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			Brand Awareness 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 FDA still has concerns with Teva's Parkinson's disease drug, Agilect Teva Pharmaceutical Industries Ltd. received a follow-up letter to the July 2004 approvable letter the company received from the Food and Drug Administration for Agilect (rasagiline mesylate) as initial monotherapy in early Parkinson's disease and as an adjunct therapy to levodopa in moderate to advanced stages of the disease. This past May, Teva submitted data to the FDA "to clarify a technical error" in the application. The FDA responded by saying it still has concerns with issues that Teva "believed it had resolved with its submissions." The agency indicated interest in having a follow-up meeting, Teva said, adding that it plans to meet with the FDA promptly to resolve the issues. Teva had intended to launch the once-daily Parkinson's disease treatment in the United States by the end of the year. In June, Agilect was launched in the United Kingdom. Brand Awareness Pozen to cease development of migraine treatment MT 100, will focus on Trexima In light of a Food and Drug Administration advisory committee's decision that Pozen Inc.'s investigational migraine treatment MT 100 (naproxen sodium/metoclopramide hydrochloride) needs to demonstrate greater improvement than it has in current studies, Pozen has decided to discontinue further development of the drug. Pozen made this decision partially because it expects "to file the Trexima NDA shortly, and Trexima has already demonstrated greater efficacy without the metoclopramide risk associated with MT 100," said Dr. John Plachetka, Pozen's chief executive officer. The Peripheral & Central Nervous System Drugs Advisory Committee decided on Thursday that MT 100's "currently demonstrated benefit in migraine patients compared to naproxen is not enough to outweigh the risk of tardive dyskinsia," according to FDAAdvisoryCommitte.com. Pozen received a non-approvable letter for MT 100 in May 2004. In the letter, the FDA cited a lack of apparent superiority to naproxen for sustained pain relief in two component studies and a lack of statistically significant improvement on nausea, photophobia and phonophobia in one of the two studies. The agency also raised concerns about a potential risk of tardive dyskinsia and carcinogenicity. Trexima is being developed as a combination of sumatriptan and naproxen sodium in a single tablet for the treatment of migraines. Pozen has licensed U.S. commercialization rights to the drug to GlaxoSmithKline Plc. Pozen shares closed at $8.29, up $0.32, or 4 percent, in heavy trading on the Nasdaq. Brand Awareness Switching from tamoxifen to AstraZeneca's Arimidex may improve event-free survival for postmenopausal women with early breast cancer, study shows In postmenopausal women with early breast cancer, switching treatment to AstraZeneca Plc's Arimidex (anastrozole) after two years of tamoxifen appears to result in reduced rates of disease recurrence, particularly with respect to distant metastases, according to a study published in the Aug. 5 issue of The Lancet. Researchers combined analyses of data from two randomized trials to investigate whether women who have received tamoxifen would benefit from switching to Arimidex. In both trials, postmenopausal women with hormone-sensitive early breast cancer who received two years of tamoxifen treatment were randomized to receive 1 mg Arimidex daily (n=1618) or 20 mg or 30 mg of tamoxifen daily (n=1606). At a median follow-up of 28 months, researchers found a 40 percent decrease in the risk of an event in the Arimidex group compared with the tamoxifen group. An event was defined as relapse at any site or cancer occurring in the other breast. In the Arimidex group, there were 67 events, while there 110 events in the tamoxifen group. Both treatments were well tolerated. Patients in the Arimidex group had significantly more bone fractures and significantly fewer thromboses compared with patients in the tamoxifen group. "Overall, the published work indicates that there are potential benefits to switching from tamoxifen to an aromatase inhibitor after two years, and that patients could benefit from the antitumor effects of tamoxifen in the short term while avoiding the complications of long-term tamoxifen therapy," the researchers concluded. Brand Awareness Lower initial doses of Risperdal effective, well tolerated in acutely exacerbated patients with schizophrenia, study finds Although physicians prescribed lower initial doses of Janssen Pharmaceutica Products L.P.'s Risperdal (risperidone) during a period of time, the drug maintained efficacy in patients with acutely exacerbated schizophrenia, including those who were highly agitated, according to a new study. Researchers in Germany conducted an open-label, observational trial from 1996 to 2002 in 180 psychiatric hospitals. A total of 1,625 patients who entered the hospital with an acute exacerbation of schizophrenia and received Risperdal within 24 hours of admission were eligible for the study. Overall, 720 patients were observed during six weeks of initial treatment throughout the seven-year period. The investigators analyzed treatment practices in these acutely exacerbated patients with schizophrenia and in the subgroup of patients who were highly agitated, defined as patients with a total score of at least 15 on the Positive and Negative Syndrome Scale's agitation subscale. At week six, the highly agitated patients received a mean daily dose of 4.8 mg of Risperdal and the other patients received a mean daily dose of 4.7 mg. More than 55 percent of all patients received the drug as monotherapy. The researchers found that the prescribed doses of Risperdal decreased during a period of seven years (mean dose of 5.7 mg/day in 1996 and 4.5 mg/d in 2002) as a result of changes in the physicians' prescribing behaviors. Even so, tolerability was significantly improved and efficacy was maintained. All patients experienced significant symptom relief, and the 256 highly agitated patients experienced the most pronounced relief of symptoms, the study's authors found. "Prescribing patterns with [Risperdal] in patients with acutely exacerbated schizophrenia, including highly agitated patients, changed with the experience gained with this compound," the researchers said. "In routine clinical practice in this indication, [Risperdal] was found to be effective and well tolerated." This study appeared in the August issue of the Journal of Clinical Psychopharmacology. Brand Awareness Addition of AstraZeneca's Casodex found to be cost effective compared with LH-RH agonist alone Combined androgen blockade therapy (CAB) using AstraZeneca Plc's Casodex (bicalutamide) is cost effective when compared with luteinizing hormone releasing hormone (LH-RH) monotherapy in patients with stage D2 metastatic prostate cancer, according to data from a recent study. The study consisted of a macro-simulation model that was developed to compare the cost effectiveness of CAB with Casodex 50 mg/day plus monthly dosing of an LH-RH agonist (LH-RHa) with monthly LH-RHa therapy. The base case was a patient with newly identified metastatic, stage D2 prostate cancer who had not previously received hormonal treatment. Model assumptions were taken from published literature. At five years, the incremental cost-effectiveness ratio (ICER) for CAB with Casodex versus an LH-RHa alone for five years was $20,489 per life-year gained without quality adjustment and $33,677 per quality-adjusted life-year gained. At 10 years, the treatment became more cost effective, with ICERs of $13,313 and $20,053, respectively. "This compares favorably to other commonly used medical interventions, including breast cancer screening with mammography . . . and colorectal cancer screening with colonoscopy . . . ," the authors noted. Although "there are difficulties comparing the cost effectiveness of health care interventions for different medical conditions and situations, it still appears that the cost effectiveness of adding [Casodex] to LH-RHa vs. LH-RHa alone is within the acceptable range for medical care interventions in general." The authors noted that this study differs from previous studies about the cost effectiveness of CAB for advanced prostate cancer in that it "focuses on men with documented metastatic disease." The authors concluded by noting that, based on currently recommended cost-effectiveness thresholds and cost effectiveness of commonly reimbursed health interventions, the addition of CAB with Casodex to LH-RHa therapy appears to be "reasonably cost effective when compared with LH-RHa therapy alone in men with stage D2 prostate cancer." In an accompanying editorial, Dr. Larry Goldenberg of the University of British Columbia suggested that previous meta-analyses of the benefits of CAB therapy might have "obscure[d] a more substantial benefit in a smaller, loosely defined subgroup of men," adding that "the cost-benefit impact would be greatly amplified if we were able to differentiate the subgroup of men who are most likely to benefit substantially from CAB." The article and editorial appeared in the August issue of The Journal of Urology. Brand Awareness Cardinal's fiscal Q4, full-year earnings fall on charges Cardinal Health Inc.'s 2005 fiscal fourth-quarter net earnings per diluted share fell 27 percent on special charges and restructuring costs. In the quarter ended June 30, 2005, the company earned $287.2 million, or $0.66 per diluted share, compared with $393.5 million, or $0.90 per diluted share, in the fiscal fourth quarter of 2004. Excluding special items, the company earned $0.78 per share. Fourth-quarter net revenue, which was driven by pharmacy, hospital and drug manufacturer demand, increased 15 percent to $19.46 billion, up from $16.92 billion in the prior year's fiscal fourth quarter. For the fiscal year 2005, Cardinal's revenue increased 15 percent from $65.05 billion in 2004 to $74.91 billion this year. The company earned $1.08 billion, or $2.48 per diluted share, in the fiscal year 2005 compared with $1.47 billion, or $3.35 per diluted share, in fiscal year 2004. For fiscal 2006, Cardinal still expects to earn between $3.30 and $3.55 per share, excluding charges and the impact of incremental equity compensation expenses. Cardinal shares closed at $59.22, up $0.23, or 0.4 percent, in moderate trading on the New York Stock Exchange. Brand Awareness Brand Awareness Johnson & Johnson Johnson & Johnson added a disclaimer to its hotline that physicians call to find out how to charge Medicare and insurance companies for Natrecor (nesiritide), according to Forbes.com. The message warns physicians that there is a "lack of clinical data" about the use of Natrecor, a treatment for patients with heart failure, outside of the hospital setting. The disclaimer adds that Scios Inc., the J&J unit that distributes Natrecor, "does not recommend Natrecor for this use." The company received a subpoena from a U.S. attorney's office in July requesting documents related to the sales and marketing of Natrecor. Earlier this year, J&J's own panel of experts suggested the drug's use be stringently restricted. Brand Awareness Brand Awareness Schering-Plough Corp. Schering-Plough Corp. and Sankyo Company Ltd. entered into a license agreement for olmesartan medoxomil, which is the active ingredient in Sankyo's Benicar and Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) hypertension therapies. According to the agreement, Sankyo granted Schering-Plough exclusive rights to market olmesartan in select Latin American countries. The companies will co-market the drug in Mexico, Venezuela, the Dominican Republic and most of Central America. Schering-Plough will be responsible for the regulatory applications for olmesartan medoxomil with or without hydrochlorothiazide in its exclusive territories and for its own brands of the products in the co-marketing areas. Financial terms were not disclosed. Brand Awareness Brand Awareness Dov Pharmaceutical Inc. Dov Pharmaceutical Inc. began a Phase III clinical trial of bicifadine, an analgesic intended for the treatment of postoperative pain following vaginal hysterectomy. The company will carry out a randomized, parallel, placebo-controlled clinical trial with 100 patients per treatment group. Patients who experience moderate to severe pain following surgery will receive the drug for up to five days. The patients' assessment of pain intensity and pain relief will serve as the primary endpoints. Brand Awareness Brand Awareness Neose Technologies Inc. Neose Technologies Inc. updated its key operational objectives and is restructuring operations, which, when completed, will reduce the size of its workforce by approximately 25 percent since the end of the first quarter. The company is restructuring to allow for enhanced focus on next-generation proteins; the process is intended to prepare for the expected transfer of production of proteins and reagents to collaborative partners and contract manufacturers now that the programs are more mature. The restructuring will also reduce unnecessary spending and supplement previously announced actions to reduce executive cash-based compensation for 2005 and capital spending. Brand Awareness Brand Awareness


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