Naming Software - Brand Institute, inc.



			Naming Software 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 Bayer, Onyx's Nexavar receives orphan drug status to treat liver cancer The Food and Drug Administration granted orphan drug status to Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc.'s Nexavar (sorafenib tosylate) tablets for the treatment of hepatocellular carcinoma. The European Commission granted the drug a similar designation for this indication earlier this month. Nexavar, an oral multikinase inhibitor that targets both the tumor cell and tumor vasculature, is currently in a Phase III trial as a single agent to treat patients with liver cancer. In a Phase II trial, the drug is being studied in combination with the chemotherapeutic agent doxorubicin hydrochloride as a treatment for liver cancer. According to the companies, Phase II data from a single agent trial presented at the 16th American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer meeting in 2004 showed that 43 percent of patients treated with Nexavar had stable disease for at least four months, while another 9 percent of patients showed tumor shrinkage. "Liver cancer is such an aggressive disease that patients diagnosed with it rarely live beyond two years," said Dr. Jordi Bruix, head of the Barcelona Clinic Liver Cancer Group at the University of Barcelona and one of the investigators of the Phase III trial. "The global medical community recognizes the need for new treatments in liver cancer, and I am hopeful of the potential of Nexavar in this patient population." Nexavar is already approved by the FDA to treat patients with advanced renal cell carcinoma. A Marketing Authorization Application has been filed for the drug as a treatment for renal cell carcinoma in Europe, where it has also been granted the orphan medicinal product designation for this indication. In addition, Nexavar is currently in Phase III trials for the treatment of metastatic melanoma and non-small cell lung cancer. Naming Software Promethazine not indicated for patients aged younger than 2 years, FDA warns The Food and Drug Administration issued an alert to warn health care professionals and patients that promethazine hydrochloride should not be administered to children aged younger than 2 years. Promethazine is an antihistamine indicated to treat various allergic reactions, anxiety, motion sickness and nausea and vomiting after surgery. The FDA has received reports of serious adverse events, including seven deaths and 22 cases of respiratory depression in children aged younger than 2 years. The agency noted that all promethazine products, including syrups, suppositories, injectables and tablets are contraindicated for use in this pediatric population. Additionally, caution should be exercised when administering the drug to pediatric patients aged 2 years or older. The label has been changed on all products to reflect the strengthened warnings. Wyeth, which markets promethazine as Phenergan, also sent a letter to health care professionals, alerting them of the labeling change for its tablet and suppository products. Naming Software SuperGen's Orathecin fails to meet endpoint in pancreatic cancer trial SuperGen Inc. said an interim analysis of a Phase II trial of Orathecin (rubitecan) for the treatment of pancreatic cancer showed the drug failed to meet a prespecified threshold for median survival in order to proceed to a Phase III trial. In the trial, which included 39 patients with advanced pancreatic cancer who had not undergone chemotherapy, participants received Eli Lilly and Co.'s Gemzar (gemcitabine hydrochloride) 1,000 mg/m2 every week for three out of four weeks with concurrent Orathecin 1.5 mg/m2 given daily for five days of each week. Patients continued on this cycle every four weeks until progression or patient withdrawal. Although the preliminary analysis (conducted after half of the patients had died) showed a median survival of six months, this survival time did not meet the threshold for median survival that was needed to move on to a randomized Phase III trial. The company said it is examining options for the drug, which has orphan drug status in the United States and European Union. "We are working with our clinical advisors, investigators and potential partners to evaluate the best options for Orathecin that will maximize this product's potential to help patients in need and realize its commercial value for our stockholders," said James Manuso, chief executive officer of SuperGen. Naming Software FDA advisory committee reviews Cellegy's pain ointment The Food and Drug Administration's Cardio-Renal Advisory Committee reviewed Cellegy Pharmaceuticals Inc.'s Cellegesic (nitroglycerin) 0.4% ointment and announced a positive recommendation for the product. Cellegy submitted a New Drug Application for Cellegesic to the FDA in June 2004 as a treatment for pain associated with anal fissures. The company received a not approvable letter in December 2004. An amended NDA was submitted in April 2005. Six committee members voted for an approval, while six other members voted for "approvable pending another study of effectiveness." title="branding company" There were no votes for non-approval. Additionally, the majority of the committee voted that, considering all three studies included in the NDA, "the data is compelling that there is an effect of the ointment on pain associated with anal fissures." title="branding company" The majority also said "the quadratic model was the proper analysis for the purpose of decision making." title="branding company" "We hope to hear soon from the FDA regarding the results of its deliberations. There are many people who are suffering from debilitating pain with this condition, and the quicker the action by the FDA, the quicker patient relief could be provided by a product manufactured in accordance with FDA good manufacturing practices standards," title="branding company" said Richard Williams, Cellegy's interim chief executive officer. Naming Software Roche's Q1 total sales up from previous year Roche reported quarterly sales of approximately $7.74 billion, up from approximately $6.37 billion in the prior-year period, due in part to strong sales of its oncology drugs and stockpiling of its influenza drug, Tamiflu (oseltamivir phosphate). Pharmaceutical division sales were approximately $6.09 billion, up from approximately $4.85 billion in the first quarter of 2005. The firm said that overall oncology sales increased 52 percent. Specifically, sales of breast cancer drug Herceptin (trastuzumab) were approximately $677.8 million, up from approximately $307.8 million in the same quarter of 2005. Lung and pancreatic cancer drug Tarceva (erlotinib hydrochloride) had sales of $135.4 million, an increase of 182 percent. Sales of Avastin (bevacizumab), a colorectal cancer drug, also increased significantly to approximately $532 million from approximately $204.6 million in 2005's first quarter. Avastin was developed by Genentech Inc., which markets the drug in the United States. Global sales of Tamiflu increased 37 percent to $472.9 million, driven by pandemic deliveries. Roche confirmed its outlook for 2006 of double-digit growth for its pharmaceuticals division sales and for the company as a whole. Naming Software Biogen Idec reports increased Q1 profit, sales Biogen Idec Inc. posted higher 2006 first-quarter earnings and sales, driven primarily by sales of Rituxan (rituximab), a treatment co-promoted with Genentech Inc. for non-Hodgkin's lymphoma and rheumatoid arthritis, and Avonex (interferon beta-1a), a multiple sclerosis treatment. The company reported net income of $123 million, or $0.36 per diluted share, in the first quarter of this year compared with $43.5 million, or $0.12 per diluted share, in the same quarter a year ago. Excluding charges, net income was $189.9 million, or $0.55 per diluted share. Analysts expected earnings of $0.48 per share, according to The Associated Press. Total revenue increased by 4 percent for the quarter, from $587.8 million a year ago to $611.2 million this year. Analysts at Thomson Financial forecast revenue of $637 million, the AP reported. Rituxan revenue increased 14 percent to $183 million, while Avonex sales increased 5 percent to $393 million. Investors, however, were disappointed by the decrease in U.S. sales of Avonex, which fell from $233 million to $232 million, according to Reuters. "The bad news was Avonex sales, which came in below consensus," said Eric Schmidt, an analyst at Cowen & Co., in the Reuters report. "On a positive note, the company does seem to be running a very tight ship on expenses." Biogen Idec singled out the recent approval of Rituxan as a treatment for RA and a Food and Drug Administration advisory committee's vote to reintroduce the MS treatment Tysabri (natalizumab) as positive factors going forward in 2006. The company said it expects an FDA decision on Tysabri by June. The company reiterated its 2006 adjusted earnings-per-share forecast of $1.95 to $2.10. Biogen Idec shares closed at $44.07, down $0.03, or 0.02 percent, in moderate trading on the Nasdaq. Naming Software Naming Software Eli Lilly and Co. Eli Lilly and Co. and Alkermes Inc. initiated a Phase III trial required for registration for their AIR inhaled insulin system. The AIR system is being studied as a treatment option for type 1 and type 2 diabetes. This particular trial, which will include approximately 400 insulin-naive patients with type 2 diabetes, is designed to examine whether the AIR system is at least as effective as is injectable pre-meal insulin in improving glucose control. The study is one component of a comprehensive Phase III pivotal program that began last July. Naming Software Naming Software Beckman Coulter Inc. Beckman Coulter Inc. and Argos Therapeutics Inc. entered into an agreement that gives Argos the exclusive rights to the soluble protein CD83, including use as a therapy for autoimmune disorders and transplant rejection. Initially, Dana-Farber Cancer Institute filed for the therapeutic use of CD83. Following that, Beckman Coulter gained license to the drug, and under the most recent agreement, retains the right to develop CD83 within the diagnostics field. Financial terms of agreement were not disclosed. Naming Software Naming Software Sanofi Pasteur Sanofi Pasteur signed an agreement with Nabi Biopharmaceuticals whereby Nabi will fractionate human plasma used to produce Imogam Rabies-HT (rabies immune globulin [human] heat treated). The rabies product provides passive protection if it is administered immediately after individuals have been exposed to the rabies virus. As part of the agreement, Nabi will fractionate human plasma containing antibodies to the rabies virus at its plant in Florida. The partially manufactured product will then be shipped to Sanofi Pasteur's facility in France for completion. Nabi said it plans to start manufacturing for the agreement in the second half of this year. Financial terms were not disclosed. Naming Software Naming Software BARRX Medical Inc. BARRX Medical Inc.'s HALO90 system received approval from the Food and Drug Administration for use in the coagulation of sites in the gastrointestinal tract, including the treatment of Barrett's esophagus. The system is approved as an independent treatment or in conjunction with the company's HALO360 system, "a balloon-based endoscopic ablation system for treating larger, circumferential areas of Barrett's esophagus," title="branding company" the company noted. Together, the products allow physicians to remove Barrett's esophagus tissue before it develops into cancer. Naming Software


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