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			Internet Poll 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 Genzyme's Myozyme receives FDA approval as treatment for Pompe disease The Food and Drug Administration approved Genzyme Corp.'s Myozyme (alglucosidase alfa), a treatment for Pompe disease. Myozyme is the first drug ever approved to treat Pompe disease and the first drug approved to treat an inherited muscle disorder, the company said. In clinical studies, patients with infantile-onset Pompe disease who were treated with Myozyme experienced an improved ventilator-free survival as compared with an untreated historical control. Myozyme has not been adequately studied for safety and efficacy as a treatment for other forms of the disease. Genzyme recently completed enrollment of a 90-patient trial involving patients with late-onset Pompe disease. The FDA granted Myozyme orphan drug designation, providing Genzyme with seven years of market exclusivity. The company plans to launch the drug in the United States within two weeks. Myozyme was approved in the European Union in March. Pompe disease is a genetic disease caused by a deficiency or malfunction of specific enzymes within the cell lysosomes. Eventually, the lysosome can become so blocked with glycogen that cells no longer function normally and muscle function is impaired. It is a debilitating, progressive and often fatal disorder that affects less than 10,000 people worldwide. Internet Poll Biomira releases final survival data from Phase IIb trial of Stimuvax in NSCLC Biomira Inc. released final survival results from an exploratory analysis of its Phase IIb trial of Stimuvax, formerly known as BLP25 liposome vaccine, in patients with stage IIIb and stage IV non-small cell lung cancer. The open-label study involved 171 patients with stable NSCLC or whose disease had responded to treatment after they finished first-line standard chemotherapy. Patients were randomized to Stimuvax plus best supportive care (which included palliative radiation therapy and/or second-line chemotherapy) or best supportive care alone. The analysis confirmed that patients with stage IIIb NSCLC had a median survival of 30.6 months if they were treated with Stimuvax and 13.3 months if they were in the control group. "Our enthusiasm around Stimuvax continues," said Dr. Alex McPherson, chief executive officer of Biomira. "These data from the Phase IIb trial are encouraging and have been reviewed by an independent statistician, who confirms our findings." McPherson added that Biomira is currently transitioning Stimuvax to Merck KGaA, the firm's development partner for the vaccine, and has started manufacturing the product for a Phase III trial that is scheduled to begin in the summer. The firm originally planned to begin a Phase III trial last year, but in September 2005 it identified problems with how the product held up under normal storage conditions. "We are hopeful that this larger randomized trial will confirm the results seen in the Phase IIb trial," McPherson said. Biomira shares closed at $1.40, up $0.16, or 12.9 percent, in heavy trading on the Nasdaq. Internet Poll Alfacell's investigational tumor drug may extend survival, interim results show Alfacell Corp.'s Onconase (ranpirnase) appears to extend median survival in patients with unresectable malignant mesothelioma (UMM), an interim analysis of the data reveal. Onconase is designed to inhibit protein synthesis, stop cell cycle proliferation and induce programmed cell death. UMM is a tumor of the thin lining on the surface of the body cavities and the organs that are contained within them. The first interim analysis is based on one third of the study's required events (105 events of 143 patients). The objective of the study is to evaluate the efficacy, safety and tolerability of the combination of Onconase and the chemotherapy drug doxorubicin hydrochloride compared with doxorubicin alone. The primary endpoint of the trial is overall survival. Results showed that patients treated with the combination therapy experienced an overall median survival time of 12 months compared with 10 months in the doxorubicin-alone group. Additionally, the interim analysis showed that 47 percent of the combination-treated patients were alive at one year compared with 36 percent of the patients treated with doxorubicin alone. Of the patients with evidence of tumor regression or stabilization, those who received the combination treatment had a median survival time of 17 months compared with 10 months in the doxorubicin arm. Researchers also observed a two-month increase in median survival in the treatment target group analysis (n=104) of a completed Phase III study, in which Onconase monotherapy-treated patients experienced an 11.6 month median survival compared with a 9.6 month survival in the doxorubicin group. The firm added that 210 events (deaths) have been documented, representing two-thirds of the required events for the study. Alfacell noted that upon reaching two thirds of the required events, the company has the option to conduct a second interim analysis of the data at any point. The first interim analysis was not designed to support filing for approval with the Food and Drug Administration since the interim analysis data included only one third of the required number of events, the company noted. In December 2002, the company received a fast track designation from the FDA for Onconase. Alfacell is also conducting a Phase I/II of Onconase as a treatment for non-small cell lung cancer. Internet Poll VA data indicate typical antipsychotics may be more dangerous than are atypical antipsychotics in certain patient group In contrast to prior evidence, a new study shows that typical--but not atypical--antipsychotics are associated with a higher adjusted mortality rate in veterans who were admitted to a hospital for pneumonia. Three Veterans Affairs databases provided information about 14,057 veterans who were admitted to a hospital for pneumonia in 2003. Patients' exposure to antipsychotics for at least 30 days within 120 days prior to admission was determined by Outpatient Pharmacy files. Of the admitted patients, 1,036 died before discharge. Nearly half (47.5 percent) of the cohort had been exposed to neuropsychiatric drugs for at least 30 days: the rates of exposure were 2.4 percent for typical antipsychotics, 8.8 percent for atypical antipsychotics, 8.5 percent for tricyclic antidepressants, 32.6 percent for other antidepressants and 18 percent for mood stabilizers. When compared with the patients who were discharged alive, those who died in the hospital had a significantly higher rate of typical antipsychotic use (2.3 percent vs. 3.7 percent, respectively) and a significantly lower rate of using mood stabilizers (18.3 percent vs. 15.3 percent). Results of a logistic regression analysis that controlled for demographic factors, comorbidity, mental health diagnoses and in-hospital clustering showed that the veterans who had taken typical antipsychotics still showed a 51 percent greater risk of dying in the hospital relative to the patients who did not receive neuropsychiatric drugs. The rate of in-hospital death was not significantly higher or lower in the patients who took atypical antipsychotics, tricyclic antidepressants, other antidepressants or mood stabilizers. These results contradict recent literature, which has suggested that prescribing atypical antipsychotics to older patients may lead to increased mortality due especially to cardiovascular and infectious events. "This is clinically significant, as the recent warnings against the use of atypical antipsychotics in geriatric patients may cause some clinicians to abandon the use of atypical antipsychotics in favor of potentially more dangerous typical antipsychotics," the study authors concluded. "Regardless, the findings should support the recommendation that antipsychotic drugs should be used only when there is an identifiable risk of harm to the patient or others, when the distress caused by the symptoms is significant or when alternate therapies have failed and symptom relief would be beneficial," they added. The complete study was published in the April issue of the Journal of Clinical Psychopharmacology. Internet Poll Novo Nordisk posts lower Q1 profit, receives not approvable letter for NovoLog Mix 30/70, 50/50 Novo Nordisk A/S posted decreased first-quarter net profit, but its sales increased from the previous year's same period. In the first quarter of 2006, the firm earned approximately $203.3 million, or $0.62 per diluted share, compared with 2005's first quarter when it earned approximately $206.8 million, or $0.62 per diluted share. Sales for the quarter were approximately $1.5 billion in 2006, up from approximately $1.22 billion in 2005. The firm's sales were led by its diabetes segment, which posted first-quarter sales of approximately $1.09 billion. The growth was particularly driven by sales of human insulin, the company said. For the full year, Novo Nordisk expects sales growth of 11 percent to 13 percent. The firm said this growth will be supported by the recent U.S. launch of Levemir (insulin detemir), a long-acting basal human insulin analog approved to treat diabetes. Novo Nordisk also said it received a not approvable letter for NovoLog Mix 30/70 (30% insulin aspart protamine suspension/70% insulin aspart injection, [rDNA origin]) and NovoLog Mix 50/50 (50% insulin aspart protamine suspension/50% insulin aspart injection, [rDNA origin]). The firm filed for approval of the insulin analogs in June 2005, but the Food and Drug Administration has requested more information and asked that "certain clinical issues" be resolved. Novo Nordisk shares closed at $64.35, down $0.50, or 0.8 percent, in heavy trading on the New York Stock Exchange. Internet Poll Majority of FDA advisory committee meetings include members with conflicts of interest, but study shows excluding such members would not change outcomes A study that examined conflict of interest disclosures at Food and Drug Administration advisory committee meetings revealed that such disclosures are common but rarely result in recusal of the members who have the conflict of interest. The objective of the cross-sectional study was to assess financial conflict disclosures at drug-related FDA committee meetings and to evaluate the relationship between the conflicts and voting behavior at meetings in which specific products were considered. In their analysis, researchers used agendas and transcripts from 221 FDA meetings conducted by 16 advisory committees from Jan. 1, 2001, to Dec. 31, 2004. They noted that the data they used were limited to self-reported conflicts and thus, the actual conflict rates could be higher. Results showed that in 73 percent of the meetings, at least one advisory committee member or voting consultant disclosed a conflict, with consulting arrangements, contracts or grants and investments being the most common types of conflict. Only 1 percent of advisory committee members who disclosed a conflict of interest were recused. The researchers further observed that a draft guidance issued by the FDA in January 2002 outlining conflict of interest disclosure policies "has had little impact on rates of recusal, restriction or disclosed conflict." title="branding company" A meeting-level analysis did not show a statistically significant relationship between conflict rates and voting patterns. However, a relative risk analysis revealed a slight but statistically significant positive correlation showing that committee members who had a conflict with a competing pharmaceutical company or those who had a conflict with either the sponsor or a competitor were more likely to vote for the drug being discussed at the meeting. "A weak relationship between certain types of conflicts and voting behaviors was detected, but excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting studied," title="branding company" the researchers concluded. "Ideally, all panels of scientific experts advising a federal decision-making body would be free of financial conflict of interest with the affected companies," they added. These data were published in the April 26 issue of JAMA. Internet Poll Internet Poll Biogen Idec Inc. Biogen Idec Inc. and Elan Corp. Plc said the European Union's Committee for Medicinal Products for Human Use issued a positive opinion to recommend marketing authorization for Tysabri (natalizumab), which was pulled from the U.S. market last year, in the treatment of relapsing-remitting multiple sclerosis. The committee recommended that the drug, which a U.S. advisory committee recently recommended be reintroduced to the market, be used as single disease-modifying therapy in patients with highly active relapsing-remitting MS who have not responded to beta-interferon treatment or in patients with a rapidly evolving severe form of the disease. Internet Poll Internet Poll Johnson & Johnson Pharmaceutical Research & Development LLC Johnson & Johnson Pharmaceutical Research & Development LLC and Ortho-McNeil Pharmaceutical Inc. plan to begin Phase III trials of tapentadol in the third quarter. The drug is a centrally acting analgesic being studied as a treatment for moderate to severe acute pain. Initiating the trials will trigger a milestone payment to Grunenthal GmbH, with whom J&JPRD is co-developing the drug. "If successfully developed, tapentadol would be the first new molecular entity to enter medical practice in the oral opioid category in over 25 years," J&JPRD said. Internet Poll Internet Poll Astellas Pharma Inc. Astellas Pharma Inc. and FibroGen Inc. entered into a licensing agreement for FibroGen's investigational oral anemia drugs, FG-2216 and FG-4592, and other similar compounds. Under the agreement, which pertains to the exclusive development and marketing of the compounds in Europe, the Middle East, South Africa and the Commonwealth of Independent States, Astellas will pay $300 million to FibroGen up front. Astellas will make milestone payments of up to $465 million and will also share in development costs for the products. Additionally, Astellas will invest $50 million in newly issued shares of FibroGen. Internet Poll Internet Poll Acuity Pharmaceuticals Inc. Acuity Pharmaceuticals Inc. and ZaBeCor Pharmaceutical Co. entered into a license option agreement for ZaBeCor's lead drug candidate, Excellair. Under the agreement, Acuity will be granted exclusive rights for ophthalmologic uses of Excellair, an anti-inflammatory, small interfering RNA. The product, which works by silencing Syk kinase, has shown promising preclinical activity in treating asthma and other inflammatory disorders, ZaBeCor said. Internet Poll


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