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			Visual Branding 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 GSK's Arranon recommended for accelerated approval GlaxoSmithKline Plc said the Food and Drug Administration's Oncologic Drugs Advisory Committee recommended accelerated approval of Arranon (nelarabine) injection, a chemotherapy agent. The company is seeking approval of Arranon for the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in pediatric and adult patients whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens. The committee voted 11-1 for accelerated approval in the pediatric population and unanimously voted for accelerated approval in the adult population, GSK said. The panel's discussion focused on two studies that included 28 adults and 39 children, Dow Jones Newswires reported. According to FDA documents released prior to the meeting, it is not clear whether the 18 percent complete response rate seen in the adult study and the 13 percent complete response rate seen in the pediatric study were due to Arranon or additional therapies. "Response duration evaluation is confounded by the fact that patients in [Arranon]-induced complete remission may have received additional therapy, including stem cell transplantation, prior to disease progression or recovery of normal peripheral blood cell counts," FDA staff wrote. As a result, the FDA staff said the drug would require further Phase IV studies even if the advisory panel recommended accelerated approval and the agency follows the recommendation. During the meeting, Dr. Richard Pazdur, the FDA's head of oncology drug products, said accelerated approval is a way for the agency to gauge if there is sufficient evidence that a drug might work in a larger patient population based on limited clinical data, Dow Jones said. "Does the drug have activity? Most rational people would say it at least deserves a chance," Pazdur told the panel, according to Dow Jones. In October 2003, Arranon was granted fast track status by the FDA for the treatment of patients with T-cell malignancies, including acute lymphoblastic leukemia and lymphoblastic lymphoma, and in August 2004, the drug received orphan drug designation from the agency. Visual Branding FDA panel recommends Revlimid approval Celgene Corp.'s Revlimid (lenalidomide) was recommended for approval by the Food and Drug Administration's Oncologic Drugs Advisory Committee in a 10-5 vote. A potential member of the new class of immunomodulatory drugs, Revlimid is intended to treat transfusion-dependent anemia that results from low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality. The recommendation was based primarily on the open-label, single arm, Phase II CC-5013-MDS-003 trial. Of 148 enrolled patients, 96 were considered evaluable. Data showed that approximately two-thirds of patients (63.5 percent) experienced a resolution in their chronic refractory anemia, leading to transfusion independence. This response, which lasted for a median 30 weeks, was linked to meaningful cytogenetic and bone marrow remission. Prior to the decision, FDA medical reviewers had worried whether a single-arm trial that did not compare the drug with placebo could warrant approval. But in a vote of 11-4, the committee members said the single-arm design could adequately characterize Revlimid's treatment effect. Most of the panel members who voted against recommending approval wanted to wait for data from a placebo-controlled, Phase III study that Celgene has started, Dow Jones Newswires reported. The reviewers also worried that 80 percent of these trial patients had dose reductions and/or delays and 80 percent experienced grade 3 or grade 4 adverse events, suggesting that the starting dose could have been inappropriately high for at least one-half of the patients. The committee voted 13-2 that data provided in the single-arm trial did not provide a basis for a recommended dose nor an adequate description of a safety profile. Thus, both the company and the regulatory agency said a restricted access program would be set up to help ensure that women who take the drug will not become pregnant, Dow Jones said. Women of childbearing age will have to submit a negative pregnancy test before beginning the therapy and subsequent negative tests to continue the drug. Revlimid is a new version of Celgene's Thalomid (thalidomide), which was once taken off the market after it was linked to birth defects. Visual Branding Bayer, Onyx's sorafenib NDA granted priority review status Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc. said the Food and Drug Administration granted priority review status to the New Drug Application for sorafenib for patients with advanced renal cell carcinoma. Completed in July, sorafenib's NDA submission was based on an ongoing Phase III trial, the largest randomized, placebo-controlled trial ever conducted in advanced renal cell cancer, the companies said. Results from this study were presented in May at the American Society of Clinical Oncology's annual meeting. "This, along with our recent European filing, put us ahead of schedule in our global regulatory strategy," said Wolfgang Plischke, president of Bayer HealthCare's global pharmaceutical division. In April, Bayer and Onyx suggested to trial investigators that sorafenib be offered to all patients enrolled in the trial after an analysis of interim data showed the drug met its primary endpoint of overall survival. The drug is currently available in the United States to sorafenib-naove patients with advanced renal cell carcinoma through a treatment protocol known as the Advanced Renal Cell Carcinoma Sorafenib study. Sorafenib was previously accepted into the FDA's Pilot 1 program for continuous marketing applications and granted an orphan drug designation. If approved, the drug could be on the market at the beginning of 2006 and could generate peak annual sales of approximately $614 million, Reuters said, adding that sorafenib is one of only two drugs from Bayer's research pipeline with "strong potential." Bayer plans to launch sorafenib to treat skin cancer in 2007 and to treat liver cancer in 2008, according to Reuters. Visual Branding Dendreon plans to seek approval for prostate cancer drug, Provenge Dendreon Corp. plans to submit a Biologics License Application to the Food and Drug Administration for its investigational immunotherapy, Provenge, for the treatment of advanced prostate cancer. The decision to seek approval for Provenge came after a pre-BLA meeting with the FDA where the company reviewed safety and efficacy data from two completed Phase III trials of Provenge involving patients with advanced prostate cancer. The company's discussion with the FDA determined that the survival benefit observed in one Phase III study in combination with supportive data obtained from another Phase III study, along with the absence of significant toxicity in both studies, is sufficient to support the clinical basis of a BLA submission. "We look forward to working closely with the FDA to bring what could be the first cancer immunotherapy agent to market for the many men with advanced prostate cancer who have few appealing treatment options," said Dr. Mitchell Gold, Dendreon's chief executive officer. A final three-year follow-up from the first Phase III study of Provenge in 127 men with asymptomatic, metastatic, androgen-independent prostate cancer demonstrated an improvement in median survival rates of more than four months and a three-fold improvement in survival at 36 months in patients who received Provenge compared with placebo. The results implied "that patients who received placebo have a 70 percent greater relative risk of dying than patients who received Provenge," Dendreon said. Final three-year follow-up from the second Phase III study of Provenge, involving 98 men with asymptomatic, metastatic, androgen-independent prostate cancer, showed a 20 percent improvement in median survival for patients who received Provenge compared with placebo. Also, the percentage of patients living at the time of follow-up in the Provenge-treated group was substantially greater than the percentage of patients living who received placebo. Dendreon shares closed at $7.02, up $0.79, or 12.7 percent, in heavy trading on the Nasdaq. Visual Branding Medicure releases positive Phase II data for investigational coexisting diabetes, hypertension treatment Medicure Inc. said its investigational treatment for coexisting diabetes and hypertension, MC-4232, met its primary blood pressure and metabolic endpoints in the Phase II MATCHED study. MC-4232 is a combination of Medicure investigational drug MC-1 and ACE inhibitor lisinopril. The randomized, parallel group, cross-over, double-blind, placebo-controlled study, which included 120 patients with coexisting type 2 diabetes and hypertension, compared 100 mg, 300 mg, 1000 mg of MC-1 or placebo alone and in combination with 20 mg of lisinopril. Results indicated the 300 mg/20 mg dose of MC-4232 had a statistically significant reduction of 12.0 mm Hg from baseline over eight weeks on the primary endpoint of mean daytime ambulatory systolic blood pressure (MDASBP). In comparison, the MDASBP of patients who received lisinopril alone fell by 7.5 mm Hg. In addition, the 300 mg/20 mg dose had a statistically significant reduction of 1.45 mmol/L versus placebo on the primary endpoint of fasting serum glucose. In patients with hemoglobin (Hb) A1C greater than the prespecified level of 8 percent, the same MC-4232 dose had an absolute HbA1C reduction of 0.63 percent compared with placebo, exceeding regulatory requirements in HbA1C reduction for diabetes drugs, Medicure said. Furthermore, the 300 mg/20 mg dose provided a statistically significant reduction of triglyceride levels versus baseline in patients with elevated triglycerides. The study also found that the 300 mg/20 mg and 1000 mg/20 mg doses had comparable clinical efficacy on all key metabolic and blood pressure endpoints; MC-4232 was safe and well tolerated at all dose levels, Medicure noted. "The MATCHED trial has exceeded our expectations, demonstrating the clinical benefits of MC-4232," said Albert Friesen, Medicure's chief executive officer. "We believe the evidence presents a unique development opportunity, advancing a novel product with combined blood pressure and multiple metabolic benefits for a patient population in desperate need for improved treatment in both areas. "We are now advancing MC-4232 into Phase III pivotal studies and these results set the stage for the development of other cardiovascular combination products," Friesen added. Medicure shares closed at $0.95, up $0.18, or 23 percent, in heavy trading on the American Stock Exchange. Visual Branding Herceptin added to chemotherapy reduces disease recurrence, improves disease-free survival in certain patients with early-stage breast cancer, interim data show An interim analysis revealed that Genentech Inc.'s Herceptin (trastuzumab) plus chemotherapy significantly reduced the risk of disease recurrence after surgery in women who have early-stage, human epidermal growth factor receptor 2-positive breast cancer. The trial, conducted by the Breast Cancer International Research Group, involved 3,222 patients who had undergone surgery. They were then randomized to receive three treatment regimens: doxorubicin and cyclophosphamide followed by Herceptin and sanofi-aventis Group's Taxotere (docetaxel; experimental arm), doxorubicin and cyclophosphamide followed by just Taxotere (control arm), or Taxotere and carboplatin plus Herceptin (TCH experimental arm). The interim analysis was conducted after approximately one-third of the necessary number of relapses occurred. The risk of disease recurrence dropped 51 percent in the experimental group and 39 percent in the TCH arm. These statistically significant reductions crossed the predefined boundary of efficacy. Moreover, adding Herceptin to the chemotherapies improved disease-free survival when compared with chemotherapy alone. Although the rate of clinically significant cardiac events, including congestive heart failure, was 1.2 percent in both the TCH and control arms and 2.3 percent in the experimental group, the independent data monitoring committee deemed the incidence of cardiac safety in the Herceptin plus chemotherapy arm to be acceptable. "Based on the strength of the data from the two U.S. adjuvant studies presented at this year's American Society of Clinical Oncology meeting, we continue to anticipate filing a supplemental Biologics License Application for Herceptin in the adjuvant setting based on data from the U.S. studies in the first quarter of 2006," said Dr. Susan Desmond-Hellmann, Genentech's president of product development. Further data, including differences in efficacy between the two Herceptin arms and overall survival, will be available later. Herceptin, which is already approved for treating metastatic breast cancer in specific patient groups, is marketed in the United States by Genentech, internationally by F. Hoffmann-La Roche Ltd. and in Japan by Chugai Pharmaceutical Co. Ltd. Visual Branding Visual Branding Barr Laboratories Inc. Barr Laboratories Inc., Teva Pharmaceuticals Industries Ltd., Par Pharmaceuticals Cos. Inc. and Apotex Corp. received approval from the Food and Drug Administration for generic versions of Aventis Pharmaceuticals Inc.'s rheumatoid arthritis treatment, Arava (leflunomide), which has approximate annual U.S. sales of $228 million. The companies' Abbreviated New Drug Applications were approved to manufacture and market leflunomide tablets, 10 mg and 20 mg strengths. All companies plan to begin shipment of the drug immediately. Visual Branding Visual Branding Genzyme Corp. Genzyme Corp. and Cyclacel Group Plc entered into an evaluation and option agreement in the area of renal diseases involving Cyclacel's preclinical stage cyclin-dependent kinase (CDK) inhibitor molecules. According to the agreement, Genzyme received the exclusive option to license two preclinical stage CDK inhibitors for additional development in renal diseases and unspecified related conditions. During the option period, the companies may pursue a collaboration and license agreement with the intent of developing and commercializing Cyclacel compounds. Financial terms of the agreement were not disclosed. Visual Branding Visual Branding ImClone Systems Inc. ImClone Systems Inc. and Bristol-Myers Squibb Co. advised health care providers of changes to the prescribing information for cancer drug Erbitux (cetuximab). The warnings section now states that a one-hour observation period is recommended following Erbitux infusion; the section also notes that longer observation periods may be required for those who have infusion reactions. Furthermore, the precautions section now states that patients should be periodically monitored for hypomagnesemia and accompanying hypocalcemia and hypokalemia, during and following the completion of Erbitux therapy. Lastly, the adverse reactions section now highlights the risk of, and need to monitor for, electrolyte depletion among patients receiving Erbitux. Visual Branding Visual Branding Gtx Inc. Gtx Inc. received a response letter from the Division of Oncology Drug Products of the Food and Drug Administration regarding Gtx's special protocol assessment about the design of its pivotal Phase III trial of Acapodene (toremifene citrate) for the prevention of prostate cancer in high-risk men. The company plans to implement the FDA's recommendations under the SPA, which they believe are adequate to support the submission of the effectiveness portion of a New Drug Application. Visual Branding Visual Branding DVC LLC DVC LLC, a Computer Sciences Corp. company, received fast track status for three biodefense vaccine development programs it is working on for the Department of Defense Joint Vaccine Acquisition Program Product Management Office. DVC's programs that received fast track status include a program to develop recombinant vaccines for plague and botulinum neurotoxin serotypes A and B and a program to develop a live, attenuated vaccine for Venezuelan equine encephalitis. DVC is a biodefense company focused on the development and licensure of biological products. Visual Branding Visual Branding


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