Naming Standards - Brand Institute, inc.



			Naming Standards 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 BIOGEN IDEC'S Q1 EARNINGS, REVENUE UP DESPITE TYSABRI WITHDRAWAL ------------------------------------------------------------------------------- Biogen Idec Inc. reported increased first-quarter 2005 revenue on the strength of its multiple sclerosis drug, Avonex (interferon beta-1a), and its cancer drug, Rituxan (rituximab). For the first quarter of 2005, Biogen Idec achieved net income of $43.5 million, or $0.12 per diluted share, compared with a net loss of $41.2 million, or $0.12 per diluted share, in the prior-year period. The company said first-quarter earnings were impacted by charges including approximately $36 million in charges, or $0.07 per share, primarily due to the voluntary suspension of the multiple sclerosis drug Tysabri (natalizumab). Biogen Idec co-developed Tysabri with Elan Corp. Plc. Excluding charges, the company reported earnings of $0.30 per share. Analysts polled by Reuters expected earnings of $0.37 per share. Total quarterly revenue rose 9 percent from $541.7 million in the same period a year ago to $587.8 million. Avonex brought in revenue of $373.6 million, up 5 percent from $354.7 million in the first quarter of 2004. Revenue from Biogen Idec's co-promotion of Genentech Inc.'s non-Hodgkin's lymphoma drug, Rituxan, grew 20 percent from $134 million in the previous-year period to $160 million. Earlier this month, Genentech reported that first-quarter U.S. sales of Rituxan increased 22 percent to $440.5 million. On April 1, Biogen Idec retracted its full-year guidance of earnings per share between $1.60 and the low $1.70s. The company now anticipates that charges will adversely impact its full-year earnings by $0.25 per share. During the second half of the year, Biogen Idec and Genentech anticipate filing a supplemental New Drug Application for Rituxan for the treatment of active rheumatoid arthritis in patients who are inadequate responders to tumor necrosis factor inhibitors. -=- CHIRON REPORTS 2005 Q1 LOSS RELATED TO LIVERPOOL FACILITY DEFICIENCIES ------------------------------------------------------------------------------- Chiron Corp. posted a net loss of $8.9 million, or $0.05 per diluted share, for the first quarter of 2005 after being hit with $39 million in costs associated with its Liverpool manufacturing facility. One year ago, the company earned $39.8 million, or $0.21 per diluted share, and $26.9 million in income from continuing operations, or $0.14 per share. Pro forma net income was $7 million for the first quarter compared with pro forma net income of $55.8 million in the previous-year quarter. While total revenue rose 7 percent from the first quarter of 2004 to $407.4 million, overall product sales declined 1 percent to $277.2 million, due mostly to the reduction in pediatric and other vaccine sales. Specifically, pro forma sales of influenza vaccines dropped 54 percent to approximately $4 million this past quarter, as there were no Fluvirin influenza virus vaccine sales in 2005. Pro forma earnings per share were $0.04 in the first quarter of this year. This was lower than Thomson First Call's average analyst estimate of $0.17 per share on sales of $410 million, TheStreet.com reported. Chiron said it expects 2005 income from continuing operations to reach between $1.06 and $1.16 per share on a generally accepted accounting principles basis. Product sales are estimated to be approximately $1.6 billion, while revenue is projected to reach approximately $2 billion. The company added the Food and Drug Administration will inspect its Liverpool manufacturing facility between mid-June and mid-July. But if Chiron fails to have addressed the deficiencies noted by the regulatory agency, "the FDA may take further action that could reduce Chiron's ability to market Fluvirin vaccine." Currently, the firm estimates it has the capacity to produce between 25 million and 30 million doses of the vaccine. Last October, the United Kingdom's Medicines and Healthcare Products Regulatory Agency temporarily suspended Chiron's license to manufacture Fluvirin influenza vaccine after citing test data and manufacturing processes at the facility that did not comply with UK Good Manufacturing Practices. -=- FDA WARNS OF IMPROPER USE OF TWO INHALED ASTHMA DRUGS ------------------------------------------------------------------------------- The Food and Drug Administration alerted health care providers about the inadvertent swallowing of asthma medication capsules that are intended for inhalation. The agency said it had received 30 cases concerning Novartis AG's Foradil Aerolizer (formoterol fumarate inhalation powder) and two cases concerning Boehringer Ingelheim GmbH's Spiriva HandiHaler (tiotropium bromide inhalation powder). According to the FDA, one patient reported breathing difficulties after swallowing a capsule, while another was hospitalized because of chronic obstructive pulmonary disease exacerbation. The agency also said there was one unrelated death. In a "Safety Page" sent to health care providers, the agency said both products' capsules resemble those usually taken orally and that their packaging does not prominently display a "not for oral use" warning or a "for inhalation use only" advisory. As it works with both manufacturers on labeling and packaging changes, the agency advised health care providers to dispense the capsules and their related inhalation device at the same time. If the capsules are dispensed separately, the agency suggested that they be affixed with a cautionary label stating, "For inhalation use with a special inhaler only." Spiriva HandiHaler--a long-acting anticholinergic agent--was approved by the FDA in 2004 for the scheduled, maintenance treatment of asthma and COPD. Foradil Aerolizer--a long-acting, selective beta-2 adrenoreceptor agonist--was approved by the FDA in 2001 for the scheduled, maintenance treatment of asthma and COPD, and for the prevention of exercise-induced bronchospasm on an as-needed basis. Schering-Plough Corp. markets Foradil products in the United States. -=- NEW STUDY FINDS TV ADS, PATIENT REQUESTS INFLUENCE PHYSICIANS' PRESCRIPTION DECISIONS ------------------------------------------------------------------------------- A new study suggests that direct-to-consumer advertising and patient requests for drugs may increase physicians' willingness to prescribe those drugs. Researchers had 18 non-obese, middle-aged white women, most with professional acting experience, make 298 visits to 152 primary care physicians in New York and California. The standardized patients (SPs) portrayed symptoms of either major depression or adjustment disorder with depressed mood. They then either made a request for a brand-specific drug (GlaxoSmithKline Plc's Paxil [paroxetine]), made a request for a general drug or did not request a drug. The standardized patients (SPs) secretly audio-recorded their physician visits. Results showed that physicians recorded a diagnosis of depression or possible depression in 80 percent of the visits of SPs presenting major depressive disorder and in 39 percent of the visits by SPs presenting adjustment disorder. They were also more likely to diagnose depression if the SP made a drug request compared with those who did not make a request. In addition, 98 percent of SPs were offered a combination of antidepressant, mental health referral or follow-up within two weeks in the major depression role making a general drug request. In the major depression group, physicians prescribed antidepressants 53 percent of the time when Paxil was specifically requested; 27 percent of the time Paxil was the antidepressant prescribed. If SPs made a general request for drug therapy, physicians prescribed drugs 76 percents of the time. When no request was made, SPs received a drug prescription 31 percent of the time. For SPs presenting adjustment disorder, antidepressant prescribing rates were 55 percent for those making a specific request, 39 percent for those making a general request and 10 percent for those making no drug request. Antidepressants are not typically indicated for adjustment disorder, researchers noted. According to the study, a simple model of DTC advertising model states that, "advertisement exposure raises consumer awareness of conditions and treatments, increased awareness motivates patients to seek medical care and request drug therapy and patients' requests lead, ceteris paribus, to increased prescribing." Researchers said that while, in this study, patients' requests barred undertreatment of major depressive disorder, they also "sound a cautionary note for DTC advertising." Dr. Matthew F. Hollon of the University of Washington in Seattle told Reuters, "Because the safety of a new drug cannot be known with certainty until it has been on the market for several years, and since drug withdrawals occur more than two-thirds of the time within three years of release, the [Food and Drug Administration] should consider a moratorium on advertisement of drugs directly to consumers for three years after initial market release." Results of the study, which was conducted from May 2003 to May 2004, were published in the April 27 issue of JAMA. -=- FEWER HOSPITALIZATIONS, SURGERIES, OTHER PROCEDURES SEEN AMONG PATIENTS WITH FISTULIZING CROHN'S DISEASE ON REMICADE MAINTENANCE THERAPY, STUDY FINDS ------------------------------------------------------------------------------- Patients with fistulizing Crohn's disease who receive maintenance treatment with Centocor Inc.'s Remicade (infliximab) have significantly reduced hospitalizations, surgeries and other procedures as compared with those on placebo maintenance therapy, according to recent findings from a randomized, controlled trial. The 282 patients were participants of the ACCENT II study, which showed that patients who continued to receive infusions of Remicade every eight weeks were significantly more likely to maintain fistula closure than patients who stopped treatment after induction. In the present analysis, investigators evaluated the effect of a Remicade maintenance regimen on hospitalizations, surgeries and procedures in these patients. The subjects received Remicade 5 mg/kg at weeks zero, two and six. At week 14, both responders and nonresponders were randomized to receive infusions of placebo (placebo maintenance) or Remicade 5 mg/kg (Remicade maintenance) at weeks 14, 22, 30, 38 and 46. Researchers defined a fistula response as at least a 50 percent reduction from baseline in the number of draining fistulas at consecutive visits conducted at least four weeks apart. Patients were followed up to week 54. Among the 282 patients, 195 were randomized as responders at week 14. Of these responders, those who received Remicade maintenance therapy had an average of 0.5 hospitalization days, which was significantly fewer than the average of 2.5 hospitalization days recorded among those who received placebo maintenance therapy. The average number of hospitalizations per 100 patients also was reduced (11 vs. 31, respectively) as were all surgeries and procedures (65 vs. 126), inpatient surgeries and procedures (7 vs. 41) and major surgeries (2 vs. 11). The incidence of adverse events was similar in the placebo and Remicade maintenance groups. "Fistulas are associated with a decreased quality of life for patients and represent a distinct therapeutic challenge, often requiring surgical intervention," the investigators noted. "Our data are the first from a large-scale, double-blind, randomized, well-controlled trial to show that medical therapy in fistulizing Crohn's disease may reduce the need for hospitalizations, surgeries and procedures, with their attendant morbidity and cost," they concluded. This data appeared in the April issue of the journal Gastroenterology. -=- SURVEY FINDS THAT NEARLY HALF OF AMERICANS VERY WORRIED ABOUT INCREASED HEALTH CARE COSTS ------------------------------------------------------------------------------- According to a recent survey, 49 percent of adults in the United States are "very worried" about having to pay more for health care or health insurance, up from 45 percent a year ago. The survey--which was conducted between March 31 and April 3 by the Kaiser Family Foundation and included 1,203 adults--found that 42 percent of respondents are very worried about not being able to afford the health care services they think they need, up from 40 percent who responded to the same questions in a Kaiser Family survey in August 2004. Thirty-five percent said they are very worried about not being able to afford the prescription drugs they need, down slightly from 38 percent in the August survey. In addition, 32 percent said they are very worried that the quality of health care services they are receiving is getting worse, up from 30 percent. Of those with health insurance (n=1053), 35 percent said they are very worried about losing their health insurance coverage, up from 34 percent, while 38 percent said they are very worried about their health plan being more concerned with saving money for the plan than with what treatment is best for them, up from 36 percent in the August survey. Respondents were also asked about how worried they are about not being able to pay their rent or mortgage, losing their job, losing their savings in the stock market and being the victim of a terrorist attack or a violent crime. For each of these possibilities, fewer than 30 percent said they are very worried. -=- Naming Standards SENATE FINANCE COMMITTEE ------------------------------------------------------------------------------- Senate Finance Chairman Chuck Grassley, R-Iowa, and Sen. Christopher Dodd, D-Conn., were expected to introduce a bill Wednesday that would establish a new drug safety office within the Food and Drug Administration. The new center would function separately from the Center for Drug Evaluation and Research, according to The Wall Street Journal. Grassley has expressed concern that the current drug safety office, which is housed within the same branch that evaluates drugs for the market, has not acted fast enough to address safety issues involving COX-2 inhibitors such as Merck & Co. Inc.'s Vioxx (rofecoxib) and antidepressants in children. -=- Naming Standards ALLERGAN INC. ------------------------------------------------------------------------------- Allergan Inc. reported a 12.6 percent gain in first-quarter 2005 pharmaceutical sales as its net income fell slightly from $80.8 million in the same quarter a year ago to $79.9 million. Diluted earnings per share remained steady at $0.60. Excluding charges, the company earned $0.76 per share. Analysts polled by Reuters expected earnings of $0.67 per share. The company achieved quarterly net sales of $527.2 million, up from $472.4 million in the first quarter of 2004. For the second quarter, Allergan expects adjusted diluted earnings per share between $0.72 and $0.74 and between $535 million and $550 million in pharmaceutical sales. The company increased its full-year guidance for adjusted diluted earnings per share by approximately $0.05 per share to between $3.15 and $3.20. Allergan shares closed at $70.32, down $2.69, or 3.7 percent, in heavy trading on the New York Stock Exchange. -=- Naming Standards ISTA PHARMACEUTICALS INC. ------------------------------------------------------------------------------- Ista Pharmaceuticals Inc. filed an Investigational New Drug application with the Food and Drug Administration for its combination ophthalmic product containing tobramycin and prednisolone acetate as an antibacterial treatment for steroid-responsive inflammatory ocular conditions at risk for bacterial infections. Upon acceptance of the IND, the company plans to initiate a Phase III clinical trial this year and hopes to submit a New Drug Application as early as the first half of 2006. -=- Naming Standards NEUROCHEM INC. ------------------------------------------------------------------------------- Neurochem Inc. said it will continue its North American Phase III clinical trials for its disease-modifying Alzheimer's disease treatment Alzhemed, based on the recommendation of an independent safety review board. The board reported there were no safety concerns in the trial, which has enrolled 562 patients who have been monitored for at least 12 weeks to date. The company will continue trials without alteration and plans to begin Phase III trials in Europe this fall. -=- Naming Standards


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