheduled to enter the clinical phase in late 2006 and a pipeline of proprietary small molecule candidates. It will also have partnerships with Novartis AG, Johnson & Johnson and Amgen Inc. As part of the agreement, Infinity shareholders will own approximately 69 percent of the combined company on a pro forma basis, while DPI stockholders will own approximately 31 percent. Naming Consultants Naming Consultants Valeant Pharmaceuticals International Valeant Pharmaceuticals International advised its partner and licensor, Metabasis Therapeutics Inc., that Valeant will continue the development of pradefovir, an investigational treatment for hepatitis B, through the beginning of Phase III trials. Valeant plans to out-license pradefovir as part of an overall restructuring of the company and is looking for a partner to complete the development and possible commercialization of the drug. Naming Consultants


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