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Name BrandsBrand 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 GSK corrects manufacturing issues, resupplies PaxilGlaxoSmithKline Plc has resupplied its antidepressant Paxil CR (paroxetine hydrochloride controlled-release) to U.S. pharmacies after resolving manufacturing issues at its Puerto Rico plant. The product will soon be made available again in other markets, as well. Batches of Paxil CR and the company's diabetes drug, Avandamet (rosiglitazone maleate/metformin hydrochloride), were seized in March by the Food and Drug Administration for failure to meet certain standards. The company withdrew the products due to manufacturing issues, promising to resupply pharmacies and wholesalers with the drugs by the middle of the year. GSK noted that both it and the regulatory agency found the manufacturing issues posed no significant safety issues for patients. The firm expects to re-establish supplies of Avandamet within two weeks. In a related story reported by Dow Jones Newswires, a GSK spokesman said the company anticipates receiving FDA approval of Avandaryl, an investigational type-2 diabetes treatment, by the end of the year. The new drug is expected to be manufactured at the Puerto Rico site. Name Brands India's Torrent Pharmaceuticals to acquire Pfizer's German generics unit, Heumann Torrent Pharmaceuticals Ltd. said it agreed to acquire Pfizer Inc.'s German generic drug unit, Heumann Pharma GmbH & Co. Generica KG. "The generics business does not fit with the strategy of the world's largest research-based drugmaker," Pfizer said in a statement mentioned in a Reuters report. The acquisition is being made through Torrent's wholly owned German subsidiary, Torrent Pharma GmbH, and excludes Heumann's manufacturing facilities, which will be retained by Heumann PCS GmbH, another of Pfizer's subsidiaries. Heumann Pharma will source its products principally from the Heumann PCS GmbH manufacturing facility, Torrent noted, although third-party manufacturers will be used as well. Torrent expects the transaction to close by August and said Pfizer units in Germany will provide support services until April 2006 "to facilitate smooth transition." "The acquisition will give [Torrent] access to the 90-year-old 'Heumann' brand name, 315 marketing authorizations and 34 product registration applications, together giving [Torrent] a strong presence in Germany," Torrent said. Heumann, which is ranked 11th in Germany's generic market, had sales of approximately $66.28 million for the fiscal year ended Nov. 30, 2004, and currently has 116 products in its portfolio. Cardiovascular, gastrointestinal and anti-infective drugs account for approximately 75 percent of its portfolio. With the acquisition, Torrent expects its annual global sales to reach approximately $230 million and its international business share to grow from 24 percent to 50 percent. "[Torrent] is now strategically well positioned to improve its business presence in regulated markets of Europe as well as North and South America," the company said. Name Brands Enoximone does not provide statistically significant benefit in Phase III heart failure trials; development halted Myogen Inc. will stop development of its enoximone capsules after two Phase III trials showed the drug failed to provide a statistically significant benefit for the three primary endpoints. The ESSENTIAL I and II double-blind studies included 1,854 patients with New York Heart Association class III and class IV congestive heart failure. Patients were randomized to receive 25 mg of enoximone or placebo three times per day. If they showed no contraindications after two weeks, patients weighing more than 50 kg increased their enoximone dose to 50 mg for the remainder of the trial period. The first endpoint, time to first cardiovascular hospitalization or all-cause mortality (across both trials), was similar between the treatment arms, with a relative hazard ratio of 0.98. The secondary endpoint was designated as the change in submaximal exercise capacity at 6 months, as measured by walking distance in six minutes. The difference in median change from baseline for enoximone versus placebo was 10 meters in ESSENTIAL I and 1.5 meters in ESSENTIAL II. The third primary endpoint was the change in patient self-assessment of well-being at 6 months, as measured by a patient global assessment instrument. In ESSENTIAL I, 43 percent and 46 percent of patients who received enoximone and placebo, respectively, reported "marked improvement." In ESSENTIAL II, 29 percent of patients in the enoximone arm and 31 percent of those in the placebo group reported the same status. Based on these results, Myogen said it will instead focus on developing ambrisentan, a treatment for pulmonary arterial hypertension, and darusentan, a treatment for resistant hypertension. "Based on termination of further development activities for oral enoximone, the company expects 2005 operating expenses will be substantially lower than previous guidance," the firm stated. Shares of Myogen closed at $6.32, down $0.57, or 8.1 percent, in heavy trading on the Nasdaq. Name Brands Genaera, FDA agree on protocol for Phase III wet AMD trials Genaera Corp. and the Food and Drug Administration reached agreement on the special protocol assessment (SPA) for the design of two Phase III trials for Evizon (squalamine lactate) as a treatment for choroidal neovascularization associated with age-related macular degeneration (AMD), or "wet" AMD. The agreement indicates that the designated clinical protocols meet specified requirements and can serve as the basis for Evizon's New Drug Application. "We are very pleased to have sought and reached agreement with the FDA on the design of our Phase III trials of Evizon in wet AMD," said Dr. Roy Levitt, chief executive officer of Genaera. "The SPA is an important milestone in our aggressive clinical development plans for Evizon and solidifies our regulatory pathway toward FDA approval. With this SPA in hand, we are ready to begin our registration trials in the very near future." The trials are identically designed and will enroll patients with predominantly classic, minimally classic and occult forms of wet AMD. Both trials will evaluate two doses of Evizon (20 mg and 40 mg) versus placebo. After receiving treatment once a week for four weeks, patients will then receive maintenance therapy every four weeks until week 104. Evizon is currently being evaluated in three U.S. Phase II trials as a treatment for wet AMD. The drug was granted fast track status in October 2004 and was selected for the FDA's Continuous Marketing Application Pilot 2 program in January of this year. "In our early Phase I and II trials Evizon has stabilized or improved vision in most everyone we have treated, including patients with two affected eyes, with a good safety profile," said Levitt. Name Brands Study finds chemotherapy effective in patients with early-stage lung cancer A study published June 23 in The New England Journal of Medicine found that adjuvant chemotherapy (vinorelbine plus cisplatin) provides a substantial survival benefit in patients with early-stage lung cancer. This finding runs contrary to data from previous studies, which failed to demonstrate any significant survival advantage. The 10-year, prospective, Phase III study, which included 482 patients with early-stage lung cancer, demonstrated superior five-year survival rates among patients treated with adjuvant chemotherapy as compared with patients in the observation group (69 percent vs. 54 percent, respectively). In response to the new findings, the American College of Clinical Oncology and the American College of Chest Physicians are rewriting their official guidelines to physicians to recommend chemotherapy for patients with early-stage lung cancer, The Wall Street Journal reported. "There's never been a lung cancer trial that showed this benefit of treatment in any stage of disease," Katherine Pisters, a University of Texas oncologist who was not involved with the study, told The Journal. In addition to the survival benefit, the study showed the chemotherapy regimen was well tolerated and could be administered safely in the outpatient setting "with limited toxicity." "We believe that a brief course of such chemotherapy should become the standard of care for patients with good performance status after complete resection of stage IB or stage II non-small cell lung cancer," the authors of the study concluded. Name Brands Levofloxacin plus amoxicillin appears to eradicate majority of H. pylori strains in patients who failed two prior regimens A new study shows a 10-day regimen of levofloxacin plus amoxicillin eradicated Helicobacter pylori infection in nearly 80 percent of patients who had failed two previous regimens. The trial included 151 patients who had persistent H. pylori infection, despite two prior treatment regimens. They had first received triple therapy with metronidazole or amoxicillin for seven days. As second-line treatment, they had received triple therapy with metronidazole or amoxicillin for seven days or quadruple therapy with a proton pump inhibitor, bismuth, metronidazole and tetracycline for 10 or 14 days. Patients were considered still positive for infection if two of three tests (endoscopies with biopsies or rapid urease tests) were positive or if culture alone was positive. They then received twice-daily treatment with a standard dose of a PPI, 250 mg of levofloxacin plus 1 g of amoxicillin for 10 days. According to the intent-to-treat (n=151) and per-protocol (n=136) analyses, the rates of eradication were 76.2 percent and 84.6 percent, respectively. Nearly one-half of the infection strains were susceptible to levofloxacin but resistant to metronidazole and clarithromycin; of these, 92.3 percent were eradicated. Also, the third-line therapy eradicated 50 percent of the overall 11.3 percent of strains resistant to all three antimicrobial agents. Full results of this trial can be found in the July issue of Alimentary Pharmacology and Therapeutics. Levofloxacin is available as a generic formulation and as Ortho-McNeil Pharmaceutical Inc.'s Levaquin. Name Brands Name Brands Merck & Co. Inc. Merck & Co. Inc. and Metabasis Therapeutics Inc. formed a collaboration to develop and commercialize small molecule therapeutics to treat conditions such as type 2 diabetes and obesity. Merck will pay Metabasis $5 million upon signing of the agreement and will provide funding for research. If a product is developed and marketed for a single indication, Metabasis will receive cash payments of approximately $54 million, excluding royalties; if a product is approved for additional indications, Metabasis will receive additional cash payments, up to a total of $74 million. Name Brands Name Brands Wyeth Wyeth raised its 2005 full-year earnings guidance to a range of $2.80 to $2.90 per diluted share, up from $2.70 to $2.80 per share. The company attributed the increase, which excludes charges, to "high single-digit revenue growth, lower than expected growth in several expense items and favorable tax developments." Analysts, on average, expected earnings of $2.83 per share, according to Reuters Estimates. Name Brands Name Brands The European Medicines Agency The European Medicines Agency (EMEA), following a review of COX-2 inhibitors, recommended the continued suspension of Pfizer Inc.'s Bextra (valdecoxib). The EMEA backed extending the indications for Abbott's Humira (adalimumab) to include treatment--in combination with methotrexate--of severe, active and progressive rheumatoid arthritis in adults not treated with methotrexate previously. The agency also recommended the drug be used to treat active and progressive psoriatic arthritis in adults when disease-modifying antirheumatic drug therapy has been shown to be ineffective. The latter recommendation is based on data from the clinical study ADEPT. Name Brands Name Brands HealthSouth Corp. HealthSouth Corp. filed a comprehensive Form 10-K with the Securities and Exchange Commission for the years 2000 through 2003 and restated its finances for 2000 and 2001. According to The Wall Street Journal, the company's actual revenue for 2000 and 2001 was $7.1 billion, a figure that is approximately $1.5 billion lower than what the company previously reported. HealthSouth said the restatement cost more than $250 million, adding that it plans to file a 10-K for 2004 by the end of the year. Name Brands Name Brands Cardinal Health Inc. Cardinal Health Inc. expects its earnings for the fiscal year ending June 30, 2005, to be in the upper half of the $3.10 to $3.20 per share range estimated previously, but the company anticipates its 2006 earnings will be below analysts' estimates. The company forecast earnings per share for fiscal 2006, excluding special items, in the range of $3.30 to $3.55, citing increased investments, business realignments and lower margins on vendors' drug sales. On average, analysts polled by Reuters Estimates expected earnings per share of $3.73 for fiscal 2006. Name Brands
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