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Name Brand ProductsBrand 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 accepts amended NDA for potential ADHD treatment patch, MTSThe Food and Drug Administration accepted for review the amended New Drug Application from Shire Pharmaceuticals Group Plc and Noven Pharmaceuticals Inc. for the methylphenidate transdermal system (MTS) patch intended to treat attention-deficit/hyperactivity disorder in children aged 6 to 12 years. The amended NDA includes efficacy, dosing, duration of wear and tolerability data for MTS. These data include results from a Phase III study of 270 patients and a Phase II study of 79 patients. After seven weeks of therapy with MTS, the patch met the primary endpoints and was well tolerated, Shire said. The FDA indicated the amendment will be reviewed during the next six months. In April 2003, Noven received a non-approvable letter saying the regulatory agency cited "clinical and other issues" in its decision. If approved, the colorless, water-resistant patch would be available in 10 mg, 16 mg, 20 mg and 27 mg strengths. The patch is attached to the child's hip each morning. Dr. Robert Findling, director of adolescent and child psychiatry at Case Western University, said that if the FDA grants MTS approval, "this will be the first ADHD treatment available in a patch formulation, providing health care providers and parents with a useful tool to tailor individualized treatment for children with ADHD." Shire acquired worldwide sales and marketing rights to MTS from Noven in February 2003. Name Brand Products FDA grants fast track designation to Pfizer's maraviroc; Phase I/IIa trial results show drug is well tolerated for HIV Pfizer Inc.'s maraviroc, an investigational drug for the treatment of HIV/AIDS, was granted fast track status by the Food and Drug Administration. The designation is based on the potential for maraviroc's mechanism of action to meet an unmet medical need in patients with HIV who have exhausted all available treatment options, according to Pfizer. Maraviroc uses a different mechanism of action than drugs currently on the market, the company said. Maraviroc, a CCR5-antagonist, blocks HIV from entering white blood cells, which is where the virus replicates, takes over the cell's DNA and eventually destroys the patient's immune system. Maraviroc was shown to be well tolerated and decreased patients' levels of HIV significantly in early-stage clinical trials presented at the Third International AIDS Society Conference on Pathogenesis and Treatment in Rio de Janeiro. Results from six short-term, multi-dose, Phase I/IIa studies of 259 healthy participants with HIV indicated that maraviroc's safety and tolerability was similar to placebo in doses up to 300 mg twice daily. The most common adverse events recorded were headache, dizziness, nausea, asthenia and flatulence. In two 10-day monotherapy studies, maraviroc reduced HIV viral load by 1.6 to 1.84 log in 63 patients, at all total daily doses tested from 200 mg to 600 mg. Currently, maraviroc is in advanced development enrolling patients in worldwide Phase IIb/III trials. Name Brand Products FDA accepts Wyeth's NDA for new oral contraceptive The Food and Drug Administration accepted Wyeth Pharmaceuticals' New Drug Application for a new combination oral contraceptive containing a low daily dose of levonorgestrel/ethinyl estradiol with a "first-of-its-kind dosing regimen." The product is designed to be taken every day, with no placebo phase, and will eliminate the menstrual cycle, potentially eliminating the associated bleeding in some women. "This NDA is an important event in the evolution of oral contraceptives. No combination oral contraceptive is currently approved with this continuous, uninterrupted regimen," said Dr. Ginger Constantine, vice president of Women's Health Care and Bone Repair at Wyeth. Included in the NDA submission were data from two one-year Phase III clinical trials, totaling 2,775 women, which evaluated the safety and efficacy of the product for the contraceptive indication. A secondary endpoint was inhibition of menses. The most common adverse events were headache, vaginal bleeding and cramps. Name Brand Products CV Therapeutics submits amendment to NDA for angina drug, Ranexa CV Therapeutics Inc. said it has submitted to the Food and Drug Administration an amendment to its New Drug Application for Ranexa (ranolazine), which is designed to treat chronic angina in a restricted patient population. The amendment--which includes positive data from a recently completed Phase III study conducted in accordance with the FDA's special protocol assessment process--is meant to provide a full response to the approvable letter CV Therapeutics received from the agency in October 2003; the complete NDA now contains data from three Phase III trials. The firm said an approval could potentially allow the launch of Ranexa in a restricted patient population in the first half of 2006. "If approved, Ranexa would represent the first new class of anti-anginal therapy in the United States in more than 25 years," CV Therapeutics said, adding that chronic angina affects approximately 6.4 million people in the United States. Name Brand Products Tumor necrosis factor blockers appear to protect against cardiovascular disease, according to new data Use of tumor necrosis factor (TNF) inhibitors may lower the risk of developing cardiovascular disease in patients with rheumatoid arthritis, a Swedish study shows. The South Swedish Arthritis Treatment Group register provided data for 531 patients with rheumatoid arthritis who were treated with the TNF inhibitors Enbrel (etanercept) or Remicade (infliximab) after Feb. 1, 1999. Enbrel is sold by Wyeth and Amgen Inc., while Remicade is marketed by Centocor Inc. Data were also collected from a separate register for 543 patients with RA who had not been exposed to TNF inhibitors. None of the patients in either cohort had been discharged from a hospital for a CVD event. Patients in both groups were followed until the occurrence of a CVD event or the study's end on Dec. 31, 2001. Throughout the observation period, there were 13 CVD events and three deaths among the patients exposed to the TNF inhibitors. By comparison, there were 85 CVD events and 29 deaths in the group of unexposed patients. After adjusting for age and sex, researchers found that 14 CVD events occurred per 1,000 patient-years for the TNF-inhibitor group and 35.4 CVD events occurred per 1,000 patient-years in the unexposed group; this meant the unexposed group was 62 percent more likely to develop CVD events when compared with the exposed patients. Even when the follow-up time was restricted to one and two years, patients in the exposed group had lower relative risks for developing CVD events. After the investigators computed the standard morbidity ratios for those who were and were not treated with TNF blockers, they found a significantly increased risk of CVD onset in the unexposed patients relative to the background population of Malmo, Sweden. The treated patients, on the other hand, had a lower risk of new CVD, with confidence intervals enclosing unity with the background population. "Our data suggest that overall treatment with TNF blockers in RA is safe from a cardiovascular point of view and appears to have a protective effect against CVD," the study authors summarized. "These findings are also compatible with the hypothesis that inflammation is an important pathogenetic factor in the development of CVD events." The study can be found in the July issue of the Journal of Rheumatology. Name Brand Products Medco, WellPoint report positive Q2 results Aided by an increase in retail prescription volume, pharmacy benefit manager Medco Health Solutions Inc. posted higher second-quarter net income and revenue. For the quarter ended June 25, 2005, Medco's net income rose 7.9 percent to $137.4 million, or $0.48 per diluted share, compared with $127.3 million, or $0.46 per diluted share, in the same period a year ago. In addition, the company's adjusted net income per share was $0.58, matching the average forecast by analysts polled by Reuters Estimates. Balanced by a 7.2 percent increase in retail volume, a higher generic dispensing rate and reduced mail-order volumes due to the loss of the Federal Employee Health Benefit Plan account last December, Medco's quarterly revenue rose 1.8 percent to $9 billion. The company now expects full-year 2005 diluted earnings per share of between $1.99 and $2.03. In the fourth quarter of fiscal 2005, Medco expects to incur "significant" new business installation costs and take approximately $20 million in development, enrollment and implementation costs related to Medicare Part D. In February, Medco agreed to acquire Accredo Health Inc. in a $2.2 billion cash-and-stock transaction that will create the nation's largest specialty pharmacy business. Medco expects the transaction to close Aug. 18. Separately, health insurer WellPoint Inc. reported strong net income gains as it realized membership gains in all customer segments during the 2005 second quarter ended June 30. Due to Anthem Inc.'s acquisition of WellPoint Health Networks Inc. in November 2004, and its subsequent name change to WellPoint, the firm reported its results in "comparable basis" analyses that include the operations of the former WellPoint Health Networks in the second-quarter 2004 historical results. WellPoint's net income totaled $559.4 million, or $0.90 per diluted share, compared with $537.8 million in the prior-year period, on a comparable basis. Discounting a $0.10-per-share charge to settle two national multi-district lawsuits, the firm topped average analysts' forecasts of $0.97 per share, Reuters reported. The company achieved revenue of $11.3 billion, up from $10.44 billion in the second quarter of 2004, on a comparable basis. In comparable terms, WellPoint said its medical enrollment grew by 1.6 million members and now exceeds 28.8 million members, The firm now foresees full-year net income of $3.91 per share. WellPoint shares closed at $67.10, down $1.19, or 1.7 percent, in heavy trading on the New York Stock Exchange. Name Brand Products Name Brand Products AstraZeneca Plc AstraZeneca Plc entered into an alliance with Astex Therapeutics Inc. to discover, develop and commercialize new small molecule inhibitors of protein kinase B (PKB), also known as Akt, for use as cancer agents. The agreement gives AstraZeneca worldwide rights to PKB inhibitors previously discovered under Astex's current PKB collaboration with the Institute of Cancer Research and Cancer Research Technology. Astex will supply drug candidates to AstraZeneca, and AstraZeneca will further develop the candidates and bring them to the market. Under the agreement, AstraZeneca will provide research funding, an up-front payment of approximately $4.78 million and milestone payments of up to approximately $261 million. Astex could also receive up to double-digit royalties and retains the option in the United States to co-promote products that result from the collaboration. Name Brand Products Name Brand Products AstraZeneca Plc AstraZeneca Plc is expected to announce Thursday that its chief executive officer, Tom McKillop, will leave the firm and join the Royal Bank of Scotland Group Plc as chairman-designate, according to a source close to the situation, Reuters reported. His departure date and successor remain unclear. Name Brand Products Name Brand Products Elan Corp. Plc Elan Corp. Plc and Map Pharmaceuticals Inc. expanded a 2004 agreement seeking to apply Elan's proprietary NanoCrystal technology, which transforms poorly water-soluble drugs into nanometer-sized particles, to defined inhalation therapies. Under the amended agreement, Map will receive additional rights to use NanoCrystal technology to treat multiple respiratory diseases, including asthma. The companies have been collaborating to develop a nebulized form of budesonide, an anti-inflammatory corticosteroid, for the treatment of asthma. The agreement includes nebulized delivery of budesonide as well as combinations of budesonide with beta agonists. Name Brand Products Name Brand Products Schering AG Schering AG and AstraZeneca Plc entered into a three-year research collaboration and licensing agreement for a new class of anti-inflammatory agents, selective glucocorticoid receptor agonists (SEGRAs). Schering currently has an advanced collection of identified SEGRAs, which have the potential to be useful in several disease areas. With a goal of identifying new SEGRAs, the companies will undertake the joint research and development program through the end of Phase I clinical trails. According to the agreement, AstraZeneca will have a worldwide license to develop and market compounds for rheumatoid and respiratory diseases, while Schering will have a worldwide license to all other indications. Schering will receive up-front fees, and both companies will have the possibility of receiving future milestone payments and royalties. The agreement's financial terms were not disclosed. Name Brand Products Name Brand Products Altana AG Altana AG plans to develop Daxas (roflumilast), a phosphodiesterase-4 inhibitor being examined as a potential therapy for chronic obstructive pulmonary disease and asthma, on its own until the drug is ready for the market, at which time it plans to enter a partnership, Hans-Joachim Lohrisch, Altana's pharmaceutical division head, told Dow Jones Newswires. Earlier this month, Pfizer Inc. and Altana terminated their co-development agreement for Daxas. Pfizer's decision to terminate the collaboration was based on data that showed Daxas did not reduce the number of asthma attacks observed in a study as compared with placebo. Daxas is an important drug for Altana, Dow Jones noted, adding that the company needs a drug to replace sales that its heartburn drug, Protonix (pantoprazole sodium), is losing to generic rivals. Wyeth sells Protonix in the United States under a license from Altana. Name Brand Products Name Brand Products
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