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			Trademarks 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 approves GSK's Fluarix influenza vaccine The Food and Drug Administration approved GlaxoSmithKline Plc's influenza vaccine, Fluarix, for adults aged 18 years or older. After reviewing data from a randomized, double-blind, placebo-controlled Phase III clinical trial involving approximately 1,000 adults (age range, 18 to 64 years), the FDA determined Fluarix was both safe and immunogenic, according to GSK. "[The] FDA's approval of Fluarix is a big step toward providing an adequate supply of flu vaccine for the American public," said Mike Leavitt, secretary of the Department of Health and Human Services. Fluarix is the first vaccine approved using the FDA's accelerated approval process, the agency said. The FDA said that previous shortages of the flu vaccine indicated the need for more influenza vaccine manufacturers for the United States. "The introduction of Fluarix is a vital step in the effort to improve vaccination rates in the United States and protect against this highly communicable infection that threatens young and old alike," said Dr. John Treanor, associate professor of medicine at the infectious diseases unit at the University of Rochester Medical Center in New York. The vaccine, which has been available outside the United States since 1992, was approved for distribution in time for the 2005-2006 flu season. More than 150 million doses of the drug have been distributed since 1992. Trademarks FDA approves first therapy for childhood growth failure due to hormone deficiency The Food and Drug Administration approved Tercica Inc.'s Increlex (mecasermin [rDNA origin] injection) as a long-term therapy for growth failure in children who have severe primary insulin-like growth factor-1 deficiency (primary IGFD) or in children who have growth hormone gene deletion and neutralizing antibodies to growth hormone. Increlex is the only therapy indicated to treat children who have severe primary IGFD and the FDA has granted the product orphan drug status for this condition. Increlex's active ingredient is identical to the body's natural IGF-1 hormone, Tercica said. The approval was based on data from 71 patients who, in response to Increlex, showed a statistically significant increase in growth rate throughout an eight-year treatment period. On average, they grew an additional one inch per year during each year of the therapy when compared with pre-treatment growth patterns. Approximately 6,000 U.S. children have severe primary IGFD, a state marked by abnormally low blood levels of IGF-1 in the presence of normal or elevated growth hormone. The IGF-1 hormone must be present to facilitate the normal growth of bones, cartilage and organs in children. Tercica acquired exclusive rights from Genentech Inc. to develop, commercialize and manufacture Increlex, Tercica's first commercial product. Tercica shares closed at $11.31, up $1.98, or 21.2 percent, in heavy trading on the Nasdaq. Trademarks Genentech warns of potential cardiotoxicity related to Herceptin Genentech Inc. issued a letter to health care providers regarding preliminary analysis of a 2,043-patient Phase III study that showed patients who took Herceptin (trastuzumab) plus standard chemotherapy had a significant increase in cardiotoxicity as compared with patients who received standard chemotherapy alone. A total of 1,019 patients with operable, HER2 overexpressing breast cancer were randomized to Herceptin plus standard chemotherapy. Among the evaluable Herceptin-treated patients with adequate cardiac function, 30.5 percent required at least one dose delay because of asymptomatic decrease in left ventricular ejection fraction (LVEF) or cardiac symptoms. Herceptin was discontinued before one year of treatment was completed in 18.6 percent of patients because of asymptomatic decrease in LVEF (14.3 percent) and symptomatic cardiac dysfunction or other cardiac toxicity (4.3 percent). Also, "a statistically significant increase in the three-year cumulative incidence of New York Heart Association class III and IV congestive heart failure and cardiac death was observed in patients who received the Herceptin-containing regimen (4.1 percent) compared with control (0.8 percent)," the letter said, adding that a final data analysis is underway. As a single agent, Herceptin is indicated to treat patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have tried at least one chemotherapy regimen for their metastatic disease. Herceptin in combination with paclitaxel is indicated to treat patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have not received chemotherapy. Trademarks sBLA submitted for Rituxan in rheumatoid arthritis Biogen Idec Inc. and Genentech Inc. submitted a supplemental Biologics License Application to the Food and Drug Administration for Rituxan (rituximab). The firms are seeking approval for Rituxan to be used in patients with active rheumatoid arthritis who have inadequately responded to an anti-tumor necrosis factor treatment. The drug is already approved to treat relapsed or refractory low-grade or follicular, CD-20-positive, B-cell non-Hodgkin's lymphoma. The sBLA submission was based on 24-week results of the double-blind, placebo-controlled REFLEX trial. In this Phase III study, the patients who were randomized to a single course of two Rituxan infusions along with a stable dose of methotrexate showed a statistically significant improvement in symptoms at 24 weeks when compared with the patients who received placebo plus methotrexate. The Rituxan antibody selectively depletes CD-20-positive B-cells without targeting stem cells or existing plasma cells; it is also being studied in other autoimmune diseases, the companies said. Rituxan is co-promoted in the United States by Biogen Idec and Genentech. It is marketed as MabThera by F. Hoffmann-La Roche Ltd. throughout the rest of the world, except in Japan, where Rituxan is co-marketed by Chugai Pharmaceutical Co. Ltd. and Zenyaku Kogyo Co. Ltd. Trademarks Pharmaxis' Bronchitol cystic fibrosis trial yields positive results; shares rise Pharmaxis Ltd. released positive results from a Phase II clinical trial of Bronchitol (mannitol) in patients with cystic fibrosis, pushing shares up 14.5 percent. In the randomized, double-blind trial, researchers compared 420 mg of Bronchitol with placebo in 49 patents with cystic fibrosis at eight centers in Australia and New Zealand. Patients received Bronchitol or placebo twice a day for 14 days in a crossover design. The trial reached its primary endpoint of improvement in lung function as measured by forced expiratory volume in one second. At the completion of the two-week treatment periods, patients had statistically significantly improved lung function when treated with Bronchitol as compared with when they received placebo, Pharmaxis said. Researchers also observed significantly better respiratory symptoms in patients when they took Bronchitol as compared with when they took placebo. There were no deleterious effects on the microbiology of the sputum observed when taking Bronchitol. Pharmaxis has received orphan drug status for Bronchitol as a treatment for cystic fibrosis from the Food and Drug Administration. Pharmaxis shares closed at $30.23, up $3.83, in heavy trading on the Nasdaq. Trademarks Sanofi-aventis Q2 net income up 26 percent; firm boosts full-year outlook Sanofi-aventis Group posted a 26 percent increase in second-quarter 2005 net income, in part due to continued strong sales of its stroke drug Plavix (clopidogrel bisulfate). Adjusted net income rose to approximately $1.88 billion, or approximately $1.40 per share, from approximately $1.5 billion, or approximately $1.13 per share, in the previous-year period. Analysts polled by Reuters expected net profit of approximately $1.8 billion. In July, the firm said net sales for the second quarter increased 6.5 percent. Net sales for the quarter increased from approximately $7.65 billion in the comparable period a year ago to approximately $8.09 billion this year, improving the company's world market share to 5.6 percent. Second-quarter sales of Plavix were approximately $612.2 million; the diabetes drug Lantus (insulin glargine [rDNA origin] injection) had sales of approximately $353.3 million; and the cancer drug Eloxatin (oxaliplatin) had approximately $446.4 million in net sales. Sanofi-aventis said that it had received 100 percent of Plavix rights in Japan as of July 5. Sanofi-aventis said it hopes to achieve merger savings more rapidly than initially foreseen but did not change the overall target of approximately $1.97 billion, Dow Jones Newswires reported. The firm said last year's merger with Aventis SA will result in no less than approximately $1.48 billion in efficiency savings, up from a previous target of approximately $1.18 billion, Dow Jones added. "The excellent first-half performance means that, barring major adverse events, sanofi-aventis expects 2005 full-year adjusted [earnings-per-share] growth of at least 20 percent (based on an exchange rate of euro 1:$1.25 . . .)," the firm said, replacing its previously reported earnings growth forecast of 18 percent, according to Dow Jones. "This takes account of substantial expenditure in preparation for the launch of [Acomplia (rimonabant)], the launch costs of Ambien CR [zolpidem tartrate controlled-release] and increased spending on clinical trials, all of which are expected to be incurred in the second half of the year," the firm added. Sanofi-aventis has not said for which indications Acomplia's New Drug Application was filed, but said the drug "is thought to represent a new approach for the comprehensive management of cardiovascular risk factors." Acomplia has been studied as a smoking cessation aid and as a treatment for metabolic disorders among overweight and obese patients. In addition, sanofi-aventis said the Food and Drug Administration agreed to consider its filing for dronedarone, an arrhythmic drug, Dow Jones reported. Dronedarone is expected to be a blockbuster with annual revenue of $1 billion or more, Dow Jones previously said. Also, the company submitted its Pentacel vaccine for marketing approval in the United States, Dow Jones reported. The vaccine protects against diptheria, tetanus, polio, whooping cough and Haemophilus influenzae type b meningitis. Finally, sanofi-aventis said it wants to build its generic drug business but is not seeking to compete with "the world's top players," Reuters reported. Sanofi-aventis shares closed at $42.76, down $0.56, or 1.3 percent, in heavy trading on the New York Stock Exchange. Trademarks Trademarks sanofi-aventis Group Sanofi-aventis Group extended the term of its research collaboration with ImmunoGen Inc. and agreed to provide ImmunoGen with $18.2 million in research support over the 12 months starting Sept. 1, 2006. This funding is in addition to support the company committed to during their previous collaboration. The original July 2003 agreement between ImmunoGen and Aventis Pharmaceuticals Inc. established a collaboration to discover, develop and commercialize new antibody-based cancer treatments. Sanofi-aventis also has another option to extend the term of the research collaboration for an additional year. Trademarks Trademarks Abbott Abbott and MedImmune Inc. amended their U.S. co-promotion agreement for Synagis (palivizumab), MedImmune's monoclonal antibody that prevents serious lower respiratory tract disease caused by respiratory syncytial virus in pediatric patients. Abbott will continue to co-promote Synagis through June 30, 2006, after which MedImmune will take full responsibility for U.S. Synagis sales and continue to make certain payments to Abbott. MedImmune said the amended agreement will reduce its earnings per share in both 2005 and 2006, but will be accretive in 2007. The firm also believes it will reach its 2009 earnings goal of $2 per share. Trademarks Trademarks Chiron Corp. Chiron Corp. said the Food and Drug Administration--after a nine-day Good Manufacturing Practices inspection--found the company's responses and proposed corrective actions at its Liverpool manufacturing facility to be "generally acceptable." Thus, Chiron may now work to return its Fluvirin influenza vaccine to the U.S. market for the 2005-2006 influenza season. However, the company must receive additional approvals from the FDA after future inspections before it can supply the vaccine to the United States. Trademarks Trademarks Cardinal Health Inc. Cardinal Health Inc. reduced its fiscal fourth-quarter and full-year 2005 earnings per share from continuing operations excluding special items by $0.01 as a result of a calculation error and an understatement of rebate billings owed to a vendor, the firm said in a filing with the Securities and Exchange Commission. Cardinal also said that it began settlement discussions with the SEC regarding some of the company's accounting and set aside a $25 million settlement reserve, although this amount may be insufficient, the company added. Trademarks Trademarks


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