Strategic Branding - Brand Institute, inc.



			Strategic Branding 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 UCB's brivaracetam granted orphan drug designation for treatment of symptomatic myoclonus The Food and Drug Administration granted an orphan drug designation to UCB's brivaracetam, a SV2A ligand, for the treatment of symptomatic myoclonus. In experimental models of epilepsy and myoclonus, and in a photosensitive epilepsy model in humans, brivaracetam demonstrated significant antiepileptic activity, according to UCB. Brivaracetam's mechanism-of-action profile differentiates it from the firm's Keppra (levetiracetam), an adjunctive therapy in treating partial onset seizures for adults and children aged 4 years or older with epilepsy, UCB noted. Brivaracetam was previously granted orphan medicinal designation for the treatment of progressive myoclonic epilepsies by the European Commission. The drug is currently being evaluated in Phase II trials in patients with refractory partial onset seizures and in patients with post-herpetic neuralgia. Strategic Branding Axonyx halts development of Phenserine, will seek licensees In an update of its clinical development program, Axonyx Inc. said it will not commit further resources to the development of Phenserine, a treatment candidate for Alzheimer's disease. The company evaluated results from three Phase III trials, interim analyses of a beta amyloid trial and recent additional patient data. None of the trials achieved statistical significance for the primary endpoints, although positive signals were observed in all the trials. Actually, results from the Phase IIb beta amyloid trial appeared to show a difference between 15 mg Phenserine and placebo in levels of beta amyloid 1-42. "The magnitude of this difference and the variability of these data show that a larger investigation than planned would be needed to demonstrate a statistically significant effect," Axonyx said. The company plans to find a partner to license the data set because the firm believes a re-formulation of the drug that provides higher drug exposure to the patient could improve the efficacy profile and amyloid-lowering effects. No additional expenses, except for those needed to close the program in an orderly manner, will be incurred for Phenserine, Axonyx said. Instead, the firm will use its financial resources to expand its pipeline. Posiphen, a drug intended to slow the progression of Alzheimer's disease, is being studied in a Phase I trial. Phase I studies for BisNorCymserine are planned for the first quarter of 2006. The compound inhibits butyrylcholinesterase, a substance found at a high concentration in the plaques of patients with Alzheimer's disease. Strategic Branding Immune response to influenza vaccine maintained in patients treated with Rebif for MS Treatment with Serono SA's Rebif (interferon beta-1a) in patients with multiple sclerosis does not affect the immune response to influenza vaccination, a recent study found. Researchers conducted an open-label study in a total of 163 patients with MS over a four-week period. Eighty-six patients received 44 mcg of Rebif subcutaneously three times weekly for at least six months before they were administered the flu vaccine. They continued their treatment with Rebif after the vaccination. The control group included 77 patients with MS who did not receive treatment with Rebif within six months before entry into the study or during the study. Both groups of patients received a single dose of the same influenza vaccine. Results from both groups were similar on the primary endpoint, defined by the proportion of patients achieving a hemagglutination inhibition titer of greater than 40 at four weeks after vaccination. This indicates the ability of patients to achieve a positive vaccine response, the company said. Additionally, more than 90 percent of the patients in both groups achieved an appropriate immune response. "These results demonstrate that treatment with Rebif does not alter the immune response to influenza vaccination, and that this vaccination can be performed safely in MS patients who are treated with Rebif. This news is important for patients treated with Rebif as vaccination may provide medical benefits to people with MS by preventing an influenza virus infection, and also by possibly avoiding MS exacerbations or worsening of neurologic symptoms due to concurrent viral infection," said Dr. Paul Lammers, chief medical officer of Serono. These results were presented in Sydney, Australia, at the XVIIIth World Congress of Neurology. Rebif is co-marketed with Pfizer Inc. Strategic Branding Dispensing errors by automated mail-order pharmacies may be fewer than those by retail pharmacies Automated mail-service pharmacies have a lower rate of dispensing errors as compared with retail pharmacies, according to findings published in the November issue of the journal Pharmacotherapy. Medco Health Solutions Inc. studied 21,252 prescriptions selected at random times between September and October 2003. The prescriptions were selected prior to shipping from the final distribution point of Medco's mail-order pharmacies. The researchers compared the contents of the containers with those printed on the product label; they also compared the label record with the original prescription order. Overall, 16 dispensing errors occurred, yielding a dispensing error rate of 0.075 percent or less than one error per 1,000 prescriptions. This rate was lower than the 1.72 percent dispensing error rate of 50 retail pharmacies. The latter finding was observed in a 2003 Auburn University study and was published in the Journal of the American Pharmaceutical Association in 2003, Medco said in a press release. All Medco dispensing errors were associated with the initial stages of prescription processing, not with the mechanical stages of product dispensing. A total of 14 errors involved incomplete or incorrect directions as compared with 40 label errors observed in retail pharmacies (0.066 percent vs. 0.89 percent). Zero errors occurred for dispensing the correct drug, dosage or dosage form, while six, eight and one occurred in the Auburn study, respectively, Medco said. "Preventable medication errors continue to plague our health care system, but through the use of quality controls and sophisticated automation, we can achieve the highest level of dispensing accuracy for the patients who rely on us for their medications," said Roger Anderson, chief pharmacist at Medco. However, Doug Hoey, chief operating officer at the National Community Pharmacists Association said the recent study does not account for patients who never received their ordered prescription or who could not have their questions answered by a pharmacist, The Associated Press reported. He acknowledged, though, that automated prescriptions allow pharmacists to spend more time with patients. Strategic Branding Bayer beats Q3 financial forecasts Bayer AG exceeded analysts' financial expectations during the third quarter and raised its guidance for full-year earnings before interest and taxes. Specifically, group sales rose to approximately $7.66 billion, up from approximately $6.44 billion one year ago, due to the acquisition of F. Hoffmann-La Roche Ltd.'s over-the-counter business, the spin-off of its Lanxess basic chemicals unit and a 7 percent increase in selling prices. Analysts had forecast sales of approximately $7.37 billion, Dow Jones Newswires reported. The Bayer HealthCare unit, spurred by Roche's consumer health business, was the strongest growth driver, lifting sales by approximately 21 percent to approximately $2.79 billion. The pharmaceuticals division showed considerable organic growth that more than offset a decline in sales due to the U.S. patent expiration of the antibiotic Cipro (ciprofloxacin). The firm reported that net income, which rose from approximately $61 million in the third quarter of 2004 to approximately $578.7 million this past quarter, was boosted by net special gains of approximately $210 million. Changes to Bayer's pension plans led to a noncash gain of approximately $328.6 million, countered by approximately $115 million in special charges. In the year-ago period, the company had approximately $90.4 million in net special charges. Just last week, Bayer HealthCare announced its plan to spin off the anti-infective research unit of its pharmaceuticals division into a new company. Santo Holding AG will own a majority holding, with Bayer HealthCare retaining a minority holding. The transaction is expected be completed in the first quarter of next year. "The third-quarter figures show that the strategic realignment of the Bayer group has sustainably improved our earning power," said Werner Wenning, the company's chief executive officer. "Our extensive cost-containment and efficiency-improvement measures have paid off." Bayer confirmed its goal of generating more than $30.51 billion in sales this year. It also predicted that full-year earnings before interest and taxes will rise by approximately 50 percent. In August, the firm had forecast that earnings for the full year would be 40 percent higher than the prior-year's $2.5 million in earnings. Bayer shares closed at $36.09, up $1.52, or 4.4 percent, in moderate trading on the New York Stock Exchange. Strategic Branding King Pharmaceuticals reports higher Q3 net income, revenue King Pharmaceuticals Inc. reported better-than-expected 2005 third-quarter net income, and the company's brand name drugs showed strong sales growth. King reported net income of $121.9 million, or $0.50 per diluted share, in the latest quarter, compared with a net loss of $8 million, or $0.03 per diluted share, during the same period of the prior year. Net income excluding special items increased 52 percent to $125.4 million and diluted earnings per share increased 53 percent to $0.52. Analysts polled by Thompson First Call estimated adjusted earnings of $0.33 per share, MarketWatch reported. Total revenue increased 31 percent to $518 million, largely due to an increase in net revenue and higher unit sales from branded pharmaceutical products, which increased 36 percent to $454.5 million. Thompson First Call analysts expected third-quarter revenue of $427.2 million. The increase in unit sales from branded pharmaceutical products is partially attributable to changes in estimates that resulted in a reduction in the reserve for returns associated with branded products of approximately $15 million and a reduction in the reserve for estimated Medicaid obligations of approximately $21 million. The changes primarily benefited net sales of the hypertension drug Altace (ramipril), the company's largest selling product. Altace had net sales of $174.2 million during the third quarter, which was a 38-percent increase from $125.9 million during the third quarter of 2004. King shares closed at $17.00, up $0.89, or 5.5 percent, in heavy trading on the New York Stock Exchange. Strategic Branding Strategic Branding Pfizer Inc. Pfizer Inc. and VirtualScopics Inc. renewed their collaboration that allows Pfizer to accelerate the discovery, validation and application of image-based biomarkers for clinical research. The alliance expands ongoing collaborative efforts between Pfizer and VirtualScopics to identify and validate image-based biomarkers and then correlate them to disease progression in several therapeutic areas. Once identified and validated, the biomarkers may be used to assess the efficacy of new pharmaceutical compounds in clinical trials, reducing drug development costs and the time to market. Strategic Branding Strategic Branding Serono SA Serono SA held talks with Novartis AG, GlaxoSmithKline Plc, sanofi-aventis Group and Pfizer Inc. about a possible $15 billion takeover, according to people familiar with the matter, The Wall Street Journal said. As previously reported, Serono confirmed that it has retained The Goldman Sachs Group Inc. "to explore strategic alternatives for the company," but the firm added that "there can be no assurances that any transaction will be consummated." Strategic Branding Strategic Branding Novavax Inc. Novavax Inc. and CombiMatrix Corp., a unit of Acacia Research Corp., are collaborating to develop a new technique for in-process monitoring of vaccine production. The new method would advance large-scale synthetic production processes and help speed up regulatory decisions. The firms are working together to test the method's efficacy on Novavax's virus-like particle process of producing H5N1 bird-flu vaccine. The traditional process of developing flu vaccines from chicken eggs is lengthy and more time-consuming, Acacia said. Strategic Branding Strategic Branding The U.S. Court of Appeals for the First Circuit The U.S. Court of Appeals for the First Circuit in Boston ruled that a Maine law requiring pharmacy benefit managers to disclose more information about their business dealings with drug manufacturers is constitutional, The Wall Street Journal reported. The ruling from a three-judge panel will allow the law to go into effect and provides guidance for how lawmakers in other states can proceed in regulating PBMs at the state level. Clients of the PBMs could benefit from the disclosure, but the effect on drug prices is unclear. Strategic Branding


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