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Global PanelBrand 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 Merck's Rotateq vaccine The Food and Drug Administration approved Merck & Co. Inc.'s Rotateq (rotavirus vaccine, live, oral, pentavalent) to prevent rotavirus gastroenteritis.According to Merck, it is the only vaccine available in the United States to prevent rotavirus gastroenteritis, a leading cause of severe diarrhea in infants and young children. The approval was based on Phase III clinical trials that included more than 70,000 infants, Merck said, adding that the data included results from REST, which was one of the largest prelicensure vaccine trials ever conducted. In these trials, Rotateq prevented 98 percent of severe cases of rotavirus gastroenteritis and 74 percent of rotavirus gastroenteritis cases of any severity caused by serotypes the vaccine targets (G1, G2, G3 or G4) compared with placebo through the first complete rotavirus season after treatment. One of the concerns prior to approval was a possible increased risk of intussusception. According to an FDA review document, Wyeth's RotaShield (rhesus rotavirus tetravalent) vaccine, which was the first rotavirus vaccine licensed, had been associated with the gastrointestinal condition. Wyeth's vaccine was withdrawn from the market in 1999. In REST, Rotateq did not increase the risk of bowel obstruction as compared with placebo, with 13 cases of intussusception reported in the vaccine group and 15 in the placebo group. Rotateq's formal indication is for the prevention of rotavirus gastroenteritis in infants and children caused by serotypes G1, G2, G3 and G4 when given as a three-dose series to infants between the ages of 6 weeks and 32 weeks. Merck said the Advisory Committee on Immunization Practices will decide later this month whether the vaccine should be added to the pediatric immunization schedule of recommended vaccines. The vaccine is available for ordering at the catalog price of $62.50 per dose when bought as a pack of 10 single-dose tubes, Merck said. Global Panel UCB's Keppra injection receives approvable letter from FDA; Keppra concentrate receives positive opinion from EMEA Regulatory agencies in the United States and Europe have moved closer to approving UCB Group's new formulations of Keppra (levetiracetam), an antiepileptic drug. In the United States, the Food and Drug Administration sent an approvable letter in response to UCB's New Drug Application for Keppra injection 100 mg/mL as adjunctive therapy to treat partial onset seizures in adult patients with epilepsy. UCB said the agency requested new product labeling and more information about manufacturing before it will complete the review. The company noted that it has already given the requested information to the FDA. In Europe, the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion to approve marketing authorization of Keppra concentrate 100 mg/mL as an intravenous administration and for use as adjunctive therapy to treat partial onset seizures with or without secondary generalization in patients aged 4 years or older who have epilepsy. Roch Doliveux, UCB's chief executive officer, said the new formulation will provide physicians an important option in emergency seizures when oral medications cannot be used. According to Doliveux, Keppra will become the first of the newer antiepileptic drugs to be available in an IV formulation if it is approved. Keppra is currently approved in the United States in tablet and oral solution formulations for adjunctive therapy to treat partial onset seizures in patients aged 4 years or older with epilepsy. The same formulations are approved in Europe for adjunctive therapy to treat partial onset seizures with or without secondary generalization in patients aged 4 years or older with epilepsy. Global Panel CryoCor's Cardiac Cryoablation system for treatment of atrial flutter not approvable CryoCor Inc. received a letter from the Food and Drug Administration stating that its Cardiac Cryoablation system is not approvable to treat atrial flutter. The FDA said the success rate demonstrated in the company's data did not meet the regulatory agency's "chronic efficacy criteria." In response, the medical device maker said it stands by its data and will continue to evaluate the safety and efficacy of the system in its pivotal trial. " ... [We] expect to continue our constructive discussions with the FDA to determine the appropriate path going forward," said CryoCor's Chief Executive Officer Greg Ayers. The company added that the Cardiac Cryoablation system's trial for the treatment of atrial fibrillation is not affected by the FDA's letter. CryoCor shares closed at $3.15, down $1.84, or 36.9 percent, in heavy trading on the Nasdaq. Global Panel FDA grants orphan drug designation to Apoxis' rare genetic disease treatment Apoxis SA received an orphan drug designation from the Food and Drug Administration for its rare disease therapeutic, APO200. The drug, which is based on Apoxis' multimerization technology, is being developed to treat x-linked hypohidrotic ectodermal dysplasia. This rare, genetic and potentially life-threatening disease causes patients to be unable to control their body temperature through sweating and has been linked to sudden infant death. In Europe, regulatory officials granted APO200 orphan designation in November, which gives Apoxis 10 years of market exclusivity if the drug is approved. In the United States, the orphan designation grants seven years of market exclusivity. Currently in preclinical trials, APO200 is expected to enter human studies in 2007, the company said, adding that it is looking for potential partners to help develop the drug. Global Panel InterMune stops Actimmune cancer trial; reports Q4, full-year results InterMune Inc. is discontinuing clinical testing on Actimmune (interferon gamma-1b) for ovarian cancer on the recommendation of an independent Data Safety Monitoring Board. Separately, the biotechnology firm reported a full-year net loss in 2005 despite a fourth-quarter profit. Based on results of an interim analysis conducted by the DSMB, InterMune said it will stop its Phase III study comparing the safety and efficacy of Actimmune in combination with standard-of-care chemotherapy (carboplatin plus paclitaxel) with carboplatin plus paclitaxel alone among patients with advanced ovarian cancer. The board found that 39.7 percent of the 426 patients treated with Actimmune plus chemotherapy died compared with 30.4 percent of the 421 patients who received chemotherapy alone. Additionally, there was difference in the time of progression free survival between the two arms. The firm noted that Actimmune was generally well tolerated in previous studies and among different disease states, but due to these recent events, it has "no plans to initiate further studies of Actimmune in oncology or in combination with such chemotherapy regimens." Actimmune is currently approved for chronic granulomatous disease and severe, malignant osteoporosis. Furthermore, InterMune is evaluating Actimmune monotherapy for the treatment of idiopathic pulmonary fibrosis in Phase III testing. Separately, InterMune released its fourth-quarter and full-year 2005 financial results. Fourth-quarter net income was $59.7 million, or $1.84 per diluted share, in 2005 versus a net loss of $21.8 million, or $0.68 per diluted share, in the year-ago period. Quarterly revenue totaled $28.7 million compared with $31.3 million in 2004, and sales from Actimmune were 9 percent lower than in 2004. For the full year, the company reported a net loss of $5.2 million, or $0.16 per diluted share, compared with a net loss of $59.5 million, or $1.87 per diluted share, in 2004. Total revenue reached $110.2 million for the full year, a 14 percent decrease from revenue of $128.7 million achieved in 2004. In particular, Actimmune revenue fell by 14 percent during the year. During the fourth quarter, InterMune divested chronic hepatitis C virus therapy Infergen (interferon alfacon-1) to Valeant Pharmaceuticals International, which led to a gain of $85.1 million, or $2.63 per share, reflected in both the quarterly and full-year earnings. However, in both reports, the company recognized a net loss from discontinued operations, including a loss of $11.4 million from Infergen. For 2006, InterMune expects revenue to reach between $75 million and $100 million, which will exclusively reflect Actimmune sales. InterMune shares closed at $18.07, down $2.54, or 12.3 percent, in heavy trading on the Nasdaq. Global Panel OccuLogix's system to treat age-related macular degeneration fails to meet study endpoint OccuLogix Inc. said preliminary results from its pivotal Phase III trial on its RHEO system to treat the dry form of age-related macular degeneration did not meet its primary clinical endpoint. Compared with patients who received placebo, patients treated with the RHEO system did not reach a statistically significant difference in the mean change of Best Spectacle-Corrected Visual Acuity applying the Early Treatment Diabetic Retinopathy Scale at 12 months, although the treated group did demonstrate a positive response. According to the firm, the placebo group had an anomalous response, which affected the results. There were, however, subgroups that demonstrated statistical significance in their Best Spectacle Corrected Visual Acuity, so further analysis of these data will be conducted, OccuLogix said. The company said it is evaluating the implications thes edata will have on its application to the Food and Drug Administration. TLC Vision Corp. owns a 51 percent share in OccuLogix. OccuLogix shares closed at $4.10, down $8.65, or 67.8 percent, while TLC Vision shares closed at $5.90, down $2.03, or 25.6 percent, both in heavy trading on the Nasdaq. Global Panel Global Panel The Food and Drug Administration The Food and Drug Administration's Center for Devices and Radiological Health is beginning a program "to identify, analyze and act on postmarket information in order to improve the safety and effectiveness of medical devices and radiation-emitting products." One of the areas the CDRH wants to improve is the collection of data. According to Reuters, the FDA receives approximately 160,000 reports per year regarding potential problems with medical devices, most of which come on paper and must be entered manually into a database. Global Panel Global Panel The Centers for Medicare & Medicaid Services The Centers for Medicare & Medicaid Services released a progress report on the Medicare drug benefit. Although officials had originally anticipated Medicare premiums to average more than $37 per month, CMS estimates individuals are paying only $25 per month on average. The agency added that the federal government now expects the cost per person in 2006 to be approximately 20 percent lower than previously estimated. The report also updated guidance on the 30-day supply of emergency drugs that insurers were instructed to provide for beneficiaries. CMS said the transitional period will now continue for 60 more days as a way to help beneficiaries arrange for lower-cost alternatives when their plan will not cover a drug. Global Panel Global Panel Boston Scientific Corp. Boston Scientific Corp. issued a statement regarding its meeting with the Food and Drug Administration to discuss warnings the regulatory agency gave to Boston Scientific last month. As previously reported, the FDA sent a corporate warning letter to Boston Scientific regarding the firm's plan to fix deficiencies at its manufacturing facilities. The device maker said the meeting was "productive" and it is dedicated to the resolution of the issues noted by the FDA. It plans to work closely with the agency. Global Panel Global Panel Alteon Inc. Alteon Inc. withdrew an Investigational New Drug application from the Food and Drug Administration for its Phase IIa study to examine alagebrium as a treatment for erectile dysfunction. The company said the FDA had requested additional preclinical testing before the trial could proceed. Alteon has decided to focus on developing alagebrium in cardiovascular diseases. With the withdrawal of the IND, the company now has no existing clinical holds on the drug from any division of the FDA. Global Panel
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