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Name BrandingBrand 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 AstraZeneca announces retirement of CEO, raises 2005 guidance on strong Q2 earningsAstraZeneca Plc's chief executive officer, Tom McKillop, will retire at the beginning of next year, the company confirmed Thursday, noting that he will be succeeded by David Brennan, executive vice president of the company's North American operations, effective Jan. 1, 2006. McKillop is expected to join the Royal Bank of Scotland Group Plc as chairman-designate, Reuters reported. Also on Thursday, AstraZeneca posted forecast-beating 2005 second-quarter earnings, led by strong drug sales. Net profit for the second quarter increased from $816 million, or $0.48 per diluted share, in 2004 to $1.22 billion, or $0.75 per diluted share, in 2005. Sales were up 16 percent for the quarter, rising from $5.29 billion in the second quarter of 2004 to $6.13 billion in the second quarter of 2005. Quarterly sales of Crestor (rosuvastatin calcium), the firm's cholesterol-lowering drug, increased 50 percent over last year's second quarter, from $207 million to $317 million. With $1.2 billion in sales for the second quarter, proton pump inhibitor Nexium (esomeprazole magnesium) experienced a 33 percent increase from last year's second-quarter sales of $891 million. For the full year, the firm now expects to earn more than $2.75 per share. Previously forecasted earnings ranged from $2.35 to $2.50 per share. The company said its performance during the first half of the year "creates a platform for good earnings growth in the following two years." Shares of AstraZeneca closed at $44.14, up $2.03, or 4.8 percent, in heavy trading on the New York Stock Exchange. Name Branding Schering, Novartis report weak results from trial of experimental cancer drug Novartis AG and Schering AG said their experimental cancer drug PTK/ZK most likely will not extend the lives of patients with colorectal cancer, based on interim data from CONFIRM 2, a clinical trial investigating the drug in combination with chemotherapy as second-line therapy. The assessment was based on a review by an independent data safety monitoring board. "Based on these findings, we will review the development strategy for PTK/ZK and continue to explore its potential," said Dr. Marc Rubin, a member of Schering's executive board. However, many analysts see a bleak future for the drug. "It looks dead now," Birgit Kulhoff told The Wall Street Journal. Kulhoff is an analyst with Sal. Oppenheim in Zurich. "We, and I think most analysts, no longer have any revenue forecast for that drug in our models, after the weak data in progression-free survival," Kulhoff added. According to The Journal, the news is likely to be most damaging to Schering, which has faced delays with other drugs in its pipeline. Novartis, on the other hand, is in a better position to deal with the setback, thanks to a strong pipeline and no major patent expirations in the near future. The companies said the Phase III CONFIRM 1 trial, a separate trial evaluating PTK/ZK as a first-line therapy in metastatic colorectal cancer, will continue as planned. Overall survival results from this trial are expected in the second half of 2006. PTK/ZK is an investigational oral vascular epithelial growth factor (VEGF) receptor tyrosine kinase inhibitor designed to block tumor angiogenesis and lymphangiogenesis by inhibiting all known VEGF receptors. Schering shares closed at $63.25, down $1.11, or 1.7 percent, in heavy trading, while Novartis shares closed at $48.81, up $0.01, in moderate trading. Both shares are traded on the New York Stock Exchange. Name Branding Genzyme's Renagel shows possible mortality benefit in subsets of dialysis patients Genzyme Corp. said results from the Dialysis Clinical Outcomes Revisited trial showed that Renagel (sevelamer hydrochloride) reduced the risk of death in certain patient populations when compared with calcium-based phosphate binders, a widely used and less expensive alternative. The three-year trial included more than 2,100 participants and was the first large-scale, prospective, randomized clinical trial to demonstrate a mortality or morbidity benefit for patients on hemodialysis. Trial data showed that Renagel, a polymer that binds excess phosphorus in the blood, reduced the risk of death for patients aged 65 or older by 22 percent and for patients who received the drug for more than two years, regardless of age, by 34 percent. Overall, Renagel-treated patients experienced a 9 percent reduction in the risk of death relative to those who received calcium-based phosphate binders, a result that was not statistically significant. "This is an unprecedented moment for patients on dialysis," said Dr. Wadi Suki, the lead researcher. "For the first time, a treatment has been shown to reduce the alarmingly high rate of death and illness seen in patients on dialysis. These results strongly suggest that Renagel treatment can have a dramatic impact on patients' lives, and will help to redefine how physicians manage phosphorus in patients on dialysis." Enthusiasm for the results was not unanimous, however. "This is a failed study no matter how you look at it," Dr. Henrik Rasmussen told The Wall Street Journal. Rasmussen is the senior vice president of clinical research at Nabi Biopharmaceuticals, which makes a calcium-based binder. "[Y]ou can always find subsets of patients who benefit," said Rasmussen. Genzyme shares closed at $75.20, up $4.70, or 6.7 percent, in heavy trading on the Nasdaq. Name Branding Topamax may be effective for prophylactic treatment of chronic migraine, findings suggest Patients with chronic migraine may experience a positive response to prophylactic treatment with Ortho-McNeil Neurologics Inc.'s Topamax (topiramate) at rates approaching those observed among patients with less severe migraine in placebo-controlled trials. Patients with a long-term history of chronic daily headache (CDH), however, seem less likely to exhibit a positive response. Researchers evaluated the efficacy of Topamax, as well as variables predictive of a negative response to treatment, in 170 patients with migraine. All patients experienced at least 15 headache days per month and were naove to treatment with Topamax. Topamax was initiated at 25 mg/day and titrated in weekly intervals to a target dosage of 50 mg twice daily. A total of 116 patients completed 60 days of treatment and achieved the target Topamax dose; these patients were included in the efficacy analysis. Of these patients, 45 (38.8 percent) exhibited a positive response to treatment, defined as at least a 50 percent reduction (from baseline) in the number of headache days per month during the second month of treatment. Previous treatment failure with more than three prophylactic agents, previous treatment failure with Abbott's Depakote (divalproex sodium) and experiencing CDH for a duration of more than six months were significantly associated with a negative response to treatment. In a multiple regression analysis, however, CDH duration for more than six months was the only significant predictor of a negative response. Among the 54 patients who were not included in the efficacy analysis, 27 discontinued treatment as a result of adverse events, 10 discontinued because of a lack of clinical improvement, nine failed to return for a follow-up visit and eight did not consistently achieve the target dose of Topamax even though they completed 60 days of treatment. This article appeared in the July/August issue of the journal Headache. Name Branding GSK beats analysts' Q2 expectations; strong drug sales offset Paxil CR manufacturing problems GlaxoSmithKline Plc topped analysts' expectations for the second quarter of 2005, reporting a net profit of approximately $2.08 billion, or $0.36 per diluted share, compared with a net profit of approximately $1.97 billion, or $0.34 per diluted share, in the second quarter of last year. Analysts polled by Thompson First Call expected the company to earn approximately $0.35 per share, MarketWatch reported. GSK's sales increased in the quarter as well, increasing from approximately $9.01 billion in 2004 to approximately $9.41 billion in 2005. Strong sales of asthma therapy Advair (fluticasone propionate/salmeterol xinafoate) helped to offset the effects of manufacturing problems at a facility in Puerto Rico that interrupted the supply of antidepressant Paxil CR (paroxetine hydrochloride). The company reported that quarterly Advair sales increased 22 percent to approximately $1.3 billion; sales of Paxil CR fell 73 percent to approximately $46.6 million. GSK was able to resupply Paxil CR to the U.S. market beginning late last month. The company said it has already gained back 41 percent of its previous share of new prescriptions. For the full year, GSK still expects the growth rate of its earnings per share to be in the low double digits. GSK shares closed at $47.65, up $0.72, or 1.5 percent, in heavy trading on the New York Stock Exchange. Name Branding BMS nearly doubles Q2 earnings, reflecting lower tax rate Boosted by a "significantly lower" effective tax rate, Bristol-Myers Squibb Co.'s second-quarter net income nearly doubled from $527 million, or $0.27 per diluted share, in the second quarter of 2004 to $1 billion, or $0.50 per diluted share, in 2005. Analysts had forecast earnings of $0.36 per share, Reuters reported. The company's second-quarter net sales, led by pharmaceuticals and nutritionals, increased to $4.89 billion, up from $4.82 billion in the second quarter of 2004. The overall increase in sales was offset in part by continued generic competition. Revenue for antipsychotic agent Abilify (aripiprazole), which BMS co-promotes with Otsuka America Pharmaceutical Inc., increased 97 percent, from $122 million in the second quarter of 2004 to $240 million this past quarter. BMS and sanofi-aventis Group's Plavix (clopidogrel bisulfate), an antiplatelet drug, also delivered strong sales during the second quarter, increasing 26 percent to $968 million from $769 million in the same quarter last year. BMS reaffirmed its 2005 guidance for adjusted earnings from continuing operations at $1.35 to $1.45 per diluted share. The company expects its final results to fall at the upper end of this range. Shares of BMS closed at $25.17, up $0.07, or 0.3 percent, in moderate trading on the New York Stock Exchange. Name Branding Name Branding Elan Corp. Plc Elan Corp. Plc revised its outlook for the year's annual sales, citing supply problems in the early part of the year. The company now anticipates 2005 sales will range from $460 million to $500 million--down, as many analysts had expected, from the company's earlier forecast of $500 million. The company posted a net loss of $0.35 per share for the quarter ended June 30, which is worse than the $0.30 loss during the same period in 2004 but better than the median Reuters' poll forecast of $0.37. The loss represents a 21 percent increase over last year's second quarter, from $117.6 million to $142.6 million. At $118.6 million, total revenue for the quarter was close to the predicted $117.5 million and up 9.4 percent from $108.4 million last year. Shares of Elan closed at $7.50, down $0.49, or 6.1 percent, in moderate trading on the New York Stock Exchange. Name Branding Name Branding Ranbaxy Pharmaceuticals Inc. Ranbaxy Pharmaceuticals Inc. said the Food and Drug Administration granted it tentative approval to manufacture and market 3 mg and 6 mg tablet formulations of glimepiride. The drug is indicated as an adjunct therapy to lower blood glucose in patients with type 2 diabetes who are unable to control their hyperglycemia through diet and exercise alone. It can also be used concomitantly with metformin and in combination with insulin, although it can increase the potential for hypoglycemia when combined with insulin. Ranbaxy said the new tablet strengths will give physicians and patients additional dosing flexibility. Glimepiride is the active ingredient in sanofi-aventis Group's Amaryl. Name Branding Name Branding Depomed Inc. Depomed Inc. and Esprit Pharma Inc. entered into a license agreement for Proquin XR (ciprofloxacin hydrochloride), a once-daily, extended-release drug for treating uncomplicated urinary tract infections. As per the agreement, Esprit will pay Depomed a $50 million license fee in exchange for exclusive rights to market and distribute the drug in the United States and Puerto Rico. In addition, Esprit will pay 15 percent to 25 percent royalties on net sales, based on escalating product sales. Esprit also has the right of first refusal for the sales and marketing of the product in Canada. Shares of Depomed closed at $5.15, up $0.68, or 15.2 percent, in heavy trading on the Nasdaq. Name Branding Name Branding Renovis Inc. Renovis Inc. said that after consulting with regulators and the SAINT II trial steering committee, AstraZeneca Plc has increased enrollment for the Phase III SAINT II trial from 1,700 to 3,200. AstraZeneca is developing the study drug, Cerovive (NXY-059), under an exclusive license from Renovis. The companies said the enrollment is being increased to confirm results observed in the SAINT I trial and to improve the statistical power of certain subgroup analyses. This change will likely push the anticipated regulatory filing date from the second half of 2006 to the second half of 2007. In the SAINT I trial, Cerovive showed a significant reduction in disability following an acute ischemic stroke when compared with placebo. Shares of Renovis closed at $15.44, down $0.44, or 2.8 percent, in moderate trading on the Nasdaq. Name Branding Name Branding
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