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			branding Research 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 pulls Caduet application from 12 European countries Pfizer Inc. pulled its Marketing Authorization Application from several European countries for Caduet (amlodipine besylate/atorvastatin calcium), a cardiovascular drug that combines Norvasc and Lipitor. The application was officially withdrawn from Belgium, Denmark, Estonia, Ireland, Italy, the Netherlands, Norway, the United Kingdom, Sweden, Germany, Greece and Finland because these countries all "had reservations as to whether the benefit of Caduet . . . had been demonstrated, based upon current European regulatory guidelines for fixed-combination products," Pfizer said in a filing with the Securities and Exchange Commission. Caduet is already approved in the United States and in several European countries. Pfizer plans to keep exploring regulatory opportunities for the drug, which, along with diet and exercise, is indicated to treat both hypertension or angina and high cholesterol. It is also indicated to lower the risk of myocardial infarction in patients with multiple risk factors for heart disease. Also in the regulatory filing, Pfizer said the U.S. Department of Justice informed the firm that it is investigating a former contractual relationship between Pharmacia Corp. and an unnamed health care intermediary. No further details were disclosed. Pfizer bought Pharmacia in 2003. In separate news, Pfizer said the Oslo District Court in Norway ruled in favor of the firm regarding one of its patents protecting Lipitor. The court ruled that the patent covering an intermediate compound used in making atorvastatin would be infringed upon if Ranbaxy Laboratories Ltd. sold its proposed generic version in Norway. The court also ruled that a patent protecting the process for converting crystalline atorvastatin to amorphous atorvastatin "is valid but not infringed by Ranbaxy in Norway." Pfizer stated that it "will continue to vigorously defend its intellectual property rights against infringement anywhere around the globe." A ruling on similar cases in the United States is expected by the end of the year. branding Research Picoplatin granted orphan drug status for small cell lung cancer NeoRx Corp.'s picoplatin received an orphan drug designation from the Food and Drug Administration for the treatment of small cell lung cancer. Picoplatin--an intravenous, next-generation, platinum chemotherapy--is designed to overcome platinum resistance in patients who do not respond to or relapse within a short time after chemotherapy. Tests that included more than 500 patients indicated that the drug could be less toxic than currently available platinum-based therapies. Picoplatin is being evaluated in a randomized, open-label Phase II trial in patients who have platinum-resistant or -refractory small cell lung cancer. Clinical trials in Europe are expected to begin in the first quarter of next year. branding Research FDA approves IV administration of Oncaspar in pediatric oncology Enzon Pharmaceuticals Inc. said the Food and Drug Administration approved a labeling change for its pediatric oncology drug, Oncaspar (pegaspargase). The new labeling allows the drug, which is a version of the naturally occurring enzyme L-asparaginase, to be administered intravenously. Previously, Oncaspar could only be delivered via an injection directly into the muscle, which Enzon noted is often painful. Oncaspar is indicated to treat acute lymphoblastic leukemia in patients who require L-asparaginase as part of their treatment regimen, but who have developed hypersensitivity to native forms of the enzyme. Enzon said it implemented the company's PEGylation technology in developing Oncaspar to give the drug therapeutic advantages over unmodified L-asparaginase, such as reduced immunogenicity and a more convenient dosing regimen. Oncaspar can be administered once every 14 days, according to Enzon, whereas regular L-asparaginase is typically administered twice a week. branding Research Biogen Idec's psoriasis treatment contraindicated in patients with HIV Biogen Idec Inc. and the Food and Drug Administration informed health care providers of a change to the contraindications section of the prescribing information for Amevive (alefacept). The drug, which is indicated to treat moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, is now contraindicated in patients with HIV. "This decision is based on the pathophysiology of HIV and the effect of Amevive on T lymphocytes," Biogen Idec said in a letter to health care providers. "This contraindication is consistent with the company decision not to study Amevive in HIV-positive psoriatic patients due to the theoretical safety concern in this patient population." The contraindication states that since Amevive reduces CD4+ T lymphocyte counts, it may accelerate the progression of, or increase the complications of, HIV. Biogen Idec said that any serious adverse events "suspected to be associated with" the use of the drug should be reported to the company or to the FDA's MedWatch Reporting System. branding Research Sexual functioning worsened with Effexor XR as compared with Wellbutrin XL When compared with GlaxoSmithKline Plc's Wellbutrin XL (bupropion hydrochloride) extended-release tablets, Wyeth's Effexor XR (venlafaxine hydrochloride) extended-release tablets led to a worsening of sexual functioning in patients with major depressive disorder in a 12-week study. Results from the head-to-head, randomized trial were presented in Las Vegas at the annual meeting of the U.S. Psychiatric and Mental Health Congress. A total of 342 patients with moderate to severe major depressive disorder received escalating doses of Wellbutrin XL (150 mg/day to 450 mg/d) or Effexor XR (75 mg/d to 225 mg/d). Researchers compared the two drugs with regard to efficacy, safety and effect on sexual functioning. The vector of average change in total scores on the Changes in Sexual Functioning Questionnaire across weeks five, six, nine and 12 indicated overall sexual functioning, using a mixed-model, repeated-measures technique. Although depressive symptoms improved, there was a statistically significant worsening in sexual functioning from baseline in the Effexor XR-treated patients as compared with the Wellbutrin XL-treated patients. Wellbutrin XL did not appear to influence sexual function. The researchers found that Effexor XR resulted in a negative effect on multiple domains of sexual functioning--such as desire/interest, desire/frequency and orgasm--as compared with Wellbutrin XL. "People taking antidepressants are often reluctant to discuss sexual side effects with their doctor, and many believe that all treatments are the same," said Dr. Anita Clayton, who led the study and works at the University of Virginia. "This trial provides comparative data on which to base treatment decisions for those patients who express concerns about or experience sexual side effects." branding Research Treatment with Adderall XR leads to significant long-term ADHD symptom control among adults, new study finds Adult patients with attention-deficit/hyperactivity disorder who were treated with Shire Pharmaceuticals Group Plc's once-daily Adderall XR (mixed salts of a single-entity amphetamine product) demonstrated significant long-term ADHD symptom control, researchers reported in Las Vegas at the annual meeting of the U.S. Psychiatric and Mental Health Congress. A total of 255 adult patients were included in an initial four-week, double-blind, placebo-controlled, parallel-group, forced-dose-escalation study of Adderall XR. Subsequently, 221 of these patients entered into a 24-month, open-label extension study. A research team led by Harvard Medical School investigators measured patients' symptoms using a validated ADHD Rating Scale (ADHD-RS). According to the findings, patients treated with Adderall XR maintained a significant average reduction in their ADHD symptoms, as measured by a change from baseline in mean ADHD-RS total scores (-7.2). Data revealed that patients who received Adderall XR for the first time as part of the open-label extension study demonstrated the most improvement (-11.6; n=56) after 24 months compared with those who continuously received Adderall XR treatment (-5.7; n=144) and those whose treatment was interrupted between the initial study and the open-label extension study (-6.0; n=21). Overall, the study drug exhibited a good tolerability profile during the trial at all doses. Most adverse events were reported in the first month of the trial and diminished as the study continued. Dry mouth, insomnia, loss of appetite, headache and nervousness were among the most frequently reported drug-related adverse events. "This study shows that this treatment can control the core symptoms of ADHD for longer periods of time," said lead investigator Dr. Joseph Biederman in a statement issued by Shire. Last month, Shire filed a lawsuit in the U.S. District Court of the Southern District of New York against Barr Laboratories Inc. and Impax Laboratories Inc., citing patent infringement and seeking to prevent the two companies from gaining FDA approval to market generic versions of Adderall XR in various doses. branding Research branding Research The Food and Drug Administration The Food and Drug Administration's Oncologic Drugs Advisory Committee recently said that the term "accelerated approval" should be renamed "conditional approval," FDAAdvisoryCommittee.com reported. The committee met to review incomplete accelerated approval commitments for drugs that were granted approval before 2002. According to FDAAdvisoryCommittee.com, the University of Southern California's Silvana Martino, who chaired the committee, said that changing the term could "give the regulation more 'bite' if sponsors fail to complete trials in a timely fashion or demonstrate benefit." The report also noted that the FDA has never withdrawn a product that received accelerated approval. branding Research branding Research sanofi pasteur Sanofi pasteur and Aphton Corp. agreed to immediately terminate their co-promotion and licensing agreement related to Aphton's anti-gastrin vaccine, Insegia (G17DT immunogen). In 1997, the companies signed an agreement whereby Aphton would be responsible for developing the immunotherapy for all human cancer applications, while sanofi pasteur would promote and distribute the product in North America and Europe. Aphton said it is now in a better position to find a new corporate partner to further develop the vaccine. branding Research branding Research Guidant Corp. Guidant Corp. released a report about the lifetime of its cardiac devices after months of safety warnings and a stalled merger with Johnson & Johnson. According to The Wall Street Journal, data from the report show that failure of lead wires is much more common than failure of the defibrillators themselves. The report also disclosed that one lead-wire defibrillator had 109 failures and another model had 70 failures, but that most Guidant defibrillators experienced fewer than five device failures during their lifetimes. branding Research branding Research King Pharmaceuticals Inc. King Pharmaceuticals Inc. entered into an alliance with Pain Therapeutics Inc. for the development and commercialization of Remoxy, which is a long-acting formulation of oxycodone, and other abuse-resistant opioid painkillers. Remoxy is intended to treat moderate to severe chronic pain and has a sticky, highly viscous mass designed to resist injection or snorting. King is responsible for all research and development expenses, which could total $100 million; Pain Therapeutics will receive an up-front payment of $150 million plus up to $150 million based on successful clinical and regulatory development of the abuse-resistant pain products. branding Research


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