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branding StrategiesBrand 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 AMGEN FORMS VENTURE CAPITAL FUND TO PROVIDE EMERGING BIOTECH COMPANIES WITH FINANCIAL RESOURCES ___________________________________________________________________________ Amgen Inc. reported Thursday that it has formed Amgen Ventures, a corporate venture capital fund intended to provide financial resources for emerging biotechnology companies to pioneer discovery of human therapeutics.Amgen Ventures, which will be based in San Diego, will provide such organizations with access to Amgen's extensive biotech capabilities while, at the same time, providing Amgen with insight into external research innovations that it could potentially collaborate on in the future. The fund's primary focus will be in areas of current therapeutic interest to Amgen but will also provide various means of addressing targets in both current and emerging therapeutic areas of interest. Amgen Ventures will initially commit $100 million to the fund. "Our internal efforts concentrate on therapeutic areas such as oncology, metabolic disorders and inflammation. However, we understand that science is a global and collective endeavor and that many of the scientific breakthroughs of tomorrow will come from early-stage companies," said Dr. Roger Perlmutter, Amgen's executive vice president of research and development. "We also understand the challenges that these companies face and believe that Amgen Ventures can permit them to benefit from our experience, people and financial resources to bring meaningful treatments to patients," he noted. ENCYSIVE'S PULMONARY ARTERIAL HYPERTENSION TREATMENT GRANTED ORPHAN DRUG STATUS ___________________________________________________________________________ Encysive Pharmaceuticals Inc.'s Thelin (sitaxsentan sodium) was designated an orphan drug by the Food and Drug Administration for the treatment of pulmonary arterial hypertension (PAH). Thelin is a small-molecule endothelin antagonist currently in Phase III development for PAH. Side effects observed in clinical testing of Thelin include liver dysfunction, headache, edema, constipation, nasal congestion and flushing, the company said. Currently, there are two FDA-approved treatments for PAH, Actelion Ltd.'s oral drug Tracleer (bosentan) and United Therapeutics Corp.'s injectable drug Remodulin (treprostinil). Tracleer generated $99.8 million in worldwide sales last year, while Remodulin had $45.1 million in sales. In addition, Myogen Inc.'s Ambrisentan and Pfizer Inc.'s sildenafil citrate, which Pfizer currently markets as Viagra for erectile dysfunction, are being tested in Phase III studies. PAH is a condition that involves high blood pressure and structural changes in the walls of the pulmonary arteries, Encysive said. PAH causes shortness of breath and is eventually fatal unless treated. The condition is estimated to affect 80,000 to 100,000 people worldwide. FOLLOW-ON DRUGS IMPROVE TREATMENT, LOWER COSTS, TUFTS STUDY FINDS ___________________________________________________________________________ Follow-on drugs provide patients with more effective and safer therapies, while lowering the cost of treatment, according to an analysis conducted by the Tufts Center for the Study of Drug Development. Development of follow-on drugs--compounds in the same class as already-approved therapies--has been criticized by some individuals who believe drug firms spend valuable resources chasing large markets rather than attempting to develop novel cures in areas of need. In order to assess the value of developing follow-on drugs, the Tufts Center examined 235 follow-on drugs approved in 72 disease categories since 1960, The Boston Globe reported. The analysis showed that, "Far from being redundant, follow-on drugs create therapeutic alternatives, which enable physicians to individualize patient treatment," Tufts Center Director Kenneth Kaitin said in a press release. He pointed out that approximately one-third of all drugs in the Tufts Center analysis were granted a priority review by the Food and Drug Administration, indicating the compounds offered therapeutic advances over drugs already on the market. He also noted that a substantial proportion of late-entering follow-on drugs received a priority review designation; in classes of drugs that had four or more follow-on drugs, 48 percent of the drugs that received a priority rating were the fourth or later follow-on. Kaitin also pointed to evidence that shows follow-on drugs increase product availability from multiple sources, thereby creating competition that results in higher-quality therapies at lower costs. The Tufts Center data showed the current monthly cost of a statin launched in 2003 is 45 percent lower than the cost of a statin launched in the early 1990s, and the cost for an ACE inhibitor launched in the mid-1990s is 72 percent lower than the cost for an ACE inhibitor that debuted in the early 1980s. The Tufts Center found that the average effective period of market exclusivity for a first-in-class drug dropped 78 percent from 8.2 years in the 1970s to 1.8 years during the period from 1995 to 1998. The investigators noted that for drug classes that received their first approval in the 1990s, nearly all follow-on drugs were already in clinical testing when the first-in-class drug was approved. "If the first drug doesn't work for you, there is no such thing as a 'me-too' drug," said Wanda Moebius, spokesperson for the Pharmaceutical Research and Manufacturers of America, according to the Globe. "You have no other alternative than to find another drug that works for you. People aren't one-size-fits-all." TREATMENT WITH ABBOTT'S ABT-874 MAY INDUCE RESPONSES, REMISSIONS IN PATIENTS WITH ACTIVE CROHN'S DISEASE ___________________________________________________________________________ New data published in the Nov. 11 issue of The New England Journal of Medicine indicate treatment with Abbott Laboratories' ABT-874, a human monoclonal antibody against interleukin-12 (anti-interleukin-12), may induce clinical responses and remissions among patients with active Crohn's disease. In the study, 79 patients were randomly assigned to receive seven weekly subcutaneous 1 mg/kg or 3 mg/kg injections of ABT-874, or placebo with either a four-week interval between the first and second injection (group one) or no interruption between the two injections (group two). Researchers defined the trial's primary endpoint as overall safety. Secondary endpoints included the rates of clinical response (defined by a reduction in the score for the Crohn's Disease Activity Index [CDAI] of at least 100 points) and remission (defined by a CDAI score of 150 or less). Patients administered seven weeks of uninterrupted ABT-874 at 3 mg/kg achieved a higher response rates than those administered placebo (75 percent vs. 25 percent, respectively). However, at week 18, the difference in response rates did not achieve statistical significance (69 percent vs. 25 percent). Differences in remission rates between the cohort administered 3 mg/kg of ABT-874 or placebo in group two did not achieve statistical significance at week seven or 18. No significant differences in response rates were observed among all treatment cohorts in group one. The rates of adverse events among ABT-874 recipients were similar to that seen in placebo recipients except for a higher rate of local injection site reactions in the ABT-874 groups. "The data from this early Phase II study provide some evidence that an antibody targeted to interleukin-12 p40 is active against the inflammation of Crohn's disease as well as show that treatment with this agent may induce clinical response and remission," the researchers noted. ICD THERAPY COST-EFFECTIVE FOR MODERATE HEART FAILURE PATIENTS, ANALYSIS SHOWS ___________________________________________________________________________ Medtronic Inc. said a cost analysis of a trial released earlier this year showed implantable cardioverter-defibrillator (ICD) therapy is a cost-effective means of treating patients with heart failure. The trial included 2,521 patients who had moderate heart failure (New York Heart Association Class II or Class III) with impaired pumping function of the left ventricle. The patients were randomly assigned to receive an ICD (n=829), placebo (n=847) or the arrhythmia drug amiodarone (n=845). All patients also received optimal conventional heart failure treatment, including ACE inhibitors and beta-blockers. During an approximate four-year follow-up period, 666 deaths occurred, including 182 in the ICD group (22 percent of patients), 240 in the amiodarone group (28 percent) and 244 in the placebo group (29 percent). Medtronic said this shows ICD therapy reduced the incidence of death by 23 percent as compared with placebo, while amiodarone did not improve survival. The analysis presented this week showed the cost associated with ICD therapy in order to add one year of life was $33,192. Medtronic said therapies that add a patient-year of life for $50,000 or less are generally considered to be cost-effective. The cost-effectiveness analysis was presented in New Orleans at the American Heart Association's Scientific Sessions 2004. Guidant Corp. and St. Jude Medical Inc. also manufacture defibrillators, which analysts have projected could grow to a $4.4 billion market this year, according to Bloomberg News. CILANSETRON IMPROVES QOL IN PATIENTS WITH IBS, STUDY FINDS ___________________________________________________________________________ Treatment with Solvay Pharmaceuticals Inc.'s investigational therapy cilansetron appears to significantly improve health-related quality of life (HRQOL) among subjects with irritable bowel syndrome-diarrhea predominance (IBS-D), according to data presented at the 69th Annual Meeting of the American College of Gastroenterology. Cilansetron is a novel 5-HT3 receptor antagonist currently under review by the Food and Drug Administration for the treatment of IBS-D for both men and women. In one Phase III study, adults meeting the Rome criteria for IBS-D were randomly assigned to receive either 2 mg of cilansetron three times a day or placebo. At the beginning of the study and again six months later, 338 of the participants completed an IBS QOL survey--a validated 34-item condition-specific, QOL measure that included eight subscales: interference with daily activity, body image, health worry, food avoidance, social reaction, sexual, relationship and dysphoria. At the end of the treatment period, HRQOL scores had improved by 17.7 for cilansetron-treated individuals and 9.6 for those who received placebo; this difference was statistically significant. All of the QOL subscales assessed on the questionnaire demonstrated significant improvements for patients receiving cilansetron, except for the sexual subscale. "[IBS] is a leading cause of worker absenteeism and can have a significant negative impact on an individual's daily activities," said researcher Dr. Kevin Olden of the University of South Alabama in Mobile. "Effective symptom control is critical to improving quality of life for the men and women who struggle with this condition on a daily basis." branding Strategies CURAGEN CORP. ___________________________________________________________________________ CuraGen Corp. received an orphan drug designation from the Food and Drug Administration for CR002, a human monoclonal antibody being examined as a treatment to slow the progression of IgA nephropathy and to delay kidney failure in patients affected by the disease. There is currently no FDA-approved treatment for IgA nephropathy, CuraGen said. The company said it plans to initiate a Phase I study to determine the safety, tolerability and pharmacokinetics of CR002. branding Strategies TENNESSEE ___________________________________________________________________________ Tennessee Gov. Phil Bredesen (D) said he plans to dissolve TennCare, the state's expanded Medicaid system, in favor of a cheaper, more basic Medicaid program, according to The Associated Press. Bredesen said he will negotiate for one more week with advocates who have won court decisions regarding the level of health care the state must provide to TennCare recipients, but an agreement is unlikely to be reached. If TennCare is eliminated, approximately 430,000 state residents will have their health coverage dropped, according to the AP; the remaining 900,000 beneficiaries would continue to receive coverage under basic Medicaid. branding Strategies IVAX CORP. ___________________________________________________________________________ Ivax Corp. said Thursday that it is not in discussions to acquire Israeli generic drug manufacturer Agis Industries Ltd. Earlier this week, the Globes daily reported Agis is negotiating with a large international pharmaceutical firm regarding a possible merger, and said the international firm was likely Ivax. branding Strategies VSM MEDTECH LTD. ___________________________________________________________________________ VSM MedTech Ltd. said it has eliminated 37 jobs at the company, including the position of chief operating officer, which was previously held by David Christie. The firm develops, manufactures and markets medical devices for the diagnosis and treatment of neurological disorders and cardiovascular diseases. branding Strategies
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