Research Panels - Brand Institute, inc.



			Research Panels 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 ROCHE TO DISCONTINUE HIV DRUG FORTOVASE IN EARLY 2006 ------------------------------------------------------------------------------- F. Hoffmann-La Roche Ltd. will stop selling its HIV drug Fortovase (saquinavir) in early 2006 due to a pronounced decline in demand for the drug, Dow Jones Newswires reported. Roche attributed the drop in demand to competition from its new formulation of saquinavir, Invirase (saquinavir mesylate), which is available in 200 mg capsules and 500 mg tablets. The company noted that the withdrawal of product from its line is not due to safety or efficacy issues and that patients will have adequate time to transition to Invirase, Dow Jones said. When compared with Fortovase, the Invirase 500 mg tablet--which the Food and Drug Administration approved in December 2004--allows for lower pill burden, improved gastrointestinal tolerability, smaller size and no need for refrigeration, Roche added. Invirase, an HIV protease inhibitor, must be taken in combination with Abbott Laboratories' Norvir (ritonavir). The FDA first approved Invirase in 1995. In 2003, Invirase was approved to be taken in 1,000 mg dosing regimens, split up twice throughout the day, along with 100 mg of Norvir. -=- PATIENTS WITH CROHN'S DISEASE RESPOND TO HUMIRA TREATMENT IN PHASE III TRIAL ------------------------------------------------------------------------------- Patients with moderate to severely active Crohn's disease who received treatment with Abbott Laboratories' Humira (adalimumab) showed continuous improvement in clinical response and clinical remission in a Phase III trial, according to data presented at the Digestive Disease Week annual meeting in Chicago. Included in the trial were 220 patients who had participated in an earlier Humira trial but who were not in remission at week zero and week four of the new study. In the new open-label study, patients were given a standard dose of Humira 40 mg every other week. Individuals who experienced flare-ups or persistent non-response to the standard dose were given Humira 40 mg every week. Thirty-three percent of the patients achieved clinical remission. Of the 156 who completed 24 weeks of therapy, 78 percent saw an improvement in their disease. Results of another Humira study in Crohn's disease patients are expected by the end of the year, according to Dow Jones Newswires. Abbott said next year it plans to file for Food and Drug Administration approval of Humira for the treatment of Crohn's disease, Dow Jones added. Humira is currently approved for the treatment of rheumatoid arthritis and is being investigated in several other diseases. -=- STUDY SHOWS NOVARTIS' BLOOD PRESSURE DRUG DIOVAN MAY REDUCE RISK OF DIABETES ------------------------------------------------------------------------------- Results of a randomized trial of two hypertensive agents, Novartis AG's Diovan (valsartan) and amlodipine besylate, show that Diovan appears to reduce the risk of diabetes more than amlodipine. The research was presented at the American Society of Hypertension's annual meeting in San Francisco by Dr. Ken Jamerson, a professor of internal medicine at the University of Michigan. The Valsartan Antihypertensive Long-Term Use Evaluation (VALUE) trial involved 15,313 patients in 942 sites in 31 countries. Of the total patients--all of whom were aged more than 50 years, had high blood pressure and were at high risk for having a cardiac event--9,995 did not have diabetes at the start of the trial. According to the results, patients taking Diovan had a 23 percent lower risk of developing diabetes. After four or more years of follow-up, 11.5 percent of patients receiving Diovan developed diabetes compared with 14.5 percent of patients taking amlodipine. According to a University of Michigan press release, the difference in diabetes onset risk seems to be attributable to Diovan and not to other underlying risk factors. In fact, the more risk factors a patient had, the greater the protective effect of the drug, the press release said. "These new results should help physicians as they select anti-hypertensive agents for their patients, especially for those at higher risk of developing diabetes," said Jamerson. "Since we know from other studies that other hypertension medications such as diuretics come with a higher risk of diabetes, this result is especially interesting." The researchers noted that prevention of diabetes was not the goal of the VALUE study and added that more research is needed to confirm the findings. -=- IN UTERO EXPOSURE TO CERTAIN ANTIDEPRESSANTS DURING LAST TRIMESTER OF PREGNANCY MAY RESULT IN A NEONATAL BEHAVIORAL SYNDROME, RESEARCH SUGGESTS ------------------------------------------------------------------------------- Researchers found that in utero exposure to certain antidepressant drugs during the last trimester of pregnancy may result in a self-limited neonatal behavioral syndrome that is manageable through supportive care. The study, which was published in the May 18 edition of JAMA, included a review of all articles from MEDLINE and PsycINFO that were related to neonatal signs after in utero serotonin reuptake inhibitor (SRI) exposure. Investigators also examined unpublished data relating to this topic from a June 2004 Food and Drug Administration advisory committee meeting. A total of 13 case reports, describing 18 cases, and nine cohort studies were included. Researchers found that infants born to women who took SRIs during the last trimester of pregnancy were three times as likely to develop a neonatal behavioral syndrome than infants born to women who either did not take SRIs or ceased taking them early on during their pregnancy. Most cases involved exposure to fluoxetine and paroxetine, which are sold as generic drugs and as Eli Lilly and Co.'s Prozac (fluoxetine hydrochloride) and Sarafem (fluoxetine hydrochloride) and GlaxoSmithKline Plc's Paxil (paroxetine hydrochloride). According to the study authors, SRI-exposed newborns primarily display central nervous system, motor, respiratory and gastrointestinal symptoms that are typically mild and disappear within two weeks. In some cases, such infants show "severe signs of toxicity" that require more aggressive treatment, including anticonvulsant therapy, fluid replacement and respiratory support, the authors added. More than 80,000 U.S. women take SRIs during pregnancy, the researchers estimated, according to The Associated Press. Dr. Eydie Moses-Kolko, the study's lead author, said that serious respiratory problems occur in "perhaps" one out of 100 infants born to these women. She added that this study is not cause for alarm but that patients and physicians should be aware of potential risks, the AP stated. Though the FDA and drug firms recently agreed to add label information about potential adverse events in infants exposed to SRIs in utero, the study authors stated, "It is important to include the well-documented health risks of depression during pregnancy in the risk-benefit decision-making process, and appropriate treatment of the depression must be a primary consideration." -=- INEX'S MARQIBO SHOWS ANTI-TUMOR ACTIVITY IN DIFFERENT TRIALS ------------------------------------------------------------------------------- Results from several clinical studies demonstrate that Inex Pharmaceutical Corp.'s Marqibo (vincristine sulfate liposomes injection) shows anti-tumor activity in patients with relapsed non-Hodgkin's lymphoma (NHL), Hodgkin's disease and pediatric malignancies. The studies were presented at the American Society of Clinical Oncology's annual meeting in Orlando, Fla. and at the American Society of Pediatric Hematology/Oncology's (ASPHO) annual meeting in Washington, D.C. At ASCO, combined results from two separate clinical trials evaluating Marqibo as a single-agent treatment for patients with relapsed aggressive NHL were presented. One study was a Phase IIa clinical trial conducted at the University of Texas' M.D. Anderson Cancer Center, while the other study was a multicenter Phase IIb trial. The combined number of patients treated was 211. Their median age was 62 years and they had received a median of three previous treatment regimens. The researchers found an overall response rate of 28 percent, of which 7 percent were complete responses. The overall median survival was approximately 8.5 months, with a time to progression of approximately four months. In another poster at ASCO, data was presented from a Phase II study of Marqibo as a single-agent treatment for patients with relapsed or refractory Hodgkin's disease. The results for 29 patients with a median age of 34 years and a median of four previous treatments were reported. Of these patients, 28 were evaluable for response and had an overall response rate of 36 percent. The researchers reported that Marqibo was well tolerated with mostly mild to moderate toxicities. In a poster at ASPHO, data was presented from a Phase II trial of Marqibo as a single-agent treatment in pediatric patients who had relapsed after standard therapy. The trial included 30 pediatric patients with a variety of malignancies. The data showed that Marqibo was well tolerated and could be used for prolonged periods of time. The drug showed "promising activity in pretreated patients with soft tissue sarcomas," Inex said. Marqibo is a formulation of the generic drug vincristine encapsulated in Inex's sphingosomal drug delivery technology, which is designed to provide prolonged blood circulation, tumor accumulation and extended drug release at the cancer site. "The data presented from these clinical studies continue to demonstrate the activity of Marqibo in a variety of different cancers. Our current focus for Marqibo is finalizing the design of Phase III clinical trials in non-Hodgkin's lymphoma and acute lymphoblastic leukemia in order to file Special Protocol Assessments with the United States Food and Drug Administration as well as continue our discussions with potential development and commercialization partners," said David Main, chief executive officer of Inex. -=- NEUROGESX'S NGX-4010 MAY SIGNIFICANTLY REDUCE HIV-ASSOCIATED SENSORY NEUROPATHY, STUDY REVEALS ------------------------------------------------------------------------------- NeurogesX Inc. reported that its investigational trans-capsaicin dermal patch, NGX-4010, was shown to significantly reduced HIV-associated sensory neuropathy (HIV-AN) in a late-stage study. The multicenter, randomized, double-blind, controlled Phase III study, which included 307 patients with HIV-AN, met its primary endpoint with patients reporting statistically significant pain reduction over a 12-week period after a single application of NGX-4010. NeurogesX plans to begin a second pivotal Phase III trial of the product later this year. The Food and Drug Administration granted fast track status and an orphan drug designation for NGX-4010 as a treatment for HIV-AN, the company said. "This is a potential breakthrough," said Dr. David Simpson, professor of neurology at Mount Sinai School of Medicine in New York and the study's lead academic investigator. "There is a great need for an effective product that controls pain without introducing safety or drug interaction concerns, particularly for HIV patients who are already taking numerous medications to manage their primary disease. We anticipate presenting the full study findings in a scientific presentation and a manuscript later in the year." "We now anticipate our development plan to include filing a New Drug Application with data from our HIV-AN program as well as our postherpetic neuralgia program in mid-2007," said Anthony DiTonno, NeurogesX's chief executive officer. "Additionally, we expect to file an application for European marketing approval in the second half of 2006." According to NeurogesX, "NGX-4010 is a topical, physician administered patch containing a high concentration of trans-capsaicin, a synthetic form of the naturally occurring capsaicin and the ingredient that makes chili peppers hot." -=- Research Panels GLAXOSMITHKLINE PLC ------------------------------------------------------------------------------- GlaxoSmithKline Plc entered into an agreement with Morphotek Inc. "to apply Morphotek's proprietary Morphodoma technology to GSK's antibody producer lines to generate cell lines that exhibit new or improved biological characteristics," Morphotek said. Under the non-exclusive agreement, Morphotek will receive funding for the necessary research and development for an initial project to be performed for GSK, which will have the option of retaining Morphotek for two additional projects. Morphotek may also receive annual licensing fees and milestone payments based on the successful achievement of project goals and the clinical development of new products. GSK will be responsible for the development and commercialization of all products, Morphotek said, adding that GSK is the eighth sublicensee of its cell-line optimization technology platform. -=- Research Panels BAYER HEALTHCARE AG ------------------------------------------------------------------------------- Bayer HealthCare AG's Biological Products Division and Asklepios Biopharmaceutical Inc. entered into an early-stage research and collaboration agreement to evaluate gene therapy for the treatment of hemophilia B. If a feasibility study produces positive results, the collaboration could lead to a joint development and commercialization agreement. Asklepios is conducting preclinical testing of a synthetically designed biological nano particle containing the factor IX gene for the treatment of hemophilia B. Up to 400,000 people worldwide have hemophilia, including approximately 50,000 people in North America and Europe, the companies said. -=- Research Panels CELL GENESYS INC. ------------------------------------------------------------------------------- Cell Genesys Inc.'s second Phase III trial of its investigational GVAX vaccine for prostate cancer was granted a special protocol assessment (SPA) by the Food and Drug Administration. The trial will enroll approximately 600 symptomatic patients with cancer-related pain and will compare GVAX vaccine plus Aventis Pharmaceuticals Inc.'s Taxotere (docetaxel) with Taxotere plus prednisone. It is designed to show a 33 percent improvement in the duration of survival for the GVAX/Taxotere arm. An SPA was also granted for the company's first Phase III trial that began in July 2004. In total, Cell Genesys is planning to conduct two Phase III clinical trials of the vaccine in patients with hormone-refractory prostate cancer and radiologic evidence of metastatic disease. An SPA is a written agreement with the FDA stating that the design and analysis of the trial are sufficient to support a license application if the trial is carried out according to the SPA. -=- Research Panels PROTEZ PHARMACEUTICALS INC. ------------------------------------------------------------------------------- Protez Pharmaceuticals Inc. entered into an exclusive licensing agreement with Sumitomo Pharmaceuticals Co. Ltd. to develop and market SMP-601, Sumitomo's broad-spectrum beta-lactam antibiotic. Under the agreement, Protez will have exclusive rights to develop and market SMP-601 in North America and Europe, while Sumitomo maintains sole rights to manufacturing and will develop the injectable drug in Asia. According to Protez, the company will provide development and marketing milestones and royalties on sales, and both companies will share development data. Protez will be responsible for completing preclinical development and plans to begin clinical studies in 2006. -=- Research Panels


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