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			branding a Product 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 GSK warns of macular edema in patients taking rosiglitazone products GlaxoSmithKline Plc sent a letter to health care providers to inform them of "very rare post-marketing reports" of new onset and worsening diabetic macular edema in patients receiving Avandia (rosiglitazone maleate) and Avandamet (rosiglitazone maleate/metformin hydrochloride), both of which are treatments for type 2 diabetes. GSK added that, in most of the reported cases of macular edema, patients also reported concurrent peripheral edema. "In some cases, the macular edema resolved or improved following discontinuation of therapy, and in one case, macular edema resolved after dose reduction," the firm said in the letter. GSK noted that macular edema is usually associated with diabetic retinopathy and is more common as retinopathy progresses. The duration of diabetes, the presence of retinopathy, poor glycemic control and hypertension are all risk factors for the condition. Decreased dark adaptation, decreased color sensitivity and blurred or distorted vision are possible symptoms, GSK said. The company is proposing that this safety information be included in patient information leaflets and product information for prescribers for all rosiglitazone products, including GSK's once-daily Avandaryl (rosiglitazone maleate/glimepiride), which was recently approved in the United States and, according to GSK, will soon be available in "some markets." branding a Product Bayer HealthCare, Nuvelo enter into agreement regarding blood clot dissolving drug Bayer HealthCare AG entered into a collaboration agreement with Nuvelo Inc. for Nuvelo's alfimeprase, a thrombolytic agent currently in Phase III development. News of the collaboration sent Nuvelo's shares up 40.6 percent in heavy trading. In accordance with the agreement, Nuvelo will keep U.S. commercialization rights to alfimeprase and all profits from U.S. sales of the drug; Bayer HealthCare will commercialize the drug outside of the United States and will pay Nuvelo tiered royalties of up to 37.5 percent. Throughout the course of the agreement, Nuvelo will receive an up-front payment of $50 million and as much as $165 million in development milestone payments and $170 million in sales and commercialization milestone payments. Nuvelo will be responsible for 60 percent of the expenses associated with the drug's global development programs and will continue to lead the programs. Bayer HealthCare will be responsible for the remaining 40 percent of development costs. "This Phase III compound has the potential to be a significant addition to our cardiology/hematology business," said Wolfgang Plischke, president of Bayer HealthCare's pharmaceutical division. "Thrombosis-related diseases are highly prevalent, and alfimeprase's ability to rapidly dissolve clots in clinical trials conducted to date suggest it may be the ideal complement to our range of products that address coagulation and thrombosis." An enzyme produced by recombinant DNA technology, alfimeprase dissolves blood clots by degrading a protein known as fibrin, which provides the structure upon which blood clots form. According to Nuvelo, a clearance mechanism of the drug apparently localizes thrombolytic activity to the site of the clot, thereby minimizing unwanted bleeding beyond the site. Alfimeprase is also being assessed in Phase III trials as a potential treatment for acute peripheral arterial occlusion and catheter occlusion. It is expected to enter a Phase II program in stroke before the end of this year and a Phase II program in deep vein thrombosis next year. Nuvelo shares closed at $12.67, up $3.66, on the Nasdaq. branding a Product Lyrica significantly controls partial seizures in patients already taking AEDs, study reveals As an add-on treatment, Pfizer Inc.'s Lyrica (pregabalin) administered twice daily in a fixed or flexible dose appears to be highly effective at controlling partial seizures in patients with or without secondary generalization who are refractory to antiepileptic drugs, study results show. The double-blind trial was designed to provide "a more rational basis for predicting the performance of a drug in clinical practice than traditional fixed-dose clinical trials," title="branding company" the investigators explained. First, 400 patients who were taking one to three AEDs participated in a six-week baseline phase; those who experienced at least four seizures and no four-week seizure-free interval continued into a 12-week treatment period. Along with their current regimen, the patients were randomized to receive placebo twice daily (n=73), Lyrica at a fixed dose of 600 mg/day (n=137) or Lyrica at a flexible dose of 150 mg/d to 600 mg/d (n=131). Patients in the flexible-dose arm escalated or reduced their doses based on their response to the drug or intolerable adverse events. Overall, 76.7 percent, 76.3 percent and 58.4 percent of patients who received placebo, Lyrica flexible-dose or Lyrica fixed-dose, respectively, completed the treatment phase. From baseline, the frequency of seizures decreased by 35.4 percent with the flexible Lyrica dose, by 49.3 percent with the fixed Lyrica dose and by 10.6 percent with placebo. Mean response ratios differed significantly between the Lyrica groups, with the fixed dose being superior. The rate of response (defined as at least a 50 percent reduction in seizure frequency) was also significantly greater with Lyrica than with placebo. "The tolerability advantage of flexible dosing does not appear to be associated with any obvious penalty in terms of decreased efficacy, since the analysis of weekly response ratio values indicates that the overall efficacy differences between the flexible- and fixed-dose regimen is confined to the first week of treatment," title="branding company" the authors remarked. "Taken together, these data suggest that the common clinical practice of adjusting the [Lyrica] dosage for the individual patient based on efficacy and tolerability within the therapeutic range of 150 mg/d to 600 mg/d may confer an overall treatment advantage," title="branding company" they concluded. The study appeared in the first December issue of the journal Epilepsia. branding a Product Allos' Efaproxyn plus whole brain radiation therapy appears to improve survival in patients with brain metastases from breast cancer Adding Allos Therapeutics Inc.'s Efaproxyn (efaproxiral) to whole brain radiation therapy (WBRT) may improve survival and response rates in patients with brain metastases, particularly metastases from breast cancer, investigators in the Phase III REACH study found. The researchers enrolled 538 patients with brain metastases from various tumors to compare the safety and efficacy of treatment with WBRT and supplemental oxygen (250 eligible patients) with that of the same therapy plus Efaproxyn (265 eligible patients). Of the eligible patients, 397 had breast cancer or non-small cell lung cancer. Overall, median survival time was 5.4 months for patients who received Efaproxyn and 4.4 months for those who did not. In the NSCLC/breast cancer subgroup, the median survival time was 6 months for those who received Efaproxyn compared with 4.4 months for those in the control group. A Cox multiple regression analysis showed a significant reduction in the risk of death for patients in the Efaproxyn arm in both study populations, although subsequent analysis suggested that only the patients with brain metastases originating from breast cancer may have experienced this benefit. "In conclusion, [Efaproxyn] is the first noncytotoxic radiation sensitizer that demonstrates a potential survival advantage as an adjunct to WBRT; however, the conclusion may be restricted to patients with primary breast cancer," the authors wrote. To confirm these findings, Efaproxyn is being studied in patients with breast cancer in the ongoing ENRICH trial. Allos expects preliminary results to be released next year. Results from the REACH trial were published in the Jan. 1 issue of the Journal of Clinical Oncology. branding a Product Metabolic response better with ARBs than with beta blockers in certain patients, study finds For patients who are obese and hypertensive, angiotensin receptor blockers such as Novartis AG's Diovan (valsartan) appear to be a more beneficial treatment choice than beta blockers, a recent study found. Patients in a study conducted in Germany who were obese and had mild to moderate, uncomplicated essential hypertension were randomized to receive a maximum dose of 160 mg/day of Diovan (n=67) or a maximum dose of 100 mg/d of the beta blocker atenolol (n=65). Patients with blood pressure higher than 140/90 mmHg on monotherapy had hydrochlorothiazide added to their treatment regimen. By the end of the 13-week treatment period, patients who received Diovan experienced a decrease in systolic blood pressure (SBP) from 160.8 mmHg to 140.5 mmHg and a decrease in diastolic blood pressure (DBP) from 96.1 mmHg to 85.1 mmHg. Those treated with atenolol experienced a decrease in SBP from 159.3 mmHg to 139.8 mmHg and a decrease in DBP from 95 mmHg to 83.5 mmHg. The researchers said neither treatment resulted in a change in body weight, nor were there any significant differences between the two treatment groups in terms of the response of lipid levels or highly sensitive C-reactive protein. To determine the cumulative effect of the treatments on glucose metabolism during the trial, the researchers calculated individual areas under the curve for homeostasis model assessment for insulin resistance over time. They found that the resulting area under the curve was significantly smaller for patients who were treated with Diovan than for those treated with atenolol. Data showed that both types of drugs, especially when combined with low-dose diuretics, effectively lowered blood pressure in this patient population. "However, metabolic responses differ between both treatment strategies, with beneficial effects of ARBs," the researcher concluded, adding that ARBs are a good choice for these patients, given their "profoundly increased" risk for diabetes. The study results appeared in the December issue of the Journal of Hypertension. branding a Product Merck, GSK's rotavirus vaccines safe, effective, studies find Two studies published in the Jan. 5 issue of The New England Journal of Medicine found Merck & Co. Inc. and GlaxoSmithKline Plc's vaccines against rotavirus, which is considered the leading cause of illness and death related to diarrhea in infants and young children, to be safe and effective. In the first study, healthy infants aged 6 to 12 weeks were randomized to receive three oral doses of Merck's RotaTeq (n=34,035) or placebo (n=34,003) at four- to 10-week intervals. RotaTeq was found to reduce hospitalizations and emergency department visits related to the G1, G2, G3 and G4 strains of rotavirus gastroenteritis occurring at least 14 days after the third dose by 94.5 percent. A nested substudy, which measured the vaccine's efficacy against any G1 to G4 strain of rotavirus gastroenteritis through the first full rotavirus season, found RotaTeq's efficacy to be 74 percent. Against severe gastroenteritis, the vaccine's efficacy was 98 percent. A primary goal of this study was to evaluate RotaTeq 's safety, since the first approved rotavirus vaccine, Wyeth's RotaShield, was taken off the market because it appeared to increase the risk of intussusception, a potentially lethal bowel obstruction. Of patients who received RotaTeq, 12 developed intussusception within a year of the first dosing compared with 15 patients in the placebo group. "[T]he results of this large trial are reassuring in indicating that not all rotavirus vaccines are associated with intussusception," the researchers said. Similar safety and efficacy results were observed in the trial of GSK's Rotarix vaccine. In this study, healthy infants received two oral doses of Rotarix (n=31,673) or placebo (n=31,552) at approximately 2 months and 4 months of age. The vaccine's efficacy against severe rotavirus gastroenteritis and rotavirus-associated hospitalization was 85 percent. Against more severe rotavirus, Rotarix was found to be 100 percent efficacious. As with RotaTeq, Rotarix was not associated with an increased risk of intussusception. Neither vaccine is approved for use in the United States. Merck, however, has filed a Biologics License Application with the Food and Drug Administration for RotaTeq, and GSK plans to do the same for Rotarix, which is approved in Mexico and in several Latin American countries. branding a Product branding a Product Bristol-Myers Squibb Co. Bristol-Myers Squibb Co. licensed Endocyte Inc.'s vitamin-targeting technology for BMS' epothilone cancer chemotherapeutic agents. BMS will be responsible for developing, manufacturing, registering and marketing the resultant products and will pay Endocyte a $3 million license payment, along with milestone payments and royalties. The license stems from a collaborative research effort between the firms, the goal of which is "to create novel folate conjugates of BMS' proprietary epothilone compounds." branding a Product branding a Product Forest Laboratories Inc. Forest Laboratories Inc. and Cypress Bioscience Inc. increased enrollment in their ongoing Phase III trial of milnacipran as a therapy for patients with fibromyalgia. Based on data from the drug's first Phase III trial, which did not meet the primary endpoint, the firms said they now aim to enroll 1,200 patients, up from the originally targeted number of approximately 800. Because of the time it will take to recruit the extra participants, initial trial results are not expected to be available until the middle of 2007 at the earliest. The firms also said they will begin a third Phase III study of the drug for this indication during this quarter. Cypress shares closed at $5.72, down $0.29, or 4.8 percent in moderate trading on the Nasdaq, while Forest shares closed at $40.55, down $0.49, or 1.2 percent, in heavy trading on the New York Stock Exchange. branding a Product branding a Product Alza Corp. Alza Corp. and Cara Therapeutics Inc. entered into a licensing agreement for Cara's peripherally acting pain treatment candidate, CR665. In addition to receiving an unspecified up-front payment and being eligible for certain milestone payments and royalties, Cara has the option to co-promote intravenous CR665 products in the United States. Cara has already completed a Phase Ia study, which assessed an IV formulation of the drug. Preclinical studies indicated that CR665 is a potent analgesic that may also have anti-inflammatory properties. branding a Product branding a Product Advancis Pharmaceutical Corp. Advancis Pharmaceutical Corp.'s proposed sale of U.S. rights to the antibiotic Keflex (cephalexin) to a private company was not completed by Dec. 31, as originally anticipated. As a result, Advancis will retain a $1 million nonrefundable deposit. The other company may, under limited circumstances, still purchase the rights on or before Feb. 28. Advancis said it plans to develop new Keflex products and to seek marketing and sales partners for the Keflex product line. Advancis shares closed at $1.30, down $0.10, or 7.1 percent, in moderate trading on the Nasdaq. branding a Product


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