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Lilly Advances Second Alzheimer's Disease Treatment Candidate Into Late-Stage Testing By Launching Two Global Trials
Eli Lilly and Company (NYSE: LLY) announced it will begin enrolling patients this month in two separate but identical Phase III clinical trials of solanezumab(i), previously referred to as LY2062430, an anti-amyloid beta monoclonal antibody being investigated as a potential treatment to delay the progression of mild to moderate Alzheimer"s disease. The trials, called EXPEDITION and EXPEDITION 2, will each include a treatment period that lasts 18 months and are expected to enroll a total of 2,000 patients age 55 and over from 16 countries.
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Cigarette Packaging Still Misleading Consumers Over Health Hazards
New research suggests that current regulations have failed to remove misleading information from cigarette packaging, revealing that a substantial majority of consumers believe cigarettes are less hazardous when the packs display words such as "silver" or "smooth," lower numbers incorporated into the brand name, lighter colours or pictures of filters.
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Boston Globe Examines Hospital's Attempt To Reduce Emergency Department Visits, Hospital Stays Among Elderly
Efforts by Massachusetts General Hospital to reduce health spending could be indicative of the difficulty the health industry faces in trying to reduce spending growth, the Boston Globe reports. Industry groups last week pledged to seek a 1.5% overall reduction in health care spending over the next 10 years.Massachusetts General"s program, which began in 2006, aims to reduce hospitalizations among the elderly by 15% to 20%, as well as to improve the quality of care the elderly receive. A study looking at 35 efforts to improve elderly care found that only six, including Massachusetts General"s program, saved money or covered their costs, the Globe reports. Massachusetts General"s program relies on nurses in primary care practices to be in regular contact with patients and provide assistance with nonmedical services. The program also uses electronic health records to coordinate care. The hospital spent $8 million to $9 million over the first three years of the program to provide enhanced services to patients. Hospital readmissions fell by 19%, admissions decreased by 17% and ED visits dropped by 15% between 2007 and 2008, according to preliminary research. The program saved enough by reducing hospital admissions and emergency department visits to cover its costs and also to generate savings of $7 million to $10 million. The overall cost for the program was about 5% less than for a group of other patients treated in a more traditional way.According to Harvard University health care economist David Cutler, improving care and reducing costs among the elderly is a necessary component of health reform. He said, "If we can"t do this, it doesn"t bode well for health reform." Eric Weil, a primary care physician and medical director of the program at Massachusetts General, said, "Medicare is looking for any and every way to save money," adding, "This is a population of patients who are sick and will get sicker over time. Any opportunity to demonstrate savings in this group of patients is good, and 5% is very good" (Kowalczyk, Boston Globe, 5/17).
Endocrinology

NICE Issues Positive Final Appraisal Determination Recommending The Use Of Basilea's Toctino

Basilea Pharmaceutica Ltd. (SWISS: BSLN) announces that the National Institute for Health and Clinical Excellence (NICE) issued the Final Appraisal Determination (FAD) recommending the use of Toctino® (alitretinoin) within its licensed indication, as a treatment option for adults with severe chronic hand eczema that has not responded to potent topical corticosteroids. The FAD published today will become the Institute"s final guidance to the National Health Service (NHS) at the end of August, according to NICE"s publication schedule, assuming no appeals are made by the appraisal consultees. "The positive Final Appraisal Determination is an important milestone for Basilea and is confirmation of the value Toctino brings to patients and the healthcare community," said Dr. Anthony Man, Chief Executive Officer, Basilea Pharmaceutica Ltd. "The NICE recommendation should provide patients in England and Wales who suffer from severe chronic hand eczema a real chance to obtain hands cleared of eczema and the possibility to resume normal activities." NICE determined that Toctino®, an innovative therapy shown to be highly effective in phase III trials, is a cost-effective use of NHS res. Toctino® is recommended for patients with severe disease, which is defined by a physician"s global assessment and a dermatology life quality index score of 15 or more. In March of this year the Scottish Medicine"s Consortium determined Toctino® should be made available to patients in Scotland. The FAD can be found on the NICE http://www.nice.org.uk website. Chronic hand eczema - a debilitating skin disease Hand eczema is a common inflammatory skin disease and is often chronic and relapsing. Hand eczema is reported to affect up to ten percent of the general population. The more severe, chronic form of the condition is thought to affect five to seven percent of these patients, causing impaired use of their hands and a considerable impact on their ability to perform everyday activities. Toctino® (alitretinoin) is the only therapy approved for severe chronic hand eczema unresponsive to potent topical corticosteroids Toctino® was developed by Basilea Pharmaceutica International Ltd. To date, Toctino® is launched in Denmark, Germany and the United Kingdom, and has received marketing authorization in Austria, Belgium, Finland, France, Luxemburg, the Netherlands and Spain. In addition, Toctino® has been recommended for approval in Italy and is under regulatory review in Canada, Switzerland and 15 additional European countries. In the largest ever phase III clinical trial program in chronic hand eczema (CHE), Toctino® was the first treatment to show effective clearing of severe CHE, with clear or almost clear hands achieved in nearly 50 percent of patients treated 30 mg Toctino®. The once-daily oral therapy is given for 12 to 24 weeks, depending on patient response, and six-month post-treatment observations in patients who responded to Toctino® indicate that treatment can provide long periods free from relapse. Toctino® is a known teratogen (a substance that can cause birth defects when women are exposed during pregnancy). Strict pregnancy prevention one month before, during, and one month after cessation of treatment as well as monthly pregnancy testing are required for women of childbearing age. A comprehensive pregnancy prevention program for Toctino® has been developed and implemented. In clinical trials, Toctino® was well tolerated and demonstrated a safety profile overall consistent with the retinoid class. Overall, the most frequently reported adverse events in the phase III clinical trials were headache and increased levels of blood lipids. Side effects were dose-dependent. A phase III clinical trial on alitretinoin for the treatment of severe chronic hand eczema is ongoing in the U.S. Basilea Pharmaceutica Ltd


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