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			Corporation Names 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 Medtronic to acquire Transneuronix Medtronic Inc. will acquire Transneuronix Inc., a privately held New Jersey firm, for an initial payment of approximately $260 million. The transaction is expected to close within the week. Transneuronix is a medical device firm focused on treating obesity through the development of its Transcend Implantable Gastric Stimulator. The device, which is already available in Europe, is similar to a pacemaker and delivers electrical pulses to the stomach. Under the agreement, Medtronic will make additional payments to Transneuronix shareholders if significant revenue objectives are met. The acquisition, already approved by Transneuronix stockholders, comes after Medtronic's recent announcement regarding the formation of its Medtronic Obesity Management business unit. "The acquisition of Transneuronix plays a key part in our strategy to deliver therapeutic solutions for the worldwide challenges of obesity," said Bill Hawkins, president of Medtronic. "Because obesity is linked to so many associated health problems, there is a great sense of urgency to find successful long-term treatment options for these patients." Recently, the Transcend product received marketing approval in Canada. Transneuronix has also completed enrollment for a U.S. trial of the device intended to demonstrate weight loss when compared with a control group. Results of the trial are expected this fall. Medtronic also noted that it has begun the Appetite Suppression Induced by Stimulation Trial. The study is designed to determine whether patients with type 2 diabetes and concomitant obesity have a minimum mean excess weight loss greater than that of a control group if they undergo gastric electrical stimulation. Shares of Medtronic closed at $52.20, down $0.70, or 1.3 percent, in moderate trading on the New York Stock Exchange. Corporation Names Canada's health minister to introduce legislation allowing ban on bulk drug exports Canada's health minister, Ujjal Dosanjh, plans to introduce legislation that would temporarily ban the bulk exporting of prescription drugs when the country's supplies are low, The Associated Press reported. "Canada cannot be the drugstore for the United States of America," Dosanjh said at a news conference in Ottawa, according to Reuters. "Two-hundred and eighty million people can't expect us to supply drugs to them . . . (at) controlled prices within our pricing regime." Four bills that would legalize drug importation from Canada, a country with approximately 34 million residents, are currently pending in Congress despite opposition from drug companies and the Food and Drug Administration, the AP noted. "In light of potential American legislation legalizing the bulk import of Canadian prescription and other medications, our priority must be the health and safety of all Canadians and the strength of our health care system," Dosanjh said. He added that he intends to create a federal drug supply network and work with provinces and drug companies to assemble data regarding Canada's drug supply. In the Reuters report, Dosanjh echoed the Canadian government's belief that it is unethical for physicians to sign prescriptions for patients they do not examine. "We will . . . require the establishment and existence of a doctor-patient relationship before cross-border prescription sales could take place," he stated. Dosanjh conceded that his proposed legislation would have a negative effect on the country's $700 million Web-based drug trade. Reuters added that two U.S. senators who support drug-importation legislation--John McCain, R-Ariz., and Debbie Stabenow, D-Mich.--said Dosanjh's move would not deter them, in part because their plan would allow imports from other industrialized nations with good drug safety protocols. Dosanjh plans to introduce the legislation to Canada's House of Commons this fall. Corporation Names Government reports show overpayment, fraud, abuse in Medicaid Several government reports released yesterday addressed issues of overpayment, fraud and abuse in Medicaid programs and highlighted the need for revised drug pricing and oversight procedures. Robert Vito, a regional inspector general for the U.S. Department of Health and Human Services, detailed results of an HHS report to the Senate Committee on Finance. "In short, the Medicaid program is vulnerable to abuse and continues to pay too much for prescription drugs compared to prices available in the marketplace," he said. While Medicare Part B generally uses average sales price (ASP) to calculate reimbursements, "Medicaid's reimbursement methodology continues to be based largely on the same inflated [average wholesale prices (AWPs)] that once plagued Medicare," Vito explained. He said data from two new HHS reports indicate that statutorily defined prices based on actual sales (average manufacturer price [AMP] and ASP) are substantially lower than published prices (AWP and wholesale acquisition cost [WAC]). Medicaid is limited to reimbursing at the federal upper limit amount, or 150 percent of the lowest AWP or WAC plus a dispensing fee. Among generic drugs, HHS found that the federal upper limit amounts were up to 19 times higher than average AMPs and 22 times higher than minimum AMPs. Based on these data, the agency estimated that Medicaid could have saved $161 million in the third quarter of last year by setting reimbursement at 150 percent of the average AMP. During the same period, Medicaid could have saved up to $300 million if the federal upper limit had been based on 150 percent of the minimum AMP. States also have considerable latitude in establishing their reimbursement amounts for prescription drugs. Vito noted that if the 42 states included in a recent HHS analysis had reimbursed at the same price as the lowest paying state for each of the drugs reviewed, Medicaid could have saved up to $86.7 million in fiscal year 2001. "We believe that Medicaid drug reimbursement should be fair and accurate. Drug reimbursement should reliably reflect the actual costs of drugs to pharmacies and be based on pricing data that can be validated. Neither of these criteria applies to AWP or WAC. There is an urgent need for the Medicaid policymaking community to assist states in strengthening their ability to make reasonable payments for Medicaid-covered drugs. For our part, [the Office of Inspector General] is committed to continue working with its many partners to help prevent fraud and abuse in the Medicaid program," Vito concluded. The full reports are available at the Web sites of the HHS Office of the Inspector General and the Government Accountability Office. Corporation Names Actos associated with significant improvements among patients with type 2 diabetes, dyslipidemia when compared with Avandia, study finds New study findings suggest that Takeda Pharmaceuticals North America Inc. and Eli Lilly and Co.'s Actos (pioglitazone hydrochloride) is associated with significant improvement in triglycerides, HDL cholesterol and LDL particle concentration and particle size among patients with type 2 diabetes when compared with GlaxoSmithKline Plc's Avandia (rosiglitazone maleate). In a 24-week prospective, multicenter, double-blind trial, researchers enrolled 802 patients with type 2 diabetes (treated through diet modifications or with oral monotherapy) and dyslipidemia (not treated with any lipid-lowering drugs). Following a four-week placebo washout period, patients were randomized to receive 30 mg/day of Actos or 4 mg/d of Avandia for 12 weeks. Doses were then increased to 45 mg/d of Actos and 4 mg twice daily of Avandia for an additional 12 weeks. While blood glucose control significantly improved in both treatment groups, researchers found that Actos and Avandia differed significantly in their effects on blood lipids. Avandia increased levels of total cholesterol and LDL cholesterol to a greater extent than did Actos (15.9 percent vs. 5.7 percent and 23.3 percent vs. 15.7 percent, respectively). Triglyceride levels, on the other hand, increased 14.9 percent among Avandia-treated patients but decreased 12 percent among patients treated with Actos. HDL cholesterol levels rose 14.9 percent and 7.8 percent for the Actos and Avandia groups, respectively. In addition, while Actos reduced LDL cholesterol particle concentration, Avandia increased it. Actos also increased LDL cholesterol particle size to a greater extent than did Avandia. "[Actos] and [Avandia] have significantly different effects on plasma lipids independent of glycemic control or concomitant lipid-lowering or other antihyperglycemic therapy," the study authors concluded. Diabetic dyslipidemia, which is characterized by increased triglycerides and decreased HDL cholesterol, is common among patients with type 2 diabetes and is an important risk factor for cardiovascular disease, the leading cause of death for these patients, according to Takeda. The study was published in the July issue of the journal Diabetes Care. Corporation Names Nasonex improves nasal congestion, polyp grade, study shows A once-daily regimen of Schering-Plough Corp.'s Nasonex (mometasone furoate monohydrate) nasal spray, 50 mcg, reduces nasal polyp grade and nasal congestion, according to data presented in Munich, Germany, at the World Allergy Congress. Nasal polyps, which are small, sac-like growths in the nasal cavity, increase with age and can reduce airflow in the nasal passages. In the study, 299 adult patients with nasal polyps were randomized to receive 200 mcg of Nasonex or placebo each morning for 16 weeks. Between baseline and endpoint, 74.3 percent of the patients who received Nasonex showed improved nasal congestion scores compared with 46.8 percent of those who received placebo. The Nasonex arm also showed improvements in polyp grade. Nasonex's efficacy was observed across ages and genders. Moreover, improvements in sense of smell, rhinitis and runny nose were observed among the patients treated with Nasonex. An assessment of quality-of-life variables also revealed that a statistically significantly higher proportion of the Nasonex arm demonstrated improvements in nose breathing (47.4 percent vs. 26.6 percent), interference with daily activities (61.8 percent vs. 45.3 percent) and sleeping disturbances (57.2 percent vs. 37.4 percent) as compared with the placebo arm. "While the recommended dose for nasal polyps is two sprays of Nasonex in each nostril twice daily, this new research provides further support for the efficacy of a once-daily regimen," said Dr. Robert Spiegel, chief medical officer of Schering-Plough. In the United States, Nasonex is the only intranasal corticosteroid approved to treat nasal polyps prior to surgery in adult patients, Schering-Plough noted. The product is also approved to prevent and treat nasal allergy symptoms in certain patient groups. Corporation Names Fabre-Kramer releases positive Phase III results for gepirone ER as treatment for major depression Fabre-Kramer Pharmaceuticals Inc. said its Phase III program for gepirone extended-release, an investigational treatment for depression, yielded positive results. The program included two double-blind, randomized, clinical studies involving a total of 454 patients with moderate depression. The first study met its pre-specified endpoint, with patients in the gepirone ER group demonstrating reduced symptoms of depression (according to the Hamilton Depression Scale) as compared with the placebo group. In the second study, patients in the gepirone ER group showed improvement in depressive symptoms by week two and throughout the trial. However, this trial did not reach statistical significance at endpoint. The firm noted that in both studies, the responder rate, defined as the number of patients having a 50 percent decrease in depressive symptoms, was statistically significant for gepirone ER compared with placebo. Lightheadedness and nausea accounted for the majority of adverse events that could be attributed to the study drug, both of which are common side effects for antidepressants. Fabre-Kramer said other side effects typically associated with antidepressants, such as sexual dysfunction, were not observed in patients treated with gepirone ER. The company said these results "augment earlier positive studies" of gepirone ER in patients with major depression and will allow the company to submit "an improved set of data" for review by the Food and Drug Administration. Fabre-Kramer plans to submit an amended New Drug Application later this year. "Gepirone ER represents the first of a new class of antidepressants, the direct serotonin agonists," said Dr. Stephen Kramer, Fabre-Kramer's chief executive officer. "Working by a new mechanism of action, gepirone ER, if approved, could provide a new treatment modality for depressed patients who are not helped by currently available treatments." In June of 2004, the FDA determined that Organon International Inc.'s NDA for gepirone ER as a treatment for major depressive disorder was not approvable. Earlier this month, Organon and Fabre-Kramer reached an agreement whereby Fabre-Kramer re-acquired all rights to gepirone ER. Under the agreement, if the FDA approves gepirone ER, Organon will receive a milestone payment and is eligible to receive royalties on sales of the drug. Corporation Names Corporation Names Biovail Corp. Biovail Corp. plans to submit a New Drug Application later this year for a "new salt" formulation of Wellbutrin XL (bupropion hydrochloride extended-release), Dow Jones Newswires reported following an event Biovail held Tuesday for investors. Once-daily Wellbutrin XL is an antidepressant developed by Biovail and marketed by GlaxoSmithKline Plc. Biovail expects the new version, believed to provide enhanced absorption and safety benefits, to reach the market in 2006. The company is targeting other Wellbutrin formulations for 2007. Corporation Names Corporation Names Keryx Biopharmaceuticals Inc. Keryx Biopharmaceuticals Inc. began a Phase III and a Phase IV study for KRX-101 (sulodexide), an oral drug candidate for treating diabetic nephropathy. Previously, the firm finalized a special protocol assessment agreement with the Food and Drug Administration as part of the Subpart-H guidelines for accelerated approval. The two trials will include a total of approximately 3,200 patients with type 2 diabetes and concomitant microalbuminuria, macroalbuminuria or overt nephropathy. Corporation Names Corporation Names Medco Health Solutions Inc. Medco Health Solutions Inc. agreed to have NeighborCare Inc. provide long-term care (LTC) pharmacy services to LTC facility residents who will be enrolled in the impending Medicare prescription drug benefit. NeighborCare said that its LTC pharmacies, which serve 34 states, "will become key elements of the pharmacy network that Medco's Part D Plan sponsor clients will use to provide LTC pharmacy services to Medicare beneficiaries enrolled in [the Prescription Drug and Medicare Advantage plans]." Corporation Names Corporation Names Millennium Pharmaceuticals Inc. Millennium Pharmaceuticals Inc. named Dr. Deborah Dunsire as its new president and chief executive officer. Dunsire, who is expected to assume her duties by Aug. 1 and who will also serve on the company's board of directors, was previously the head of Novartis Pharmaceutical Corp.'s North American oncology operations. Dunsire succeeds Mark Levin, the company's co-founder, who will continue to serve as a board member. Kenneth Weg, also a board member, will replace Levin as the firm's chairman. Corporation Names Corporation Names


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