Name Drugs - Brand Institute, inc.



			Name Drugs 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 FDA APPROVES NEW FORMULATION OF MERCK'S FOSAMAX The Food and Drug Administration approved Merck & Co. Inc.'s osteoporosis drug, Fosamax Plus D (alendronate sodium/cholecalciferol), a once-weekly tablet containing 70 mg of Fosamax (alendronate sodium) and 2,800 IU of vitamin D3. Fosamax Plus D is indicated for the treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis. According to Merck, Fosamax Plus D is the only bisphosphonate with the added benefit of a weekly dose of vitamin D, which is essential for the development of strong bones as it helps increase the intestinal absorption of calcium. Vitamin D insufficiency is linked to bone loss and increased risk of fracture. Merck added that patients at increased risk for vitamin D insufficiency, such as those aged 70 years or older, and patients with gastrointestinal malabsorption syndromes should receive vitamin D supplementation beyond that provided in Fosamax Plus D. The catalog price of Fosamax Plus D will be equivalent to the price of Fosamax 70 mg tablets, the company said. "Having a product like Fosamax Plus D available to help physicians better manage vitamin D nutrition in their patients should be welcomed news for the estimated 10 million Americans who have osteoporosis and the physicians who treat them," said Dr. Robert Heaney, professor of medicine at Creighton University. -=- TAKEDA CEASES DEVELOPMENT OF INVESTIGATIONAL DIABETES THERAPY Takeda Pharmaceutical Co. Ltd. discontinued development of its investigational compound TAK-559, a diabetes therapy. Phase III trials of TAK-559, an insulin-resistance improving drug, were put on hold by the company in December 2004 due to abnormalities in liver enzyme tests among a small number of patients. Takeda said it decided to discontinue the product's development "due to the lack of a sufficiently positive benefit/risk relationship relative to existing medicines." The compound had been under development in Japan, Europe and the United States, Takeda said. Takeda Pharmaceuticals North America Inc. and Eli Lilly and Co. co-market Takeda's diabetes drug Actos (pioglitazone) in the United States. -=- CELGENE COMPLETES NDA FOR BLOOD CANCER DRUG REVLIMID Celgene Corp. completed the rolling submission of the New Drug Application for its lead immunomodulatory drug, Revlimid (lenalidomide), to the Food and Drug Administration's Division of Oncology Drug Products. The company is seeking approval to market Revlimid as a treatment for transfusion-dependent patients with myelodysplastic syndromes (MDS) with a 5q deletion chromosomal abnormality. MDS is a malignant disorder of blood cell production that may eventually lead to acute leukemia. The company is also evaluating Revlimid for multiple myeloma and solid tumor cancers. In 2004, Revlimid received orphan drug status and a fast track designation from the FDA for the treatment of MDS. Last month, Celgene said it would unblind Phase III trials of the drug after results showed that Revlimid, when used in combination with dexamethasone, a standard chemotherapy agent, significantly improves time to disease progression among patients with multiple myeloma. -=- BUSH ADMINISTRATION TELLS STATES THEY CANNOT RECOMMEND SPECIFIC PRESCRIPTION DRUG PLANS TO MEDICARE BENEFICIARIES The Bush administration denounced a federal advisory board recommendation that said states should be able to enroll low-income Medicare patients "in one or more preferred prescription drug plans," The New York Times reported. Some states ensure that patients who cannot afford prescription drugs get them by either offering state-funded drug plans or enrolling beneficiaries in other specific drug plans. In the future, many states hope these plans will supplement the impending Medicare prescription drug plan. A federal advisory board, appointed last June, said that states should be allowed to continue steering people toward specific drug plans, but a Bush administration memorandum said that doing so could be "contrary to Medicare policy goals" and "may violate federal fraud and abuse laws," The Times reported. According to the advisory commission, 1.3 million low-income people received assistance from state-funded programs in 21 states. Leslie Norwalk, deputy administrator of the Centers for Medicare & Medicaid Services, told The Times that steering people to specific plans limits patients' freedom of choice and could allow states to receive illegal reimbursements or rebates for sending patients to a specific programs. The Bush administration wants states to help customers make comparisons between drug plans, but not recommend a specific one. Thomas Snedden, director of the Pharmaceutical Assistance for the Elderly program in Pennsylvania, said it would be difficult to coordinate all of the program benefits in the state. "We want to be able to pick a single plan and enroll our people," Snedden said. Some states have been drafting legislation to allow them to act as "authorized representatives" for residents and enroll certain residents in a preferred Medicare drug plan. Bush Administration officials are worried that by doing this, states are illegally discriminating against certain Medicare programs, causing increases in the cost of all programs and limiting the ability of the programs that are not recommended to compete in the market. However, the federal advisory board contends that a law passed by Congress in 2003 allows states to enroll individuals in a certain plan as long as they have the option of quitting the program for a different one. -=- NEW RESEARCH SUGGESTS ATYPICAL ANTIPSYCHOTICS ASSOCIATED WITH GREATER LONG-TERM TREATMENT COMPLIANCE COMPARED WITH TYPICAL ANTIPSYCHOTICS; LONGER TREATMENT DURATION LINKED WITH IMPROVED PATIENT OUTCOMES The results of new research presented this month at the International Congress on Schizophrenia Research in Savannah, Georgia, suggest patients with schizophrenia taking atypical antipsychotics are more likely to continue treatment compared with patients who are taking older typical antipsychotics. A separate analysis also concluded that a longer treatment duration is, in turn, associated with improved patient outcomes. The first study was conducted as part of the Schizophrenia Care and Assessment program, a three-year, nonrandomized naturalistic study. Researchers identified 1,028 patients who experienced a total of 1,666 treatment episodes (1,132 episodes with atypical antipsychotics and 534 with typical antipsychotics). The study authors compared the time to all-cause discontinuation of treatment, defined as the number of days before medication was discontinued for at least 30 days during the first year of treatment, between patients taking atypical and typical antipsychotics. Atypical antipsychotics included Eli Lilly and Co.'s Zyprexa (olanzapine), AstraZeneca Plc's Seroquel (quetiapine fumarate) and Pfizer's Geodon (ziprasidone hydrochloride or ziprasidone mesylate) as well as clozapine and risperidone; typical antipsychotics included perphenazine and haloperidol. Results indicated that Zyprexa and clozapine--but not other atypical antipsychotics--were associated with a significantly longer time to treatment discontinuation compared with perphenazine. Specifically, mean time to discontinuation was 48 days longer in Zyprexa-treated patients and 84 days longer in clozapine-treated patients. Additionally, Zyprexa, clozapine and risperidone were each associated with a longer time to treatment discontinuation compared with a combination of haloperidol and prophylactic anticholinergic agents (87 days, 123 days and 64 days, respectively). "When we observed a highly diverse group of patients with schizophrenia undergoing treatment in real-word settings, we found that patients taking the atypical antipsychotics clozapine or [Zyprexa] had a consistently and significantly longer time to medication discontinuation compared to patients treated with perphenazine and other typical antipsychotics," said Haya Ascher, Ph.D., senior research scientist with U.S. Outcomes Research at Lilly. "The results were consistent across many diverse systems of care in both urban and rural environments regardless of gender, age and ethnicity." In the second study, a retrospective analysis of 15 randomized placebo-controlled trials, researchers determined the risk of medication discontinuation with several antipsychotics as compared with Zyprexa. Findings suggested that patients taking Geodon, Seroquel, haloperidol and risperidone were 60 percent, 40 percent, 40 percent and 30 percent more likely to discontinue treatment compared with Zyprexa, respectively. Lastly, in a third analysis, investigators compared patient outcomes as a function of treatment duration using data from six long-term (at least 24 weeks), randomized double-blind trials. Results indicated that patients who participated in the trial for longer periods of time were more likely to have a better clinical outcome (measured with the Positive and Negative Syndrome Scale) and health-related quality of life (measured with the Short Form Health Survey and the Heinrichs-Carpenter Quality of Life Scale). According to previous research, almost 60 percent of patients with schizophrenia do not take their medications as they have been prescribed. Additionally, the American Psychiatric Association's practice guidelines for the treatment of patients with schizophrenia state that 60 to 70 percent of patients with schizophrenia relapse within one year without maintenance treatment, and nearly 90 percent relapse within two years. -=- GROUPS NOT WELL REPRESENTED IN CLINICAL TRIALS HAVE SIMILAR BENEFITS FROM STATIN USE, STUDY SUGGESTS Compared with groups that are well represented in clinical trials of statin use, groups that are not well represented in these trials, such as older patients and women, experience similar benefits from statins, a recent study suggests. Researchers conducted an observational cohort study using a record linkage database. The study population consisted of 4,892 patients who were discharged from Tayside, Scotland, hospitals after their first myocardial infarction (MI) between January 1993 and December 2001. The main outcome measure was all-cause mortality and the recurrence of cardiovascular events. Out of the total patient population, 2,463, or approximately half, were taking statins during an average follow-up of 3.7 years. Statin use rose significantly from 3.1 percent in 1993 to 62.9 percent in 2001. Five statins--Pfizer Inc.'s Lipitor (atorvastatin calcium), Bayer AG's Baycol (cerivastatin sodium), Novartis AG's Lescol (fluvastatin sodium), Bristol-Myers Squibb Co.'s Pravachol (pravastatin sodium) and Merck & Co. Inc.'s Zocor (simvastatin)--were available during the study period. Zocor accounted for approximately 80 percent of statin use. Researchers found that there were 319 deaths among the statin-treated group and 1,200 deaths among the group not treated with statins. Statin use reduced all-cause mortality by 31 percent and recurrent MI or cardiovascular death by 18 percent. Statin users were generally younger than non-users and tended to be prescribed more cardiovascular co-medication, the researchers noted. Additionally, the proportion of older and female patients in Tayside was higher than in clinical trials. Researchers cited study data showing that the mean age of patients in trials was 59.8 and that women accounted for 16.9 percent of the patients. In this study, patients had a mean age of 67.8 years and women accounted for 39.6 percent of the patients. "The community effectiveness of statins in those groups that were not well represented in clinical trials was similar to the efficacy of statins in [clinical] trials," the study authors concluded. The study was published online March 24, ahead of publication in the April 9 issue of the British Medical Journal. -=- Name Drugs LIGAND PHARMACEUTICALS INC. Ligand Pharmaceuticals Inc. exercised its final option under a November 2004 contract with Eli Lilly and Co. and will buy down an additional portion of the royalties payable to Lilly on sales of Ligand's Ontak (denileukin diftitox) cancer treatment in the United States. The option provides Lilly with a one-time cash payment of $13 million in exchange for elimination of the Ontak royalties due to the company on U.S. net sales in 2006. The company will use a reduced, reverse-tiered royalty scale on net sales in the United States in the future. In January 2005, Ligand exercised its first option, a one-time payment of $20 million to Lilly for elimination of Ontak royalty obligations. -=- Name Drugs ZELTIA SA Zeltia SA's Phase III investigational drug Yondelis, which is being co-developed with Johnson & Johnson, received orphan drug status from the Food and Drug Administration for the treatment of ovarian cancer, Reuters reported. In October 2004, the FDA granted Yondelis orphan drug status as a treatment for soft tissue sarcoma. -=- Name Drugs INNOVATE ONCOLOGY INC. Innovate Oncology Inc. entered into an exclusive agreement with Prostagenics LLC, acquiring the rights to develop and market Capridine-Beta, a novel nitroacridine derivative, intended for the treatment of prostate cancer. The company said it is currently preparing to submit an Investigational New Drug application to the Food and Drug Administration to conduct a Phase I trial to determine the maximum tolerated dose of Capridine-Beta administered as a single agent to patients with prostate cancer who have advanced solid tumors. -=- Name Drugs ARRAY BIOPHARMA Array BioPharma expanded its agreement with Genentech Inc. to develop small-molecule clinical candidates against an additional protein target for cancer treatment. The companies initiated the collaboration in January 2004 to advance two of Array's oncology products into clinical development. The expanded agreement includes increased research funding, milestone payments and product royalties for Array. Genentech will remain solely responsible for clinical trials and marketing of the products. -=- Name Drugs


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