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			Strategic Name Development 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 ANALYSIS REVEALS GREATER INCIDENCE OF HEART ATTACKS, STROKE WITH BEXTRA ___________________________________________________________________________ Pooled data show that patients receiving Pfizer Inc.'s Bextra (valdecoxib) had a 2.19-fold greater incidence of heart attacks and stroke than subjects who received placebo, according to a New York Times report. The findings, presented in New Orleans at the American Heart Association Scientific Session meeting, came from 12 trials with 5,930 patients. Pfizer said in a press release that these "unsubstantiated conclusions" about Bextra's cardiovascular safety are based on information that has not undergone an independent scientific review nor has been published in a medical journal. The firm pointed to an article published earlier this year in the American Journal of Therapeutics in which investigators evaluated a clinical trials database of nearly 8,000 patients treated with Bextra for up to one year. The peer-reviewed analysis showed that short- and intermediate-term Bextra treatment was not linked to an increased risk of thrombotic events as compared with nonselective nonsteroidal anti-inflammatory drugs or placebo in patients with osteoarthritis and rheumatoid arthritis. Dr. Joseph Feczko, Pfizer's president of worldwide development, also noted that the pharmaceutical company has shared clinical results with regulatory authorities in a timely manner and last month provided American health care professionals with a summary of currently available data. Furthermore, the heart problem with Bextra only appeared in studies involving patients who were at very high risk for heart disease and who were undergoing cardiac surgery, Pfizer spokeswoman Susan Bro told the Times. Bro added that the newest findings grouped samples that were too disparate for conclusive results. Last month, Pfizer sent a letter to health care professionals notifying them of a change in Bextra's label regarding a risk of Stevens-Johnson Syndrome, a rare but serious skin reaction. Earlier this week, Forbes.com reported that in Pfizer's filing with the Securities and Exchange Commission, the pharmaceutical company said it will likely be required to add a black box warning to Bextra. New sources have also reported, according to the Times, that the filing referenced a rejection by the Food and Drug Application for an application seeking approval for Bextra as a migraine treatment. ADVANCED MEDICAL OPTICS AGREES TO ACQUIRE VISX IN $1.27 BILLION TRANSACTION ___________________________________________________________________________ Advanced Medical Optics Inc., maker of ophthalmic surgical devices and eye care products, entered into a definitive agreement to acquire the laser vision correction device firm Visx Inc. in a cash-and-stock transaction valued at approximately $1.27 billion. The merger of the two ophthalmic companies will create a firm with a broad range of superior technologies and a singular focus on serving the vision care needs of global practitioners and patients, according to an Advanced Medical Optics press release. Specifically, the merger will provide surgeons and patients with brands such as Visx's Star Laser System and CustomVue custom ablation technology plus Advanced Medical Optics' Amadeus microkeratome, Verisyse phakic IOL and Rezoom, Array and Tecnis multifocal IOL. "With its proprietary laser systems and custom ablation technologies, skilled service organization and long-standing reputation for reliability, Visx is the manufacturer of choice in laser vision correction," said Jim Mazzo, Advanced Medical Optics' chief executive. "Adding their robust product platform to our existing refractive business represents a bold step forward to achieve one of Advanced Medical Optics' core strategic goals to build a leading refractive surgical business," he noted. Terms of the agreement provide that Visx stockholders receive 0.552 shares of Advanced Medical Optics stock plus $3.50 in cash for each Visx share owned, creating a total value of $26.52 per Visx share based on the closing price of Advanced Medical Optics' common stock on Monday. Upon completion of the transaction, which has already been approved by the companies' boards of directors, Advanced Medical Optics' shareholders will own approximately 58.5 percent of the combined firm while Visx shareholders will retain nearly 41.5 percent ownership. Shares of Visx closed at $24.36, up $6.36, or 34.6 percent, while Advanced Medical Optics shares closed at $38.80, down $3.64, or 8.6 percent, both in heavy trading on the New York Stock Exchange. NORVASC BENEFITS CAD PATIENTS WITH NORMAL BLOOD PRESSURE, STUDY INDICATES ___________________________________________________________________________ Pfizer Inc.'s calcium-channel blocker Norvasc (amlodipine besylate) reduced by 31 percent the risk of a cardiovascular event observed in a two-year trial of patients who had coronary artery disease (CAD) but normal blood pressure. According to the study investigators, there is no consensus regarding administration of hypertension drugs to normotensive patients with CAD, but strong epidemiological data suggest the lowest cardiovascular event rates occur in patients with systolic blood pressure readings that are much lower than current treatment guidelines. Therefore, the researchers designed a study that would compare the CCB Norvasc and the ACE inhibitor enalapril against placebo in these patients. Enalapril is marketed by Merck & Co. Inc. as Vasotec. In all, 1,991 patients were randomly assigned to one of the three treatments for 24 months. Baseline blood pressure averaged 129/78 mm Hg, and most patients were using aspirin (95 percent), a statin (83 percent) or a beta-blocker (76 percent). Blood pressure increased by 0.7/0.6 mm Hg in the placebo group during the course of the study; it dropped by 4.8/2.5 mm Hg and 4.9/2.4 mm Hg in the Norvasc and enalapril groups, respectively. During the study, a cardiovascular event occurred in 151 placebo-treated patients (23.1 percent), 110 Norvasc-treated patients and 136 enalapril-treated patients. As compared with the placebo group, patients in the Norvasc and enalapril groups had a 31 percent and 15 percent reduced risk of cardiovascular event. The difference between Norvasc and placebo was statistically significant; the differences between enalapril and Norvasc and between enalapril and placebo were not statistically significant. The study authors noted that, as compared with placebo, 16 patients would need to be treated with Norvasc in order to prevent one cardiovascular event during a two-year period. A substudy of 247 patients who underwent intravascular ultrasound at baseline and study completion showed patients who received placebo had a significant increase in the progression of plaque build-up in coronary arteries, while patients receiving Norvasc had no progression. Subjects in the enalapril group had a non-significant trend toward disease progression. "Administration of [Norvasc] to patients with CAD and normal blood pressure resulted in reduced adverse cardiovascular events. Directionally similar, but smaller and nonsignificant, treatment effects were observed with enalapril," the study authors concluded. "These results suggest that the optimal blood pressure range for patients with CAD may be substantially lower than indicated by current guidelines," they added. The study was presented in New Orleans at the American Heart Association's Scientific Sessions 2004 and was published in the Nov. 10 issue of JAMA. HDL CHOLESTEROL DRUG NIASPAN IMPROVES CAD OUTCOMES WHEN ADDED TO STATIN, STUDY SHOWS ___________________________________________________________________________ Combination treatment using a statin and Kos Pharmaceuticals Inc.'s Niaspan (niacin, extended-release), which raises HDL cholesterol levels, slowed progression of atherosclerosis and lowered the rate of coronary events in a recent trial as compared with statin monotherapy. The study included 167 patients with coronary artery disease who were using an LDL cholesterol-lowering statin at trial initiation. These patients were randomly assigned to add Niaspan or a placebo to their statin therapy for one year. The primary efficacy measurement was the change in carotid intima-media thickness (CIMT). The mean baseline CIMT was 0.884 mm in the entire study cohort. Twelve-month data showed CIMT increased significantly in the statin-plus-placebo group (+0.044 mm) but did not increase significantly in the Niaspan group (+0.014 mm). The between-group difference in CIMT change, however, was not statistically significant. Kos said these data showed Niaspan slowed disease progression 68 percent more than statin therapy alone. Clinical cardiovascular events occurred in three Niaspan-treated patients (3.8 percent) versus seven patients in the placebo group (9.6 percent), reflecting a 60 percent reduction with Niaspan. HDL cholesterol increased from 39 mg/dL to 47 mg/dL in the Niaspan group, but remained unchanged in the placebo group. Triglycerides also decreased significantly in the Niaspan group. Kos said the improvement in clinical outcomes seen with Niaspan were attributed to these lipid changes. "Kos Pharmaceuticals recognizes that any further gains to be made in reducing patients' heart disease risk will be achieved by going beyond the treatment of LDL cholesterol alone, and the evidence for this approach continues to mount," said Kos Chief Executive Officer Adrian Adams. These data were presented in New Orleans at the American Heart Association's Scientific Sessions 2004 and are accessible on the Web site of the journal Circulation. COREG SHOWS POTENTIAL BENEFITS OVER METOPROLOL IN PATIENTS WITH DIABETES, HYPERTENSION, FINDINGS INDICATE ___________________________________________________________________________ In the presence of renin-angiotensin system blockage, GlaxoSmithKline Plc's Coreg (carvedilol) stabilized a measure of blood sugar control, improved insulin resistance and slowed development of microalbuminuria as compared with metoprolol tartrate among a group of patients with type 2 diabetes mellitus and hypertension. During the Glycemic Effects in Diabetes Mellitus: Carvedilol-- Metoprolol Comparison in Hypertensives (GEMINI) trial, 1,235 subjects were randomized to receive 6.25 mg to 25 mg of Coreg or 50 mg to 200 mg of metoprolol twice daily for seven weeks; once the target blood pressure or the highest dose level was reached, maintenance therapy continued for five or more months. Additionally, the patients took 12.5 mg of hydrochlorothiazide followed by a dihydropyridine calcium antagonist as necessary to achieve the target blood pressure. At baseline, mean hemoglobin A1c, a long-term measure of glucose control, was 7.2 percent. This amount increased by 0.15 percent with metoprolol treatment, while Coreg had no effect on HbA1c. Blood pressure remained similar between the two groups, but the patients demonstrated differences in insulin resistance and microalbuminuria. Coreg-treated patients showed a significant 9.1 percent drop in insulin resistance, while metoprolol-treated patients had a non-significant 2 percent reduction. When compared with metoprolol therapy, Coreg resulted in a 16 percent risk reduction in the albumin:creatinine ratio, which is a measure of microalbuminuria. Coreg was also associated with improvement in total cholesterol and a smaller increase in triglyceride levels relative to metoprolol. "It is our hope that the GEMINI trial will impact the future of diabetes management because it provides evidence of a positive impact of Coreg on cardiovascular risk factors for this hypertensive patient population without negatively affecting HbA1c," said Dr. George Bakris, director of the Hypertension Research Center at Chicago's Rush University Medical Center. These data were presented in New Orleans at the American Heart Association's Scientific Session 2004 and were also published in the Nov. 10 issue of JAMA. TRIAL SHOWS FOSINOPRIL, BUT NOT PRAVACHOL, LOWERS URINARY ALBUMIN EXCRETION, MAY REDUCE CARDIOVASCULAR EVENTS IN MICROALBUMINURIC SUBJECTS ___________________________________________________________________________ Findings from a new study indicate treatment with fosinopril, but not with Bristol-Myers Squibb Co.'s Pravachol (pravastatin sodium), has a significant effect on urinary albumin excretion and may reduce cardiovascular events in patients with microalbuminuria. "Small clinical studies and post-hoc analysis of large trials show that the degree of reduction of proteinuria or albuminuria during ACE inhibitor or angiotensin II receptor antagonist therapy is associated with the degree of cardiovascular and renal protection," wrote researchers. "However, it is unknown whether intervention specifically aimed at reducing urinary albumin excretion will reduce cardiovascular events." In the Prevention of Renal and Vascular End-stage Disease Intervention Trial (PREVEND IT), the authors examined the effects of fosinopril and Pravachol in reducing the incidence of cardiovascular events in patients with microalbuminuria (15 to 300 mg/24 hours). PREVEND IT is a substudy of the PREVEND program, which was designed to evaluate microalbuminuria as an indicator of increased cardiovascular and renal risk in the general population. Among the 8,592 individuals in the PREVEND cohort, a total of 864 fulfilled the inclusion criteria of PREVEND IT (persistent microalbuminuria, blood pressure less than 160/100 mm Hg with no antihypertensive medication and total cholesterol less than 8.0 mmol/L [less than 5.0 mmol/L with previous myocardial infarction] with no use of lipid-lowering medication) and were included. Mean age was 51 years and 3.4 percent had a previous cardiovascular event; mean cholesterol was 5.8 mmol/L, mean blood pressure was 130/76 mm Hg and median urinary albumin excretion was 22.8 mg/24 hours. Participants were randomized to receive fosinopril 20 mg or matching placebo and to Pravachol 40 mg or matching placebo. The primary endpoint was a combination of cardiovascular mortality and hospitalization for cardiovascular morbidity. During a mean 46-month follow-up, the primary endpoint occurred in 45 participants (5.2 percent). Fosinopril significantly reduced urinary albumin excretion by 26 percent, while Pravachol had no effect on albuminuria. Participants treated with fosinopril had a 40 percent lower incidence of the primary endpoint, while those treated with Pravachol had a 13 percent lower incidence. "PREVEND IT did not generate a definitive answer to the question of whether primary prevention is indicated in microalbuminuric subjects without any other indication for primary prevention; however, the results of the intervention with fosinopril, particularly in the high-albuminuria (higher-risk) group, support the hypothesis that treatment that has a significantly favorable effect on urinary albumin excretion rate is associated with a beneficial clinical outcome," the authors concluded. "Therefore, the results of PREVEND IT favor further (larger) studies in subjects with microalbuminuria but with no other indication for primary prevention. Moreover, intervention directed at the renin-angiotensin system appears to be the therapy of first choice in such studies." Complete study details were published in the Nov. 2 issue of Circulation. Strategic Name Development AMGEN INC. ___________________________________________________________________________ Amgen Inc. said it expects Medicare reimbursement changes recently enacted by the federal government to negatively impact 2005 sales of its anemia drug Aranesp (darbepoetin alfa) and its infection-fighting drugs Neulasta (pegfilgrastim) and Neupogen (filgrastim). The company said it expects reimbursement rates next year to be lower than the 2004 reimbursement rates for these products, but cannot yet predict the full impact on the company's financial results. Strategic Name Development NDCHEALTH CORP. ___________________________________________________________________________ NDCHealth Corp. commenced an orderly process to retain an investment bank to assist the firm in a review and analysis of strategic alternatives available to NDC, the company said in a press release. The initiative was approved by stockholders at the company's annual meeting Oct. 28. Strategic Name Development ESP PHARMA INC. ___________________________________________________________________________ ESP Pharma Inc. received an orphan drug designation from the Food and Drug Administration for I.V. Terlipressin, an experimental treatment for type I hepato-renal syndrome. ESP Pharma acquired U.S. marketing rights for the product from Orphan Therapeutics LLC earlier this year. Orphan Therapeutics has initiated a Phase III trial of I.V. Terlipressin in Type I HRS, a condition that involves acute kidney failure arising from severe liver disease. Strategic Name Development MERCK & CO. INC. ___________________________________________________________________________ Merck & Co. Inc. acquired from Ono Pharmaceutical Co. Ltd. a worldwide license for ONO-2506, a prospective treatment for acute stroke. The product is currently in Phase II development. Ono will receive an upfront payment as well as milestone payments and potential royalties on sales. 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