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			How to name your company 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 Roche says Tamiflu effective against avian flu, disputes Lancet article's findings about use of Tamiflu Roche released results from an animal study that showed its oral antiviral drug Tamiflu (oseltamivir) was effective against the H5N1 avian influenza virus when administered early. The announcement came the day after the company responded to an article published online Jan. 19 in the journal The Lancet that said Tamiflu should not be used to treat or prevent seasonal influenza. In The Lancet article, Dr. Tom Jefferson and colleagues conducted a meta-analysis and found that the efficacy of Tamiflu 75 mg/day against symptomatic influenza was 61 percent and the efficacy of Tamiflu 150 mg/d was 73 percent. They added that the treatment did not appear to be effective against asymptomatic influenza. The authors of the study concluded that because of low effectiveness, Tamiflu "should not be used in seasonal influenza control and should only be used in a serious epidemic or pandemic alongside other public health measures." One of the reasons they cited for this conclusion was that Tamiflu is ineffective against influenza-like illnesses. Jefferson and colleagues also said they found no credible evidence that the treatment worked against the bird flu. In response to the article, Roche said Tamiflu has been approved to prevent and treat influenza by health authorities across the globe. The company cited studies that showed Tamiflu provided a 38 percent reduction in the severity of symptoms of the flu and a 37 percent reduction in the duration of the illness. Roche also noted that the treatment provided up to 89 percent overall protective efficacy against clinical influenza in adults and adolescents who had been in close contact with influenza-infected patients. Regarding the claim by Jefferson and colleagues that Tamiflu does not work against influenza-like illnesses, Roche said influenza is easy to diagnose once it is circulating and symptoms have been clearly defined. The company added that it "has never advocated the use of Tamiflu for control of influenza-like symptoms." According to Reuters, the World Health Organization said it would continue to recommend the use of Tamiflu. In a separate press release, Roche cited a study that showed Tamiflu can prevent H5N1 mortality in animals. The study, which was presented at the Bird Flu: First Pandemic of the 21st Century--A Central Role for Antivirals conference in London, examined the efficacy of 5 mg/kg of body weight of Tamiflu (the human equivalent of 75 mg twice daily) in ferrets four hours after infection with currently circulating H5N1 virus. Roche said that Tamiflu prevented viral replication in the upper respiratory tract and effectively treated ferrets with no deaths, while all animals in the control group died. "These initial results are encouraging as they demonstrate that early treatment with [Tamiflu] is effective in treating the H5N1 avian influenza virus," said Dr. Elena Govorkova, lead investigator of the study. "However, further studies are being carried out to determine the effectiveness following administration at 24 and 48 hours to identify the optimal dosage and duration of treatment with [Tamiflu]." How to name your company Three cases of severe Ketek-induced liver injury reported in journal; FDA issues health advisory Sanofi-aventis Group's antibiotic Ketek (telithromycin) may be linked with severe hepatotoxicity, according to new case reports released online Jan. 20 in the Annals of Internal Medicine. All three of the case patients were previously healthy and presented with acute hepatitis within a few days of receiving Ketek and no other prescriptions. They had jaundice and abnormal liver function test results. Viral serologic test results were negative. One patient recovered, another patient underwent orthotopic liver transplantation and the last patient died. Physicians noted massive hepatic necrosis in the latter two patients, the report revealed. Ketek was approved in 2004 to treat acute exacerbation of chronic bronchitis, acute bacterial sinusitis and mild to moderate community-acquired pneumonia. The Food and Drug Administration's Adverse Event Reporting System has since cited 10 post-marketing cases of hepatic adverse events linked with Ketek use, but eight of the cases involved a wide range of additional agents taken concomitantly with Ketek, according to the Annals report. Based on the new reports, the FDA said on its Web site that it "is continuing to evaluate the issue of liver problems in association with use of [Ketek] in order to determine if labeling changes or other actions are warranted." The product's label does advise about the potential for liver-related adverse events, the FDA added. In the meantime, it recommended that health care providers be aware of signs and symptoms of liver problems and should stop the treatment if patients develop these. Patients should seek their provider's guidance if they experience any symptoms, such as jaundice or blurry vision. Lastly, the agency said Ketek should only be used for infections caused by a susceptible microorganism. "Caution is advised in prescribing this drug pending additional post-marketing surveillance data," the Annals researchers concluded. The case studies will be published in the March 21 print edition of Annals. How to name your company Updated analysis suggests survival benefit linked with use of Dor BioPharma's Orbec Dor BioPharma Inc. announced updated survival data in favor of oral Orbec (beclomethasone dipropionate) for the treatment of patients with gastrointestinal graft-versus-host disease (GVHD). The biopharmaceutical firm completed its follow-up and analysis of survival data from previously published clinical trials in response to a specific request from the Food and Drug Administration. The FDA told Dor BioPharma "a very high emphasis would be placed on (Orbec's) survival data." The firm's Phase II trial included 60 patients with gastrointestinal GVHD and the Phase III trial included 129 patients. Both trials were placebo-controlled. Patients in the Phase II study received an induction course of conventional prednisone plus either Orbec orally or placebo. Initial responders continued an oral dose of Orbec or placebo for another 20 days, during which prednisone was rapidly tapered. The primary endpoint was whether the patients were or were not able to consume at least 70 percent of their daily caloric intake by mouth at day 30. The Phase III trial had a similar design, BioPharma said. The new follow-up data and analysis suggested that the day 200 post-transplant survival results on Orbec from the Phase II study, which had not been previously analyzed, was in agreement with the approximate 70 percent decrease in mortality achieved at day 200 in the Phase III trial. The long-term survival benefit found in favor of Orbec in both the Phase II and Phase III studies was also in concordance. In the Phase III study, 16 patients who were treated with placebo (24 percent) died compared with five patients who were treated with Orbec (8 percent) at the prospectively defined day 200 post-transplant mortality endpoint. Dor BioPharma said this difference was statistically significant. Based on this day 200 survival endpoint, the company said there were no previously undetected imbalances between the Orbec and placebo groups that could have favored Orbec over placebo. There was a higher proportion of patients classified as high risk in the Orbec group, therefore putting this group at a disadvantage to begin with, Dor BioPharma observed. However, the updated evidence suggests that Orbec "was still the factor with the strongest statistical association with survival." The complete details of the updated data will be reported in Honolulu at the annual Tandem Bone Marrow Transplant Meeting of the American Society for Blood and Marrow Transplantation, which will take place in February. How to name your company FDA accepts one of Oscient Pharmaceuticals' sNDA filing for Factive, refuses second filing The Food and Drug Administration accepted Oscient Pharmaceuticals Corp.'s supplemental New Drug Application filing for the use of Factive (gemifloxacin mesylate) tablets (320 mg once daily) for the five-day treatment of mild to moderate community-acquired pneumonia (CAP) but rejected the company's sNDA for the use of Factive for the five-day treatment of acute bacterial sinusitis (ABS). Oscient said the FDA granted the standard 10-month review period for the five-day CAP sNDA and expects the agency to rule on the filing by the end of September. According to the company, the sNDA filing for ABS was refused because the FDA believed that the drug did not show an acceptable risk-versus-benefit profile for that indication and that the possibility of demonstrating an acceptable risk would not be possible because of the agency's belief of the potential risk of rash in patients with ABS. Steven Rauscher, Oscient's chief executive officer, said the company was pleased with the acceptance of the sNDA filing for CAP, but disappointed by the agency's decision on the ABS filing. "We will continue to pursue short-course indications and will discuss with the FDA potential paths that would allow us to file for the ABS indication," he added. Currently, Factive is approved for the five-day treatment of acute bacterial exacerbations of chronic bronchitis, as well as the seven-day treatment of mild to moderate CAP. Oscient shares closed at $2.26, down $0.49, or 17.8 percent, in heavy trading on the Nasdaq. How to name your company Inspire halts development of macular edema treatment Inspire Pharmaceuticals Inc. stopped two Phase II pilot trials of denufosol tetrasodium intravitreal injection (INS37217 ophthalmic) in patients with macular edema and is not planning to conduct any more studies of the drug for the treatment of retinal disease. Data from the first trial, which was slated to enroll 15 patients with persistent macular edema associated with uveitis, was available for 12 patients. Although there were no significant safety or tolerability issues identified in the trial, denufosol did not reduce retinal thickness or improve visual acuity, the company said. No patients were yet enrolled in the second trial, which was designed to include 15 patients with persistent macular edema following cataract surgery. Patients who received treatment in the first trial will be followed for a year, as specified in the trial protocol. Christy Shaffer, Inspire's chief executive officer, said the company was ending the retinal program to focus on programs with more potential. "Our utilization of small pilot trials to explore potential new indications enables us to gather information quickly and make prudent development decisions efficiently, thereby minimizing the time and expense of drug development." Currently, Inspire's U.S. specialty sales force promotes two ophthalmology products, Elestat (epinastine hydrochloride) ophthalmic solution 0.05% and Restasis (cyclosporine) ophthalmic emulsion 0.05%, for its partner, Allergan Inc. How to name your company Keppra appears to have long-term retention rate comparable to those of other new AEDs, data show Long-term retention rates with UCB Pharma Inc.'s Keppra (levetiracetam) appear comparable to those reported for other second-generation antiepileptic drugs, according to new data. Researchers in London evaluated Keppra's three-year retention rate as a surrogate marker of the drug's efficacy and safety in clinical practice. A total of 811 patients with epilepsy were identified. Thirty-one of these patients with an undetermined duration of therapy were not included in retention rate calculations; however, the authors noted that 27 of these 31 patients were still taking Keppra at their last visit. None of the patients was naïve to AED therapy, and most (91 percent) had received treatment with at least one new AED. After a mean follow-up of 16.7 months, 65 percent of patients were still taking Keppra and the three-year retention rate was 58 percent. Overall, 10 percent of patients discontinued Keppra due to adverse events, 13.6 percent discontinued due to inefficacy, and an additional 9 percent discontinued due to a combination of both of these factors. The authors noted that previous studies conducted at the same clinic yielded three-year retention rates for Ortho-McNeil Neurologics Inc.'s Topamax (topiramate), GlaxoSmithKline Plc's Lamictal (lamotrigine) and gabapentin of 30 percent, 29 percent and less than 10 percent, respectively. "Discontinuation rates due to adverse events and inefficacy for [Topamax, Lamictal and gabapentin] were 59 percent, 56 percent and 76 percent, respectively, compared with 33 percent for [Keppra], suggesting that, in this setting, [Keppra] is either better tolerated or more efficacious, or both," title="branding company" they added. In general, patients who took fewer concomitant AEDs and those who reached a higher maximum daily dosage of Keppra were less likely to discontinue the drug due to adverse events or inefficacy. For each additional concomitant AED, the risk for discontinuing treatment due to adverse events or inefficacy were 20 percent and 30 percent higher, respectively. At the same time, for each additional 1,000 mg of Keppra taken per day, the risks for discontinuing treatment due to an adverse event or inefficacy were 62 percent and 31 percent lower, respectively. The use of other new AEDs did not influence the likelihood of discontinuing Keppra due to an adverse event. However, patients who had tried more than two new AEDs were significantly more likely to discontinue Keppra due to inefficacy as compared with patients who had tried zero to two new AEDs (risk, 60 percent higher). Age at onset, age at the start of treatment, starting dose, titration schedule, sex and seizure type had no effect on the discontinuation rate due to adverse events or inefficacy. Among all patients evaluated, 11 percent achieved seizure freedom for at least six months, including 11 percent of patients with cryptogenic or symptomatic focal epilepsy and 19 percent of patients with idiopathic generalized epilepsy. An additional 29 percent exhibited a response to treatment, defined as a reduction in seizure frequency of 50 percent or more. "[T]he favorable tolerability and efficacy profiles of [Keppra] and its distinct putative mechanism of action hold promise for the development of a new category of AED," title="branding company" the authors concluded. These data were published in January in the Journal of Neurology, Neurosurgery and Psychiatry. How to name your company How to name your company The New York Times The New York Times and Bob Hilliard of Hilliard & Munoz LLP were granted access by a Texas district court to handwritten notes from Guidant Corp.'s cardiac rhythm management division that showed the division's president "evaluating and considering" options after learning the firm's heart defibrillators may short circuit and deciding to sell off the defective inventory, according to The Associated Press. Hilliard is representing two Texas residents in a lawsuit against Guidant accusing the device maker of knowingly selling the defective defibrillators without notifying the public. The case is set to go to trial in February. Guidant recalled or issued warnings on approximately 88,000 defibrillators and there are approximately 120 lawsuits against the firm regarding the devices, The Wall Street Journal said. How to name your company How to name your company Bristol-Myers Squibb Co. Bristol-Myers Squibb Co. confirmed its agreement to sell its Argentine unit and related assets to Laboratorios Roemmers, according to a Dow Jones Newswires report. BMS expects the transaction to close in the first quarter of the year, and the company will cover severance payments related to the transfer, Dow Jones said. The Argentine-based Roemmers will gain a line of 31 products, including antibiotics and anti-inflammatory products. BMS plans to continue selling products in Argentina that are not included in the agreement, including the HIV treatment Reyataz (atazanavir sulfate). How to name your company How to name your company PDI Inc. PDI Inc. and Align Pharmaceuticals signed a three-year commercialization agreement for three new oncology drugs. Two of the products, Numoisyn lozenges and Numoisyn liquid, were designed to treat dry mouth caused by radiation therapy or Sjogren's syndrome. PDI said its sales team will oversee the sales of the drugs, which will target radiation oncologists and select rheumatologists. How to name your company How to name your company AVI BioPharma Inc. AVI BioPharma Inc. said three independent laboratories confirmed Neugene antisense efficacy in preclinical studies against multiple strains of influenza, including the avian influenza strain, H5N1. Factoring in an earlier study, the company now has positive reports about the antisense technology from four laboratories using different endpoints and methodologies. Denis Burger, AVI's chief executive officer, said the company plans to file an Investigational New Drug application with the Food and Drug Administration for the treatment of influenza A with Neugene antisense drugs. AVI shares closed at $7.58, up $1.69, or 28.7 percent, in heavy trading on the Nasdaq. How to name your company


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