Pharmaceutical Naming - Brand Institute, inc.



			Pharmaceutical Naming 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 BIOVAIL, DEPOMED RECEIVE APPROVAL FOR GLUMETZA DIABETES DRUG Biovail Corp. and Depomed Inc. received final approval from the Food and Drug Administration for Glumetza (metformin hydrochloride), a once-daily, extended-release formulation for the treatment of type 2 diabetes. The companies received an approvable letter in February indicating that the drug could be approved pending finalization of a manufacturing specification. They addressed this issue in their response submitted in April. "Glumetza may offer potential advantages such as less frequent dosing and proven effectiveness in combination with other diabetes drugs," the companies said. "Glumetza also offers excellent tolerability that allows physicians to more quickly administer a high enough dose to provide glycemic control without significantly increasing the incidence of nausea, diarrhea and other side effects that are sometimes caused by metformin products." Depomed's Gastric Retention drug-delivery technology was used to develop Glumetza 500 mg; Biovail's Smartcoat delivery technology was used for the 1,000 mg dosage. Biovail, which is currently seeking partners to market Glumetza in the United States, filed the New Drug Application for both dosages in April 2004. The approval triggers a $25 million milestone payment by Biovail to Depomed. Depomed shares closed at $4.72, up $0.42, or 9.8 percent, in heavy trading on the Nasdaq. Biovail shares closed at $15.75, down $0.24, or 1.5 percent, in light trading on the New York Stock Exchange. -=- CHIRON'S PULMINIQ FAILS TO MEET TRIAL ENDPOINT, FDA REPORT STATES Food and Drug Administration staff reviewers said results from a small clinical trial do not demonstrate that Chiron Corp.'s Pulminiq (cyclosporine) inhalation solution, an immunosuppressant, was more effective than placebo in preventing acute rejection in patients receiving allogeneic lung transplants. "This randomized, double-blind clinical trial was designed as a small Phase II study to show a treatment difference in terms of acute rejection. It failed to achieve that objective," agency staff said. The reviewers released their report ahead of Monday's review of Pulminiq by the agency's Pulmonary-Allergy Drugs Advisory Committee. Although a post hoc analysis of the study revealed a difference in survival between the two treatment arms, FDA reviewers found major flaws in the 56-patient study, specifically: it was conducted at one center and led by one investigator; it was vulnerable to bias; it was not randomized and the treatment arms were not balanced (owing to the small sample size); it failed to establish a treatment regimen; and it raised concerns regarding biological plausibility and reliability. The reviewers agreed with Chiron that exposure to Pulminiq was not associated with a detectible increase in systemic toxicity, but they noted that safety data are limited on the potential adverse effects of aerosolized cyclosporine when administered using Pulminiq's method of delivery. While cyclosporine is commonly used in oral or intravenous formulations for other types of organ transplants, Pulminiq delivers the active ingredient directly to the lungs via inhalation. "Overall, the safety database is smaller than usually expected in a commercial application," the reviewers stated. "The acceptability of the safety information in this [New Drug Application] must be weighed against the degree of certainty of the potential clinical benefit." Chiron is seeking approval of Pulminiq to be used in combination with standard immunosuppressive therapy to increase survival and prevent chronic rejection in the previously noted patient population. Chiron shares closed at $37.57, down $0.46, or 1.2 percent, in moderate trading on the Nasdaq. -=- CRESTOR MORE COST-EFFECTIVE STATIN THAN LIPITOR, ZOCOR, PRAVACHOL, RESEARCH SUGGESTS AstraZeneca Plc's Crestor (rosuvastatin calcium) appears to be more cost effective than Pfizer Inc.'s Lipitor (atorvastatin calcium), Merck & Co. Inc.'s Zocor (simvastatin) and Bristol-Myers Squibb Co.'s Pravachol (pravastatin sodium) when it comes to helping patients achieve lower LDL cholesterol levels. Researchers applied drug acquisition costs to assess the cost effectiveness of each of the agents using clinical data from the STELLAR trial, a six-week trial that compared the change in plasma LDL cholesterol concentration among 2,431 patients with hypercholesterolemia randomized to receive Crestor, Lipitor, Zocor or Pravachol at varying doses. In the current analysis, only the 10 mg dose of Crestor was compared with the other drugs; researchers said the 10 mg, 20 mg and 40 mg doses of Crestor cost the same, and most patients initiating treatment with Crestor are prescribed the 10 mg dose. Overall, the mean costs per 1 percent decrease in LDL cholesterol levels and per patient treated to achieve LDL goals, as established by National Cholesterol Education Program Adult Treatment Panel III guidelines, were lowest for Crestor, followed by Lipitor. With a value of $6 to $54 placed on the 1 percent decrease in LDL levels and a value of $449 to $8,368 placed on reaching the LDL cholesterol goal, Crestor 10 mg was the most cost-effective option, according to the trial data. Further, when the value dropped to levels lower than those noted, Crestor maintained its cost effectiveness as compared with the other agents. The full analysis was published in the June 1 edition of The American Journal of Cardiology. -=- PRICES OF PAINKILLERS RISE AFTER VIOXX WITHDRAWAL, NEW ANALYSIS SHOWS Since Merck & Co. Inc. pulled its COX-2 inhibitor, Vioxx (rofecoxib), from the market last September, prices for some prescription painkillers have risen at higher than average rates, according to the most recent Consumer Reports Best Buy Drugs analysis. The report found that between September 2004 and March 2005, prices increased for 36 prescription painkillers. However, prices decreased for 17 prescription drugs in this class and were unchanged for 10 others. The average price increase during this time for all prescription nonsteroidal anti-inflammatory drugs, including generic and branded products, was 2.4 percent. Boehringer Ingelheim GmbH's NSAID, Mobic (meloxicam), which experienced a 136 percent spike in prescriptions since the withdrawal of Vioxx, increased in price by an average of 9 percent. Prescriptions for generic ibuprofen rose 28 percent, with only a modest price increase. Consumer Reports noted that prescribing patterns following the withdrawal were divided largely between Mobic and generic ibuprofen. Boehringer Ingelheim and Abbott Laboratories co-market Mobic. "This split may be symbolic of trends in pharmaceutical prescribing in general," the report noted. "It is caught between continued hype and promotion surrounding many newer and more costly drugs and powerful pressure to lower costs and shift to generics whenever possible." The full report, which is based on data from NDCHealth Corp., is available on the Consumer Reports Best Buy Drugs Web site. -=- STUDY SUGGESTS SANOFI PASTEUR'S WHOOPING COUGH VACCINE SAFE, EFFECTIVE Sanofi pasteur's whooping cough vaccine, Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap]), is safe and effective, according to the results of a new study; the data support potential routine immunization of adolescents and adults. In a prospective, modified double-blind, comparative trial conducted between August 2001 and August 2002, researchers randomized 4,480 healthy participants aged 11 through 64 years to either Adacel or tetanus-diphtheria vaccine (Td). Researchers found that participants who received Adacel had a substantially higher level of whooping cough, or pertussis, antibodies after one dose than did infants who received three doses of analogous pediatric diphtheria-tetanus-acellular pertussis vaccine (DTaP) in a previous efficacy trial. While it is unclear how long immunity with Adacel will last, Dr. Michael Pichichero, the study's lead author, said the vaccine "should be at least 83 percent effective at preventing severe illness in adults and adolescents," according to The Associated Press. The AP report noted that a Centers for Disease Control and Prevention committee is expected to decide on June 29 whether Adacel should be part of mass immunization programs. It also said that, based on CDC data, the number of cases of whooping cough in the United States quadrupled in three years' time, to nearly 19,000 cases in 2004. The study authors wrote that "[a]lthough increased awareness and improved diagnostic methods may increase reporting, factors such as the variable efficacy of whole-cell pertussis vaccines previously used in the United States, undervaccination in childhood and waning immunity in adolescents and adults may also explain an increase in incidence." A Food and Drug Administration advisory committee recommended approval of Adacel in March. Sanofi pasteur, part of the sanofi-aventis Group, provided funding for the study, which was published online June 2, ahead of print in the June 22 issue of the Journal of American Medical Association. -=- DRUG ERRORS CONTINUE TO OCCUR IN HIGHLY COMPUTERIZED HOSPITALS, NEW STUDY SHOWS Even after introducing computerized drug systems into hospitals, high rates of drug errors, such as incorrect drug dosing, monitoring and ordering, continue to occur, trial outcomes reveal. Researchers evaluated the rate of adverse drug events occurring in hospitals that have begun using computerized drug ordering systems, including computerized physician order entry (CPOE), which is specifically designed to reduce drug errors. In particular, the investigators reviewed a random sample of electronic medical records from all admissions to a Veterans Administration hospital over a 20-week period. Of 937 hospital admissions assessed, 483 clinically significant adverse drug events were detected, translating to a rate of 52 adverse drug events per 100 admissions. Further, researchers found that 25 percent of the hospitalizations involved at least one adverse drug event. Of those events evaluated, 9 percent resulted in serious harm, and 22 percent required a combination of additional monitoring and intervention. Another 32 percent required additional intervention only, and 11 percent called for further monitoring only. According to the authors, another 27 percent should have resulted in additional intervention or monitoring. Medication errors contributed to 27 percent of the adverse drug events, including problems with ordering, monitoring, proper administration and dispensing. The researchers noted that only 76 percent of the adverse drug events were mentioned in the medical records. They added that because the VA's computerized patient record system probably makes adverse drug events more noticeable than a paper-based system would, "this study does not support the interpretation that the VA computerized patient record system induces [adverse drug events]." The data were published in the May 23 issue of the Archives of Internal Medicine. -=- Pharmaceutical Naming JOHNSON & JOHNSON Johnson & Johnson completed its acquisition of Closure Medical Corp. in a cash-for-stock exchange worth an estimated $370 million. J&J agreed to pay Closure Medical shareholders $27 cash per share; approximately 15.6 million fully diluted shares were outstanding. J&J said previously that upon closing, it would incur a one-time, after-tax charge of approximately $68 million, or $0.02 per share, to write off certain research and development expenses. -=- Pharmaceutical Naming GENENTECH INC. Genentech Inc. and Exelixis Inc. signed an agreement to collaborate on the discovery and development of therapeutics to target cancer, inflammatory diseases and tissue growth and repair. According to Exelixis, Genentech will focus on generating antibodies to proteins Exelixis provides. Genentech will pay Exelixis an up-front fee and provide research and development funding for three years. In addition, Exelixis will receive milestone and royalty payments for cancer-related therapeutics developed under the agreement. Exelixis also has the option of sharing part of the costs and profits associated with the development, manufacturing and commercialization of products in the areas of tissue growth and repair or inflammation. -=- Pharmaceutical Naming MCNEIL CONSUMER & SPECIALTY PHARMACEUTICALS McNeil Consumer & Specialty Pharmaceuticals is voluntarily recalling all lots and all flavors of Children's Tylenol (acetaminophen) Meltaways 80 mg packaged in bottles and blister packs, Children's Tylenol SoftChews 80 mg in blister packs and Jr. Tylenol Meltaways 160 mg in blister packs. The firm said the blister package design, as well as labeling information, may be confusing and could lead to improper dosing, including overdosing. McNeil, a division of Johnson & Johnson, said it is working with the Food and Drug Administration on this recall. -=- Pharmaceutical Naming GUIDANT CORP. Guidant Corp. continued to sell Ventak Prizm 2 DR Model 1861 implantable cardioverter defibrillators (ICDs) after discovering they were potentially flawed, The New York Times reported. Guidant told The Times it continued to sell the devices because the company believed them to be reliable. According to the report, the Food and Drug Administration is examining the company's decision to sell the older devices even after producing a newer version in mid-2002 that eliminated the potential electrical flaw. Guidant recently notified physicians of failures involving the older ICDs. -=- Pharmaceutical Naming


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