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Generating Pharmaceutical Sales before Marketing Authorization
Submitted Tuesday, February 06, 2007 / Views 64 / Comment (0)
When a patient has a serious illness and there is no approved drug available, the physician may want to try one which has not been authorized for marketing by national health authorities but has shown promise in clinical trials. European Named Patient Programs, like US compassionate use programs, offer physicians access to pharmaceuticals which have not yet been licensed. However, there is one important difference: in Europe an unlicensed drug can be reimbursed. This presents drug-makers with an opportunity to generate revenues while development is still in-progress.
Significant Revenues Are Possible
The additional revenues can be considerable. For example, Pharmion, a US based company focusing on Oncology and Hematology reported dramatic increases in its Thalidomide sales from $1.9 million in 2Q '03 to $15.3 million in 2Q '04, primarily due to named patient sales in Europe for Multiple Myeloma. Thalidomide sales accounted for approximately 75% of Pharmion's total revenues for the first half of 2004, according to company sources, and were generated while the product awaits marketing approval for this indication. Before receiving European Marketing Approval, Shire's Argylin® for essential thrombocythaemia generated about 5% of its total sales from its European named patient program.
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Pharmaceuticals: The Next Frontier in America's War on Drugs
Submitted Tuesday, February 06, 2007 / Views 363 / Comment (149)
America's war on drugs, which has been fought in the opium fields of Afghanistan and the cocaine plantations of Columbia, will have to reinvent itself to combat what is set to be America's biggest drug abuse problem, pharmaceuticals. One in five American's, nearly 48 million, have used prescription drugs for non-medical purposes at least once in their lives. The current past month misuse rate among Americans is 6.2 million. According to a recent white paper by Carnevale Associates, this rate of use is already higher than the historical highs of both cocaine and heroin epidemics.
For some, the road to illicit use of prescription medications starts innocently. After a car accident, back injury, or, even, a mental/emotional breakdown a physician prescribes medication for a legitimate use. Over time, tolerance builds up so that more and more of the drug is needed until a state of dependence is reached. At this point, there is no easy way to get off the drug, and stopping can involve painful withdrawal symptoms. Some doctors have been known to become afraid and cut their patients off at this point. Patients have been known to steal prescription pads, or visit numerous doctors to get the drugs they have become addicted to.
more of Pharmaceuticals: The Next Frontier in America's War on Drugs >
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