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			Healthcare Market Research 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 announces safety concerns related to Cangene, Baxter's autoimmune bleeding disorder product The Food and Drug Administration, Cangene Corp. and Baxter Healthcare Corp. sent a letter to health care professionals informing them of revisions to the warnings, precautions and adverse reactions sections within the prescribing information for WinRho SDF (Rho(D) Immune Globulin Intravenous [Human]). Cangene and Baxter's WinRho SDF is used to treat a critical bleeding disorder called immune thrombocytopenic purpura, which is an autoimmune bleeding disorder caused by an abnormally low level of platelets. According to the FDA Web site, the revisions indicate that "[c]ontinued postmarketing safety surveillance has shown rare, but severe and sometimes fatal, intravascular hemolysis and potentially serious complications," which occur within four hours of administration in most cases. Some signs and symptoms linked with intravascular hemolysis include back pain, fever, discolored urine, decreased urine output, sudden weight gain and shortness of breath. A new patient information sheet on these signs and symptoms is available for distribution. Furthermore, maltose-containing intravenous immune globulin products, such as the liquid formulation of WinRho SDF, may falsely elevate glucose readings when using certain blood glucose monitoring systems. The FDA and the two drug firms suggested that health care professionals only use glucose-specific systems. Healthcare Market Research CDC updates childhood, adolescent immunization schedule The Centers for Disease Control and Prevention released the 2006 Recommended Childhood and Adolescent Immunization Schedule with new recommendations for administering vaccines for hepatitis A and hepatitis B, pertussis, meningitis and influenza. Specifically, the new schedule emphasizes the importance of the hepatitis B vaccine birth dose, stating that it should be delayed only in rare circumstances. In addition, the hepatitis A vaccine is now universally recommended for all children between the ages of 12 and 23 months. The CDC also recommends administering GlaxoSmithKline Plc's pertussis vaccine, Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed [Tdap]), which was approved in May, to adolescents aged 11 to 12 years and to those aged 13 to 18 years who did not receive the earlier Tdap booster. Tdap boosters should be given every 10 years under the new guidelines. Another new recommendation is to administer sanofi pasteur's Menactra (meningococcal [groups A, C, Y and W-135] polysaccharide diphtheria toxoid conjugate vaccine), approved by the Food and Drug Administration last January, to all adolescents aged 11 to 12 years and to any unvaccinated adolescents at high school entry (age 15 years). In addition, college freshmen living in dormitories should receive the meningitis vaccine. Finally, the agency said the influenza vaccine should be given to children 6 months or older "with certain risk factors, which now specifically include conditions that can compromise respiratory function or handling of respiratory secretions or that can increase the risk for aspiration." Healthcare Market Research Data suggest patients with aggressive RA benefit more from early treatment with combined Humira, methotrexate than either therapy alone Combination therapy with Abbott's Humira (adalimumab) and methotrexate is more effective than monotherapy with either of these drugs among patients with recently diagnosed aggressive rheumatoid arthritis who have not previously received methotrexate, according to data from the PREMIER study. The two-year, double-blind trial included 799 individuals with active RA duration for less than three years. All were methotrexate-naïve. The patients were randomized to one of three treatment groups: Humira 40 mg subcutaneously every other week plus 20 mg of oral methotrexate weekly; Humira 40 mg subcutaneously every other week plus placebo; or weekly oral methotrexate plus placebo. For patients who did not achieve an American College of Rheumatology 20 response at week 16 or later, the frequency of Humira dosing could be increased to weekly once methotrexate dosing had been optimized. The study's endpoints were ACR 50 improvement and mean change from baseline in the modified total Sharp score (TSS). At the one-year evaluation, 62 percent of patients who received the combination therapy achieved ACR50. This response rate was significantly greater than that for patients who received methotrexate monotherapy (46 percent) or Humira monotherapy (41 percent). At two years, ACR50 responses were sustained in the combination treatment group, and continued to be clinically and statistically superior to responses in both monotherapy treatment arms. In terms of radiographic progression, patients treated with combination therapy had a mean increase in TSS of 1.3 units at year one compared with 3 units among those treated with Humira only and 5.7 units for those treated with methotrexate only. At year two, combination treatment continued to lead to less radiographic progression (mean change in TSS, 1.9 units for combination therapy vs. 5.5 units and 10.4 units for Humira and methotrexate monotherapy, respectively). "For those patients who are able to tolerate [methotrexate], combination therapy provides substantial improvement over either [Humira] monotherapy or [methotrexate] monotherapy," title="branding company" the study authors concluded. The trial appeared in the January issue of the journal Arthritis & Rheumatism. Healthcare Market Research Betaseron better than interferon beta-1a at reducing brain lesions in patients with MS, study suggests Treatment with Berlex Inc.'s Betaseron (interferon beta-1b) administered every other day appears to be more effective than interferon beta-1a administered once a week at reducing the number of active brain lesions in patients with multiple sclerosis, according to a study published in the February issue of the journal Multiple Sclerosis. Interferon beta-1a is marketed as Avonex by Biogen Idec Inc. and as Rebif by Serono SA and Pfizer Inc. Researchers examined data from a study that included 149 participants and compared the two treatments. Participants were instructed to self-administer either 250 mcg of Betaseron every other day or 30 mcg of interferon beta-1a once a week for two years. The number of patients with at least one 'active' lesion, as observed through magnetic resonance imaging, was significantly lower in those who received Betaseron compared with those who received interferon beta-1a. Furthermore, treatment with Betaseron significantly reduced the risk of MRI activity throughout the entire study period. While patients who received Betaseron had significantly more neutralizing antibodies than those who received interferon beta-1a, there was no evidence that these antibodies increased risk of relapse and "did not seem to have any impact on the changes in MRI activity associated with [Betaseron] treatment," the authors wrote. They suggested that the apparent increased effectiveness of Betaseron is likely due to the higher dose and frequency of administration, particularly since the two drugs that were studied have "very similar chemical structures and, probably, identical mechanisms of action." Healthcare Market Research Patients undergoing PCI who exhibit drug resistance to Plavix, aspirin may be at risk for thrombotic complications, data find Among patients undergoing percutaneous coronary intervention, there appears to be a lower response to Bristol-Myers Squibb Co. and sanofi-aventis Group's Plavix (clopidogrel bisulfate) when patients are also aspirin-resistant, new study findings show. These resistant patients may be at a greater risk for thrombotic complications. Investigators identified 150 patients scheduled for elective PCI between November 2003 and February 2005. All patients received aspirin but not Plavix for at least one week before PCI. Immediately following PCI, all patients received Plavix and aspirin. Blood samples were collected at baseline and between 20 and 24 hours after PCI. Aspirin resistance, defined by mixed factors (0.5 mg/mL arachidonic acid-induced platelet aggregation of 20 percent or more, 5 mcmol/L adenosine diphosphate-induced platelet aggregation of 70 percent or more and/or rapid platelet function assay-aspirin of 550 or more aspirin reaction units), was noted among 19 patients (12.7 percent). Thirty-six patients (24 percent) were Plavix-resistant, which was defined as baseline minus post-treatment aggregation of 10 percent or less in response to 5 mcmol/L and 20 mcmol/L adenosine diphosphate. Overall, 47 percent of the patients who were resistant to aspirin were also resistant to Plavix. Approximately 20 percent of aspirin-sensitive patients were Plavix resistant. The study showed that aspirin-resistant patients were more likely to be female and have diabetes compared with aspirin-sensitive patients. These patients also had a lower response to Plavix. There were no such differences between Plavix resistance and Plavix sensitivity. Elevated creatine kinase-myocardial band levels, a marker of myonecrosis, occurred more frequently in aspirin-resistant versus aspirin-sensitive patients, Plavix-resistant versus Plavix-sensitive patients and dual drug-resistant versus dual-sensitive patients. The researchers said the findings should be confirmed in a larger-scale study. "Our data would imply that this approach may not be sufficient and that other platelet inhibitors acting on additional targets (other than cyclooxygenase-1 and P2Y12) should be developed and investigated," they concluded. Results of the analysis were published in the Jan. 3 issue of the Journal of the American College of Cardiology. Healthcare Market Research Annual schizophrenia treatment costs similar between newer, conventional antipsychotics despite differential costs A cost-effectiveness analysis shows that patients with schizophrenia who are required to first fail less expensive conventional antipsychotics prior to receiving Eli Lilly and Co.'s more expensive Zyprexa (olanzapine) did not yield savings in total treatment costs. Adults with schizophrenia, schizoaffective disorder or schizophreniform disorder were randomized to begin a treatment episode with one of three open-label antipsychotic regimens: Zyprexa as first-line therapy (n=229), first-line treatment with up to two conventional agents potentially followed by a switch to Zyprexa (n=214) or first-line treatment with Johnson & Johnson's Risperdal (risperidone; n=221). As long as no clinically significant adverse events occurred, patients were expected to remain on their randomized treatment for at least eight weeks, but could continue to receive their initial regimen for as long as necessary during the one-year trial. Direct medical costs from the perspective of the public payer health care system were analyzed. Among those patients who completed the trial, rates of switching antipsychotics were significantly lower for the patients who began on Zyprexa than the rates for those who began on conventional treatments or Risperdal (16.1 percent vs. 57.4 percent and 32.5 percent, respectively). After accounting for differential switching rates, Zyprexa also proved to be significantly more effective than conventional antipsychotics on clinical measures (as assessed by Brief Psychiatric Rating Scale scores) and social measures (as evaluated by Lehman Quality of Life Scale social relations scores). Regarding social measures, Zyprexa was also superior to Risperdal. These results occurred while annual average total costs per patient between the three treatment groups remained similar: $21,283 for the conventional drugs, $20,891 for Zyprexa and $21,347 for Risperdal. On an intent-to-treat basis, the minimal differences in total average costs were not statistically significant. Indeed, patients who started a treatment episode on an antipsychotic and then had to switch saved an average $195 in annual drug costs, but required an additional $3,741 for other nonmedication resources, mostly for acute/intensive services. "These data showed that regardless of whether a person was initiated on a conventional or atypical antipsychotic, the overall direct costs of treating a person with schizophrenia for one year were essentially the same," title="branding company" concluded Dr. Ralph Aquila, one of the study investigators, in a Lilly press release. The study findings were published online Dec. 19 in the journal Value in Health. Healthcare Market Research Healthcare Market Research Bristol-Myers Squibb Co. Bristol-Myers Squibb Co. and Athersys Inc. extended their existing partnership for up to three years to apply Athersys' patented RAGE technology to BMS with a guaranteed minimum number of validated drug targets delivered by Athersys annually. The companies originally entered into a research and collaboration agreement in 2001, but expanded it in 2002. During the course of the alliance, Athersys said it has supplied multiple drug targets to BMS in a variety of therapeutic areas. Athersys is entitled to receive license fees, milestone payments and royalties for compounds developed from the targets. Healthcare Market Research Healthcare Market Research King Pharmaceuticals Inc. King Pharmaceuticals Inc. began Phase III testing on Vanquix (diazepam), which will be administered using King's auto-injector technology. Vanquix is intended for acute, repetitive seizures associated with epilepsy. King said the only commercially available treatment for the disease that does not have to be given by a health care provider is a diazepam rectal gel. King also initiated Phase II studies for topical drug MRE0094 intended to treat patients with chronic, neuropathic, diabetic foot ulcers. The novel, adenosine A2A receptor agonist promotes tissue remodeling, King said. Healthcare Market Research Healthcare Market Research Enzon Pharmaceuticals Inc. Enzon Pharmaceuticals Inc. is returning its rights to ATG-Fresenius S, an organ transplant drug, to Fresenius Biotech GmbH. According to Enzon, the companies are working to ensure a seamless transition for the ongoing clinical trial of the drug, a polyclonal antibody preparation used for T-lymphocyte suppression to prevent organ graft rejection in organ transplants. Enzon said its decision "was based on its ongoing efforts to redirect its research and development investments to projects strategically aligned with its business objectives, including an increasing focus on cancer and adjacent therapeutic areas." Healthcare Market Research Healthcare Market Research BioDelivery Sciences International Inc. BioDelivery Sciences International Inc. submitted an Investigational New Drug application to the Food and Drug Administration for its Bema Long Acting analgesic. Bema LA is formulated with an FDA-approved opioid analgesic and uses BDSI's licensed Bema platform to deliver the unnamed active ingredient across the buccal mucosa of the mouth. The company believes the product, which uses a compound BDSI says is more potent than morphine but not as prone to adverse reactions and abuse, could generate sales of between $250 million and $500 million if approved. Healthcare Market Research


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