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			Research Panel 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 CEPHALON, LUNDBECK DISCONTINUE PARKINSON'S DISEASE DRUG TRIAL ---------------------------------------------------------------------------- --- Cephalon Inc. and H. Lundbeck A/S discontinued a Phase II/III clinical trial of CEP-1347, an investigational treatment for Parkinson's disease. According to the companies, an independent data safety monitoring board conducted a planned review of the interim results and concluded that the trial data "are unlikely to provide evidence of significant effect." They added that there were no safety concerns with the drug. The Parkinson Study Group--a nonprofit group of health care providers experienced in caring for patients with Parkinson's disease--was conducting the study. "While we are disappointed with results of the trial, our collaboration with Lundbeck will continue as a valuable part of our ongoing research program in neurodegenerative disorders," said Dr. Jeffry Vaught, Cephalon's president of research and development. "We will continue to actively evaluate compounds for further clinical development with Lundbeck." -=- FDA GRANTS FAST TRACK STATUS TO DELCATH CHEMOTHERAPY DELIVERY SYSTEM; SHARES CLIMB ---------------------------------------------------------------------------- --- Delcath Systems Inc. said its investigational system designed to deliver high-doses of chemotherapy to targeted organs received fast track status from the Food and Drug Administration for treating metastatic melanoma in the liver with GlaxoSmithKline Plc's anticancer agent Alkeran (melphalan hydrochloride). According to Delcath, the agency's decision was based on results of an initial company-sponsored clinical trial conducted at the National Cancer Institute. Though the study was not designed to prove efficacy and lacked sufficient patients to make statistical claims, Delcath said it showed that some patients experienced reductions in the size of melanoma tumors in the liver. "Melanoma, metastatic to the liver, is a serious or life-threatening disease. New treatment methods that can induce disease remission will be an important addition to the current treatment armamentarium," the FDA stated in its letter to Delcath. Alkeran for injection is indicated for the palliative treatment of patients with multiple myeloma who cannot take oral therapy. Delcath shares closed at $3.74, up 0.94, or 33.6 percent, in heavy trading on the Nasdaq. -=- NDA FOR SCHERING AG'S CANCER DRUG BONEFOS DEPENDENT ON TRIAL RESULTS EXPECTED IN 2008 ---------------------------------------------------------------------------- --- Schering AG said Wednesday that the New Drug Application for its cancer drug Bonefos (clodronate) is dependent on trial results that are expected in 2008. According to Schering, the Food and Drug Administration said in a recent meeting with the company that it would not approve the drug until results of the ongoing National Surgical Adjuvant Breast and Bowel Project B-34 study are known. The study completed enrollment of 3,323 women with breast cancer in March 2004. The FDA issued an approvable letter for the drug in January. At the time, Schering said its U.S. affiliate, Berlex Inc., would request a meeting with the agency to determine what additional information would be required for approval. "Based on the broad clinical experience with Bonefos in many countries, and the fact that there is a significant unmet medical need, we remain hopeful about options to make Bonefos available as an adjuvant oral treatment for patients with breast cancer," said Carlo Montagner, head of Schering's global oncology business unit. "This is bad news. It was completely unclear what the outcome of the discussions with regulators would be, but this is a surprise," said Sal. Oppenheim analyst Marcus Konstanti, Reuters reported. "There was a chance this drug would have been on the market in 2006 or 2007, but now a launch before 2009 looks unlikely," Konstanti added. According to Reuters, analysts had predicted that Bonefos' peak annual sales could be up to approximately $1 billion. Bonefos--which is currently approved in 67 countries--is designed to reduce the occurrence of bone metastases in the post-surgical treatment of patients with breast cancer. Schering shares closed at $67.99, down $0.91, or 1.3 percent, in moderate trading on the New York Stock Exchange. -=- ARENA PHARMACEUTICALS' OBESITY DRUG SHOWS POSITIVE RESULTS IN PHASE II TRIAL ---------------------------------------------------------------------------- --- Results of Arena Pharmaceuticals Inc.'s Phase II trial of its orally administered obesity drug, APD356, showed patients receiving the higher dose of the drug had statistically significant weight loss compared with those receiving placebo. The drug is a selective agonist of receptors in the hypothalamus, a part of the brain that helps control food intake and metabolism, according to Arena. In the double-blind study, 352 obese patients were randomized to receive 1 mg APD356, 5 mg APD356, 15 mg APD356 or placebo. The average weight of patients was 223 pounds, and the average body mass index was 36. Patients were monitored for 28 days, during which time they were told to maintain their normal diets and activity levels, but to not drink alcohol. Only the 15 mg dose of the drug was associated with a statistically significant weight loss compared with placebo. Patients in the 15 mg group lost an average of 2.9 pounds compared with 0.7 pounds in the placebo group. Echocardiogram tests given at day 29 showed no signs of adverse effects on the heart. Additional echocardiograms are pending, Arena said. "The prevalence of obesity has increased substantially in recent years and has reached alarming rates. Obesity is a serious health risk. . . . The results of this trial are very supportive of further study and provide hope that obese individuals could have a new therapeutic option in the future to help control their weight in an effective, safe and controlled manner," said Dr. Steven Smith, principal study investigator and associate professor of the Pennington Biomedical Research Center. Arena said it will soon begin a Phase IIb trial of the obesity drug, enrolling approximately 300 to 400 patients for a three-month period. Arena Pharmaceuticals shares closed at $6.49, up $0.52, or 8.7%, in heavy trading on the Nasdaq. -=- DECODE GENETICS' MYOCARDIAL INFARCTION DRUG SHOWS KEY BIOMARKER REDUCTIONS IN PHASE II STUDY ---------------------------------------------------------------------------- --- Results of a Phase II clinical trial show that deCODE Genetics Inc.'s investigational drug for the prevention of myocardial infarctions lowered key biomarkers that might lead to a higher risk for an MI. The drug, DG031, is designed to inhibit the 5-lipoxygenase activating protein (FLAP) that is encoded by a gene that deCODE has linked to an increased risk of MI. The main outcome measures for the study were the changes in levels of biomarkers that are associated with the risk of MI. The study enrolled 172 patients in Iceland who had a history of MI and/or coronary artery disease and who carried one or more of the genes identified as a risk factor for MIs. For the first four weeks, half of the patients received placebo while the other half were randomized to 250 mg tablets of DG031 once, twice or three times per day. After a washout period of two weeks, patients originally taking placebo were switched to the dosing regimen of 250 mg once, twice or three times daily. The other group who had initially taken the drug received placebo. Results showed the patients receiving 750 mg/day of DG031 reduced their myeloperoxidase levels by 12 percent and their levels of leukotriene B4 (LTB4) by 26 percent. C-reactive protein (CRP) levels decreased 25 percent two weeks after the dosing period ended for the groups receiving 500 mg and 750 mg of the drug. "The results of our Phase II clinical work with DG031 show that it can, by inhibiting FLAP, effectively reduce the production of LTB4 in a dose-dependent manner," said Kari Stefansson, chief executive officer of deCODE. In the follow-up study, 75 patients were enrolled for eight days and were randomized to receive one 375 mg dose per day, two 375 mg doses per day or three 250 mg doses per day. The results of the follow-up study showed the drug reduced CRP levels by 23 percent for all patients, including a 38 percent reduction in the group receiving 250 mg three times per day. On day eight, six hours after dosing, myeloperoxidase levels decreased for all patients by 20 percent and by 31 percent for those patients receiving 250 mg three times per day. "These results are particularly intriguing because the reduction observed in CRP is in addition to the beneficial effects that may have been achieved with statins, which were taken by 85 percent of the study participants," study researchers said. DeCODE officials said the drug would likely be used in conjunction with statins should it reach the market, which it expects will happen by 2008 or 2009, Reuters reported. The company said it plans to begin Phase III clinical trials with DG031 by the fall to test if there is a direct link between the drug and MI prevention, Reuters noted. Results of the study were published in the May 11 issue of JAMA. -=- PFIZER'S LIPITOR MAY PROVIDE POSITIVE EFFECT ON PROGRESSIVE DETERIORATION OF COGNITIVE FUNCTION IN PATIENTS WITH ALZHEIMER'S DISEASE, RESULTS INDICATE ---------------------------------------------------------------------------- --- Pfizer Inc.'s cholesterol-lowering drug, Lipitor (atorvastatin calcium), appeared to delay the progressive deterioration of cognitive function in patients with mild to moderate Alzheimer's disease during a recent study. The investigators conducted a pilot intention-to-treat, proof-of-concept, double-blind trial in 67 patients. These subjects had mild to moderate Alzheimer's disease based on scores of between 12 and 28 on the Mini-Mental State Examination. They were randomized to 80 mg of Lipitor or placebo each day for a one-year exposure. The 63 patients who completed the three-month visit were considered evaluable. Later, 56 patients, 48 patients and 46 patients completed the six-month, nine-month and 12-month visits. Data were assessed using a last observation carried forward analysis of covariance. At three months, both therapy groups showed deterioration on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) that measures cognitive function. Thereafter, subjects who received placebo continued to deteriorate approximately one point per quarter. However, at six and 12 months, the Lipitor-treated patients demonstrated approximately 3.5 points of superiority over the placebo group on the ADAS-cog. The differences in ADAS-cog scores between the groups were significant at six months and all but significant at 12 months. Similarly, scores on the Clinical Global Impression of Change scale, a test of clinical efficacy, showed a trend for difference between the two arms at nine months and 12 months. "We believe that we provide evidence for proof of concept, and establishment of similar benefit of [Lipitor] in a multicenter trial investigating the effect in a much larger population may provide proof of therapy," the researchers concluded, adding that two studies of this kind are in progress. These data were published in the May issue of Archives of Neurology. -=- Research Panel PFIZER INC. ---------------------------------------------------------------------------- --- Pfizer Inc. said it would continue to discuss options with the Food and Drug Administration for returning its arthritis drug Bextra (valdecoxib) to the market. Company officials issued a statement saying they believe Bextra could have benefits for certain patient populations. Pfizer suspended Bextra sales in April after the FDA said the drug could cause cardiovascular problems and a life-threatening skin allergy. -=- Research Panel KV PHARMACEUTICAL CO. ---------------------------------------------------------------------------- --- KV Pharmaceutical Co. signed an agreement with FemmePharma Inc. to acquire worldwide marketing rights to a new endometriosis product in a transaction worth $25 million. KV previously only had marketing rights for the product in North America. KV also signed an agreement with Strides Arcolab Ltd., an Indian generic drug company, for exclusive marketing rights for 10 new generic drugs in the United States and Canada. The agreement allows KV to market two of the products in Europe and lays out plans for the companies to work together beyond the first 10 products. -=- Research Panel VICURON PHARMACEUTICALS INC. ---------------------------------------------------------------------------- --- Vicuron Pharmaceuticals Inc. said the Food and Drug Administration expects to complete priority review of the New Drug Application for its antibiotic, dalbavancin, by September 21, 2005. This represents a three-month extension from the original Prescription Drug User Fee Act action date of June 21. The FDA extended the review period after "classifying recent responses to questions in the chemistry, manufacturing and controls section of the NDA as a major amendment to the NDA," Vicuron said. "We continue to expect to launch dalbavancin, if approved, in the first quarter of 2006," said George Horner, Vicuron's chief executive officer. Dalbavancin is a once-weekly antibiotic intended to treat complicated skin and soft tissue infections. -=- Research Panel MEDEOREX INC. ---------------------------------------------------------------------------- --- Medeorex Inc. signed a term sheet to acquire CardioGenics Inc., a privately held biotechnology company. Medeorex said CardioGenics will merge with a new Ontario, Canada-based subsidiary that the company is planning to form. After the merger, CardioGenics' shareholders will hold 75 percent of Medeorex's outstanding shares, while Medeorex's shareholders will retain the remaining 25 percent. Complete financial terms were not disclosed. Medeorex expects the transaction to close by June 24, 2005. -=- Research Panel


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