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			branding Design 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 PFIZER TO ACQUIRE VICURON FOR $1.9 BILLION ------------------------------------------------------------------------------- Pfizer Inc. agreed to buy biotechnology company Vicuron Pharmaceuticals Inc. for approximately $1.9 billion in cash with the goal of expanding Pfizer's lineup of anti-infectives. Pfizer will acquire all the outstanding shares of Vicuron common stock at a price of $29.10 per share. The transaction is expected to close in the third quarter of this year. New Drug Applications for two of Vicuron's products, anidulafungin and dalbavancin, are currently under review by the Food and Drug Administration. Anidulafungin was shown to be superior to fluconazole in treating invasive candidiasis/candidemia during Phase III testing. Meanwhile, dalbavancin has shown positive results in Phase III studies as a treatment for complicated skin and soft tissue infections and in Phase II testing as a treatment for catheter-related bloodstream infections, according to Vicuron. Pfizer hopes the acquisition will compensate for lost sales of its fungal treatment Diflucan (fluconazole), which recently lost patent protection, and for an expected decline in sales of its antibiotic Zithromax (azithromycin), which will likely face competition from generic versions later this year, Reuters reported. Vicuron shares closed at $28.21, up $12.41, or 78.5 percent, in heavy trading on the Nasdaq. -=- FDA APPROVES WYETH'S FIRST-IN-CLASS ANTIBIOTIC, TYGACIL ------------------------------------------------------------------------------- Wyeth Pharmaceuticals Inc. received approval from the Food and Drug Administration for Tygacil (tigecycline), an intravenous antibiotic, for the treatment of complicated intra-abdominal infections (cIAIs) and complicated skin and skin structure infections (cSSSIs) in adults. The drug can be used as an empiric monotherapy in the treatment of community- or hospital-acquired cIAIs or cSSSIs, including complicated appendicitis, infected burns, intra-abdominal abscesses, deep soft tissue infections and infected ulcers. Tygacil has demonstrated efficacy in treating infections caused by drug-resistant bacteria, including methicillin-resistant Staphylococcus aureus. "Life-threatening infections are a growing concern globally," said Dr. Joseph Camardo, Wyeth Pharmaceuticals' senior vice president of global medical affairs. "Bacterial infections are becoming more difficult to treat, with resistant strains on the increase." The drug, the first in a new class called glycylcyclines, is administered intravenously every 12 hours and does not require dosage adjustment in patients with impaired renal function, according to Wyeth. Tygacil can be used as a broad-spectrum option at the onset of treatment, when specific bacteria present have not yet been identified, the company added. Tygacil is currently pending approval by other regulatory agencies worldwide. -=- FDA COMMITTEE RECOMMENDS APPROVAL OF BIDIL, LABEL CHANGES FOR HYPERTENSION DRUGS ------------------------------------------------------------------------------- The Food and Drug Administration's Cardiovascular & Renal Drugs Advisory Committee provided recommendations on NitroMed Inc.'s chronic heart-failure treatment, BiDil (isosorbide dinitrate/hydralazine hydrochloride), and proposed changes to the indications sections of labels for hypertension drugs. The committee unanimously voted that the FDA should approve BiDil, and all but one voting member said the agency should limit the use of the drug to black patients, the population for which the drug has shown the most efficacy, according to an FDAAdvisoryCommittee.com news alert. Briefing documents note that BiDil's New Drug Application is based on three studies. Initial results from the first two studies "were suggestive of a benefit in heart-failure patients of all races, but the dataset was not adequate to gain FDA approval." Additional analyses of the trials' data "generated the hypothesis that the observed benefit of [BiDil] occurred primarily in black patients," leading to a third study of the drug in that population. "Taken as a whole, the results from these three trials support approval of BiDil to treat heart failure in black patients," the FDA's briefing documents said. According to Dow Jones Newswires, this advisory committee meeting was different from most, as it focused not on how well BiDil worked, but on whether the drug should be approved for just one race. The FDA is expected to make its decision regarding approval of the drug next week. Separately, FDAAdvisoryCommittee.com reported that the same committee recommended that a general statement on the cardiac benefits from the blood-pressure lowering effects of hypertension drugs should be included in the drug class' indications. The committee said a brief statement should appear in the label's "Indications" section, with more detailed information provided in the "Clinical Trials" section. Several versions of how the new labeling could be worded were included in briefing documents. One potential version states that the drug "is indicated for the treatment of [mild to severe] hypertension to reduce the risk of cardiovascular events, primarily strokes and myocardial infarction." The committee did not determine a specific risk-reduction figure; some panelists suggested using a reduction range. According to FDAAdvisoryCommittee.com, many committee members believed that products not included in studies with cardiovascular endpoints should have a distinction made on their labels stating that "while the class has been studied, outcomes data are not available for the specific product." Diuretics, beta blockers, calcium channel blockers, ACE inhibitors and angiotensin II receptor inhibitors are the hypertension drug classes that have displayed cardiovascular benefits in clinical trials, FDAAdvisoryCommittee.com noted. -=- ADVANCIS, PAR'S AMOXICILLIN PULSYS FAILS TO MEET PRIMARY ENDPOINT IN STREP THROAT TRIAL ------------------------------------------------------------------------------- Advancis Pharmaceutical Corp. and Par Pharmaceutical Cos. Inc.'s shares fell after the companies revealed that a Phase III trial of amoxicillin Pulsys, a treatment intended for adults and adolescents with strep throat (pharyngitis/tonsillitis resulting from Group A streptococcal infections), failed to meet its endpoints. The trial compared 775 mg tablets of Advancis' amoxicillin Pulsys, dosed once a day for seven days, with 250 mg of penicillin VK, dosed four times a day for 10 days. The companies said amoxicillin Pulsys, which uses Advancis' oral drug delivery technology that enables once daily pulsatile dosing, failed to demonstrate statistical non-inferiority to penicillin VK in the primary endpoint, bacterial eradication at the post-therapy test-of-cure (TOC) visit; the drug also failed to demonstrate non-inferiority in the trial's secondary endpoints, which included clinical cure at the TOC visit and bacterial eradication at the late post-therapy visit. "We are disappointed in the trial results for our adult amoxicillin Pulsys product. We will further investigate these results and look to the results of our pediatric Phase III trial that we anticipate receiving next month before deciding upon the next steps for our amoxicillin program," said Dr. Edward Rudnic, Advancis' chief executive officer. Even if the pediatric study meets its endpoints, Advancis said it will most likely need to conduct another Phase III trial in adults and adolescents before filing a New Drug Application. This requirement would delay the NDA filing by at least a year, according to the company. Under the terms of a 2004 agreement, Par has the exclusive right to sell and distribute the product while Advancis is responsible for manufacturing. The companies will jointly market the product and split any operating profits equally. Advancis shares closed at $2.03, down $2.96, or 59.3 percent, in heavy trading on the Nasdaq. Par shares closed at $31.57, down $1.94, or 5.8 percent, in heavy trading on the New York Stock Exchange. -=- ROMARK'S ALINIA APPROVED TO TREAT DIARRHEA CAUSED BY CRYPTOSPORIDIUM PARVUM INFECTION IN TEENS, ADULTS ------------------------------------------------------------------------------- Romark Laboratories LC's Alinia (nitazoxanide) tablets and oral suspension were approved by the Food and Drug Administration to treat diarrhea caused by Cryptosporidium parvum infection in patients aged 12 years or older. A study of patients with Cryptosporidium-caused diarrhea showed Alinia to significantly reduce the duration of diarrhea and other gastrointestinal symptoms as compared with placebo. Ninety-six percent of patients who took Alinia tablets and 87 percent of patients who took Alinia oral suspension recovered within seven days after beginning treatment. Only 41 percent of placebo-treated patients were well within the same amount of time. Alinia was also found to be safe and well tolerated in this study. Romark said the FDA's decision makes Alinia the first treatment approved for use by adults and teenagers with infections caused by Cryptosporidium, a protozoan that is reportedly found in 65 percent to 97 percent of surface water in the United States. Cryptosporidium is the leading cause of waterborne disease outbreaks, the company said, noting that this type of infection is usually spread through contaminated food or water or through person-to-person contact. Alinia, which received priority review, was already approved to treat diarrhea caused by Giardia or Cryptosporidium in children aged at least 1 year. Romark is currently researching the drug's effectiveness in other GI diseases, such as Clostridium difficile-associated diarrhea and Crohn's disease. -=- NEWER PRESCRIPTION DRUGS, CBT PROVIDE BEST TREATMENT FOR INSOMNIA, NIH PANEL SAYS ------------------------------------------------------------------------------- Newer prescription sleeping pills and cognitive behavioral therapy (CBT) appear to be the best treatments for insomnia, according to an expert panel convened by the National Institutes of Health, The Associated Press reported. The NIH panel found that many people self-medicate for insomnia. Alcohol and over-the-counter sedating antihistamines are the most commonly used treatments for the condition, even though alcohol disrupts sleep quality and antihistamines can cause cognitive problems and drowsiness the following day. Despite the side effects and lack of evidence that it offers more than a two-week benefit, the most prescribed insomnia treatment is trazodone hydrochloride, a sedating antidepressant, panel members found. As to why physicians continue to prescribe less effective treatments such as trazodone hydrochloride, the panelists suggested that some may hesitate to prescribe controlled substances, a category that includes most prescription sleep aids. Panel members noted that, compared with the older class of sleep drugs known as benzodiazepines, there is not as much need for concern over side effects with many of the newer sleep aids, such as King Pharmaceuticals Inc.'s Sonata (zaleplon), Sepracor Inc.'s Lunesta (eszopiclone) and sanofi-aventis Group's Ambien (zolpidem tartrate). Dr. Charles Zorumski, psychiatry chief at Washington University School of Medicine and one of the expert panelists, said the newer drugs, classified as nonbenzodiazepines, do not have as much abuse potential because they leave the body much faster than benzodiazepines. CBT is highly effective in treating insomnia and presents no risk of undesirable side effects, according to the NIH panel; however, panelists acknowledged that it can be difficult to find health care providers trained in the technique. The panel called for additional research on insomnia, explaining that if scientists can better understand the sleep disorder's underlying causes, they can develop more effective treatments. -=- branding Design SANOFI-AVENTIS GROUP ------------------------------------------------------------------------------- Sanofi-aventis Group reported that a U.S. District Court accepted an inequitable conduct claim by Amphastar Pharmaceuticals Inc. regarding the patent for sanofi-aventis' blood thinner, Lovenox (enoxaparin sodium injection). Sanofi-aventis intends to appeal the ruling and "vigorously defend its intellectual property rights covering Lovenox." According to Reuters, Aventis initiated a lawsuit against Amphastar and Teva Pharmaceuticals USA in 2003 for allegedly infringing on the Lovenox patent by trying to sell generic versions of the drug. Sanofi-aventis shares closed at $41.17, down $2.10, or 4.9 percent, in heavy trading on the New York Stock Exchange. -=- branding Design MYLAN LABORATORIES INC. ------------------------------------------------------------------------------- Mylan Laboratories Inc. and Watson Pharmaceuticals Inc.'s joint venture, Somerset Pharmaceuticals Inc., submitted a response to the Food and Drug Administration's action letter regarding Emsam (selegiline transdermal system), an investigational monoamine oxidase inhibitor for acute and maintenance treatment of major depressive disorder. The FDA issued a Prescription Drug User Fee Act goal date of Nov. 27, 2005, for submissions, after accepting Somerset's response as complete. -=- branding Design AETNA INC. ------------------------------------------------------------------------------- Aetna Inc. reaffirmed its full-year 2005 guidance for operating earnings of $4.52 to $4.57 per share, according to a filing with the Securities and Exchange Commission. The company also reaffirmed projected second-quarter 2005 operating earnings of $1.05 per share. These estimates exclude capital gains and losses, as well as favorable development of health care cost estimates from the previous period. Thomson First Call analysts expect earnings of $4.58 per share, Dow Jones Newswires reported. Aetna shares closed at $82.37, down $1.75, or 2.1 percent, in moderate trading on the New York Stock Exchange. -=- branding Design AMERISOURCEBERGEN CORP. ------------------------------------------------------------------------------- AmerisourceBergen Corp. agreed to sell substantially all operating assets of one of its subsidiaries, Bridge Medical, to Cerner Corp. for approximately $11 million. Additional contingent payments may be made based on performance targets achieved through Jan. 1, 2006. The agreement will enable AmerisourceBergen to continue offering Bridge Medical products as part of its array of patient-safety solutions. The transaction is expected to close in July; AmerisourceBergen said it does not expect any changes in its fiscal-year 2005 or fiscal-year 2006 earnings as a result. The company does, however, anticipate recording an after-tax loss of approximately $5 million to $6 million in the third quarter ending June 30 from discontinued operations related to Bridge Medical. -=- branding Design PRANA BIOTECHNOLOGY LTD. ------------------------------------------------------------------------------- Prana Biotechnology Ltd. announced its Chief Executive Officer Dr. Jonas Alsenas resigned effective immediately. Geoffrey Kempler will reassume the responsibilities of CEO and executive chairman while the company conducts a search for Alsenas' successor. Prana also announced it completed a review of its investigational Alzheimer's disease treatment PBT2 and "reaffirmed its commitment to the development" of the drug. In April, Prana discontinued testing of PBT1, of which PBT2 is a backup compound. Prana reiterated its confidence that PBT2 "will not present the impurity problems that were found in PBT1." -=- branding Design


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