 |
 |
||||||||
 |
|||||||||
ProprietaryBrand 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 RECEIVES APPROVAL LETTER FOR TRAMADOL ODT DISINTEGRATING TABLETS FOR PAIN; REPORTS Q1 EARNINGS, REVISES GUIDANCEBiovail Corp. received an approval letter from the Food and Drug Administration for Tramadol ODT (tramadol hydrochloride) to treat moderate to moderately severe pain in adults. Tramadol ODT is an orally disintegrating 50 mg tablet formulation of the analgesic tramadol hydrochloride. The company said it filed a Complete Response in March to address issues brought up in the FDA's approvable letter sent in early January. According to Biovail, the areas cited by the FDA involved resolution of labeling issues, including resolution of final packaging, content and format for the drug's blister card and carton. The company cited a 2004 study of Americans that found nearly 40 percent of adults have problems swallowing tablets, which leads to a significant portion of these respondents failing to comply with their treatment regimens. "Patients may benefit from the convenience of Tramadol in an orally disintegrating dosage format--particularly those who have difficulty swallowing tablets or those who may not, or do not, always have access to water," said Dr. Douglas Squires, Biovail's chief executive officer. The U.S. market for analgesics is considerable, with sales for the 12 months ended March 30 reaching $14.3 billion, according to Biovail. The company said that in this same period, revenue of tramadol-based products reached $463.3 million. Ortho-McNeil Pharmaceutical Inc., a division of Johnson & Johnson, currently markets tramadol hydrochloride under the brand name Ultram. Several generic formulations are also available. Also on Friday, Biovail reported its first-quarter earnings for 2005 and revised its full-year earnings guidance. Net income for the first quarter of 2005 fell to $11.1 million, or $0.07 per diluted share, from $21.1 million, or $0.13 per diluted share, in the same period of the previous year. Analysts from Thompson First Call had estimated earnings of $0.08 per share, according to Dow Jones Newswires. The company reported total revenue of $175.3 million for the first quarter of 2005, compared with revenue of $186.6 million in the first quarter of 2004. In addition, Biovail revised its guidance for full-year 2005, reducing revenue estimates, but increasing earning estimates. Revenue for 2005 is now expected to be between $860 million and $930 million, down from previous revenue guidance of between $925 million and $1 billion. The company increased its diluted earnings per share guidance for 2005 from between $1.50 and $1.60 to between $1.70 and $1.75. Biovail shares closed at $15.03, up $1.04, or 7.4 percent, in heavy trading on the New York Stock Exchange. FDA ADVISES MONITORING FOR DEPRESSION, SUICIDAL THOUGHTS AMONG ACCUTANE USERS AS IT CONTINUES TO ANALYZE REPORTS OF SUICIDE, SUICIDE ATTEMPTS The Food and Drug Administration is continuing to evaluate reports of suicide and suicide attempts that could be associated with the use of F. Hoffmann-La Roche Ltd.'s acne drug, Accutane (isotretinoin), the agency said in an alert posted on its Web site. "Although causality has not been established for these reports, awareness of signs and symptoms is important. All patients treated with [Accutane] should be observed closely for symptoms of depression or suicidal thoughts, such as sad mood, irritability, anger, loss of pleasure or interest in social or sports activities, sleeping too much or too little, changes in weight or appetite, school or work performance going down or trouble concentrating," the FDA's notice for health care professionals said. The notice added that besides discontinuing the drug, further psychiatric evaluation and intervention may be necessary. The FDA went on to say that preclinical and neuroimaging data suggest the drug produces murine behavioral effects and impairment of neuronal division and reductions in human orbitofrontal brain metabolic rates, "data [that] may suggest biological plausibility for the suspected psychiatric adverse events associated with [Accutane]." Between 1982 and August 2004, the FDA said it has received 4,992 spontaneous reports of psychiatric disturbances associated with use of the drug in the United States. Through January 2005, there were 190 reported suicides nationwide among Accutane users. The number of reported suicides between 1982 and 2002 was 165, fewer than the 220 predicted based on U.S. vital statistics data. "However, because the degree of under-reporting of suicides is unknown, the fact that the reported number is lower than the predicted number cannot be interpreted as evidence against a causal association," the notice concluded. According to a statement by Shelley Rosenstock, a Roche spokeswoman, the information provided on the Web site is "consistent with the information that we have been providing to the health care community on Accutane," Dow Jones Newswires reported. Roche noted that suicide is the third leading cause of death among people aged 15 to 24 years, the age group of a majority of Accutane users. FDA PROVIDES DETAILS REGARDING PROPOSED DRUG SAFETY OVERSIGHT BOARD, "DRUG WATCH" WEB SITE The Food and Drug Administration issued details regarding its proposed Drug Safety Oversight Board (DSB) and a draft guidance outlining a plan for a Web site that would feature "important drug safety information concerning marketed drug products." The DSB would have 15 voting members, including three each from the Center for Drug Evaluation and Research's Office of Drug Safety and Office of New Drugs and one each from five other offices within CDER. The deputy director of CDER would chair the board. In a manual of policies and procedures, the agency said that the DSB will "provide independent oversight and advice to the center director." Other listed responsibilities center around the management of drug safety issues and the dissemination of important drug safety information to consumers and health care professionals. As such, the DSB will also manage the proposed drug safety information Web site, which is known as "Drug Watch." According to a draft guidance, Drug Watch is meant "to identify drugs for which [the] FDA is actively evaluating early safety signals." The Web site's purpose will be "to provide a forum in which we can communicate emerging safety information to the public while we continue to evaluate that information." The guidance refers to three types of information that Drug Watch will include: recently observed and reported serious adverse events associated with the use of a drug; information about significant risks that the agency believes could be associated with the drug but might be avoided by appropriate patient selection; and information about an important risk minimization procedure put into place by a drug's sponsor as a result of emerging information. Factors influencing the DSB's decision to place information on Drug Watch will be whether the new safety information could have a significant effect on prescribing decisions or patient monitoring, whether prevention or mitigation of harm can take place as a result of posting information and whether off-label use of a drug appears to present a significant risk to patients. A DSB Drug Watch subcommittee would make timely decisions about the placement, removal or addition of information on the Web site. Prior to posting information, the DSB would undertake "at least a preliminary analysis to determine that the new safety information is sufficiently credible to warrant public dissemination." The agency emphasized that listing a drug on Drug Watch does not mean the drug is unsafe. "Rather, inclusion on the Drug Watch signifies that [the] FDA is attempting to assess the meaning and potential consequences of emerging safety information," the guidance noted. A drug's sponsor will be notified "shortly before the first instance in which information about that drug is posted on the Web site," the agency said. The FDA added that it plans on developing patient information sheets for all approved drugs and health care professional information sheets for all molecular entities and certain other drugs. ALDARA ADMINISTERED ONCE DAILY FOR SIX WEEKS PROVES SAFE, EFFECTIVE FOR SUPERFICIAL BASAL CELL CARCINOMA, DATA INDICATE New research suggests that 3M Pharmaceuticals' Aldara (imiquimod) cream 5% administered seven times weekly for six weeks is a safe and effective treatment for superficial basal cell carcinoma (sBCC) when compared with vehicle cream. Investigators enrolled 166 patients who had at least one histologically confirmed sBCC tumor to participate in the Phase III study. Patients were randomized to apply Aldara cream or vehicle cream to the target tumor once daily for six weeks. Researchers marked the target tumor location before treatment began and clinically assessed the treated site for treatment response 12 weeks after treatment ended. They then excised the site for histological evaluation. Efficacy assessments utilized by the investigators included the composite response rates (proportion of subjects with clinical and histological clearance) and response rates based solely on histology (proportion of subjects with histological clearance). For the intent-to treat dataset, researchers found a statistically significant difference between the Aldara and vehicle groups for both composite and histological clearance rates. Overall, 77 percent and 6 percent of patients treated with Aldara and vehicle cream, respectively, demonstrated composite clearance. The corresponding rates for histological clearance were 80 percent and 6 percent. The authors added that the most frequently reported safety findings were investigator-assessed local skin reactions and spontaneous reports by subjects of application site reactions, which were more frequent in the Aldara-treated group. "The results of this study therefore indicate that patients and physicians now have the option of a locally-applied topical therapy for sBCC," the study authors concluded. This study was published April 28, ahead of print in the British Journal of Dermatology. NEW SURVEY INDICATES CONSUMERS PREFER OLDER DRUGS The majority of American consumers surveyed in a new study would choose older drugs over newer drugs. Investigators surveyed 1,092 insured adults to assess consumer perceptions, attitudes and behaviors related to health care and prescription drug coverage. Seven out of 10 respondents indicated a preference for drugs that have been on the market for 10 or more years, and nearly 31 percent of survey participants said that older drugs are safer than newer drugs. However, one-third of survey participants said newer drugs are more effective than older drugs. In addition, the survey showed that more than 80 percent of respondents aged 40 to 58 years were familiar with the drug safety issues associated with COX-2 inhibitors. Approximately 86 percent of survey respondents indicated they would use generic drugs for common ailments such as allergies and headaches, but only 46 percent said they would use generic drugs for severe health problems like cancer. The survey was conducted by TSC, a division of Yankelovich Partners for Medco Health Solutions Inc. The findings were presented May 5 at Medco's 2005 Drug Trend Symposium in Orlando. FOUR OUT OF 10 EMERGENCY PHYSICIANS NOT LIKELY TO PRESCRIBE RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR FOR STROKE New survey results indicate 40 percent of emergency physicians are unlikely to prescribe recombinant tissue plasminogen activator (rtPA) for acute ischemic stroke, even in an ideal setting. Genentech Inc.'s Activase (alteplase, recombinant) is the only drug approved by the Food and Drug Administration for treating acute ischemic stroke, according to Genentech. Although it was first approved in 1996, the product is only used in approximately 10 percent of eligible patients, according to the survey, which was performed by the University of Michigan Health System. Researchers from the system's Stroke Program sent questionnaires to 2,600 randomly selected emergency physicians who were active members of the American College of Emergency Physicians. A total of 1,105 physicians responded, and their answers were cross-analyzed according to several variables. Overall, 40 percent of the physicians said it was "very unlikely," "unlikely" or "uncertain" they would give the drug to an ideal patient in an ideal setting. Of those who said they were not likely to use rtPA, 65 percent said their decision was based on the risk of symptomatic intracerebral hemorrhage, 23 percent said it was their perceived lack of benefit and 12 percent said both reasons were the cause of their decision. However, most of the physicians said if they had appropriate help from neurologists and an available brain scanner to help them diagnose and treat patients, they would give the drug. "This survey shows that there's still major resistance to [rtPA] use in the emergency medicine community, but we shouldn't blame [emergency department] physicians or ask them to handle this decision alone," said Dr. Devin Brown, a stroke neurologist and one of the study investigators. "Only through team decision-making will we be able to change current practice and improve acute stroke care delivery." Even more physicians said they would prescribe rtPA if the risk of associated bleeding could be reduced. RtPA has a bleeding risk of approximately 6.4 percent, according to the Stroke Program. On average, the physicians said an upper limit of 3.4 percent intracranial hemorrhage risk would be acceptable. The researchers also noted that 30 percent of the physicians said their own experience with rtPA had influenced their survey answers. "It appears that individual anecdotal experience is influencing decision-making, when it should be the medical literature that leads the way," Brown added. The study authors predicted that use of rtPA will increase as hospitals begin forming stroke teams of neurologists, radiologists, emergency physicians and other specialists to prepare for, diagnose and treat patients with stroke. These results were published online April 30 at the Web site of Annals of Emergency Medicine. Proprietary AMGEN INC. Amgen Inc. submitted a supplemental Biologics License Application for its anemia treatment, Aranesp (darbepoetin alfa), based on data from Phase III trials. Amgen believes the data will show the safety and efficacy of Aranesp when administered every three weeks to treat chemotherapy-induced anemia in patients with nonmyeloid malignancies. Aranesp would be the first therapy approved by the FDA for this dosing regimen in the treatment of anemia in these patients, Amgen said. The FDA approved Aranesp for the weekly treatment of chemotherapy-induced anemia in patients with nonmyeloid malignancies in 2002. Proprietary THE DEPARTMENT OF HEALTH AND HUMAN SERVICES The Department of Health and Human Services awarded a $122.7 million contract to BioPort Corp. for 5 million doses of Anthrax Vaccine Adsorbed (AVA). As part of the Strategic National Stockpile, this supply will be available for use in case of a bioterror anthrax incident, the HHS said. This is the third contract awarded under Project BioShield, a program intended to accelerate the development of medical countermeasures to biological, chemical, radiological and nuclear threats. The Project BioShield Act of 2004 passed through Congress in July. Proprietary CARDINAL HEALTH INC. Cardinal Health Inc. will discontinue its pharmaceutical-trading business, noting the initiative is a "business decision" driven by shifts in the industry, according to The Wall Street Journal. The therapies purchased in Cardinal's pharmaceutical-trading business accounted for between $180 million and $190 million in revenue, year to date, The Journal noted. A company spokesman said the decision is designed to further enhance the security of the firm's supply chain. Proprietary REATA PHARMACEUTICALS INC. Reata Pharmaceuticals Inc. received clearance from the Food and Drug Administration to begin clinical testing of RTA 744 in patients with advanced brain cancers. A Phase I clinical trial of RTA 744--an anthracycline derivative that crosses the blood-brain barrier--in patients with recurrent, advanced primary brain cancer is scheduled to begin in the next few months, Reata said. The company also plans to evaluate the drug in combination with other brain cancer therapies and as treatment for patients with central nervous metastases. Additionally, the company said it has changed its name from Reata Discovery Inc. to Reata Pharmaceuticals "to reflect the clinical status of its drug development programs." Proprietary
|
|||||||||
| - biotech brand - biotech branding - biotech brands - biotech name - biotech names - biotech naming - biotechnology brand - biotechnology branding - biotechnology brands - biotechnology name - biotechnology names - biotechnology naming - Brand agencies - Brand agency - Brand analysis - Brand companies - Brand company - Brand Consultant - brand consultants - Brand Consulting - Brand Design - brand designing - Brand Development - brand equity - brand identity - Brand Institute - Brand Name - brand names - brand naming - brand research - Brand Services - brand strategies - brand strategy - brand - branding Agencies - branding Agency - branding companies - branding company - branding Consultants - branding Service - branding Services - branding - brands - Company Brand - Company Branding - Company Brands - Company Name - Company Names - Company Naming - Conjoint Analysis - Conjoint - Corporate Brand - Corporate Branding - Corporate Brands - Corporate Name - Corporate Names - Corporate Naming - Drug Brand - Drug Branding - Drug Brands - drug labeling - Drug Name - drug names - Drug Naming - Drug package - drug packaging - Gap analysis - Generic Brand - Generic Branding - generic brands - generic name - Generic Names - Generic Naming - Healthcare Brand - Healthcare Branding - Healthcare Brands - Healthcare Name - Healthcare Names - healthcare naming - label design - Labeling Design - language research - linguistics - market research - Marketing Research - medical recruiting - name a drug - Name a product - name analysis - Name Brand Products - Name Brand - Name Branding - name brands - Name Consultant - name consultants - Name Consulting - Name Design - name drug - name drugs - Name Services - naming agency - naming companies - naming company - naming - online recruiting - online research - package design - pharma brand - pharma branding - pharma brands - pharma name - pharma names - pharma naming - pharmaceutical brand - pharmaceutical branding - pharmaceutical brands - pharmaceutical name - pharmaceutical names - pharmaceutical naming - physician recruiting - practitioner panels - product branding - Product name - Product names - Product Naming - Product Position - product positioning - Proprietary Name - Proprietary Names - Proprietary Naming - Proprietary - Quantitative Research - regulatory consultants - survey hosting - The Brand Institute - Thebrandinstitute - trade name - Trade names - Trade Naming - Trademark Name - Trademark Names - Trademark Naming - TURF Analysis - USAN Name - USAN Names - USAN Naming - USAN/INN Name - USAN/INN Naming - USAN/INN - USAN |
|||||||||
 |
|||||||||
Austin / Chicago / Geneva / London / Los Angeles / Miami / New York / Ottawa / Raleigh Durham / Rockville / San francisco / Tokyo
|
|||||||||
 |
|||||||||
|
|
|
|
|
|
|
|
|
|
|
