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Proprietary NamesBrand 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 RISPERDAL NOT APPROVABLE AS TREATMENT FOR AUTISMJohnson and Johnson Pharmaceutical Research & Development LLC received a not approvable letter from the Food and Drug Administration for its supplemental New Drug Application for Risperdal (risperidone) in the treatment of autism. Noting the lack of treatments for autism, the company plans to "evaluate the letter and determine the appropriate next steps." A study published in The New England Journal of Medicine in 2002 showed Risperdal to be an effective, well-tolerated treatment for tantrums, aggression and self-injurious behavior in children with autistic disorder. Risperdal, an antipsychotic, is approved to treat schizophrenia; it is also approved as a short-term treatment for acute manic or mixed episodes associated with bipolar 1 disorder, both as a monotherapy and in combination with lithium or valproate. The drug is marketed by Janssen Pharmaceutica Products LP, a division of J&J. -=- FDA APPROVES DEPOMED'S PROQUIN XR TO TREAT UTI The Food and Drug Administration approved Depomed Inc.'s Proquin XR (ciprofloxacin hydrochloride), an extended-release antibiotic, for the treatment of uncomplicated urinary tract infections (UTIs). Proquin XR is Depomed's first FDA-approved product, the company noted. "Proquin XR is a new, once-daily version of ciprofloxacin that caused fewer incidences of gastrointestinal side effects, including nausea and diarrhea, in the recent multicenter Phase III clinical trial of over 1,000 patients," said Dr. Neal Shore, medical director at Carolina Urologic Research Center. Proquin XR is the first ciprofloxacin formulation to list nausea and diarrhea as '"uncommon" adverse events in its label, rather than as "common" adverse events, according to Depomed. Proquin XR is designed to release its active ingredient gradually over six hours, Depomed said, whereas Bayer AG's UTI treatment Cipro (ciprofloxacin hydrochloride) and generic equivalents were shown in Depomed's dissolution studies to release their entire dosage within approximately 30 minutes. Bayer's extended-release formulation, Cipro XR, releases all of its active ingredient within approximately two hours, Depomed added. Extending the release time prevents large quantities of the drug from being dumped into a patient's intestinal system, where it can cause side effects or interact with gastrointestinal drugs, Depomed said. Depomed submitted the New Drug Application for Proquin XR in July of 2004 and is in negotiations with potential marketing partners for the drug. The company anticipates FDA approval next month of a second extended-release drug, Glumetza (metformin hydrochloride), for the treatment of type 2 diabetes. Depomed and marketing partner Biovail Corp. received notification in March from the FDA that Glumetza was deemed "approvable." Depomed shares closed at $4.47, up $0.40, or 9.8 percent, in heavy trading on the Nasdaq. -=- ACTAVIS GROUP TO ACQUIRE AMIDE PHARMACEUTICAL FOR UP TO $600 MILLION Iceland's Actavis Group reached an agreement to acquire Amide Pharmaceutical Inc. for as much as $500 million in cash. Depending on business performance, Actavis could pay up to an additional $100 million over the next two years. "The transaction is a significant step in our strategy to build one of the world's leading generic pharmaceutical companies," said Robert Wessman, Actavis' chief executive officer. The firm's U.S. operations will be consolidated with Amide's New Jersey offices when the transaction is completed, according to Actavis. Amide's president, Divya Patel, will become a member of Actavis' executive board. Actavis expects the acquisition to increase its pretax profit by 45 percent to 50 percent and its earnings per share by 30 percent to 35 percent during the first full year following the transaction's completion. The transaction is expected to close in the third quarter, Reuters reported. Following the acquisition, Actavis said it will have more than 500 products on the market, with minimal product overlap, and 136 products under development. In addition, the firm expects to file at least 15 Abbreviated New Drug Applications in 2005. "We are extremely enthusiastic about the mutual benefits to be gained from this transaction," Patel said. "There is an excellent strategic fit between the two companies, and [the acquisition] provides Amide with the ability to leverage its market position as well as expand its product portfolio in the coming years." -=- PRAECIS CUTS WORKFORCE BY 60 PERCENT; SUSPENDS DEVELOPMENT OF ONE DRUG, SALES OF ANOTHER As part of a restructuring plan, Praecis Pharmaceuticals Inc. will cut approximately 60 percent of its workforce, suspend development of Apan, a compound intended to treat Alzheimer's disease, and discontinue U.S. promotions of prostate cancer therapy Plenaxis (abarelix). Praecis said it will work with the Food and Drug Administration to make Plenaxis available to current patients but will stop promoting the drug in the United States because it is unlikely the company will meet established revenue goals for Plenaxis "on an acceptable timeline." The company decided to suspend development of Apan "to conserve funds," adding that it will continue to seek development partners for possible future development. Following the restructuring, Praecis said it will focus on developing PPI-2458, an oral compound intended to treat cancer and autoimmune diseases, and on advancing its Direct Select drug discovery technology through research collaborations and partnerships. Additionally, Praecis plans to continue its collaboration with Schering AG in which the companies are seeking approval to market Plenaxis in the European Union and other territories. The company expects these restructuring efforts to decrease annual cash utilization from approximately $60 million to less than $30 million in 2006. It also expects to incur approximately $4.1 million in cash restructuring charges; half of the charges will occur during the second quarter of this year and the other half by year-end. -=- STUDY EVALUATES COST EFFECTIVENESS OF VARIOUS CHRONIC HBV INFECTION TREATMENT STRATEGIES Researchers recently conducted a cost-effectiveness analysis of treatment alternatives for chronic hepatitis B virus infection, and found that neither GlaxoSmithKline Plc's Epivir (lamivudine) nor Gilead Sciences Inc.'s Hepsera (adefovir) monotherapy were cost-effective options. However, a strategy that reserved Hepsera only for Epivir-associated viral resistance appeared to be very cost effective in most health care settings. The study authors noted that while Hepsera is more expensive than Epivir or interferon treatment, which are associated with either viral resistance or side effects, certain circumstances may make an Hepsera treatment strategy more cost effective. To further explore this issue, they performed a cost-utility analysis of hypothetical cohort patients with chronic HBV infection who had elevated aminotransferase levels but no evidence of cirrhosis. Several strategies were examined from a third-party payer perspective: no treatment; interferon monotherapy; Epivir monotherapy; Hepsera monotherapy; and Hepsera salvage therapy, which was defined as initial Epivir therapy with crossover to Hepsera upon viral resistance. While the no-treatment strategy was the least expensive, it also was the least effective. Additionally, the analysis revealed that both the Epivir monotherapy and Hepsera monotherapy strategies were more expensive yet less effective than the other alternatives. Compared with the no-treatment strategy, a gain of one additional quality-adjusted life year (QALY) with interferon monotherapy cost an incremental $6,337. Compared with interferon monotherapy, the Hepsera salvage approach cost an incremental $8,446 per QALY gained. The base-case analysis showed that the restricted use of Hepsera as salvage therapy was more cost effective than both Epivir and Hepsera monotherapies. In sensitivity analyses that stratified patients by hepatitis B e antigen (HBeAg) status, the results demonstrated that among health care systems with tight budgetary constraints and a high prevalence of HBeAg-negative patients, interferon monotherapy is the most cost-effective strategy. "Of the active therapeutic strategies currently available for chronic HBV infection, only interferon monotherapy and [Hepsera] salvage therapy are potentially cost effective," the investigators concluded. "Whereas [Hepsera] salvage is likely to be highly cost effective across most health care settings independent of HBeAg status, interferon may be preferred in health care systems with limited resources, especially in those serving populations with a high prevalence of HBeAg-negative HBV." In response to this study, Drs. Douglas Owens and Martin Black commented, "The conclusion that [Hepsera] salvage is a dominant (HBeAg-positive patients) or cost-effective (HBeAg-negative patients) strategy may change if newer drugs, or combinations of current drugs, are more effective, cheaper or both. Thus, if new drug therapies become available for HBV . . . Kanwal and colleagues' analysis should be revisited." Both the study and editorial comment can be found in the May 17 issue of Annals of Internal Medicine. -=- ANTIBIOTIC USE ASSOCIATED WITH REDUCED RISK OF FLARE IN CROHN'S DISEASE PATIENTS, DATA SUGGEST Antibiotic use appears to have somewhat of a protective effect on the risk of flare among patients with Crohn's disease, according to results of a large study. Researchers hypothesized that antibiotic use might decrease the risk of flare in patients with inflammatory bowel disease, since antibiotic therapy alters intestinal microbial flora, which may have a role in IBS pathogenesis. To test this hypothesis, they examined antibiotic use during the two months preceding recorded flares among 1,205 individuals with Crohn's disease and 2,230 with ulcerative colitis. In examining patient records, flares were considered to have occurred when a patient received a new prescription for either corticosteroids or mesalamine after an interval of four months or longer without a prescription for either type of agent. A flare was 22 percent less likely to occur among Crohn's disease patients with an exposure to antibiotics. This association was most pronounced when the exposure was more recent. While patients with ulcerative colitis overall demonstrated no significant reduction in the likelihood of flare with antibiotic use, there was a potentially protective effect for those who had antibiotic exposure within the previous 15 days. The investigators concluded that antibiotic use within 60 days lowers the risk of flare of Crohn's disease, but not ulcerative colitis, although this effect in patients with Crohn's disease appears to decrease with time. The study appeared in the May issue of the journal Clinical Gastroenterology and Hepatology. -=- Proprietary Names MYLAN LABORATORIES INC. Mylan Laboratories Inc. named Hal Korman president of its generic division, Mylan Pharmaceuticals. Korman previously served as president of another Mylan subsidiary, UDL Laboratories. He will be succeeding Lou DeBone, who was serving as president of Mylan Pharmaceuticals in addition to the offices he still holds as president and chief operating officer of Mylan Laboratories. -=- Proprietary Names LIGAND PHARMACEUTICALS INC. Ligand Pharmaceuticals Inc. intends to restate its consolidated financial statements for 2002, 2003 and the first three quarters of 2004. An internal audit revealed that the company had not properly recognized revenue on product shipments to distributors. The revised statements will be based on the sell-through accounting method, Ligand said, which does not recognize revenue until after a product has been shipped from wholesalers. The firm is also reviewing the accounting and classification of its sales of royalty rights. Because the company has delayed filing its 2004 annual report and its report for the quarter ended March 31, 2005, Ligand is currently not in compliance with Nasdaq's listing requirements. A Nasdaq panel agreed to continue listing the company's securities as long as Ligand files the annual and quarterly reports by July 29, 2005. -=- Proprietary Names SOLEXA INC. Solexa Inc. said it reduced its workforce by approximately 17 percent as part of a strategic restructure reflecting a transition from Lynx Therapeutics Inc.'s bead-based MPSS technology to Solexa's new sequencing-by-synthesis and cluster molecule array technology (the "SBS-Cluster System"). The company will retain approximately 116 employees and expects to record approximately $350,000 in charges related to the restructuring for the quarter ending June 30. Solexa plans to introduce its new system commercially by the end of the year. -=- Proprietary Names RINCON PHARMACEUTICALS INC. Rincon Pharmaceuticals Inc. and Biogen Idec Inc. are collaborating on a research project "to evaluate Rincon's eukaryotic algae production platform for therapeutic nonglycosylated proteins." Rincon said it has shown algae's utility in expressing and assembling complex mammalian proteins, such as monoclonal antibodies. "A tremendous opportunity exists for a new recombinant protein production system that is more rapid, scalable and cost effective than current approaches," said Bruce Steel, Rincon's chief executive officer. "We hope to leverage Biogen Idec's expertise in this field to more quickly commercialize our technology platform." -=- Proprietary Names
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