Global Survey - Brand Institute, inc.



			Global Survey 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 Pfizer's 2006 forecast below analysts' expectations Pfizer Inc. expects its 2006 revenue to remain flat on slightly lower earnings as the firm continues to feel the effects of generic competition. "While near-term results will be tempered by loss of exclusivity of older medicines, we see a bright, long-term future driven by growth of current and new medicines, productivity enhancements and new initiatives to enhance shareholder value," said David Shedlarz, Pfizer's vice chairman. The company expects adjusted earnings per share of approximately $2 in 2006, which is below the average analyst forecast of $2.04, according to Reuters Estimates. In 2005, the firm reported adjusted earnings per share of $2.02. Revenue for 2006 is expected to be "comparable" to that of 2005, and the firm expects revenue growth to resume in 2007. Pfizer expects its cholesterol-lowering drug, Lipitor (atorvastatin calcium), to have sales of more than $13 billion in 2006, which would be an increase of at least 6.5 percent from 2005's $12.2 billion in sales. In 2005, however, the statin's sales grew 12 percent from 2004. Reuters noted that concerns about Lipitor's growth began when the drug's 2005 fourth-quarter sales only increased 3 percent from the fourth quarter of 2004 due to insurers steering patients to equally potent competitor drugs or "older, less potent alternatives." The company expects sales from COX-2 inhibitor Celebrex (celecoxib) to exceed $2 billion in 2006. Additionally, the firm expects to launch six new medicines in 2006. Pfizer also reiterated that it is considering selling its consumer health care division. It expects to make a decision regarding options for Pfizer Consumer Healthcare in the third quarter of this year. "This is the right time to undertake this review, given the premium the marketplace is placing on similar large, high-quality consumer businesses," Shedlarz said. The strategic review of the health care unit is part of the firm's larger focus on changing its business portfolio. The firm is doing this in an effort to "enhance shareholder value." It will also focus on increasing its dividend payout and yield and purchasing shares. Additionally, the firm will reduce its worldwide plant network from 93 to 66. "This is a time of transformation for Pfizer and our industry," said Hank McKinnell, Pfizer's chief executive officer. "We are responding directly to the realities of our operating environment as we build value today while aggressively investing in the future. We have many significant opportunities ahead of us." Pfizer shares closed at $25.68, down $0.66, or 2.5 percent, in moderate trading on the New York Stock Exchange. Global Survey Genentech, Biogen's Rituxan approved for additional form of non-Hodgkin's lymphoma Genentech Inc. and Biogen Idec Inc.'s Rituxan (rituximab) was approved by the Food and Drug Administration for a new indication. The drug, in combination with anthracycline-based chemotherapy regimens, is now approved as a first-line treatment for diffuse large B-cell, CD20-positive, non-Hodgkin's lymphoma. "With this approval, Rituxan in combination with chemotherapy becomes the first FDA-approved treatment to improve survival for patients with this type of non-Hodgkin's lymphoma since the introduction of the CHOP [cyclophosphamide, doxorubicin, vincristine and prednisone] chemotherapeutic regimen more than 25 years ago," said Dr. Sandra Horning, chair of the lymphoma group at the Eastern Cooperative Oncology Group. The drug's latest approval is based on data from three randomized trials involving 1,854 treatment-naive patients with diffuse large B-cell lymphoma (DLBCL), which is an aggressive form of non-Hodgkin's lymphoma. In each of the trials, Rituxan was given in combination with CHOP or another anthracycline-based chemotherapy regimen. Results after two years of follow-up showed that, in each study, more patients were alive in the Rituxan-containing arms as compared with the control arms. The GELA trial, which yielded five years of follow-up, showed that treatment with Rituxan plus CHOP improved overall survival by 47 percent compared with CHOP therapy alone. Genentech developed Rituxan and comarkets it in the United States with Biogen Idec; Roche markets the drug as MabThera in other countries except Japan, where it is comarketed by Chugai Pharmaceutical Co. Ltd. and Zenyaku Kogyo Co. Ltd. Rituxan is also indicated for use as a single agent in relapsed or refractory, low-grade or follicular, CD20-positive, B-cell non-Hodgkin's lymphoma. Global Survey Schering-Plough Corp. releases data from discontinued vicriviroc trial Schering-Plough Corp. released data from its discontinued Phase II trial of vicriviroc, its investigational CCR5 receptor antagonist being studied in patients with HIV, at the 13th Conference on Retroviruses and Opportunistic Infections in Denver. In October, the firm discontinued the trial, which involved 92 treatment-naive patients with HIV, following a recommendation from the trial's independent Data Safety Monitoring Board. An increased incidence of detectable virus was observed in some patients late in therapy compared with the trial's control regimen of GlaxoSmithKline Plc's Combivir (lamivudine/zidovudine) and Bristol-Myers Squibb Co.'s Sustiva (efavirenz). In the trial, CCR5-tropic patients with HIV in Europe and Canada were randomized to receive vicriviroc (25 mg, 50 mg or 75 mg) or placebo once a day for 14 days. All patients then added Combivir to their regimens. Placebo-arm patients were given Sustiva as well. At two weeks, primary analysis showed a clear dose response to treatment, as measured by the decline of viral load. Specifically, patients who received vicriviroc 25 mg had an average decrease in viral load of 0.93 log10, patients who took vicriviroc 50 mg had an average decrease of 1.18 log10, those who took vicriviroc 75 mg had an average decrease of 1.34 log10 and patients who took placebo had an average decease of 0.07 log10. According to Schering-Plough, these results prove a strong predictor of sustained virologic response throughout the study. The firm noted that shifts in tropism were infrequent and observed in all treatment groups of the trial. Subsequent treatment with optimal highly active antiretroviral therapy caused viral suppression, the company said. "These results have proven instructive to the further development of vicriviroc and will inform our plans for designing additional studies," title="branding company" said Dr. Wayne Greaves, senior director of global clinical development at Schering-Plough Research Institute. "While the optimal dose of vicriviroc and its role in antiretroviral regimens require further evaluation, vicriviroc was shown to be well tolerated by patients in this trial with no marked safety concerns--specifically, no liver toxicity." Vicriviroc is currently being studied in a Phase II trial of treatment-experienced patients with HIV. Schering-Plough said it will not begin patient screening for the Phase III program until all available data have been evaluated. Global Survey Amylin's pramlintide shows potential as obesity drug in clinical study Amylin Pharmaceuticals Inc.'s pramlintide, an investigational obesity treatment, showed positive results in a 16-week Phase II study evaluating its safety and weight effects in patients who were obese. The double-blind, dose-ranging study included 408 patients who were obese (average body mass index of approximately 38 kg/m2). The patients were randomized to receive placebo or one of six dosages of pramlintide for 16 weeks. All of the patients participated in a lifestyle intervention program that included counseling on diet, exercise and behavior modification. Patients in the pramlintide treatment groups lost an average of 8.4 lbs to 13.4 lbs during the study period compared with an average loss of 6.2 lbs in the placebo group. Amylin said both the twice-daily regimen and the three-times daily regimen demonstrated clear efficacy. Further, weight loss among patients in the pramlintide groups was progressive through week 16. According to Amylin, pramlintide was well tolerated, and researchers observed "no new safety signals" even though higher doses of the drug were administered than in previous studies. The company noted that approximately 75 percent of patients treated with pramlintide chose to participate in an ongoing extension study in which they will continue to receive the study drug. Pramlintide is a synthetic analog of human amylin, a hormone known to affect appetite and food intake. It is also the active ingredient in Amylin's diabetes drug Symlin (pramlintide actetate). Amylin also reported financial results for the fourth quarter and full year of 2005. Net loss for the most recent quarter was $67.2 million, or $0.61 per share, compared with a net loss of $46.4 million, or $0.49 per share, in the same period of the previous year. Total revenue was $63.5 million in the fourth quarter compared with $6.6 million in the final quarter of 2004. In 2005, the company launched Symlin and diabetes drug Byetta (exenatide) injection. Amylin's net loss for 2005 was $206.8 million, or $1.96 per share, compared with the previous year's net loss of $157.2 million, or $1.67 per share. The firm posted annual revenue of $140.5 million compared with $34.3 million in 2004. Amylin shares closed at $37.20, down $0.90, or 2.4 percent, in heavy trading on the Nasdaq. Global Survey Penwest's new formulation of nalbuphine pain treatment shows positive results in clinical trial Penwest Pharmaceuticals Co.'s investigational extended-release pain treatment nalbuphine ER (PW4142) significantly reduced pain intensity compared with placebo in a Phase IIa trial. Nalbuphine ER, a new formulation of nalbuphine hydrochloride, contains both immediate release and controlled release components and is designed to be taken twice daily. The pharmacokinetic-pharmacodynamic trial, which included 165 patients, was designed to correlate the level of analgesia in patients with the plasma level of the drug and determine if there is an exposure-response relationship, as well as the duration of analgesia. The goal of the trial was to evaluate the degree and duration of pain relief of nalbuphine ER at two different dose levels. Patients underwent third molar extractions; those who experienced pain at a score of four or more on a 0 to 10 numerical pain rating scale following the procedures received blinded study medication. A single low-dose nalbuphine, high-dose nalbuphine or placebo was administered to the patients and their pain responses were evaluated at pre-specified intervals during the 12-hour study period. The results of the trial demonstrated that nalbuphine ER positively reduced pain intensity in a dose-dependent manner during the 12-hour study period. The difference compared with placebo began at 90 minutes post-dose for the higher dose of nalbuphine ER and at six hours for the low dose of nalbuphine ER. This response was maintained at all time points during the study. Additionally, more patients in the nalbuphine groups experienced at least a 50 percent reduction in pain intensity as compared with the placebo group. There were no unusual side effects reported during the 12-hour dosing interval. If approved, Penwest expects nalbuphine ER to compete in the moderate to moderately severe pain treatment category. Penwest is deciding whether it will seek a partner for further development and commercialization of the drug. Global Survey American Cancer Society report reveals drop in cancer deaths An annual American Cancer Society report showed that the actual number of Americans who died of cancer decreased from the previous year, despite a larger, older population. The report, titled Cancer Facts & Figures 2006, was based on records from the National Center for Health Statistics for 2002 and 2003, the most recent data available. The data showed that the actual number of deaths from cancer was 557,271 in 2002 and 556,902 in 2003. This resulted in a net decrease in cancer deaths of 369. The number of cancer deaths between 2002 and 2003 decreased by 778 in men, while the number increased by 409 in women. The society projected that the actual number of cancer deaths will continue to drop in 2006; however, the number of new cancer cases is expected to rise as the size and age of the U.S. population increase. The report estimated that 1.4 million Americans will receive a diagnosis of cancer in 2006 and 565,000 will die from the disease. Additionally, approximately one third of these deaths will be related to tobacco use and another third will be related to nutrition, physical activity or being overweight or obese. According to the association, the majority of the predicted cancer deaths could be prevented. Furthermore, the report showed that lung cancer death rates continued to decrease for men, but leveled off for women. In 2006, approximately 174,000 new cases of lung cancer are estimated, and approximately 162,000 deaths from lung cancer are expected. Lung cancer is once again expected to be the leading cause of cancer death among adults in 2006; an estimated 87 percent of these deaths will be associated with smoking. Other than skin cancer, breast cancer remained the most common cancer among women and prostate cancer remained the most common among men. Although cancer death rates have been decreasing since 1991, never before has the actual number of deaths been lower than those of the previous year. "Now, for the first time, the advances we've made in prevention, early detection and treatment are outpacing even the population factors that in some ways have obscured that success," said John Seffrin, chief executive officer of the American Cancer Society. Global Survey Global Survey The Food and Drug Administration The Food and Drug Administration may postpone the implementation date of its more stringent distribution program for acne treatment isotretinoin, Dr. Sandra Kweder, deputy director of the FDA Office of New Drugs, said in a Reuters report. The drug was initially marketed by Roche as Accutane and is now also available in several generic versions. The new program, which was approved last August and was expected to take full effect March 1, is intended to prevent use of the drug during pregnancy because it has been shown to cause miscarriages and serious birth defects. On Friday, an FDA advisory committee heard from physicians who said the new process being used to register patients is "time-consuming and cumbersome." The physicians also voiced concern that patients may turn to Internet pharmacies for the drug and could end up with counterfeit formulations. According to Reuters, the American Academy of Dermatology Association asked for a two-month delay in fully implementing the program so that existing problems can be ironed out. Dr. Peter Gross, the advisory panel's chairman, said the agency's primary concern is for patient safety. Global Survey Global Survey Abbott Abbott was suspended from membership of The Association of the British Pharmaceutical Industry for at least six months due to "serious" breaches in the ABPI code of practice. Anonymous complaints were submitted to the ABPI concerning inappropriate hospitality for health professionals. According to the ABPI, Abbott initiated an investigation of the events and a review of its procedures. Since the complaints were made, three Abbott employees involved in the incident have left the company. Global Survey Global Survey AstraZeneca Plc AstraZeneca Plc is expected to significantly reduce the number of sales representatives it contracts from PDI Inc. PDI, which has approximately 800 representatives currently under contract with AstraZeneca, said it "is engaged in discussions with AstraZeneca regarding the status of [our] fee-for-service contract sales engagements." title="branding company" PDI anticipates "significant reductions" title="branding company" in the number of contracted representatives and said it will release more details once it knows more about the timing and scope of the expected changes. PDI shares closed at $12.00, down $2.28, or 16 percent, in heavy trading on the Nasdaq. Global Survey Global Survey Shire Plc Shire Plc said it believes the possible relationship between cardiovascular adverse events and attention-deficit/hyperactivity disorder drugs should be further studied before a black box warning be put on these drugs, as was recently recommended by a Food and Drug Administration advisory committee. "Obtaining this information is crucial prior to taking what would be an unprecedented action to include something in a black box that [has] not been supported by sufficient data," title="branding company" Shire said. The firm, which makes ADHD treatments Adderall (mixed amphetamine salts) and Adderall XR, said it supports the goals of the advisory panel's meeting, but does not feel the data warrant further action on the drugs' labeling. Global Survey Global Survey Genentech Inc. Genentech Inc. was granted a non-exclusive, worldwide license to Lonza Group Ltd.'s GS Gene Expression system for research and development purposes. The agreement includes options for a multiproduct license to the GS system for commercial purposes, as well as further options to acquire the licenses for the use of Lonza's Protein Free Media system for research, development and commercial purposes. The agreement includes license fees and milestone payments. Additional financial terms were not disclosed. Global Survey


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