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Berlex

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Submitted By dweber57
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Case Study: Berlex and Chiron

Berlex and Chiron worked together to develop a drug named Betaseron. Berlex Laboratories was in charge of clinical developments, trials, and all the marketing. Chiron is the manufacturer.
Betaseron is used to help aide and improve the quality of life for people suffering from Multiple Sclerosis or MS. Currently there is not an exact number for people diagnosed with MS but experts say there is around 2.5 million worldwide and 200 diagnosed in America weekly. Betaseron is a self-administered shot taken every other day. The drug has been shown to reduce the frequency and severity of exacerbations in people who have ambulatory Ms with a relapsing remitting form of the disease.
In 1993 Betaseron was approved by the FDA in one year, it usually takes three years to get an approval. This resulted in insufficient supplies. Shortages of the drug were predicted to last until 1996. Chiron, who produced the drug, only did so in small quantities, due to experimental use was unprepared for the great demand. After years of highly risky and expensive research was affecting the cost of the drug. Berlex had no other manufacturer to turn to because getting the approval from the FDA for another facility would be time consuming. Chiron had enough Betaseron for 12,000 to 20,000 patients in 1993 and 40,000 in 1994. Cost, distribution and availability are the biggest concerns for Berlex.
Demand for Betaseron is extremely high, in the U.S. alone, one third out of 300,000 patients have ambulatory MS that relapses and is remitting. The Betaseron has shown to work for those individuals. Due to research, quality control, over paid scientist and doctors the estimated cost for a patient in one year is $10,000.
Since quanties are low distribution should be on a case by case basis. Patients who are determined most severe should be supplied Betaseron. Chiron should keep producing the medicine while opening another laboratory, that way production will not stop.

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