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Proprietary NameBrand 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 SANOFI-AVENTIS EXECUTIVES IMPLY FIRM SUBMITTED OBESITY DRUG ACOMPLIA FOR APPROVAL IN U.S.; Q1 NET INCOME, SALES UPDuring a conference call last week, sanofi-aventis Group executives implied that the company filed for Food and Drug Administration approval of its obesity drug, Acomplia (rimonabant). When asked if sanofi-aventis was seeking priority review of its application, the executives noted that fast track status is "a nice thing to have but not totally vital." However, they would not disclose if the company was seeking such a designation for Acomplia. The FDA must also approve the brand name. The call did make it clear that the drug would be evaluated for both the metabolic/weight loss and smoking cessation indications. The executives acknowledged that the firm had filed for approval of Acomplia in Europe and that the drug's earliest possible launch date would be the end of the fourth quarter of 2005. Analysts forecast that Acomplia could achieve annual sales of more than $3 billion, Reuters reported. On Friday, sanofi-aventis also reported results for the first quarter of 2005. The firm realized adjusted net income of approximately $1.84 billion, or approximately $1.37 per share, up from adjusted proforma net income of approximately $1.36 billion, or $1.02 per share, in the prior-year period. Analysts polled by Reuters expected net income of approximately $1.71 billion and earnings per share of approximately $1.28. The company achieved net sales of approximately $8.32 billion, compared with approximately $7.28 billion in the previous-year period. In the United States, net sales totaled approximately $2.79 billion. Antiplatelet drug Plavix (clopidogrel bisulfate) and anticoagulant Lovenox (enoxaparin sodium) achieved worldwide sales of approximately $648.5 million and approximately $607 million, respectively. Hanspeter Spek, the firm's executive vice president for pharmaceutical operations, said during the conference call that the firm is confident that its insomnia drug Ambien CR (zolpidem tartrate), the controlled-release version of the original Ambien, will be launched during the summer. Last month, sanofi-aventis received an approvable letter from the FDA for Ambien CR. Sanofi-aventis shares closed Friday at $44.17, up $0.19, or 0.4 percent, in light trading on the New York Stock Exchange. -=- GENTA RELEASES UPDATED RESULTS OF PHASE III TRIAL OF GENASENSE FOR RELAPSED, REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA Genta Inc. released updated results from a Phase III trial of Genasense (oblimersen sodium) injection in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), stating that during a six-month follow-up period an additional patient achieved a nodular partial response. Additionally, the duration of complete responses or nodular partial responses was "significantly superior" for the Genasense treatment group. The Phase III trial consisted of 241 patients who had failed standard treatment for CLL, including fludarabine phosphate. Of these patients, 120 were randomized to receive Genasense plus chemotherapy (fludarabine and cyclophosphamide) and 121 were randomized to receive chemotherapy only. The preliminary results, announced in December 2004, demonstrated that the trial had met its primary endpoint of achieving a significant increase in the proportion of patients receiving Genasense who achieved either a complete response or nodular partial response. With the additional Genasense patient achieving a nodular partial response in the six-month follow-up period, a total of 17 percent of patients in the Genasense arm achieved a complete or nodular partial response compared with 7 percent of patients in the chemotherapy only group. The extended follow-up showed that in the Genasense treatment arm, 20 percent of the patients relapsed compared with 63 percent of the patients in the chemotherapy only arm. The incidence of any Grade 3 or Grade 4 serious adverse event was higher in the Genasense arm. However, Genta said the number of serious adverse events that led to discontinuation of therapy was equal between the treatment arms. In the Genasense arm, nine patient deaths due to treatment-emergent adverse effects were reported compared with five deaths in the chemotherapy arm, the company said. "For the first time, these updated results enable a direct comparison of the quality of major responses that were achieved in the Phase III Genasense trial," said Dr. Raymond Warrell Jr., Genta's chief executive officer. "Having achieved the primary endpoint, the additional follow-up has shown not only that most major responses on the Genasense arm are durable (that is exceeding six months in duration), but also that their duration is significantly superior to those achieved using chemotherapy alone." Genasense shares closed at $1.42, up $0.12, or 9.2 percent, in heavy trading on the Nasdaq. -=- DEPOMED ANNOUNCES DISAPPOINTING RESULTS FOR ITS FUROSEMIDE GR PHASE II TRIAL Depomed Inc. released disappointing data from its extended Phase II trial of Furosemide GR to treat edema in congestive heart failure patients and is re-evaluating the program. The additional data from 10 patients taking Furosemide GR, a controlled-release formulation of the diuretic furosemide, showed that the drug "continued to produce comparable diuresis to immediate-release furosemide, however with variable urinary urgency and frequency between the two treatment groups," the company said. The results from the original Phase II trial of 30 patients with congestive heart failure, which were reported in September 2004, demonstrated similar results between the controlled-release and immediate-release groups, but the results related to urinary urgency and frequency were inconsistent. The extension of the trial was designed to evaluate any potential differences between the controlled-released product compared with the immediate-release formulation, especially related to urinary frequency and urgency. The data for the follow-up did not "show a consistent improvement in urinary urgency and frequency as was observed in our Phase I trial in healthy volunteers," according to John Fara, Ph.D., chief executive officer of Depomed. The company said that while it is re-evaluating its Furosemide GR program, it will reallocate resources from the program to grow its pipeline and support other late-stage programs. -=- AETNA TO ACQUIRE ACTIVEHEALTH MANAGEMENT Aetna Inc. entered into an agreement to acquire ActiveHealth Management, a privately held health management and health care data analytics company, for approximately $400 million. Aetna said the transaction will be financed from available cash. Aetna expects the transaction to close during the second quarter of 2005 and "that it will become accretive to earnings within 12 months following the closing." ActiveHealth, headquartered in New York City, will operate as a branded, stand-alone business, led by Dr. Lonny Reisman, its current chief executive officer. It will continue to provide clinical decision support to physicians and members as well as health care data analytic tools powered by the company's CareEngine System. The CareEngine System has been private-labeled by Aetna under the name MedQuery. Aetna said it has been an ActiveHealth customer since 2002. "This acquisition positions Aetna to enhance the scope of our medical cost, quality and patient safety capabilities, while increasing our ability to serve new market segments," said Ronald Williams, Aetna's president. "Evidence-based medical management is critical for the entire health care industry. We intend to profitably grow ActiveHealth, with its unique service model, as a standalone medical management business that provides world-class service to a full line of customers." -=- FOSAMAX NOT COST-EFFECTIVE FOR WOMEN WITH OSTEOPENIA, DATA INDICATE The use of Merck & Co. Inc.'s Fosamax (alendronate sodium) in postmenopausal women with low bone mass appears not to be cost-effective, according to a new analysis. Using a Markov model, researchers compared the costs of Fosamax treatment with no treatment for women aged between 55 and 75 years with femoral neck T scores between -1.5 and -2.4 across eight health states (no fracture, post-distal forearm fracture, post-clinical vertebral fracture, post-radiographic vertebral fracture, post-hip fracture, post-hip and vertebral fractures, post-other fractures [i.e. ribs, pelvis, tibia] and death). The women had osteopenia, but had no additional fracture risk factors. The cost per quality-adjusted life year (QALY) gained ranged between $70,000 and $332,000, depending on age and femoral neck bone density. For women with a T score of -1.5, the incremental cost-effectiveness ratio was in excess of $250,000 per QALY gained. "This conclusion should be reconsidered, however, if the cost of drug therapy is significantly lowered, if drug therapy is shown to reduce the risk for nonvertebral fractures in this population or if fracture reduction benefit persists longer than 10 years after a five-year treatment course," the study authors noted. Findings were published in the May 3 edition of Annals of Internal Medicine. -=- PHARMACIST-DIRECTED PROGRAMS FOR IMPLEMENTING MEDICATION THERAPY MANAGEMENT PROGRAMS THROUGH MEDICARE MAY BE LINKED WITH COST-SAVING OUTCOMES, ANALYSIS SHOWS New data indicate that offering a pharmacist-directed medication therapy management program to Medicare enrollees with more than one chronic disease who are using multiple drugs may lead to improved prescription use, lower out-of-pocket expenses and better access to necessary therapies. A team of researchers assessed the advantages associated with a pharmacist-directed multidisciplinary model adaptable to providing medication therapy management programs in a managed care setting by evaluating the services provided by one program, the Pharmacist Review to Increase Cost Effectiveness (PRICE) Clinic, which has been operating with a medical group in Sacramento, Calif., since 2001. In the noncontrolled retrospective study, the investigators recorded the number and type of interventions performed, as well as the drug class involved in the intervention, among the 520 participants seen through the PRICE clinic in 2002. Study patients were Medicare-eligible, low-income individuals (average age, 78 years) with multiple chronic diseases who were taking multiple drugs (average of six drugs for four conditions) and had high drug expenses (average $185 per month out-of-pocket). Pre- and post-analysis data demonstrated any changes due to interventions. On average, the PRICE Clinic conducted 2.5 interventions per patient. Most often, these interventions included enrollment in patient-assistance programs offered through the pharmaceutical industry (accounting for 51 percent of the interventions provided to 65 percent of the patients), generic substitutions (provided to 23 percent of the patients), therapeutic interchange (17 percent of the patients) and mail-order services (11 percent of the patients). Interventions involved lipid-lowering drugs most often (44 percent of the patients), followed by ACE inhibitors (17 percent) and asthma and allergy drugs (15 percent). As a result of the interventions, analyses revealed that generic drug use rose from 51 percent to 56 percent, a relative increase of 9.8 percent. Furthermore, a patient's out-of-pocket costs fell 68 percent, from $185 per month to $60 per month. In total, 215 patients reported discontinuation of, or plans to discontinue, a prescribed drug because of cost. However, after the PRICE Clinic interventions, 186 of these patients (87 percent) were able to comply with their treatment regimen. With the passage of the Medicare Prescription Drug, Improvement and Modernization Act in 2003, prescription drug sponsors for Medicare, including health plans and pharmacy benefit managers, will be required to offer medication therapy management services provided by pharmacists or other health care professionals as of 2006. "The results of this study suggest that a collaborative, team-centered clinic offering pharmacist-directed services has the potential to achieve these objectives and to serve as a replicable model that can be integrated into managed care settings to improve clinical, service and cost outcomes," the researchers concluded. The research results were published in the May issue of the Journal of Managed Care Pharmacy. -=- Proprietary Name BAYER PHARMACEUTICALS CORP. Bayer Pharmaceuticals Corp. and Onyx Pharmaceuticals Inc. are initiating a Phase III trial of sorafenib, formerly BAY 43-9006, in combination with carboplatin and paclitaxel in patients with advanced metastatic melanoma. The double-blind study is expected to enroll more than 200 patients who have failed one previous treatment with either dacarbazine or Schering-Plough Corp.'s Temodar (temozolomide). The primary endpoint will be progression-free survival. The companies said the Food and Drug Administration completed a Special Protocol Assessment for the trial. Sorafenib is an oral multikinase inhibitor that targets serine/threonine and receptor tyrosine kinases in the tumor cell and tumor vasculature. -=- Proprietary Name MCKESSON CORP. McKesson Corp. said the Federal Trade Commission is investigating the company for possible anticompetitive practices with other wholesale pharmaceutical distributors. The FTC investigation was revealed in McKesson's annual report filed with the Securities and Exchange Commission. The investigation is in a preliminary stage and McKesson said it is responding to the FTC's request for documents. The McKesson SEC filing said the request for documents was part of an FTC investigation to find if the company may have engaged, or may be engaging, in anticompetitive practices "in order to limit competition for provider customers seeking distribution services." -=- Proprietary Name REGENERON PHARMACEUTICALS INC. Regeneron Pharmaceuticals Inc., in collaboration with sanofi-aventis Group, initiated a safety and tolerability study of vascular endothelial growth factor (VEGF) Trap delivered intravenously in combination with FOLFOX-4 in patients with advanced solid malignancies that are metastatic or unresectable. FOLFOX-4 is a combination of Sanofi-Synthelabo Inc.'s Eloxatin (oxaliplatin), 5-fluorouracil (5FU) and leucovorin. The study will also measure response rate, duration of response and time to tumor progression, Regeneron said. Regeneron and sanofi-aventis are working together to develop and commercialize the VEGF Trap in oncology. -=- Proprietary Name MARTEK BIOSCIENCES CORP. Martek Biosciences Corp. said a study of docosahexaenoic acid's (DHA) therapeutic effects on lipid profiles, blood pressure and other cardiovascular risk factors in obese, mildly dyslipidemic subjects failed to meet its primary endpoint. After 26 weeks, patients given 1g of DHA per day had significantly lower triglyceride levels as compared with baseline, but the reduction was not statistically significant when compared with the placebo group. Martek said these results are consistent with earlier studies using similar low doses of omega-3 fatty acids from fish oils. -=- Proprietary Name
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