FDA, SciClone meet agreement on distribution of melanoma treatment
NEW YORK The Food and Drug Administration has reached an agreement with a drug maker on the design of a phase 3 trial of a skin cancer drug.
SciClone Pharmaceuticals announced Monday that it had reached the agreement with the agency concerning the drug thymalfasin, which it sees as a potential treatment for stage 4 melanoma.
“Patients suffering from stage 4 melanoma have very few treatment options available,” SciClone chief medical officer Israel Rios said in a statement. “Based on the positive data from an earlier phase 2 trial, thymalfasin could provide new treatment modalities for this high unmet medical need.”
The drug, if approved, will be sold under the brand name Zadaxin. The full name of its active ingredient is thymosin alpha 1.
Diabetes costs above $217 billion, national economic study asserts
NEW YORK The total costs of undiagnosed, pre-diabetes and diabetes last year cost the United States an estimated $217.5 billion in higher medical expenditures and lost productivity, researchers reported today.
The research, from a National Diabetes Economic Barometer study sponsored by Novo Nordisk, found big increases in clinical-care costs for the fast-growing disease, which now affects some 20 million Americans. Beyond the estimated $174 billion that is widely accepted as the cost of diagnosed diabetes in 2007, an additional $18 billion was spent on 6.3 million people with undiagnosed diabetes, according to the study. Another $25 billion went for 57 million American adults with pre-diabetes, and $623 million was spent for the 180,000 pregnancies where gestational diabetes was diagnosed.
The National Diabetes Economic Barometer research was conducted by The Lewin Group and commissioned by the National Changing Diabetes Program, an initiative created by Novo Nordisk. Lewin Group vice president Tim Dall said diabetes can trigger rising health costs even before patients are diagnosed with the disease.
“In individuals with pre-diabetes, we observed a significant increase in ambulatory visits for a wide variety of medical conditions, including hypertension, endocrine, metabolic and kidney complications,” Dall said. “Additionally, the data show that during the two years before diagnosis people exhibit an increase in ambulatory and hospital-based care for diabetes-related complications.”
As the leading source of health insurance, covering about 158 million non-elderly people in America, employers are beginning to feel the financial sting. To that end, “We encourage businesses to take action to reduce the devastating economic consequences of this disease by learning about their workforce, engaging their employees, and making purchasing decisions that will encourage better health choices,” said Dana Haza, senior director of the Changing Diabetes program.
“If companies can help their employees learn how to better manage their health, businesses can potentially cut down on their own healthcare spending while improving the quality of life of those who work for them.”
Diabetes is an escalating health crisis in the United States, and the number of Americans with the disease is projected to double by 2025. In 2007, the Changing Diabetes program undertook a multi-phase initiative—the National Diabetes Triple Barometer—designed to evaluate the current state of diabetes in America in three critical indicators: societal, economic and clinical, according to Novo Nordisk. After all three barometers are complete, they will be packaged and serve as a national benchmark and measurement system to create behavior change, drive policy change and catalyze momentum for further strategic system improvements, the company announced.
Covidien reports results for 4Q 2008
HAMILTON, Bermuda The rise in the dollar will likely reduce sales for a manufacturer of drugs, medical supplies and medical devices.
Covidien released fiscal fourth quarter 2008 sales Monday, showing that sales rose to $2.6 billion, a 12 percent increase over the same period last year. The company’s fiscal fourth quarter ended Sept. 26. Net profit increased from $34 million last year to $409 million this year.
Still, the Bermuda-based company expects weaker sales next year.
“Looking at 2009, we remain comfortable with the operational growth targets communicated at our investor day in September,” chairman, president and chief executive Richard Meelia said in a statement. “Although reported results will most likely be negatively impacted by the recent strengthening of the U.S. dollar, we have a strong pipeline of new products, fueled by strategic investments in R&D, that will enhance our growth in the coming year and beyond.”