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			Survey Tools 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 Aromasin approved for new indication in breast cancer Pfizer Inc.'s Aromasin (exemestane tablets) received approval from the Food and Drug Administration as an adjuvant treatment for postmenopausal women who have estrogen-receptor positive early breast cancer after two to three years of tamoxifen therapy. The approval was based on results from the IES trial during which 4,700 postmenopausal women with estrogen-receptor positive breast cancer were followed for a mean 35 months. Those who had five years of hormonal therapy that included two to three years of tamoxifen followed by a switch to Aromasin had 31 percent more protection from cancer recurrence than those who remained on tamoxifen for the entire five years. The significant reduction in recurrence risk included fewer local and distant tumors as well as new cancers in the other breast. Pfizer noted that after these trial results were published in The New England Journal of Medicine, the American Society of Clinical Oncology and the National Comprehensive Cancer Network updated their guidelines to support the use of a new switch regimen using Aromasin adjuvant therapy. Aromasin is already indicated for treating advanced breast cancer in postmenopausal women whose tumors have stopped responding to tamoxifen. Survey Tools ZymoGenetics' Interleukin 21 receives orphan drug status from FDA The Food and Drug Administration granted orphan drug designation to ZymoGenetics Inc.'s Interleukin 21 (IL-21) for the treatment of patients with advanced or aggressive melanoma. IL-21 is being tested in a continuing Phase Ib clinical trial in melanoma and renal cell carcinoma. The trial's dosing regimen is administered in an outpatient setting. "Our studies have shown that IL-21 stimulates cells of the immune system that are thought to have a critical role in eliminating malignant cells. We believe IL-21 may come to play an important role in helping cancer patients who need an effective therapy with manageable side effects," said Dr. Bruce Carter, president and chief executive officer of ZymoGenetics. IL-21 is a cytokine that affects a number of immune effector cells, like cytotoxic T cells and natural killer cells. These specific cell types are believed to play key roles in eliminating malignant and infected cells from the body, the company said. Survey Tools AmerisourceBergen buys Canadian firm Trent Drugs for approximately $83 million Pharmaceutical services company AmerisourceBergen Corp. bought Trent Drugs Ltd., a private Canadian drug distributor, for approximately $83 million. According to AmerisourceBergen, which claims annual revenue in excess of $54 billion, Ontario-based Trent generated approximately $500 million in revenue during the last 12 months. Trent's distribution channels reach about 80 percent of the Canadian population. "Trent's national coverage and its management team provide a solid foundation for expanding our pharmaceutical distribution capability into the Canadian marketplace," said R. David Yost, AmerisourceBergen's chief executive officer. The company said it borrowed from a credit line to finance the transaction, which includes the assumption of $43 million in debt. The acquisition is expected to be accretive to fiscal year 2006 earnings per share by $0.01 to $0.02; analysts surveyed by Thomson Financial are projecting 2006 earnings of $4.02 on sales of $53.95 billion, according to The Associated Press. Richard Normandeau will continue to serve as president of Trent Drugs and has been named a regional vice president with AmerisourceBergen in Canada. Shares of AmerisourceBergen closed at $75.90, down $1.97, or 2.5 percent, in moderate trading on the New York Stock Exchange. Survey Tools On-demand Prevacid effective alternative for maintaining heartburn control Continuous therapy using TAP Pharmaceutical Product Inc.'s Prevacid (lansoprazole) followed by on-demand Prevacid treatment may be an effective alternative to intermittent and continuous therapy for maintaining heartburn control in patients with gastroesophageal reflux, concludes a French study. The double-blind trial enrolled patients aged 18 to 80 years who had at least three episodes of moderate to severe heartburn throughout the week before entering the study. During the trial's acute phase, 203 patients received 15 mg/day of Prevacid for 28 days. Then, 181 patients (intent-to-treat) who were asymptomatic during the last week of the acute phase entered the six-month, follow-up phase. After randomization to 15 mg/d of Prevacid or placebo, the patients were instructed to take one capsule per day to relieve their heartburn, only if necessary, but to stop taking the treatment when their heartburn became controlled. The primary efficacy criterion was the percentage of patients in each treatment group who completed the on-demand phase. Of the intent-to-treat patients, a significantly higher percentage who received Prevacid rather than placebo completed the study (81 percent vs. 60.8 percent). The same significant difference in trial completion was also evident in the 150 per-protocol patients who made no major protocol deviations and after adjustments for sex or for patients who had Helicobacter pylori at inclusion. In the intent-to-treat group, the proportion of Prevacid-treated patients who discontinued due to insufficient heartburn control was also significantly lower than that of placebo-treated patients (15.5 percent vs. 27.8 percent). While this difference between treatment arms was similar in the per-protocol patients, it did not reach statistical significance. Moreover, the average time between starting the on-demand phase and discontinuing the study was longer with Prevacid than with placebo in the intent-to-treat analysis (162.4 days vs. 136.7 days, respectively); this result also was observed in the per-protocol analysis. The study investigators even judged treatment efficacy to be "excellent" or "good" for a statistically significantly higher proportion of the Prevacid arm (71.4 percent) than the placebo arm (54.6 percent). The per-protocol findings were similar. The researchers explained that "on-demand treatment has the advantage of allowing flexibility of drug dosage according to the severity and duration of acute symptoms" as well as "the free availability of medication to control symptoms." Therefore, they found on-demand therapy to be a very useful alternative to continuous and intermittent treatment. This study appears in the first October issue of Alimentary Pharmacology & Therapeutics. Survey Tools LymphoStat-B fails in Phase II study, but evidence of clinical effect prompts firm to plan for Phase III studies Shares of Human Genome Sciences Inc. fell 29.4 percent after the company reported its LymphoStat-B (belimumab) had a clinical effect in patients with systemic lupus erythematosus (SLE) during a Phase II trial but failed to reduce the signs and symptoms of SLE or increase the time to first SLE flare. The company still plans to move forward with a Phase III program. A total of 449 patients with SLE were randomized to receive standard therapy plus placebo or LymphoStat-B in doses of 1 mg/kg of body weight, 4 mg/kg or 10 mg/kg. LymphoStat-B or placebo was administered on days 0, 14 and 28 and every 28 days thereafter for up to 52 weeks. A majority of the patients (82 percent) were also receiving background prednisone. The trial results did not meet the primary efficacy endpoints, which consisted of reducing the signs and symptoms of SLE based on the Safety of Estrogens in Lupus Erythematosus-National Assessment SLE Disease Activity Index (SELENA SLEDAI) score at week 24 or increasing the time to first SLE disease flare throughout the study (SLE Flare Index). Analysts had predicted the trial would have a hard time meeting its primary endpoints because the SELENA SLEDAI scale might not be sensitive enough to detect a modest response to the drug, according to Reuters. However, in the 75 percent of patients who were seropositive, LymphoStat-B statistically significantly reduced SLE signs and symptoms at week 52 as measured by the SELENA SLEDAI and the Physician's Global Disease Assessment. When compared with placebo, LymphoStat-B also produced targeted and statistically significant reductions in both circulating B cells and anti-dsDNA autoantibodies, which are related to disease severity and autoimmune activity. "We now have the data that I believe support our proceeding on a path toward Phase III development of LymphoStat-B for the treatment of SLE," said Dr. David Stump, executive vice president of drug development at Human Genome Sciences. Chief Executive Officer H. Thomas Watkins reiterated, "Planning is underway, and we look forward to our initial steps on that path as we discuss the precise development strategy in this indication as quickly as possible with our LymphoStat-B collaborator, GlaxoSmithKline [Plc], clinical experts and regulatory authorities." Under terms of a 1996 agreement, GSK and Human Genome Sciences are equally sharing Phase III/IV development costs, sales and marketing expenses and profits for any resulting commercialized product. The firms are negotiating the remaining terms. Human Genome Sciences created LymphoStat-B through a collaboration with Cambridge Antibody Technology Group Plc. Shares of Human Genome Sciences closed at $9.87, down $4.10, in heavy trading on the Nasdaq. Survey Tools Intron A does not improve outcome in patients with stage IIb/III melanomas, study shows Schering-Plough Corp.'s Intron A (interferon alfa-2b, recombinant) appeared to have no effect on time to distant metastases or overall survival when taken after surgery by patients with stage IIb/III melanomas. The EORTC 18952 randomized trial included 1,388 patients who had resected stage IIb melanoma (node negative and tumor thickness of 4 mm or more) or who had curative dissection of regional lymph node metastases (melanoma stage III that was node positive and involved a primary tumor of any size). Ten weeks after surgery, the patients began receiving Intron A or observation. Those who were randomized to Intron A first received 10 MU of Intron A for five days for each of four weeks. Then, they received the same dose three times per week for one year or 5 MU three times per week for two years. After a median follow-up of 4.65 years, 760 patients developed distant metastases: 309 with the shorter Intron A therapy, 287 with the longer Intron A therapy and 164 with the observation strategy. The estimated rates of disease metastases-free interval (DMFI) were similar across the three groups--47.2 percent for the 25-month Intron A arm, 43.2 percent for the 13-month Intron A arm and 40 percent for the observation arm. Thus, at 4.5 years, the 25-month Intron A arm showed a 7.2 percent increase in the rate of DMFI and the 13-month Intron A arm showed a 3.2 percent increase when compared with the 40 percent DMFI rate increase in the observation arm. Throughout the same follow-up period, 681 patients died. While longer treatment with Intron A led to a 5.4 percent improvement in overall survival, the shorter course of Intron A did not extend survival. The researchers did note that Intron A had acceptable toxicity and that the stage of melanoma at randomization was an important prognostic factor. Full data can be found in the Oct. 1 issue of The Lancet. Because the data suggested "that both duration of treatment and tumor load are important variables in the potential efficacy of therapy with [Intron A]," the investigators said another study has randomized 1,256 patients with stage III melanoma to undergo observation or pegylated interferon treatment. Final results are expected next year. Intron A is already approved in several other indications, including malignant melanoma. Survey Tools Survey Tools Schering-Plough Corp. Schering-Plough Corp. received notice from the European Commission that revised dosing instructions have been approved for Peg-Intron (peginterferon alfa-2b) and Rebetol (ribavirin), which are used in combination to treat patients with chronic hepatitis C virus. The revised dosing, which cuts the previously approved treatment duration of 48 weeks in half, applies only to patients who meet specific criteria--those with genotype 1 infection and a low viral load (less than 600,000 IU/mL) who have achieved a rapid virologic response after 4 weeks of treatment and who maintain that response through 24 weeks of therapy. In the United States, the approved regimen is still 1.5 mcg/kg of Peg-Intron once a week along with 800 mg/day of Rebetol for a period of 48 weeks. Survey Tools Survey Tools Chiron Corp. Chiron Corp. and Nektar Therapeutics initiated clinical testing in a Phase III program intended to determine the efficacy and safety of tobramycin inhalation powder (TIP), an investigational inhaled antibiotic, in the treatment of lung infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis (CF). The TIP Phase III program includes two clinical trials. The first trial, ASPIRE I, is currently underway. The second trial, ASPIRE II, is designed to assess the safety of TIP versus tobramycin inhalation solution, USP (TOBI) in CF patients, and is expected to begin in 2006. TOBI is an approved antibiotic that is inhaled directly into the lungs to treat P. aeruginosa lung infections in CF patients. Survey Tools Survey Tools Vertex Pharmaceuticals Inc. Vertex Pharmaceuticals Inc. plans to focus its 2006 development investment on Phase II clinical advancement of its drug candidates VX-950 for hepatitis C virus infection and VX-702 for rheumatoid arthritis, and to bring its investigational drug candidate for cystic fibrosis into clinical development. The company's decision to concentrate on the clinical development of these candidates "is based on an analysis of commercial opportunity and available clinical data across all of the company's portfolio of programs." Vertex also said it will continue collaborations with other companies to develop small molecule drugs for cancer and HIV. Survey Tools Survey Tools The Medicines Co. The Medicines Co. revised its 2005 guidance as a result of lower-than-anticipated demand for Angiomax (bivalirudin), an intravenous drug used to help prevent clot formation in patients undergoing coronary angioplasty procedures. The company also cited restructuring of its wholesaler agreements as a reason for the revised forecast. The new figures reflect expected net revenue of approximately $150 million for 2005; previously, the projected range was from $195 million to $204 million. In addition, the company now expects to report a loss for the year of $10 million, whereas before it expected earnings of $24 million to $31 million. Despite the slower sales of Angiomax, the company's senior executives said the drug continues to gain market share. Survey Tools Survey Tools


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