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			Company Logos 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 advisory panel recommends approval of Novartis' Exjade The Food and Drug Administration's Blood Products Advisory Committee unanimously recommended approval of Novartis AG's Exjade (deferasirox), an oral iron chelator intended to treat chronic iron overload caused by blood transfusions, Reuters reported. Although the committee agreed that the product was effective in removing excess iron, it recommended that Novartis conduct additional trials after Exjade goes to market, according to Reuters. FDA documents released ahead of the meeting examined whether Exjade is noninferior to the standard of care in iron chelation, deferoxamine mesylate. Novartis markets deferoxamine as Desferal. "Unfortunately, deferoxamine can only be administered by prolonged subcutaneous or intravenous infusion (eight to 12 hours/day, five to seven days/week), and therefore compliance is poor, leading to suboptimal efficacy of this therapy in preventing morbidity and mortality," Novartis said in briefing documents posted on the FDA's Web site. Novartis said Exjade, which is taken once daily after it is dispersed in a glass of water or orange juice, has a favorable benefit-to-risk profile compared with deferoxamine when administered at starting doses of 20 and 30 mg/kg of body weight. "At these doses, [Exjade] has similar efficacy to deferoxamine but is not associated with the complications and burden of subcutaneous or intravenous infusion," the company said. Smaller doses of the drug did not achieve noninferiority to deferoxamine in clinical trials. According to Reuters, panelists are concerned that there is not enough data on the safety of Exjade, especially long-term data. "(Desferal) has many, many shortcomings, so we are anxious to find a replacement," said Dr. Gary Brittenham, a pediatrician at New York's Columbia University. "But Exjade is not deferoxamine, and we need to be acutely aware of the differences of these drugs." Company Logos Lilly adds black box warning to Strattera regarding suicidal thoughts in children, adolescents Eli Lilly and Co. will add a black box warning to the label for Strattera (atomoxetine hydrochloride), a drug used to treat attention-deficit/hyperactivity disorder, "to communicate new information regarding uncommon reports of suicidal thoughts among children and adolescents" taking the drug. The warning came after the Food and Drug Administration asked the company to submit an analysis of adverse event data from clinical trials of the drug. The analysis revealed a small but statistically significant risk of suicidal thoughts in younger patients. Simultaneously, the FDA issued a Public Health Advisory to make physicians aware of the dangers associated with Strattera, advising health care providers and caregivers to closely monitor younger patients who receive the drug for "clinical worsening, as well as agitation, irritability, suicidal thinking or behaviors, and unusual changes in behavior," particularly in the first few months of treatment or when changing the dosage. "While suicidal thinking was uncommon in patients on the medication during clinical trials, it is important for parents to be aware it can occur, and to discuss any unusual symptoms with a physician," said Dr. Alan Breier, Lilly's chief medical officer. The company is working with foreign regulatory agencies to include this safety information worldwide. According to the FDA, the trial data analysis revealed that 0.4 percent of children treated with Strattera reported suicidal thoughts, while none of the children treated with placebo reported having such thoughts. Company Logos FDA approves Berlex's Angeliq menopause treatment Berlex Inc.'s Angeliq (estradiol/drospirenone) was approved by the Food and Drug Administration for the treatment of moderate to severe vasomotor symptoms associated with menopause. "Angeliq provides menopausal women and health care professionals with a new treatment option containing the progestin drospirenone, which is also found in [Schering AG's] Yasmin [drospirenone/ethinyl estradiol], the No. 1 brand of oral contraceptive in the United States and worldwide," said Reinhard Franzen, chief executive officer of Berlex Laboratories. According to Berlex, a Schering affiliate, Angeliq is the only approved hormone therapy that contains drospirenone, a spironolactone analog with anti-aldosterone activity. This property can cause excess sodium and water to be excreted without affecting potassium levels, Berlex noted, cautioning that women with liver, kidney or adrenal disease should not take the product. Clinical trials that included more than 1,759 postmenopausal women found Angeliq to be safe and efficacious in providing endometrial protection, with an acceptable bleeding profile, the company said, noting that Angeliq typically diminishes vasomotor symptoms such as hot flashes, night sweats and vaginal atrophy within four weeks of starting therapy. Data on Angeliq are scheduled to be presented today at the 16th annual meeting of the North American Menopause Society in San Diego. Currently available in Europe, Angeliq is expected to hit the U.S. market by mid-2006 in a formulation containing 1 mg estradiol and 0.5 mg drospirenone. Company Logos Forest Labs, Cypress Bioscience's milnacipran does not meet primary endpoint as treatment for fibromyalgia Forest Laboratories Inc. and Cypress Bioscience Inc. said that preliminary results from a pivotal Phase III trial of milnacipran as a therapy for patients with fibromyalgia did not reach statistical significance for the study's primary endpoint. The randomized, double-blind, placebo-controlled study included 888 patients with fibromyalgia. The study's primary endpoint was a composite response rate of an assessment of pain, as measured by the Patient Experience Diary, and an assessment of overall impression of patient well-being, as measured by the Patient Global Impression of Change. Although not all results reached statistical significance, the companies said they intend to continue their planned development program for milnacipran, including an ongoing Phase III study and a soon-to-be-initiated additional Phase III study by Forest. The companies noted, however, that they have only been able to review initial results and must complete further analyses before confirming the developmental roadmap. Milnacipran is the first in a class of drugs known as norepinephrine serotonin reuptake inhibitors, which work by preferentially inhibiting the reuptake of norepinephrine over serotonin. Forest shares closed at $38.50, down $3.80, or 9 percent, in heavy trading on the New York Stock Exchange, while Cypress shares closed at $5.53, down $7.17, or 56.5 percent, in heavy trading on the Nasdaq. Company Logos Berlex updates data from long-term Betaseron study of patients with MS Berlex Inc., a U.S. affiliate of Schering AG, disclosed updated data from the Betaseron (interferon beta-1b) 16-Year Long-Term Follow-up (16-Year LTF) study of patients with multiple sclerosis. The data are being presented at the 130th Annual Meeting of the American Neurological Association in San Diego. The most recent data show that 331 of 372 patients involved in the original pivotal trial (conducted from 1988 to 1990) have been identified thus far, and that 51 percent of those identified who were originally assigned to the Betaseron 250 mcg treatment group reported being able to walk with or without assistance compared with 45 percent of those identified who were originally assigned to placebo. Further, 95 percent of identified patients originally assigned to the Betaseron group are still living, while 83 percent of the identified patients originally assigned to placebo are living. Additionally, a preliminary assessment of 210 patient case reports received to date indicated that half of the 210 patients have been treated with Betaseron 250 mcg for 10 years or longer, with a median duration of therapy of 14 years for those in the original Betaseron 250 mcg treatment arm. Moreover, 86 of these patients have been taking the drug for more than 80 percent of the time since the end of the original trial. According to Ralph Makar, vice president of Berlex Laboratories' therapeutics business unit, the results of the follow-up study "will provide valuable information regarding the potential impact of early treatment initiation and the long-term safety, efficacy and tolerability of Betaseron." "I am impressed by the fact that even after 16 years, the investigators in this study were able to identify nearly 90 percent of the patients from the original trial in a short period of time," said George Ebers, the study's lead researcher. "This is important because results from follow-up studies with retention rates higher than 80 percent can be viewed with greater confidence." The company expects to release final results next year. Company Logos FDA approves new manufacturing process, production sites for Zyflo Critical Therapeutics Inc. said the Food and Drug Administration approved the company's supplemental New Drug Application to manufacture and market Zyflo (zileuton) tablets. No material changes were made to the prescribing information insert for the drug, which is indicated for the prevention and chronic treatment of asthma in patients aged 12 years or older. The company expects to make Zyflo available to patients by the end of October. With its unique mechanism of action, Zyflo inhibits production of the main enzyme responsible for the production of leukotrienes, 5-lipoxygenase, allowing the drug to work early in the inflammatory cascade. "This approval of our lead product is a major step forward and positions us to generate top-line revenue growth," said Dr. Paul Rubin, Critical Therapeutics' chief executive officer. According to Rubin, the drug's mechanism of action "provides another approach to manage severe persistent or difficult-to-treat asthma for patients who are not well controlled on usual care." Zyflo was approved to treat asthma in the United States in 1996. The drug has not been marketed since 2003 when Critical Therapeutics acquired the worldwide rights to the drug and other formulations of zileuton from Abbott, Reuters reported. Critical Therapeutics shares closed at $9.25, up $1.78, or 23.8 percent, in heavy trading on the Nasdaq. Company Logos Company Logos Schering AG Schering AG ended its license, supply and distribution agreement with Praecis Pharmaceuticals Inc. for the injectable prostate cancer therapy Plenaxis (abarelix) 100 mg because the drug did not receive marketing approval from German regulatory authorities by June 30. Plenaxis is approved in the United States, but Praecis stopped promoting the drug in May because the company was unlikely to meet established revenue goals for the drug "on an acceptable timeline." Praecis noted that Plenaxis was approved this week for use in the German market. Company Logos Company Logos Takeda Pharmaceutical Co. Ltd. Takeda Pharmaceutical Co. Ltd. and Merck KGaA entered into an agreement to jointly develop and commercialize Merck's matuzumab, a humanized monoclonal antibody intended to treat cancer. Under the agreement's terms, Merck will receive an up-front payment of approximately $72.1 million, along with "significant" milestone payments. The companies will share profits, with Merck booking sales everywhere except Japan. Currently, matuzumab is being tested in Phase II trials in patients with non-small cell lung cancer, gastric cancer and colorectal cancer. Company Logos Company Logos Eisai Co. Ltd. Eisai Co. Ltd. signed an in-licensing agreement with Dainippon Pharmaceutical Co. Ltd. for the investigational diabetic neuropathy drug AS-3201, also known as ranirestat. The drug was discovered by Dainippon; under the agreement, Eisai will assume the exclusive rights to further develop, manufacture and market AS-3201 worldwide, with the exception of Japan. Dainippon will retain full rights to the drug in Japan, along with the right to co-promote the drug with Eisai in major countries. Dainippon is currently conducting Phase III clinical trials of AS-3201 in the United States and Canada, and Phase II trials with Kyorin Pharmaceutical Co. Ltd. in Japan. Company Logos Company Logos Cordis Corp. Cordis Corp. acquired LuMend Inc., a private developer of chronic total occlusion (CTO) devices designed to treat peripheral vascular disease. LuMend currently markets the Frontrunner XP CTO and the Outback LTD Re-Entry Catheter, both of which facilitate guidewire placement in procedures such as angioplasty and stenting. Cordis said these products will complement the company's endovascular product portfolio. Financial terms of the transaction were not disclosed. Company Logos


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